Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Pl... | NCT02819518 | Trialant
NCT02819518
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Nov 27, 2024Actual
Enrollment
882Actual
Phase
Phase 3
Conditions
Triple Negative Breast Cancer (TNBC)
Interventions
Pembrolizumab
Nab-paclitaxel
Paclitaxel
Gemcitabine
Carboplatin
Normale Saline Solution
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02819518
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-355
Secondary IDs
ID
Type
Description
Link
163422
Registry Identifier
JAPAN-CTI
MK-3475-355
Other Identifier
MSD
KEYNOTE-355
Other Identifier
MSD
2016-001432-35
EudraCT Number
Brief Title
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)
Official Title
A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Nov 2024
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
Jul 27, 2016Actual
Primary Completion Date
Jun 15, 2021Actual
Completion Date
Oct 30, 2023Actual
First Submitted Date
Jun 28, 2016
First Submission Date that Met QC Criteria
Jun 28, 2016
First Posted Date
Jun 30, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 8, 2022
Results First Submitted that Met QC Criteria
Jun 8, 2022
Results First Posted Date
Jul 5, 2022Actual
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
Nov 22, 2024
Last Update Posted Date
Nov 27, 2024Actual
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)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
The study will consist of two parts.
In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy.
In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy.
The primary hypotheses are that:
the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in:
all participants,
participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and
participants with PD-L1 CPS ≥10 tumors, and
the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in:
all participants,
participants with PD-L1 CPS ≥1 tumors, and
participants with PD-L1 CPS ≥10 tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Triple Negative Breast Cancer (TNBC)
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
882Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Pembrolizumab + Nab-paclitaxel
Experimental
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle.
Biological: Pembrolizumab
Drug: Nab-paclitaxel
Part 1: Pembrolizumab + Paclitaxel
Experimental
Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle.
Biological: Pembrolizumab
Drug: Paclitaxel
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Experimental
Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Biological: Pembrolizumab
Drug: Gemcitabine
Drug: Carboplatin
Part 2: Pembrolizumab + Chemotherapy
Experimental
Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
IV infusion
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Part 1: Pembrolizumab + Nab-paclitaxel
Part 1: Pembrolizumab + Paclitaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 39 months
Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 39 months
Part 2: Progression-Free Survival (PFS) - All Participants
Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Secondary Outcomes
Measure
Description
Time Frame
Part 2: Objective Response Rate (ORR) - All Participants
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.
Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines.
Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence.
Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.
Has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by local radiology review.
Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study drug.
Has a life expectancy ≥12 weeks from randomization.
Demonstrates adequate organ function, within 10 days prior to the start of study drug.
Female participants are eligible to participate if they are not pregnant or breastfeeding AND they are not a woman of childbearing potential (WOCBP) OR is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention AND has a negative highly-sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.
Male participants are eligible to participate if they agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic.
Exclusion Criteria:
Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization.
Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously administered therapy.
Has neuropathy ≥ Grade 2.
Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.
Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases and did not receive chemotherapy for metastatic breast cancer.
Has history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
Has active, or a history of, interstitial lung disease.
Has a known history of active tuberculosis (TB).
Has an active infection requiring systemic therapy.
Has a history of Class II-IV congestive heart failure or myocardial infarction within 6 months of randomization.
Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug.
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical studies.
Has a known history of human immunodeficiency virus (HIV).
Has known active hepatitis B or hepatitis C.
Has received a live vaccine within 30 days prior to randomization.
Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components.
Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
Rugo HS, Cescon DW, Schmid P, Nowecki Z, Im SA, Md Yusof M, Gallardo C, Iwata H, Lipatov O, Cruz F, Barrios CH, Hegg R, Loi S, Gion M, Otero MT, Arkosy P, Tarnawski R, Yao L, Mejia J, Pan W, Cortes J. Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events. NPJ Breast Cancer. 2026 Jun 26. doi: 10.1038/s41523-026-00971-8. Online ahead of print.
35 participants were randomized to Part 1 (Safety Run-in) of the study, and 847 participants were randomized in Part 2 (phase 3) of the study. 12 participants randomized to the Part 2: Pembrolizumab + Chemotherapy arm received a second course of pembrolizumab at the investigator's discretion. Per protocol, response/progression or adverse events (AEs) that occurred during the second course were not counted towards efficacy outcome measures or safety outcome measures respectively.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Pembrolizumab + Nab-Paclitaxel
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
Participants receive placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Drug: Nab-paclitaxel
Drug: Paclitaxel
Drug: Gemcitabine
Drug: Carboplatin
Drug: Normale Saline Solution
Part 2: Pembrolizumab + Chemotherapy
MK-3475
KEYTRUDA®
Nab-paclitaxel
Drug
IV infusion
Part 1: Pembrolizumab + Nab-paclitaxel
Part 2: Pembrolizumab + Chemotherapy
Part 2: Placebo + Chemotherapy
ABRAXANE®
Paclitaxel
Drug
IV infusion
Part 1: Pembrolizumab + Paclitaxel
Part 2: Pembrolizumab + Chemotherapy
Part 2: Placebo + Chemotherapy
TAXOL®
Gemcitabine
Drug
IV infusion
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Part 2: Pembrolizumab + Chemotherapy
Part 2: Placebo + Chemotherapy
GEMZAR®
Carboplatin
Drug
IV infusion
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Part 2: Pembrolizumab + Chemotherapy
Part 2: Placebo + Chemotherapy
PARAPLATIN®
Normale Saline Solution
Drug
IV infusion
Part 2: Placebo + Chemotherapy
Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Part 2: Overall Survival (OS) - All Participants
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Up to approximately 53 months
Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Up to approximately 53 months
Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Up to approximately 53 months
Up to approximately 53 months
Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Up to approximately 53 months
Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Up to approximately 53 months
Part 2: Duration of Response (DOR) - All Participants
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
Up to approximately 53 months
Part 2: Disease Control Rate (DCR) - All Participants
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Up to approximately 53 months
Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Up to approximately 53 months
Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Up to approximately 53 months
Part 2: Percentage of Participants Who Experienced an AE- All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 81 months
Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 81 months
Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Baseline and Week 15
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Baseline and Week 15
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
Baseline and Week 15
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
Baseline and Week 15
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
Baseline and Week 15
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
Baseline and Week 15
Derived
Im SA, Cortes J, Cescon DW, Yusof MM, Iwata H, Masuda N, Takano T, Huang CS, Chung CF, Tsugawa K, Park YH, Matsumoto K, Inoue K, Kwong A, Loi S, Fu W, Pan W, Karantza V, Rugo HS, Schmid P. Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC. NPJ Breast Cancer. 2024 Sep 12;10(1):79. doi: 10.1038/s41523-024-00679-7.
Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809.
Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828. doi: 10.1016/S0140-6736(20)32531-9.
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
FG002
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
FG003
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
FG004
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
FG00011 subjects
FG00114 subjects
FG00210 subjects
FG003566 subjects
FG004281 subjects
Treated
FG00013 subjectsOne participant randomized did not receive treatment. 3 participants randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Nab-Paclitaxel treatment in error
FG00110 subjects3 participants randomized to Pembrolizumab + Paclitaxel received pembrolizumab + Nab-Paclitaxel in error; 1 participant received pembrolizumab Gemcitabine/Carboplatin in error
FG00211 subjects1 participant randomized to Pembrolizumab + Paclitaxel group received Pembrolizumab + Gemcitabine/Carboplatin in error
FG003562 subjects
FG004281 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00011 subjects
FG00114 subjects
FG00210 subjects
FG003566 subjects
FG004281 subjects
Type
Comment
Reasons
Death
FG0009 subjects
FG00112 subjects
FG0029 subjects
FG003475 subjects
FG004244 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00325 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG00334 subjects
FG004
Transferred to extension study
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG00332 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Pembrolizumab + Nab-Paclitaxel
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
BG001
Part 1: Pembrolizumab + Paclitaxel
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
BG002
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
BG003
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
BG004
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00114
BG00210
BG003566
BG004281
BG005882
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
BG00054.6± 13.5
BG00160.4± 15.3
BG00259.6± 11.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00114
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Programmed Cell Death Ligand 1 (PD-L1) Status (Combined Positive Score [CPS] Cutoff of 1)
PD-L1 protein expression in triple-negative breast cancer (TNBC) is determined by using CPS, which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The number of participants with PD-L1 Status CPS<1 and CPS≥1 at baseline is presented.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
PD-L1 CPS ≥1
BG0008
BG001
PD-L1 Status (CPS Cutoff of 10)
PD-L1 protein expression in TNBC is determined by using CPS, which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. The number of participants with PD-L1 Status CPS<10 and CPS≥10 at baseline is presented.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
PD-L1 CPS ≥10
BG0001
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
Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.
Posted
Number
Percentage of Participants
Up to approximately 39 months
ID
Title
Description
OG000
Part 1: Pembrolizumab + Nab-Paclitaxel
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
OG001
Part 1: Pembrolizumab + Paclitaxel
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
OG002
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG00013
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
Primary
Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.
Posted
Number
Percentage of Participants
Up to approximately 39 months
ID
Title
Description
OG000
Part 1: Pembrolizumab + Nab-Paclitaxel
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
OG001
Part 1: Pembrolizumab + Paclitaxel
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
OG002
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Primary
Part 2: Progression-Free Survival (PFS) - All Participants
Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Primary
Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Primary
Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Primary
Part 2: Overall Survival (OS) - All Participants
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Primary
Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Primary
Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Median
95% Confidence Interval
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: Objective Response Rate (ORR) - All Participants
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors
Objective response rate is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: Duration of Response (DOR) - All Participants
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
All randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Posted
Median
Full Range
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
All randomized participants with PD-LI CPS ≥1 tumors regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Posted
Median
Full Range
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors
For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
All randomized participants with PD-LI CPS ≥10 tumors regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.
Posted
Median
Full Range
Months
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Disease Control Rate (DCR) - All Participants
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Secondary
Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Participants with PD-L1 CPS ≥1 tumors at baseline were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Secondary
Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors
Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
Participants with PD-L1 CPS ≥10 tumors at baseline were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 53 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Secondary
Part 2: Percentage of Participants Who Experienced an AE- All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
All randomized participants who received at least 1 dose of study intervention. Participants were included in the group corresponding to the study intervention actually received.
Posted
Number
Percentage of Participants
Up to approximately 81 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
All randomized participants who received at least 1 dose of study intervention. Participants were included in the group corresponding to the study intervention actually received.
Posted
Number
Percentage of Participants
Up to approximately 81 months
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Secondary
Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Secondary
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
Posted
Least Squares Mean
95% Confidence Interval
Scores on a scale
Baseline and Week 15
ID
Title
Description
OG000
Part 2: Pembrolizumab + Chemotherapy
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
Time Frame
Up to approximately 81 months
Description
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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 1: Pembrolizumab + Nab-Paclitaxel
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
9
11
3
13
13
13
EG001
Part 1: Pembrolizumab + Paclitaxel
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
12
14
4
10
10
10
EG002
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
9
10
9
11
11
11
EG003
Part 2: Pembrolizumab + Chemotherapy (First Course)
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to ~1 year).
484
566
169
562
551
562
EG004
Part 2: Pembrolizumab + Chemotherapy (Second Course)
Eligible participants received up to 17 additional administrations (up to approximately 1year) of pembrolizumab 200 mg IV on day 1 of each 21-day cycle.
5
12
3
12
11
12
EG005
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
249
281
68
281
273
281
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0023 events2 affected11 at risk
EG00312 events11 affected562 at risk
EG0040 events0 affected12 at risk
EG0058 events6 affected281 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0022 events1 affected11 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Papilloedema
Eye disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0022 events1 affected11 at risk
EG003
Intestinal pseudo-obstruction
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Asthenia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Death
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Face oedema
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Fat necrosis
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Malaise
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Steatohepatitis
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Abscess
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cystitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Mastitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Skin infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Streptococcal sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Superinfection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Procedural pneumothorax
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Transfusion-related acute lung injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Vascular access complication
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Blood corticotrophin increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cortisol decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Transaminases increased
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0021 events1 affected11 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0022 events2 affected11 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Scleroderma
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Tumour necrosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected10 at risk
EG0020 events0 affected11 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG00013
OG00110
OG00211
Title
Denominators
Categories
Title
Measurements
OG00038.5
OG00150.0
OG00227.3
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000566
OG001281
Title
Denominators
Categories
Title
Measurements
OG0007.5(6.3 to 7.7)
OG0015.6(5.4 to 7.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0120
One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus [vs] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS <1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).
Hazard Ratio (HR)
0.82
2-Sided
95
0.70
0.98
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000425
OG001211
Title
Denominators
Categories
Title
Measurements
OG0007.6(6.6 to 8.0)
OG0015.6(5.4 to 7.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0016
One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Hazard Ratio (HR)
0.75
2-Sided
95
0.62
0.91
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000220
OG001103
Title
Denominators
Categories
Title
Measurements
OG0009.7(7.6 to 11.3)
OG0015.6(5.3 to 7.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0018
One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Hazard Ratio (HR)
0.66
2-Sided
95
0.50
0.88
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Units
Counts
Participants
OG000566
OG001281
Title
Denominators
Categories
Title
Measurements
OG00017.2(15.3 to 19.0)
OG00115.5(13.9 to 17.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0797
One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS <1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Hazard Ratio (HR)
0.89
2-Sided
95
0.76
1.05
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Units
Counts
Participants
OG000425
OG001211
Title
Denominators
Categories
Title
Measurements
OG00017.6(15.5 to 19.5)
OG00116.0(12.8 to 17.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0563
One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Hazard Ratio (HR)
0.86
2-Sided
95
0.72
1.04
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Units
Counts
Participants
OG000220
OG001103
Title
Denominators
Categories
Title
Measurements
OG00023.0(19.0 to 26.3)
OG00116.1(12.6 to 18.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0093
One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Hazard Ratio (HR)
0.73
2-Sided
95
0.55
0.95
Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.
Superiority
Units
Counts
Participants
OG000566
OG001281
Title
Denominators
Categories
Title
Measurements
OG00040.8(36.7 to 45.0)
OG00137.0(31.4 to 42.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1413
Difference in ORR (%) vs. Control
3.8
2-Sided
95
-3.2
10.6
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS <1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Superiority
Units
Counts
Participants
OG000425
OG001211
Title
Denominators
Categories
Title
Measurements
OG00044.9(40.1 to 49.8)
OG00138.9(32.2 to 45.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0725
Difference in ORR (%) vs. Control
6.1
2-Sided
95
-2.1
14.0
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Superiority
Units
Counts
Participants
OG000220
OG001103
Title
Denominators
Categories
Title
Measurements
OG00052.7(45.9 to 59.5)
OG00140.8(31.2 to 50.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0213
Difference in ORR(%) vs. Control
12.1
2-Sided
95
0.4
23.4
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).
Superiority
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000231
OG001104
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse
OG0016.5(1.5 to NA)NA indicates upper limit not reached due to insufficient number of responding participants with relapse
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000191
OG00182
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse
OG0016.8(1.5 to NA)NA indicates upper limit not reached due to insufficient number of responding participants with relapse
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000116
OG00142
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)NA indicates median, upper limit, lower limit not reached due to insufficient number of responding participants with relapse
OG0017.3(1.5 to NA)NA indicates upper limit not reached due to insufficient number of responding participants with relapse
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000566
OG001281
Title
Denominators
Categories
Title
Measurements
OG00056.0(51.8 to 60.1)
OG00151.2(45.2 to 57.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0966
Difference in DCR (%) vs. control
4.7
2-Sided
95
-2.4
11.8
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS <1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).
Superiority
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000425
OG001211
Title
Denominators
Categories
Title
Measurements
OG00058.6(53.7 to 63.3)
OG00153.6(46.6 to 60.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1164
Difference in DCR (%) vs. Control
5.0
2-Sided
95
-3.2
13.1
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).
Superiority
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000220
OG001103
Title
Denominators
Categories
Title
Measurements
OG00065.0(58.3 to 71.3)
OG00154.4(44.3 to 64.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.0327
Difference in DCR (%) vs. Control
10.8
2-Sided
95
-0.7
22.3
Based on Miettinen & Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).
Superiority
Units
Counts
Participants
OG000562
OG001281
Title
Denominators
Categories
Title
Measurements
OG00098.6
OG00198.2
Units
Counts
Participants
OG000562
OG001281
Title
Denominators
Categories
Title
Measurements
OG00020.5
OG00113.2
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000554
OG001278
Title
Denominators
Categories
Title
Measurements
OG000-3.52(-5.61 to -1.42)
OG001-2.15(-4.97 to 0.67)
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000415
OG001208
Title
Denominators
Categories
Title
Measurements
OG000-3.92(-6.42 to -1.44)
OG001-3.15(-6.54 to 0.24)
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000216
OG001100
Title
Denominators
Categories
Title
Measurements
OG000-2.69(-5.86 to 0.48)
OG001-0.88(-5.41 to 3.64)
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000554
OG001278
Title
Denominators
Categories
Title
Measurements
OG00012.50(10.84 to 14.15)
OG00112.36(10.06 to 14.65)
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
Units
Counts
Participants
OG000415
OG001208
Title
Denominators
Categories
Title
Measurements
OG00013.00(11.08 to 14.91)
OG00111.86(9.17 to 14.55)
OG001
Part 2: Placebo + Chemotherapy
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.