Study of Pembrolizumab (MK-3475) Monotherapy in Advanced... | NCT01840579 | Trialant
NCT01840579
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Jun 22, 2021Actual
Enrollment
57Actual
Phase
Phase 1
Conditions
Solid Tumor
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Interventions
Pembrolizumab 2 mg/kg
Pembrolizumab 10 mg/kg
Pembrolizumab 200 mg
Cisplatin 75 mg/m^2
Pemetrexed 500 mg/m^2
Carboplatin AUC 5 mg/mL/min
Carboplatin AUC 6 mg/mL/min
Paclitaxel 200 mg/m^2
Nab-paclitaxel 100 mg/m^2
Ipilimumab 1 mg/kg
Etoposide 100 mg/m^2
G-CSF (pegfilgrastim) 3.6 mg
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01840579
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-011
Secondary IDs
ID
Type
Description
Link
132249
Registry Identifier
JAPIC-CTI
MK-3475-011
Other Identifier
Merck
KEYNOTE-011
Other Identifier
Merck
Brief Title
Study of Pembrolizumab (MK-3475) Monotherapy in Advanced Solid Tumors and Pembrolizumab Combination Therapy in Advanced Non-small Cell Lung Cancer/ Extensive-disease Small Cell Lung Cancer (MK-3475-011/KEYNOTE-011)
Official Title
A Phase I Study of MK-3475 Alone in Subjects With Advanced Solid Tumors and in Combination With Platinum-Doublet Chemotherapy or Immunotherapy in Subjects With Advanced Non-Small Cell Lung Cancer/Extensive-Disease Small Cell Lung Cancer.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 26, 2013Actual
Primary Completion Date
Feb 28, 2020Actual
Completion Date
Feb 28, 2020Actual
First Submitted Date
Apr 23, 2013
First Submission Date that Met QC Criteria
Apr 23, 2013
First Posted Date
Apr 25, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 23, 2021
Results First Submitted that Met QC Criteria
Feb 23, 2021
Results First Posted Date
Mar 22, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 28, 2021
Last Update Posted Date
Jun 22, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study using pembrolizumab (MK-3475) will be done in 5 parts. In Part A, successive participant cohorts with advanced solid tumors will receive pembrolizumab to assess the safety and tolerability of monotherapy. In Parts B, C, and D, participants with advanced non-small cell lung cancer (NSCLC) will receive pembrolizumab in combination with either cisplatin/pemetrexed or carboplatin/pemetrexed (Part B); with either carboplatin/paclitaxel or carboplatin/nab-paclitaxel (Part C); or with ipilimumab (Part D) by non-random assignment to assess the safety and tolerability of the combination therapy. In Part E, participants with untreated Extensive-disease (ED) Small Cell Lung Cancer (SCLC) will receive pembrolizumab in combination with either cisplatin/etoposide, carboplatin/etoposide, or cisplatin/etoposide with prophylactic use of granulocyte colony-stimulating factor (lasting G-CSF [pegfilgrastim]) by non-random assignment to assess the safety and tolerability of the combination therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumor
Non-small Cell Lung Cancer
Small Cell Lung Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
57Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab 2 mg/kg
Experimental
In Part A, participants receive intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Biological: Pembrolizumab 2 mg/kg
Pembrolizumab 10 mg/kg
Experimental
In Part A, participants receive IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Biological: Pembrolizumab 10 mg/kg
Pembrolizumab+Cisplatin/Pemetrexed
Experimental
In Part B, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Cisplatin 75 mg/m^2
Drug: Pemetrexed 500 mg/m^2
Pembrolizumab+Carboplatin/Pemetrexed
Experimental
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab 2 mg/kg
Biological
Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
Pembrolizumab 2 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug:
Grade (G) 4 neutropenia lasting >7 days
Grade 3 and Grade 4 febrile neutropenia
Grade 4 thrombocytopenia (<25,000/mm^3)
Grade 4 anemia
Grade 4 non-hematologic toxicity (not laboratory)
Grade 3 non-hematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care
Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for >7 days.
(Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
Cycle 1 (first dose and up to 4 weeks in Part A, 3 weeks in Parts B, C, E, and 6 weeks in Part D)
Number of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Up to approximately 51.3 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Cmax was the maximum observed concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Cmax was planned for Parts A, B, C, D, and E.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
In Part A: has a histological or cytological diagnosis of solid tumor, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy
In Part B, C, and D: has a histologically- or cytologically-confirmed diagnosis of NSCLC (Stage IIIB/IV) and are naïve to systemic therapy
In Part C: has a histologically- or cytologically-confirmed diagnosis of squamous cancer
In Part E: has a histologically- or cytologically-confirmed diagnosis of SCLC (ED stage) and are naïve to systemic therapy
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Has adequate organ function
Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents
Exclusion criteria:
Has had cancer therapy within 2 weeks (Part E) or 4 weeks (Parts A, B, C, and D) prior to the first dose of study therapy, or not recovered from the adverse events of agents administered more than 4 weeks prior to the first dose of study therapy.
Part A: Chemotherapy, radiation therapy, biological therapy or kinase inhibitors
Parts B, C, D and E: Radiation therapy
For Part B: has a histological diagnosis of squamous cancer
Is currently participating or has participated in a study with an investigational agent or using an investigational device within 30 days of first dose of study therapy
Is expected to require any other form of antineoplastic therapy while on study
Is on chronic systemic steroid therapy within two weeks prior to the first dose of trial treatment or on any other form of immunosuppressive medication
For Part C: Has pre-existing peripheral neuropathy that is ≥ Grade 2 by Common Terminology Criteria for Adverse Events version 4 criteria
Has interstitial lung disease detected by chest computed tomography (CT), or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. Lymphangitic spread of the NSCLC is not exclusionary.
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
FG001
Part A: Pembrolizumab 10 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Sep 24, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Japan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: Pembrolizumab 200 mg
Drug: Pemetrexed 500 mg/m^2
Drug: Carboplatin AUC 5 mg/mL/min
Pembrolizumab+Carboplatin/Paclitaxel
Experimental
In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Carboplatin AUC 6 mg/mL/min
Drug: Paclitaxel 200 mg/m^2
Pembrolizumab+Carboplatin/Nab-paclitaxel
Experimental
In Part C, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Carboplatin AUC 6 mg/mL/min
Drug: Nab-paclitaxel 100 mg/m^2
Pembrolizumab+Ipilimumab
Experimental
In Part D, participants receive IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Biological: Pembrolizumab 200 mg
Biological: Ipilimumab 1 mg/kg
Pembrolizumab+Cisplatin/Etoposide
Experimental
In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Cisplatin 75 mg/m^2
Drug: Etoposide 100 mg/m^2
Pembrolizumab+Carboplatin/Etoposide
Experimental
In Part E, participants receive IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Carboplatin AUC 5 mg/mL/min
Drug: Etoposide 100 mg/m^2
Pembrolizumab+Cisplatin/Etoposide+G-CSF
Experimental
In Part E, participants receive IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Biological: Pembrolizumab 200 mg
Drug: Cisplatin 75 mg/m^2
Drug: G-CSF (pegfilgrastim) 3.6 mg
KEYTRUDA®
Pembrolizumab 10 mg/kg
Biological
Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
Pembrolizumab 10 mg/kg
KEYTRUDA®
Pembrolizumab 200 mg
Biological
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Carboplatin/Etoposide
Pembrolizumab+Carboplatin/Nab-paclitaxel
Pembrolizumab+Carboplatin/Paclitaxel
Pembrolizumab+Carboplatin/Pemetrexed
Pembrolizumab+Cisplatin/Etoposide
Pembrolizumab+Cisplatin/Etoposide+G-CSF
Pembrolizumab+Cisplatin/Pemetrexed
Pembrolizumab+Ipilimumab
KEYTRUDA®
Cisplatin 75 mg/m^2
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Cisplatin/Etoposide
Pembrolizumab+Cisplatin/Etoposide+G-CSF
Pembrolizumab+Cisplatin/Pemetrexed
Pemetrexed 500 mg/m^2
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Carboplatin/Pemetrexed
Pembrolizumab+Cisplatin/Pemetrexed
Carboplatin AUC 5 mg/mL/min
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Carboplatin/Etoposide
Pembrolizumab+Carboplatin/Pemetrexed
Carboplatin AUC 6 mg/mL/min
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Carboplatin/Nab-paclitaxel
Pembrolizumab+Carboplatin/Paclitaxel
Paclitaxel 200 mg/m^2
Drug
Administered as an IV infusion on Day 1 of each 21-day cycle
Pembrolizumab+Carboplatin/Paclitaxel
Nab-paclitaxel 100 mg/m^2
Drug
Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle
Pembrolizumab+Carboplatin/Nab-paclitaxel
ABRAXANE®
Ipilimumab 1 mg/kg
Biological
Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days)
Pembrolizumab+Ipilimumab
YERVOY®
Etoposide 100 mg/m^2
Drug
Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle
Pembrolizumab+Carboplatin/Etoposide
Pembrolizumab+Cisplatin/Etoposide
TOPOSAR®, VEPESID®, ETOPOPHOS®, EPOSIN®
G-CSF (pegfilgrastim) 3.6 mg
Drug
Administered as a subcutaneous injection on Day 4 of Cycle 1
Pembrolizumab+Cisplatin/Etoposide+G-CSF
Neulasta®
Up to approximately 37.9 months
At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 2: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 2 at pre-dose and 0-30 minutes post-dose. Cycle 2 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 2 was only planned for Part A.
Cycle 2 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 4: Parts A and D
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 4 at pre-dose and 0-30 minutes post-dose and for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle 4 length for Part A was 14 days. Cycle 4 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 4 was only planned for Parts A and D.
Cycle 4 Day 1 pre- and post-dose (Part A) and Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dose (Part D)
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 6: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 6 at pre-dose and 0-30 minutes post-dose. Cycle 6 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 6 was only planned for Part A.
Cycle 6 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 8: Parts A, B, C, and E
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Parts A, B, C and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 length for Part A was 14 days. Cycle 8 length for Parts B, C, and E was 21 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 8 was only planned for Parts A, B, C, and E.
Cycle 8 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 10: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 10 at pre-dose and 0-30 minutes post-dose. Cycle 10 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 10 was only planned for Part A.
Cycle 10 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 12: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 12 at pre-dose and 0-30 minutes post-dose. Cycle 12 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 12 was only planned for Part A.
Cycle 12 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 14: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 14 at pre-dose and 0-30 minutes post-dose. Cycle 14 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 14 was only planned for Part A.
Cycle 14 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 16: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 16 at pre-dose and 0-30 minutes post-dose. Cycle 16 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 16 was only planned for Part A.
Cycle 16 Day 1 pre- and post-dose
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 18: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose and 0-30 minutes post-dose. Cycle 18 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 18 was only planned for Part A.
Cycle 18 Day 1 pre- and post-dose
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 1 was planned for Parts A, B, C, D, and E.
At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 4: Part D
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 4 was only planned for Part D.
Cycle 4 Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dose
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 8: Parts B, C, and E
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 for Parts B, C, and E was 21 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 8was planned for Parts B, C, and E.
Cycle 8 Day 1 pre- and post-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 1 Ctrough was taken for Parts A, B, C, D, and E on Day 1 of Cycle 2 at pre-dose (prior to Cycle 2 infusion). Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 1 Ctrough was planned for Parts A, B, C, D, and E.
Cycle 2 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 2: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 2 Ctrough was taken for Part D on Day 22 of Cycle 2 at pre-dose (prior to Cycle 3 infusion). Cycle 2 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 2 Ctrough was only planned for Part D.
Cycle 2 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Part D on Day 22 of Cycle 3 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
Cycle 3 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 4 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part A was 14 days. Cycle 3 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
Cycle 4 Day 1 at Pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 4: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 4 Ctrough was taken for Part D on Day 22 of Cycle 4 at pre-dose (prior to Cycle 5 infusion). Cycle 4 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 4 Ctrough was only planned for Part D.
Cycle 4 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 5: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 5 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 6 at pre-dose (prior to Cycle 6 infusion). Cycle 5 length for Part A was 14 days. Cycle 5 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 5 Ctrough was only planned for Parts A, B, C, and E.
Cycle 6 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 6: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 6 Ctrough was taken for Part D on Day 22 of Cycle 6 at pre-dose (prior to Cycle 7 infusion). Cycle 6 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 6 Ctrough was only planned for Part D.
Cycle 6 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 7: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 7 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 8 at pre-dose (prior to Cycle 8 infusion). Cycle 7 length for Part A was 14 days. Cycle 7 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 7 Ctrough was only planned for Parts A, B, C, and E.
Cycle 8 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 8: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 8 Ctrough was taken for Part D on Day 22 of Cycle 8 at pre-dose (prior to Cycle 9 infusion). Cycle 8 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 8 Ctrough was only planned for Part D.
Cycle 8 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 9: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 9 Ctrough was taken for Part A on Day 1 of Cycle 10 at pre-dose (prior to Cycle 10 infusion). Cycle 9 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 9 Ctrough was only planned for Part A.
Cycle 10 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 10: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 10 Ctrough was taken for Part D on Day 22 of Cycle 10 at pre-dose (prior to Cycle 11 infusion). Cycle 10 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 10 Ctrough was only planned for Part D.
Cycle 10 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 11: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 11 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 12 at pre-dose (prior to Cycle 12 infusion). Cycle 11 length for Part A was 14 days. Cycle 11 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 11 Ctrough was only planned for Parts A, B, C, and E.
Cycle 12 Day 1 Pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 12: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 12 Ctrough was taken for Part D on Day 22 of Cycle 12 at pre-dose (prior to Cycle 13 infusion). Cycle 12 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 12 Ctrough was only planned for Part D.
Cycle 12 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 13: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 13 Ctrough was taken for Part A on Day 1 of Cycle 14 at pre-dose (prior to Cycle 14 infusion). Cycle 13 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 13 Ctrough was only planned for Part A.
Cycle 14 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 14: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 14 Ctrough was taken for Part D on Day 22 of Cycle 14 at pre-dose (prior to Cycle 15 infusion). Cycle 14 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 14 Ctrough was only planned for Part D.
Cycle 14 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 15: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts A, B, C, and E on Day 1 of Cycle 16 at pre-dose (prior to Cycle 16 infusion). Cycle 15 length for Part A was 14 days. Cycle 15 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 15 Ctrough was only planned for Parts A, B, C, and E.
Cycle 16 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 16: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 16 Ctrough was taken for Part D on Day 22 of Cycle 16 at pre-dose (prior to Cycle 17 infusion). Cycle 16 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 16 Ctrough was only planned for Part D.
Cycle 16 Day 22 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 17: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose (prior to Cycle 18 infusion). Cycle 17 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 17 Ctrough was planned for Part A.
Cycle 18 Day 1 pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 19: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 20 at pre-dose (prior to Cycle 20 infusion). Cycle 19 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 19 Ctrough was only planned for Parts B, C, and E.
Cycle 20 Day 1 Pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 23: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 24 at pre-dose (prior to Cycle 24 infusion). Cycle 23 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 23 Ctrough was only planned for Parts B, C, and E.
Cycle 24 Day 1 Pre-dose
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 27: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 28 at pre-dose (prior to Cycle 28 infusion). Cycle 27 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 27 Ctrough was only planned for Parts B, C, and E.
Cycle 28 Day 1 Pre-dose
Area Under the Concentration Time Curve From 0-28 Days (AUC 0-28) for Part A Cycle 1
AUC 0-28 was the AUC of pembrolizumab from time zero to 28 days after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-28 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-28 was only planned for Part A Cycle 1.
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
Area Under the Concentration Time Curve From 0-Infinity (AUC 0-inf) for Part A Cycle 1
AUC 0-inf was the AUC of pembrolizumab from time zero to infinity after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-inf is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-inf was only planned for Part A Cycle 1.
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
Terminal Half-Life (t1/2) of Pembrolizumab Over Time for Part A Cycle 1
t1/2 was the time required to divide the pembrolizumab concentration by two after reaching pseudo-equilibrium. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and pre-dose Day 1 of the following cycle prior to pembrolizumab infusion. Cycle 1 length A was 28 days. t1/2 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for t1/2 was only planned for Part A Cycle 1.
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
Volume of Distribution (Vz) of Pembrolizumab Over Time for Part A Cycle 1
Vz was the volume of distribution during the terminal phase. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. Vz is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Vz was only planned for Part A Cycle 1.
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
Clearance (CL) of Pembrolizumab Over Time for Part A Cycle 1
CL was the volume of plasma from which pembrolizumab was eliminated per unit time. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. CL is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for CL was only planned for Part A Cycle 1.
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
Derived
Nogami N, Umemura S, Kozuki T, Zenke Y, Ohtani J, Ishii M, Han S, Noguchi K, Horinouchi H. A phase 1 study of pembrolizumab plus ipilimumab as first-line treatment in Japanese patients with advanced non-small-cell lung cancer. Respir Investig. 2025 May;63(3):296-302. doi: 10.1016/j.resinv.2025.02.010. Epub 2025 Mar 3.
Nogami N, Tokito T, Zenke Y, Satouchi M, Seto T, Saka H, Ohtani J, Han S, Noguchi K, Nishio M. Phase 1 study of pembrolizumab plus chemotherapy in Japanese patients with extensive-stage small-cell lung cancer. Invest New Drugs. 2024 Feb;42(1):136-144. doi: 10.1007/s10637-023-01411-1. Epub 2024 Feb 1.
Kurata T, Nakagawa K, Satouchi M, Seto T, Sawada T, Han S, Homma M, Noguchi K, Nogami N. Phase 1 study of pembrolizumab plus chemotherapy as first-line treatment in Japanese patients with advanced NSCLC. Cancer Treat Res Commun. 2021;29:100458. doi: 10.1016/j.ctarc.2021.100458. Epub 2021 Sep 15.
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
FG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
FG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
FG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
FG005
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
FG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
FG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
FG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
FG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
FG0003 subjects
FG0017 subjects
FG0026 subjects
FG0036 subjects
FG0048 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
FG0093 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0033 subjects
FG0044 subjects
FG0052 subjects
FG0064 subjects
FG0073 subjects
FG0083 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0022 subjects
FG0033 subjects
FG0044 subjects
FG0054 subjects
FG0062 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
Type
Comment
Reasons
Status not recorded
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG0044 subjects
FG0053 subjects
FG0060 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
Progressive disease
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing in study
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Follow-up ended by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
BG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
BG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
BG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
BG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
BG005
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
BG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
BG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
BG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
BG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0017
BG0026
BG0036
BG0048
BG0056
BG0066
BG0076
BG0086
BG0093
BG01057
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00061.3± 6.4
BG00164.3± 13.6
BG00257.3± 15.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
An ECOG Performance Status of 0 (fully active, able to carry on all pre-disease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature) was required for inclusion in the study. Participants were categorized by ECOG score.
Count of Participants
Participants
Title
Denominators
Categories
ECOG = 0
Title
Measurements
BG0002
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
The following toxicities graded per the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were considered DLTs if judged by the investigator to be related to either study drug:
Grade (G) 4 neutropenia lasting >7 days
Grade 3 and Grade 4 febrile neutropenia
Grade 4 thrombocytopenia (<25,000/mm^3)
Grade 4 anemia
Grade 4 non-hematologic toxicity (not laboratory)
Grade 3 non-hematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care
Any Grade 3 non-hematologic laboratory value if medical intervention is required to treat the participant or the abnormality persists for >7 days.
(Part D only) Missing the second dose of pembrolizumab (Cycle1 Day 22) due to drug-related adverse event
The DLT analysis set included all participants who received at least at least 90% of the prescribed dose of pembrolizumab and the combination regimen and were evaluable for DLTs in the DLT evaluation period.
Posted
Count of Participants
Participants
Cycle 1 (first dose and up to 4 weeks in Part A, 3 weeks in Parts B, C, E, and 6 weeks in Part D)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Number of Participants Who Experienced at Least One Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
The analysis population consisted of all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 51.3 months
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Primary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
The analysis population consisted of all participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 37.9 months
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Cmax was the maximum observed concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Cmax was planned for Parts A, B, C, D, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Parts A, B, C, D, and E Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 2: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 2 at pre-dose and 0-30 minutes post-dose. Cycle 2 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 2 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 2 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Counts
Participants
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 4: Parts A and D
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 4 at pre-dose and 0-30 minutes post-dose and for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle 4 length for Part A was 14 days. Cycle 4 length for Part D was 42 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 4 was only planned for Parts A and D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Cycle 4 Parts A and D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 4 Day 1 pre- and post-dose (Part A) and Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dose (Part D)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 6: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 6 at pre-dose and 0-30 minutes post-dose. Cycle 6 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 6 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 6.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 6 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Counts
Participants
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 8: Parts A, B, C, and E
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Parts A, B, C and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 length for Part A was 14 days. Cycle 8 length for Parts B, C, and E was 21 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 8 was only planned for Parts A, B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Parts A, B, C, and E Cycle 8. There were no participants that contributed data for the analysis of Cmax for the Pembrolizumab+Cisplatin/Etoposide+G-CSF arm in Part E of Cycle 8.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 8 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 10: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 10 at pre-dose and 0-30 minutes post-dose. Cycle 10 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 10 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 10.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 10 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Counts
Participants
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 12: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 12 at pre-dose and 0-30 minutes post-dose. Cycle 12 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 12 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 12. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 12.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 12 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 14: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 14 at pre-dose and 0-30 minutes post-dose. Cycle 14 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 14 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 14. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 14.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 14 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 16: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 16 at pre-dose and 0-30 minutes post-dose. Cycle 16 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 16 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 16. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 16.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 16 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Secondary
Maximum Serum Concentration (Cmax) of Pembrolizumab for Cycle 18: Part A
Cmax was the maximum observed concentration of pembrolizumab in serum. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose and 0-30 minutes post-dose. Cycle 18 length for Part A was 14 days. Cmax is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cmax in Cycle 18 was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cmax in Part A Cycle 18. There were no participants that contributed data for the analysis of Cmax for the 2 mg/kg arm in Part A of Cycle 18.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 18 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Secondary
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. For Part A, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), 6 hour (hr) (±30 min), and 24hr; Days 2, 3, 8, 15, and 22 (±2 hr for Day 2 to Day 22) after completion of infusion. For Parts B, C, and E, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), and Day 15 (±24 hr) after completion of infusion. For Part D, samples were collected on Day 1 at pre-dose, post-dose (to +30 min), and 24hr; Day 5 (96hr was preferred, 72hr or 120hr were also acceptable, ±2 hr), Day 15, and Day 22 (±24 hr) after completion of infusion. Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 1 was planned for Parts A, B, C, D, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Tmax in Parts A, B, C, D, and E Cycle 1.
Posted
Median
Full Range
days
At designated timepoints in Cycle 1 for Parts A, B, C, D, and E (up to approximately 22 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Secondary
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 4: Part D
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Part D on Day 22 of Cycle 4 at pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and 0-30 minutes post-dose. Cycle length for Part D was 42 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 4 was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for Tmax in the Cycle 4 analysis of Part D.
Posted
Median
Full Range
days
Cycle 4 Day 22 pre-dose (Day 1 of the following cycle prior to pembrolizumab infusion) and post-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Time to Maximum Serum Concentration (Tmax) of Pembrolizumab for Cycle 8: Parts B, C, and E
Tmax was the time required to reach the maximum concentration of pembrolizumab in serum. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 8 at pre-dose and 0-30 minutes post-dose. Cycle 8 for Parts B, C, and E was 21 days. Tmax is reported as median and full range. Per protocol, analysis for Tmax in Cycle 8was planned for Parts B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Tmax in Parts B, C, and E Cycle 8. There were no participants that contributed data available for the analysis of Tmax for the Pembrolizumab+Cisplatin/Etoposide+G-CSF arm in Part E of Cycle 8.
Posted
Median
Full Range
days
Cycle 8 Day 1 pre- and post-dose
ID
Title
Description
OG000
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG001
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 1: Parts A, B, C, D, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 1 Ctrough was taken for Parts A, B, C, D, and E on Day 1 of Cycle 2 at pre-dose (prior to Cycle 2 infusion). Cycle 1 length for Part A was 28 days. Cycle 1 length for Parts B, C, and E was 21 days. Cycle 1 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 1 Ctrough was planned for Parts A, B, C, D, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 1 Ctrough in Parts A, B, C, D, and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 2 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 2: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 2 Ctrough was taken for Part D on Day 22 of Cycle 2 at pre-dose (prior to Cycle 3 infusion). Cycle 2 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 2 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 2 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 2 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Part D on Day 22 of Cycle 3 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 3 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 3 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 3: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 3 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 4 at pre-dose (prior to Cycle 4 infusion). Cycle 3 length for Part A was 14 days. Cycle 3 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV).
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 3 Ctrough in Parts A, B, C, and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 4 Day 1 at Pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 4: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 4 Ctrough was taken for Part D on Day 22 of Cycle 4 at pre-dose (prior to Cycle 5 infusion). Cycle 4 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 4 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 4 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 4 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 5: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 5 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 6 at pre-dose (prior to Cycle 6 infusion). Cycle 5 length for Part A was 14 days. Cycle 5 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 5 Ctrough was only planned for Parts A, B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 5 Ctrough in Parts A, B, C, and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 6 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 6: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 6 Ctrough was taken for Part D on Day 22 of Cycle 6 at pre-dose (prior to Cycle 7 infusion). Cycle 6 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 6 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 6 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 6 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 7: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 7 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 8 at pre-dose (prior to Cycle 8 infusion). Cycle 7 length for Part A was 14 days. Cycle 7 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 7 Ctrough was only planned for Parts A, B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 7 Ctrough in Parts A, B, C, and E.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 8 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 8: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 8 Ctrough was taken for Part D on Day 22 of Cycle 8 at pre-dose (prior to Cycle 9 infusion). Cycle 8 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 8 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 8 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 8 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 9: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 9 Ctrough was taken for Part A on Day 1 of Cycle 10 at pre-dose (prior to Cycle 10 infusion). Cycle 9 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 9 Ctrough was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 9 Ctrough in Part A.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 10 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Counts
Participants
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 10: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 10 Ctrough was taken for Part D on Day 22 of Cycle 10 at pre-dose (prior to Cycle 11 infusion). Cycle 10 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 10 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 10 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 10 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 11: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 11 Ctrough was taken for Parts A, B, C, and E on Day 1 of Cycle 12 at pre-dose (prior to Cycle 12 infusion). Cycle 11 length for Part A was 14 days. Cycle 11 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 11 Ctrough was only planned for Parts A, B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 11 Ctrough in Parts A, B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm and Part E Pembrolizumab+Carboplatin/Etoposide and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 12 Day 1 Pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 12: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 12 Ctrough was taken for Part D on Day 22 of Cycle 12 at pre-dose (prior to Cycle 13 infusion). Cycle 12 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 12 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 12 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 12 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 13: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 13 Ctrough was taken for Part A on Day 1 of Cycle 14 at pre-dose (prior to Cycle 14 infusion). Cycle 13 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 13 Ctrough was only planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 13 Ctrough in Part A. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 14 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 14: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 14 Ctrough was taken for Part D on Day 22 of Cycle 14 at pre-dose (prior to Cycle 15 infusion). Cycle 14 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 14 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 14 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 14 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 15: Parts A, B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts A, B, C, and E on Day 1 of Cycle 16 at pre-dose (prior to Cycle 16 infusion). Cycle 15 length for Part A was 14 days. Cycle 15 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 15 Ctrough was only planned for Parts A, B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 15 Ctrough in Parts A, B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm; Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Carboplatin/Etoposide and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 16 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 16: Part D
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling for Cycle 16 Ctrough was taken for Part D on Day 22 of Cycle 16 at pre-dose (prior to Cycle 17 infusion). Cycle 16 length for Part D was 42 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 16 Ctrough was only planned for Part D.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 16 Ctrough in Part D.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 16 Day 22 pre-dose
ID
Title
Description
OG000
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG000
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 17: Part A
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Part A on Day 1 of Cycle 18 at pre-dose (prior to Cycle 18 infusion). Cycle 17 length for Part A was 14 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 17 Ctrough was planned for Part A.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 17 Ctrough in Part A. There were no participants that contributed data for the analysis of Ctrough for the Part A 2 mg/kg arm.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 18 Day 1 pre-dose
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Units
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 19: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 20 at pre-dose (prior to Cycle 20 infusion). Cycle 19 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 19 Ctrough was only planned for Parts B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 19 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 20 Day 1 Pre-dose
ID
Title
Description
OG000
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG001
Part B: Pembrolizumab+Carboplatin/Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 23: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 24 at pre-dose (prior to Cycle 24 infusion). Cycle 23 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 23 Ctrough was only planned for Parts B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 23 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 24 Day 1 Pre-dose
ID
Title
Description
OG000
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG001
Part B: Pembrolizumab+Carboplatin/Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab for Cycle 27: Parts B, C, and E
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose. Blood sampling was taken for Parts B, C, and E on Day 1 of Cycle 28 at pre-dose (prior to Cycle 28 infusion). Cycle 27 length for Parts B, C, and E was 21 days. Ctrough is reported as geometric mean with a percent coefficient of variation (%CV). Per protocol, analysis for Cycle 27 Ctrough was only planned for Parts B, C, and E.
The analysis population consisted of all participants who received pembrolizumab and contributed blood samples for analysis of Cycle 27 Ctrough in Parts B, C, and E. There were no participants that contributed data for the analysis of Ctrough for the Part C Pembrolizumab+Carboplatin/Paclitaxel and Pembrolizumab+Carboplatin/Nab-paclitaxel arms; and Part E Pembrolizumab+Cisplatin/Etoposide, Pembrolizumab+Carboplatin/Etoposide, and Pembrolizumab+Cisplatin/Etoposide+G-CSF arms.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 28 Day 1 Pre-dose
ID
Title
Description
OG000
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG001
Part B: Pembrolizumab+Carboplatin/Pemetrexed
Secondary
Area Under the Concentration Time Curve From 0-28 Days (AUC 0-28) for Part A Cycle 1
AUC 0-28 was the AUC of pembrolizumab from time zero to 28 days after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-28 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-28 was only planned for Part A Cycle 1.
The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for AUC 0-28 in Part A Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•day/mL
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Area Under the Concentration Time Curve From 0-Infinity (AUC 0-inf) for Part A Cycle 1
AUC 0-inf was the AUC of pembrolizumab from time zero to infinity after dosing. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 pre-dose. Cycle 1 length was 28 days. AUC 0-inf is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for AUC 0-inf was only planned for Part A Cycle 1.
The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for AUC 0-inf in Part A Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg•day/mL
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Terminal Half-Life (t1/2) of Pembrolizumab Over Time for Part A Cycle 1
t1/2 was the time required to divide the pembrolizumab concentration by two after reaching pseudo-equilibrium. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and pre-dose Day 1 of the following cycle prior to pembrolizumab infusion. Cycle 1 length A was 28 days. t1/2 is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for t1/2 was only planned for Part A Cycle 1.
The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for t1/2 in Part A Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
days
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Volume of Distribution (Vz) of Pembrolizumab Over Time for Part A Cycle 1
Vz was the volume of distribution during the terminal phase. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. Vz is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for Vz was only planned for Part A Cycle 1.
The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for Vz in Part A Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/kg
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Secondary
Clearance (CL) of Pembrolizumab Over Time for Part A Cycle 1
CL was the volume of plasma from which pembrolizumab was eliminated per unit time. Blood sampling was taken at the following timepoints: Part A Cycle 1 Day 1 at pre-dose, 0-30 minutes post-dose, and at 6, 24, 48, 168, 336, 504 hours after completion of pembrolizumab infusion and Day 1 of Cycle 2 prior to pembrolizumab infusion. Cycle 1 length A was 28 days. CL is reported as geometric mean with a percent coefficient of variation. Per protocol, analysis for CL was only planned for Part A Cycle 1.
The analysis population consisted of all participants who received pembrolizumab and had blood samples assessed for CL in Part A Cycle 1.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/day/kg
At designated timepoints in Cycle 1 for Part A (Up to approximately 28 days)
ID
Title
Description
OG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
Time Frame
Up to approximately 51.3 months
Description
Serious and Non-serious AEs presented for participants who received ≥1 dose of study drug. Per protocol, MedDRA preferred terms "Neoplasm progression (NP)", "Malignant NP" & "Disease progression" not related to study treatment are excluded as AEs. Data for all-cause mortality presented for randomized participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Pembrolizumab 2 mg/kg
In Part A, participants received intravenous (IV) Pembrolizumab 2 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
0
3
0
3
3
3
EG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
0
7
1
7
7
7
EG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
5
6
2
6
6
6
EG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
5
6
5
6
6
6
EG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
5
8
3
8
8
8
EG005
Part C: Pembrolizumab+Carboplatin/Nabpaclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
3
6
3
6
6
6
EG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
4
6
1
6
5
6
EG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
5
6
3
6
6
6
EG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
5
6
2
6
6
6
EG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
2
3
0
3
3
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0071 events1 affected6 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected3 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Laryngeal stenosis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0025 events4 affected6 at risk
EG0037 events4 affected6 at risk
EG0043 events3 affected8 at risk
EG00510 events6 affected6 at risk
EG0061 events1 affected6 at risk
EG0073 events2 affected6 at risk
EG0086 events6 affected6 at risk
EG0092 events2 affected3 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG00210 events4 affected6 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG00211 events5 affected6 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected7 at risk
EG0026 events2 affected6 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Uveitis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0029 events4 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0014 events1 affected7 at risk
EG00220 events6 affected6 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Chest pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Extravasation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Face oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0013 events3 affected7 at risk
EG0026 events1 affected6 at risk
EG003
Feeling hot
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Gait disturbance
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Injection site pain
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Malaise
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0024 events4 affected6 at risk
EG003
Oedema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Oedema peripheral
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0015 events3 affected7 at risk
EG0024 events2 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Clostridial infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0023 events1 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Parotitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Wound infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Breast injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Gastrointestinal injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Wound complication
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0023 events3 affected6 at risk
EG003
Amylase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Platelet count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
QRS axis abnormal
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Weight decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Weight increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events3 affected7 at risk
EG00214 events6 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0014 events3 affected7 at risk
EG0022 events2 affected6 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0023 events3 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0024 events2 affected6 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0025 events4 affected6 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Laryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Organising pneumonia
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected6 at risk
EG003
Palmoplantar pustulosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected7 at risk
EG0023 events3 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Embolism
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hot flush
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
6
OG0046
OG0056
OG0066
OG0076
OG0086
OG0093
0
OG0042
OG0050
OG0060
OG0073
OG0080
OG0090
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0036
OG0048
OG0056
OG0066
OG0076
OG0086
OG0093
Title
Denominators
Categories
Title
Measurements
OG0003
OG0017
OG0026
OG0036
OG0048
OG0056
OG0065
OG0076
OG0086
OG0093
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0036
OG0048
OG0056
OG0066
OG0076
OG0086
OG0093
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0035
OG0044
OG0053
OG0062
OG0071
OG0081
OG0090
OG001
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0036
OG0048
OG0056
OG0066
OG0076
OG0086
OG0093
Title
Denominators
Categories
Title
Measurements
OG00047.4± 19
OG001250± 23
OG00252.51± 24.44
OG00347.46± 17.04
OG00456.39± 18.88
OG00553.79± 14.18
OG00672.71± 10.12
OG00774.33± 14.04
OG00884.55± 7.38
OG00988.65± 19.14
OG0003
OG0016
Title
Denominators
Categories
Title
Measurements
OG00082.7± 12
OG001322± 36
OG002
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
Units
Counts
Participants
OG0002
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00093.0± 44
OG001367± 35
OG00286.21± 3.59
OG0002
OG0012
Title
Denominators
Categories
Title
Measurements
OG000115± 15
OG001286± 19
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG0033
OG0041
OG0052
OG0061
OG0073
OG0080
Title
Denominators
Categories
Title
Measurements
OG000115± 15
OG001298± NA%CV was not planned to be calculated for ≤2 participants.
OG002124.47± NA%CV was not planned to be calculated for ≤2 participants.
OG00395.51± 17.38
OG004122.00± NA%CV was not planned to be calculated for ≤2 participants.
OG00566.62± NA%CV was not planned to be calculated for ≤2 participants.
OG006150.00± NA%CV was not planned to be calculated for ≤2 participants.
OG007131.78± 9.46
OG0001
OG0011
Title
Denominators
Categories
Title
Measurements
OG000133± NA%CV was not planned to be calculated for ≤2 participants.
OG001266± NA%CV was not planned to be calculated for ≤2 participants.
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001357± NA%CV was not planned to be calculated for ≤2 participants.
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001335± NA%CV was not planned to be calculated for ≤2 participants.
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001348± NA%CV was not planned to be calculated for ≤2 participants.
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001329± NA%CV was not planned to be calculated for ≤2 participants.
Part A: Pembrolizumab 10 mg/kg
In Part A, participants received IV Pembrolizumab 10 mg/kg on Day 1 of Cycle 1 (28 days), Cycle 2 and any additional cycles (14 days).
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0017
OG0026
OG0036
OG0048
OG0056
OG0066
OG0076
OG0086
OG0093
Title
Denominators
Categories
Title
Measurements
OG0000.223(0.00208 to 0.233)
OG0010.00903(0.000694 to 0.232)
OG0021.98(0.94 to 4.94)
OG0032.52(0.033 to 13.91)
OG0040.028(0.025 to 1.08)
OG0050.027(0.022 to 1.02)
OG0060.026(0.024 to 0.029)
OG0070.026(0.026 to 0.029)
OG0080.028(0.023 to 0.041)
OG0090.031(0.025 to 0.033)
3
Title
Denominators
Categories
Title
Measurements
OG0000.026(0.025 to 0.030)
OG002
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG003
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG004
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0002
OG0013
OG0021
OG0032
OG0041
OG0053
OG0060
Title
Denominators
Categories
Title
Measurements
OG0000.024(0.022 to 0.025)
OG0010.026(0.025 to 0.026)
OG0020.028(0.028 to 0.028)
OG0030.027(0.024 to 0.029)
OG0040.029(0.029 to 0.029)
OG0050.026(0.023 to 0.031)
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part D: Pembrolizumab+Ipilimumab
In Part D, participants received IV Pembrolizumab 200 mg on Day 1 of each 21-day cycle + IV Ipilimumab 1 mg/kg on Day 1 of every other 21-day cycle (every 42 days) for a maximum of 18 cycles of Ipilimumab (35 doses of Pembrolizumab).
OG007
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG009
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0003
OG0016
OG0026
OG0036
OG0046
OG0056
OG0063
OG0075
OG0086
OG0093
Title
Denominators
Categories
Title
Measurements
OG00011.2± 51
OG00147.9± 50
OG00219.88± 46.61
OG00315.79± 33.24
OG0049.45± 31.31
OG00510.96± 17.19
OG0068.26± 16.20
OG00714.57± 10.56
OG00815.30± 19.82
OG00917.88± 9.58
5
Title
Denominators
Categories
Title
Measurements
OG00020.10± 24.59
4
Title
Denominators
Categories
Title
Measurements
OG00030.30± 19.38
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0002
OG0014
OG0025
OG0034
OG0043
OG0054
OG0064
OG0075
OG0083
Title
Denominators
Categories
Title
Measurements
OG00037.2± 13
OG00183.0± 265
OG00232.71± 30.35
OG00325.38± 22.12
OG00424.80± 9.28
OG00523.63± 4.79
OG00632.20± 21.52
OG00730.43± 25.67
OG00834.31± 22.05
4
Title
Denominators
Categories
Title
Measurements
OG00028.08± 23.62
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0002
OG0013
OG0024
OG0034
OG0043
OG0054
OG0063
OG0074
OG0082
Title
Denominators
Categories
Title
Measurements
OG00046.5± 12
OG00138.3± 1640
OG00237.70± 7.95
OG00323.84± 69.26
OG00435.33± 16.60
OG00533.91± 14.66
OG00647.82± 14.28
OG00738.63± 25.56
OG00846.47± NA%CV was not planned to be calculated for ≤2 participants.
1
Title
Denominators
Categories
Title
Measurements
OG00040.10± NA%CV was not planned to be calculated for ≤2 participants
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0002
OG0011
OG0022
OG0033
OG0041
OG0054
OG0061
OG0073
OG0081
Title
Denominators
Categories
Title
Measurements
OG00054.9± 13
OG001134± NA%CV was not planned to be calculated for ≤2 participants
OG00239.33± NA%CV was not planned to be calculated for ≤2 participants
OG00337.44± 8.87
OG00442.70± NA%CV was not planned to be calculated for ≤2 participants
OG00532.44± 29.15
OG00654.0± NA%CV was not planned to be calculated for ≤2 participants
OG00748.92± 15.61
OG00843.10± NA%CV was not planned to be calculated for ≤2 participants
1
Title
Denominators
Categories
Title
Measurements
OG00035.20± NA%CV was not planned to be calculated for ≤2 participants
OG0001
OG0011
Title
Denominators
Categories
Title
Measurements
OG00068.4± NA%CV was not planned to be calculated for ≤2 participants.
OG001125± NA%CV was not planned to be calculated for ≤2 participants.
1
Title
Denominators
Categories
Title
Measurements
OG00036.30± NA%CV was not planned to be calculated for ≤2 participants
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0033
OG0041
OG0051
OG0061
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG001159± NA%CV was not planned to be calculated for ≤2 participants.
OG00239.30± NA%CV was not planned to be calculated for ≤2 participants.
OG00345.00± 6.84
OG00432.60± NA%CV was not planned to be calculated for ≤2 participants.
OG00557.80± NA%CV was not planned to be calculated for ≤2 participants.
OG00652.20± NA%CV was not planned to be calculated for ≤2 participants.
1
Title
Denominators
Categories
Title
Measurements
OG00030.90± NA%CV was not planned to be calculated for ≤2 participants
Units
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001147± NA%CV was not planned to be calculated for ≤2 participants.
1
Title
Denominators
Categories
Title
Measurements
OG00028.40± NA%CV was not planned to be calculated for ≤2 participants
OG002
Part B: Pembrolizumab+Cisplatin/Pemetrexed
In Part B, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG003
Part B: Pembrolizumab+Carboplatin/Pemetrexed
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG004
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG007
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG008
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0000
OG0011
OG0021
OG0032
OG0040
OG0050
OG0061
OG0070
OG0080
Title
Denominators
Categories
Title
Measurements
OG001199± NA%CV was not planned to be calculated for ≤2 participants.
OG00247.50± NA%CV was not planned to be calculated for ≤2 participants.
OG00356.27± NA%CV was not planned to be calculated for ≤2 participants.
OG00652.50± NA%CV was not planned to be calculated for ≤2 participants.
1
Title
Denominators
Categories
Title
Measurements
OG00030.70± NA%CV was not planned to be calculated for ≤2 participants
Counts
Participants
OG0000
OG0011
Title
Denominators
Categories
Title
Measurements
OG001125± NA%CV cannot be calculated for 1 participant.
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG002
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG003
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG004
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00048.50± NA%CV was not planned to be calculated for ≤2 participants.
OG00150.98± NA%CV was not planned to be calculated for ≤2 participants.
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG002
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG003
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG004
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00042.40± NA%CV was not planned to be calculated for ≤2 participants.
OG00151.72± NA%CV was not planned to be calculated for ≤2 participants.
In Part B, participants receive IV Pembrolizumab 200 mg + IV Carboplatin Area Under The Curve (AUC) 5 mg/mL/minute + IV Pemetrexed 500 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pemetrexed in combination with IV pembrolizumab is permitted per standard of care, followed by IV pembrolizumab 200 mg every 3 weeks.
OG002
Part C: Pembrolizumab+Carboplatin/Paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute + IV Paclitaxel 200 mg/m^2 on Day 1 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG003
Part C: Pembrolizumab+Carboplatin/Nab-paclitaxel
In Part C, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 6 mg/mL/minute on Day 1 of each 21-day cycle + IV Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG004
Part E: Pembrolizumab+Cisplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG005
Part E: Pembrolizumab+Carboplatin/Etoposide
In Part E, participants received IV Pembrolizumab 200 mg + IV Carboplatin AUC 5 mg/mL/minute on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
OG006
Part E: Pembrolizumab+Cisplatin/Etoposide+G-CSF
In Part E, participants received IV Pembrolizumab 200 mg + IV Cisplatin 75 mg/m^2 on Day 1 of each 21-day cycle + IV Etoposide 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for a maximum of 4 cycles + lasting granulocyte colony-stimulating factor (G-CSF) (pegfilgrastim) 3.6 mg on Day 4 of Cycle 1. After completion of the initial therapy, maintenance therapy with IV pembrolizumab 200 mg every 3 weeks.
Units
Counts
Participants
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
Title
Denominators
Categories
Title
Measurements
OG00053.90± NA%CV was not planned to be calculated for ≤2 participants.
OG00168.20± NA%CV was not planned to be calculated for ≤2 participants.