Study of Epacadostat (INCB024360) Alone and In Combinatio... | NCT02862457 | Trialant
NCT02862457
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Aug 19, 2022Actual
Enrollment
34Actual
Phase
Phase 1
Conditions
Neoplasms
Carcinoma, Non-Small-Cell Lung
Interventions
Epacadostat 25 mg
Epacadostat 100 mg
pembrolizumab 200 mg
Cisplatin 75 mg/m^2
Carboplatin Area Under the Curve (AUC) 5
Pemetrexed 500 mg/m^2
Paclitaxel 200 mg/m^2
Carboplatin AUC 6
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02862457
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-434
Secondary IDs
ID
Type
Description
Link
MK-3475-434
Other Identifier
Merck Protocol Number
163423
Registry Identifier
JAPIC-CTI
Brief Title
Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)
Official Title
A Phase I Study of INCB024360 (Epacadostat) Alone, INCB024360 in Combination With Pembrolizumab (MK-3475), and INCB024360 and Pembrolizumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors (KEYNOTE-434)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Aug 2022
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
Aug 23, 2016Actual
Primary Completion Date
Nov 20, 2020Actual
Completion Date
Nov 20, 2020Actual
First Submitted Date
Aug 3, 2016
First Submission Date that Met QC Criteria
Aug 8, 2016
First Posted Date
Aug 11, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 5, 2021
Results First Submitted that Met QC Criteria
Nov 5, 2021
Results First Posted Date
Jan 11, 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
Aug 17, 2022
Last Update Posted Date
Aug 19, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, non-randomized, Phase I study of epacadostat (INCB024360) alone and in combination with pembrolizumab with chemotherapy and pembrolizumab without chemotherapy in participants with advanced solid tumors. The primary objective of the trial is to evaluate the safety and tolerability of epacadostat administered alone and in combination with pembrolizumab with and without chemotherapy.
With protocol amendment 02 (26-April-2019), treatment with epacadostat was stopped in the "Epacad+Pembro+Cisplatin+Pemetrexed", "Epacad+Pembro+Carboplatin+Pemetrexed", and "Epacad+Pembro+Carboplatin+Paclitaxel" study arms.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasms
Carcinoma, Non-Small-Cell Lung
Keywords
Advanced Solid Tumors
PD-1
PD1
Programmed Cell Death-1
Programmed Cell Death 1
Programmed Cell Death-Ligand 1 (PD-L1)
Programmed Cell Death-Ligand 2 (PD-L2)
PDL1
PDL2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
34Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A Cohort 1: epacadostat 25 mg
Experimental
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Drug: Epacadostat 25 mg
Biological: pembrolizumab 200 mg
Part A Cohort 1: epacadostat 100 mg
Experimental
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Drug: Epacadostat 100 mg
Biological: pembrolizumab 200 mg
Part A Cohort 2: epacadostat 25 mg+pembrolizumab
Experimental
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Drug: Epacadostat 25 mg
Biological: pembrolizumab 200 mg
Part A Cohort 2: epacadostat 100 mg+pembrolizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Epacadostat 25 mg
Drug
Oral administration
Part A Cohort 1: epacadostat 25 mg
Part A Cohort 2: epacadostat 25 mg+pembrolizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
A DLT was defined as the occurrence of any treatment-emergent adverse event occurring up to and including Study Day 7 for Part A Cohort 1 or Day 21 for Part A Cohort 2 and Part B. The following criteria defined DLTs: Grade (G) 4 thrombocytopenia; G4 neutropenia (despite optimal supportive care in Part B) lasting >1 week; febrile neutropenia (only if considered clinically significant in Part B); G4 toxicity; G3 laboratory abnormality lasting >1 week: G3 toxicity excluding nausea or vomiting controlled within 72 hours, rash in the absence of desquamation, no mucosal involvement, does not require systemic steroids, and resolves to G1 by the next scheduled dose of pembrolizumab or 14 days; G2 or higher episcleritis, uveitis, or iritis; unable to receive 75% of epacadostat or 1 dose of pembrolizumab during the DLT observation period because of toxicity, even if the toxicity does not meet DLT criteria; or >2 week delay in initiating Cycle 2 due to toxicity.
Up to Day 7 for Part A Cohort 1; up to Day 21 for Part A Cohort 2 and Part B
Number of Participants Who Experienced At Least One Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experienced an AE was reported for each arm.
Up to approximately 39.7 months
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event (AE)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Concentration (Cmax) of Epacadostat in Part A
Cmax was the maximum observed concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Cmax for Cohort 1 was measured on Days 1, 5, and 12 and Cmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For Part A: Has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
For Part B: Has a histologically-confirmed or cytologically confirmed diagnosis of non-small cell lung carcinoma (NSCLC) stage IIIB/IV, be naïve to systemic therapy, and have confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated. Cohort 1 and 2 must have a histological or cytological diagnosis of non-squamous cancer.
Has at least one measurable lesion by computed tomography or magnetic resonance imaging per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Has a life expectancy of ≥3 months
Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
Women of childbearing potential and male participants must agree to use adequate contraception during the study through 120 days after the last dose of study medication
For Part A: Has provided tissue for programmed cell death ligand 1 (PD-L1)/ Indoleamine 2,3-dioxygenase 1 (IDO1) expression evaluation from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. For Part B submission of tissue is optional.
Exclusion Criteria:
Has received prior therapy with an anti-Programmed cell death protein (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agents (including ipilimumab or any other antibody/drug specifically targeting T-cell co-stimulation or checkpoint pathways), or IDO1 inhibitor
Is currently participating or has participated in a study with an investigational compound or device within 4 weeks, or 5 times half-life of the investigational compound, whichever is longer, of initial dosing on this study
For Part A: Has had chemotherapy, targeted small molecule therapy, radiotherapy, major surgery, or biological cancer therapy (including monoclonal antibodies) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication, or who has not recovered (≤ Grade 1 or baseline) from adverse events due to a previously administered treatment
For Part B: Has received radiotherapy within 7 days of the first dose of trial treatment or radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication
Is expected to require any other form of systemic or localized anti-neoplastic therapy while in study
Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has symptomatic ascites or pleural effusion
Has an active autoimmune disease that has required systemic treatment
Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 1 week prior to the first dose of study medication
Has an active infection requiring systemic therapy
Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
Has received a live vaccine within 4 weeks prior to the first dose of study medication
Has a known hypersensitivity to the components of the trial treatment or another monoclonal antibody
For Part B: Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel, or pemetrexed.
For Part B: Is on chronic systemic steroids with the exception of use of bronchodilators, inhaled steroids, or local steroid injections
For Part B cohort 1 and 2: Is unable to interrupt aspirin or other nonsteroidal ant-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
For Part B cohort 1 and 2: Is unable or unwilling to take folic acid or vitamin B12 supplementation
Is Human Immunodeficiency Virus (HIV)-positive (HIV 1/2 antibodies)
Has known history of or is positive for active Hepatitis B (Hepatitis B surface antigen reactive) or has active Hepatitis C (Hepatitis C virus ribonucleic acid)
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children during the study through 120 days after the last dose of study medication
Has received monoamine oxidase inhibitors (MAOIs) within the 3 weeks before the first dose of study medication
Has any history of Serotonin Syndrome after receiving serotonergic drugs
Has presence of a gastrointestinal condition that may affect drug absorption
Yamamoto N, Satouchi M, Doi T, Fujiwara Y, Yanagitani N, Kawa Y, Yoh K, Leopold L, Munteanu M, Sawada T, Han S, Noguchi K, Nishio M. KEYNOTE-434 part B: A phase 1 study evaluating the combination of epacadostat, pembrolizumab, and chemotherapy in Japanese patients with previously untreated advanced non-small-cell lung cancer. Invest New Drugs. 2024 Jun;42(3):261-271. doi: 10.1007/s10637-024-01422-6. Epub 2024 Mar 26.
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Apr 26, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Japan
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Drug: Epacadostat 100 mg
Biological: pembrolizumab 200 mg
Part B Cohort 1: pembrolizumab+cisplatin+pemetrexed
Experimental
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Drug: Epacadostat 100 mg
Biological: pembrolizumab 200 mg
Drug: Cisplatin 75 mg/m^2
Drug: Pemetrexed 500 mg/m^2
Part B Cohort 2: pembrolizumab+carboplatin+pemetrexed
Experimental
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Drug: Epacadostat 100 mg
Biological: pembrolizumab 200 mg
Drug: Carboplatin Area Under the Curve (AUC) 5
Drug: Pemetrexed 500 mg/m^2
Part B Cohort 3: pembrolizumab+carboplatin+paclitaxel
Experimental
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Drug: Epacadostat 100 mg
Biological: pembrolizumab 200 mg
Drug: Paclitaxel 200 mg/m^2
Drug: Carboplatin AUC 6
INCB024360
Epacadostat 100 mg
Drug
Oral administration
Part A Cohort 1: epacadostat 100 mg
Part A Cohort 2: epacadostat 100 mg+pembrolizumab
Part B Cohort 1: pembrolizumab+cisplatin+pemetrexed
Part B Cohort 2: pembrolizumab+carboplatin+pemetrexed
Part B Cohort 3: pembrolizumab+carboplatin+paclitaxel
INCB024360
pembrolizumab 200 mg
Biological
Intravenous (IV) infusion
Part A Cohort 1: epacadostat 100 mg
Part A Cohort 1: epacadostat 25 mg
Part A Cohort 2: epacadostat 100 mg+pembrolizumab
Part A Cohort 2: epacadostat 25 mg+pembrolizumab
Part B Cohort 1: pembrolizumab+cisplatin+pemetrexed
Part B Cohort 2: pembrolizumab+carboplatin+pemetrexed
Part B Cohort 3: pembrolizumab+carboplatin+paclitaxel
MK-3475
KEYTRUDA®
Cisplatin 75 mg/m^2
Drug
IV infusion
Part B Cohort 1: pembrolizumab+cisplatin+pemetrexed
Platinol®
Platinol-AQ®
Carboplatin Area Under the Curve (AUC) 5
Drug
IV infusion
Part B Cohort 2: pembrolizumab+carboplatin+pemetrexed
Paraplatin®
Pemetrexed 500 mg/m^2
Drug
IV infusion
Part B Cohort 1: pembrolizumab+cisplatin+pemetrexed
Part B Cohort 2: pembrolizumab+carboplatin+pemetrexed
Alimta®
Paclitaxel 200 mg/m^2
Drug
IV infusion
Part B Cohort 3: pembrolizumab+carboplatin+paclitaxel
Taxol®
Abraxane®
Onxol®
Carboplatin AUC 6
Drug
IV infusion
Part B Cohort 3: pembrolizumab+carboplatin+paclitaxel
Paraplatin®
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who discontinued due to an AE was reported for each arm.
Up to approximately 38.5 months
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
Time to Maximum Concentration (Tmax) of Epacadostat in Part A
Tmax was the time required to reach the maximum concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Tmax for Cohort 1 was measured on Days 1, 5, and 12 and Tmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Tmax is presented as a Median with a full range.
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
AUC0-t was defined as the AUC from zero to the time of the last measurable concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, AUC0-t for Cohort 1 was measured on Days 1, 5, and 12 and AUC0-t for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). AUC0-t is presented as a geometric mean with a percent geometric coefficient of variation.
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
Trough Concentration (Ctrough) of Epacadostat in Part A
Ctrough was the lowest concentration of epacadostat in plasma just before the next dose for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Ctrough for Cohort 1 was measured on Days 1, 5, and 12 and Ctrough for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose
Terminal Half-Life (t1/2) of Epacadostat in Part A
t1/2 was the time required to divide the epacadostat concentration by two after reaching pseudo-equilibrium. Plasma t1/2 was measured for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, t1/2 for Cohort 1 was measured on Days 1, 5, and 12 and t1/2 for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). t1/2 is presented as a geometric mean with a percent geometric coefficient of variation.
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
Maximum Concentration (Cmax) of Pembrolizumab in Part A Cycle 1
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion
Maximum Concentration (Cmax) of Pembrolizumab in Part B Cycle 1
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+ 3 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, blood sampling for Ctrough was taken at predose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+3 combined. Per protocol, blood sampling for Ctrough was taken at pre-dose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion
Derived
Doi T, Fujiwara Y, Shitara K, Shimizu T, Yonemori K, Matsubara N, Ohno I, Kogawa T, Naito Y, Leopold L, Munteanu M, Yatsuzuka N, Han SR, Samkari A, Yamamoto N. The safety and tolerability of epacadostat alone and in combination with pembrolizumab in patients with advanced solid tumors: results from a first-in-Japanese phase I study (KEYNOTE-434). Invest New Drugs. 2021 Feb;39(1):152-162. doi: 10.1007/s10637-020-00942-1. Epub 2020 Jun 20.
FG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
FG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
FG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
FG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
FG005
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
FG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG0047 subjects
FG0056 subjects
FG0066 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0047 subjects
FG0053 subjects
FG0065 subjects
NOT COMPLETED
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0040 subjects
FG0053 subjects
FG0061 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
The baseline analysis population is all participants that received at least one dose of treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
BG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
BG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
BG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
BG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
BG005
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
BG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0013
BG0023
BG0036
BG0047
BG0056
BG0066
BG00734
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
BG00063.7± 7.8
BG00171.0± 4.6
BG00262.0± 12.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
A DLT was defined as the occurrence of any treatment-emergent adverse event occurring up to and including Study Day 7 for Part A Cohort 1 or Day 21 for Part A Cohort 2 and Part B. The following criteria defined DLTs: Grade (G) 4 thrombocytopenia; G4 neutropenia (despite optimal supportive care in Part B) lasting >1 week; febrile neutropenia (only if considered clinically significant in Part B); G4 toxicity; G3 laboratory abnormality lasting >1 week: G3 toxicity excluding nausea or vomiting controlled within 72 hours, rash in the absence of desquamation, no mucosal involvement, does not require systemic steroids, and resolves to G1 by the next scheduled dose of pembrolizumab or 14 days; G2 or higher episcleritis, uveitis, or iritis; unable to receive 75% of epacadostat or 1 dose of pembrolizumab during the DLT observation period because of toxicity, even if the toxicity does not meet DLT criteria; or >2 week delay in initiating Cycle 2 due to toxicity.
All participants in Parts A and B who received ≥1 dose of study treatment and who completed all safety evaluations in the pre-specified time frame for DLT analysis
Posted
Count of Participants
Participants
Up to Day 7 for Part A Cohort 1; up to Day 21 for Part A Cohort 2 and Part B
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants Who Experienced At Least One Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experienced an AE was reported for each arm.
All participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 39.7 months
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Primary
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event (AE)
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who discontinued due to an AE was reported for each arm.
All participants who received ≥1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 38.5 months
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Secondary
Maximum Concentration (Cmax) of Epacadostat in Part A
Cmax was the maximum observed concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Cmax for Cohort 1 was measured on Days 1, 5, and 12 and Cmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Cmax. Per protocol, Cmax was only measured on Day 5 for Part A Cohort 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG001
Part A Cohort 1: Epacadostat 100 mg
Secondary
Time to Maximum Concentration (Tmax) of Epacadostat in Part A
Tmax was the time required to reach the maximum concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Tmax for Cohort 1 was measured on Days 1, 5, and 12 and Tmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Tmax is presented as a Median with a full range.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Tmax. Per protocol, Tmax was only measured on Day 5 for Part A Cohort 2.
Posted
Median
Full Range
hours
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG001
Part A Cohort 1: Epacadostat 100 mg
Secondary
Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
AUC0-t was defined as the AUC from zero to the time of the last measurable concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, AUC0-t for Cohort 1 was measured on Days 1, 5, and 12 and AUC0-t for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). AUC0-t is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of AUC 0-t. Per protocol, AUC0-t was only measured on Day 5 for Part A Cohort 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM•hour
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Secondary
Trough Concentration (Ctrough) of Epacadostat in Part A
Ctrough was the lowest concentration of epacadostat in plasma just before the next dose for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Ctrough for Cohort 1 was measured on Days 1, 5, and 12 and Ctrough for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Ctrough. Per protocol, Ctrough was only measured on Day 5 for Part A Cohort 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
nM
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG001
Part A Cohort 1: Epacadostat 100 mg
Secondary
Terminal Half-Life (t1/2) of Epacadostat in Part A
t1/2 was the time required to divide the epacadostat concentration by two after reaching pseudo-equilibrium. Plasma t1/2 was measured for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, t1/2 for Cohort 1 was measured on Days 1, 5, and 12 and t1/2 for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). t1/2 is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of t1/2. Per protocol, t1/2 was only measured on Day 5 for Part A Cohort 2.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours
Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
ID
Title
Description
OG000
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG001
Part A Cohort 1: Epacadostat 100 mg
Secondary
Maximum Concentration (Cmax) of Pembrolizumab in Part A Cycle 1
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Cmax. Per protocol, the Cmax of pembrolizumab for Part A was planned to be measured using data combined for Cohort 1 and Cohort 2 for the 200 mg pembrolizumab dose regimen irrespective of epacadostat dose received.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion
ID
Title
Description
OG000
Part A Combined Cohort 1
All participants who received either dose (25 or 100 mg) of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat BID on Days 1-21.
Secondary
Maximum Concentration (Cmax) of Pembrolizumab in Part B Cycle 1
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+ 3 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part B that contributed blood samples for analysis of Cmax.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusion
ID
Title
Description
OG000
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG001
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
Secondary
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, blood sampling for Ctrough was taken at predose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Ctrough. Per protocol, the Ctrough of pembrolizumab for Part A was planned to be measured using data combined for Cohort 1 and Cohort 2 for the 200 mg pembrolizumab dose regimen irrespective of epacadostat dose received.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion
ID
Title
Description
OG000
Part A Combined Cohort 1
All participants who received either dose (25 or 100 mg) of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat BID on Days 1-21.
Secondary
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+3 combined. Per protocol, blood sampling for Ctrough was taken at pre-dose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
The analysis population consisted of all participants in Part B that contributed blood samples for analysis of Ctrough.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose prior to the Cycles 1, 2, 4, 6, and 8 infusion
ID
Title
Description
OG000
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG001
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Time Frame
Up to approximately 39.7 months
Description
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization 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 A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
1
3
0
3
3
3
EG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
3
3
2
3
2
3
EG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
2
3
2
3
3
3
EG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
3
6
1
6
6
6
EG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
0
7
1
7
7
7
EG005
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
2
6
2
6
6
6
EG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
1
6
2
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
Liver disorder
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Gastroenteritis radiation
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected6 at risk
EG0042 events1 affected7 at risk
EG0055 events3 affected6 at risk
EG0062 events1 affected6 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Anal erosion
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0025 events2 affected3 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Periodontal disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Malaise
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vagus nerve disorder
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Nail ridging
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0004 events2 affected3 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Vascular pain
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
6
OG0047
OG0056
OG0066
1
OG0041
OG0052
OG0062
OG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG005
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0047
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
OG0023
OG0036
OG0047
OG0056
OG0066
OG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG004
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m^2 cisplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG005
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG006
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
OG0047
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0053
OG0063
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG000327± 15.9
OG0011060± 19.7
Day 5
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Day 12
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0002.00(2.00 to 2.00)
OG0012.00(2.00 to 2.00)
Day 5
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Day 12
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
OG001
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG000855± 13.0
OG0014250± 7.1
Day 5
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Day 12
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Day 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG000NA± NACtrough not calculated predose Cycle 1 Day 1 because it preceded exposure.
OG001NA± NACtrough not calculated predose Cycle 1 Day 1 because it preceded exposure.
Day 5
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Day 12
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG002
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
OG003
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
Units
Counts
Participants
OG0003
OG0013
OG0023
OG0036
Title
Denominators
Categories
Day 1
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Title
Measurements
OG0003.94± NAPercent geometric coefficient of variation could not be calculated on data from 2 participants.
OG0012.55± 40.9
Day 5
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
Day 12
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
OG001
Part A Combined Cohort 2
All participants who received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat orally BID on Days 1-21 for each 21-day cycle.
OG002
Part A Combined Cohorts 1 and 2
All participants in Cohorts 1 and 2 combined.
Units
Counts
Participants
OG0006
OG0019
OG00215
Title
Denominators
Categories
Title
Measurements
OG00080.0± 12.3
OG00173.8± 25.7
OG00276.2± 21.1
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG002
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG003
Part B Combined Cohorts 1, 2, and 3
All participants in Cohorts 1, 2, and 3 combined.
Units
Counts
Participants
OG0007
OG0016
OG0026
OG00319
Title
Denominators
Categories
Title
Measurements
OG00073.8± 25.0
OG00164.3± 32.1
OG00265.3± 22.4
OG00368.0± 26.0
OG001
Part A Combined Cohort 2
All participants who received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received either dose (25 or 100 mg) of epacadostat orally BID on Days 1-21 for each 21-day cycle.
OG002
Part A Combined Cohorts 1 And 2
All participants in Cohorts 1 and 2 combined.
Units
Counts
Participants
OG0006
OG0019
OG00215
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG00215
Title
Measurements
OG000NA± NACtrough less than the limitation of quantification of the assay (20 nM)
OG001NA± NACtrough less than the limitation of quantification of the assay (20 nM)
OG002NA± NACtrough less than the limitation of quantification of the assay (20 nM)
Cycle 2
ParticipantsOG0006
ParticipantsOG0018
ParticipantsOG00214
Title
Measurements
OG000
Cycle 4
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0029
Title
Measurements
OG000
Cycle 6
ParticipantsOG0003
ParticipantsOG0014
ParticipantsOG0027
Title
Measurements
OG000
Cycle 8
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0024
Title
Measurements
OG000
OG002
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
OG003
Part B Combined Cohorts 1, 2, and 3
All participants in Cohorts 1, 2, and 3 combined.
Units
Counts
Participants
OG0007
OG0016
OG0026
OG00319
Title
Denominators
Categories
Cycle 1
ParticipantsOG0007
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00319
Title
Measurements
OG000NA± NACtrough less than the limitation of quantification of the assay (20 nM)
OG001NA± NACtrough less than the limitation of quantification of the assay (20 nM)
OG002NA± NACtrough less than the limitation of quantification of the assay (20 nM)
OG003
Cycle 2
ParticipantsOG0006
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG00314
Cycle 4
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG00312
Cycle 6
ParticipantsOG0005
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00310
Cycle 8
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0039
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0047 events6 affected7 at risk
EG0055 events5 affected6 at risk
EG0061 events1 affected6 at risk
3 events
2 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0048 events4 affected7 at risk
EG0058 events5 affected6 at risk
EG0066 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0045 events4 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0062 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
3 events
2 affected
6 at risk
EG0044 events4 affected7 at risk
EG0052 events2 affected6 at risk
EG0063 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
3 events
2 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0043 events3 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0049 events4 affected7 at risk
EG0052 events2 affected6 at risk
EG0066 events3 affected6 at risk
1 events
1 affected
6 at risk
EG0044 events3 affected7 at risk
EG0052 events2 affected6 at risk
EG0065 events3 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0049 events1 affected7 at risk
EG0054 events2 affected6 at risk
EG0064 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0053 events3 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0049 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0065 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0056 events3 affected6 at risk
EG0063 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0042 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
2 events
2 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
2 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
2 events
1 affected
6 at risk
EG0044 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0068 events3 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0052 events2 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0064 events4 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
1 events
1 affected
6 at risk
EG0041 events1 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
2 events
2 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0053 events2 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0042 events2 affected7 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected6 at risk
1 events
1 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
0 events
0 affected
6 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected6 at risk
0 events
0 affected
6 at risk
EG0041 events1 affected7 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
Title
Measurements
OG000269± 19.3
OG0011100± 36.8
OG002371± 10.7
OG003852± 74.0
Title
Measurements
OG000294± 43.8
OG0011200± 27.0
Title
Measurements
OG0002.00(2.00 to 2.00)
OG0012.00(2.00 to 4.00)
OG0022.00(2.00 to 2.00)
OG0032.00(1.00 to 4.00)
Title
Measurements
OG0002.00(2.00 to 2.00)
OG0012.00(2.00 to 4.00)
Title
Measurements
OG0001060± 24.0
OG0014670± 22.7
OG0021260± 8.8
OG0033950± 38.8
Title
Measurements
OG0001020± 27.3
OG0014710± 17.9
Title
Measurements
OG000NA± NACtrough less than the limitation of quantification of the assay (20 nM).
OG00187.7± 21.7
OG002NA± NACtrough less than the limitation of quantification of the assay (20 nM).
OG003106.0± 64.1
Title
Measurements
OG000NA± NACtrough less than the limitation of quantification of the assay (20 nM).
OG00195.4± 31.8
Title
Measurements
OG0003.01± 70.6
OG0012.82± 45.1
OG0022.62± 9.7
OG0033.77± 21.9
Title
Measurements
OG0004.27± 86.0
OG0012.43± 16.1
17.3
± 26.6
OG00117.9± 33.5
OG00217.6± 29.6
24.5
± 31.3
OG00141.8± 21.1
OG00235.0± 36.0
28.5
± 25.3
OG00151.0± 17.4
OG00239.8± 37.5
38.2
± NA
Percent geometric coefficient of variation could not be calculated on data from 1 participant.
OG00147.9± 13.9
OG00245.2± 16.1
NA
± NA
Ctrough less than the limitation of quantification of the assay (20 nM)
Title
Measurements
OG00016.6± 27.6
OG00117.4± 36.6
OG0028.69± 122
OG00313.3± 73.9
Title
Measurements
OG00037.8± 20.2
OG00128.1± NAPercent geometric coefficient of variation could not be calculated on data from 2 participants.
OG00225.4± 25.7
OG00331.5± 28.5
Title
Measurements
OG00053.8± 29.5
OG00140.5± NAPercent geometric coefficient of variation could not be calculated on data from 2 participants.
OG00221.5± 130
OG00338.6± 73.5
Title
Measurements
OG00065.4± 18.6
OG00152.7± NAPercent geometric coefficient of variation could not be calculated on data from 2 participants.