A Study of the Safety, Tolerability, and Efficacy of Epac... | NCT02327078 | Trialant
NCT02327078
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Aug 14, 2025Actual
Enrollment
307Actual
Phase
Phase 1Phase 2
Conditions
B-cell Malignancies
Colorectal Cancer (CRC)
Head and Neck Cancer
Lung Cancer
Lymphoma
Melanoma
Ovarian Cancer
Glioblastoma
Interventions
Nivolumab
Epacadostat
Chemotherapy
Countries
United States
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02327078
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 24360-204 / ECHO-204
Secondary IDs
ID
Type
Description
Link
2016-002423-29
EudraCT Number
Brief Title
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Official Title
A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Aug 2025
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
Nov 26, 2014Actual
Primary Completion Date
Jun 16, 2020Actual
Completion Date
Jun 16, 2020Actual
First Submitted Date
Dec 1, 2014
First Submission Date that Met QC Criteria
Dec 23, 2014
First Posted Date
Dec 30, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 16, 2021
Results First Submitted that Met QC Criteria
Apr 24, 2023
Results First Posted Date
Apr 26, 2023Actual
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 12, 2025
Last Update Posted Date
Aug 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Name
Class
Bristol-Myers Squibb
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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 a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC).
Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).
Detailed Description
Not provided
Conditions Module
Conditions
B-cell Malignancies
Colorectal Cancer (CRC)
Head and Neck Cancer
Lung Cancer
Lymphoma
Melanoma
Ovarian Cancer
Glioblastoma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
307Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
Experimental
Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Drug: Nivolumab
Drug: Epacadostat
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
Experimental
Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Drug: Nivolumab
Drug: Epacadostat
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
Experimental
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Drug: Nivolumab
Drug: Epacadostat
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
Experimental
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Drug: Nivolumab
Drug: Epacadostat
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
Experimental
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360mg Q3W and 5-FU/Platinum( Carboplatin or Cisplatin+5-Fluorouracil) administered intravenously (IV).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Drug
specified dose and dosing schedule
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT > 3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
Day 42
Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT > 3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
Day 42
Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
Secondary Outcomes
Measure
Description
Time Frame
Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, age 18 years or older
Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma
Exclusion Criteria:
Laboratory and medical history parameters not within Protocol-defined range
Currently pregnant or breastfeeding
Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
Subjects with any active or inactive autoimmune process
Evidence of interstitial lung disease or active, noninfectious pneumonitis
Subjects with any active or inactive autoimmune process
Ocular MEL
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Lance Leopold
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UAB Comprehensive Cancer Center
Birmingham
Alabama
35294
United States
The Angeles Clinic and Research Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 307 participants were enrolled in this study, 48 participants were enrolled in Phase 1 and 259 participants were enrolled in Phase 2. Participants in Phase 1 Part 2 and Phase 2 received dose per select solid tumor types (Colorectal, Melanoma I/O Naïve, Melanoma I/O relapsed, Melanoma I/O refractory, Non-small cell lung cancer (NSCLC), Ovarian, Squamous cell carcinoma of the head and neck (SCCHN), Diffuse large B-cell lymphoma (DLBCL) and Glioblastoma).
Recruitment Details
Participants took part in 22 study sites in the United States and 2 study sites in the United Kingdom from 26 November 2014 to 16 June 2020.
Participants received epacadostat 25 mg, orally, twice daily (BID) in combination of nivolumab 3 mg/kg intravenously (IV), on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
Experimental
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Pemetrexed/Platinum (Carboplatin orCisplatin+Pemetrexed) administered intravenously (IV).
Drug: Epacadostat
Drug: Chemotherapy
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
Experimental
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Paclitaxel/Platinum(Carboplatin+Cisplatin+Paclitaxel)administered intravenously (IV).
Drug: Epacadostat
Drug: Chemotherapy
Phase 2 Epacadostat 100mg BID + Nivolumab
Experimental
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W or 480 mg Q4W based on tumor type administered intravenously (IV).
Drug: Nivolumab
Drug: Epacadostat
Phase 2 Epacadostat 300mg BID + Nivolumab
Experimental
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).
Drug: Nivolumab
Drug: Epacadostat
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
Phase 2 Epacadostat 100mg BID + Nivolumab
Phase 2 Epacadostat 300mg BID + Nivolumab
Epacadostat
Drug
oral twice daily continuous at the protocol-defined dose
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
Phase 2 Epacadostat 100mg BID + Nivolumab
Phase 2 Epacadostat 300mg BID + Nivolumab
Chemotherapy
Drug
Specified dose on specified days
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
up to approximately 39 months
Phase 2: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR per RECIST v 1.1 was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Data is reported as per dose received by the participants with a particular cancer type. CR per Cheson criteria was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR per Cheson criteria was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.
From first dose up end of the study (up to approximately 6 years)
Phase 2: Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.
From first dose up end of the study (up to approximately 6 years)
Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma
OS rate is defined as the proportion of participants alive 9 months after the start of treatment.
Month 9
From first dose up end of the study (up to approximately 6 years)
Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM
ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Per Cheson criteria, CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses. Per RANO criteria, CR: Complete disappearance of all enhancing measurable and non-measurable disease sustained. PR: at least ≥50% decrease compared with baseline in the SOD of all measurable enhancing lesions sustained.
From first dose up end of the study (up to approximately 6 years)
Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
From first dose up end of the study (up to approximately 6 years)
Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first.
From first dose up end of the study (up to approximately 6 years)
Phase 2: Duration of Response
DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
From first dose up end of the study (up to approximately 6 years)
Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
Duration of disease control is the time from the first dose to the first objective response of PD, or death, whichever occurs first, for participants who reported a best overall response of SD or better. PD was defined as at least a 20% increase in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters.
From first dose up end of the study (up to approximately 6 years)
Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug. Adverse events of grade 5 which result in death are called as fatal AEs.
up to approximately 35 months
Los Angeles
California
90025
United States
USC Norris Cancer Center
Los Angeles
California
90033
United States
UCSF - University of California San Francisco
San Francisco
California
94115
United States
University of Colorado Anschutz Medical Campus
Aurora
Colorado
80045
United States
The University of Kansas Clinical Research Center
Fairway
Kansas
66205
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21231
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Lahey Hospital & Medical Center
Burlington
Massachusetts
01805
United States
NYU Cancer Center
New York
New York
10016
United States
Columbia University, Herbert Irving Comprehensive Cancer Center
New York
New York
10032
United States
Duke University Medical Center
Durham
North Carolina
27710
United States
Wake Forest Medical Center Boulevard
Winston-Salem
North Carolina
27157
United States
Sanford Research
Fargo
North Dakota
58122
United States
University of Pittsburgh School of Medicine
Pittsburgh
Pennsylvania
15232
United States
Sanford Research
North Sioux City
South Dakota
57104
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Texas Oncology Research
Austin
Texas
78705
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Utah Cancer Specialists
Salt Lake City
Utah
84106
United States
Huntsman Cancer Institute
Salt Lake City
Utah
84112
United States
Medical College of Wisconsin
Milwaukee
Wisconsin
53226
United States
The Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom
Oxford University Hospitals NHS Trust
Oxford
OX3 7LJ
United Kingdom
Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, once every 3 weeks (Q3W), on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, once every 2 weeks (Q2W), on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion once every 4 weeks (Q4W) on Days 1 and Day 29 of each 8-week cycle.
FG008
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
FG0003 subjects
FG0016 subjects
FG00214 subjects
FG00313 subjects
FG0046 subjects
FG0053 subjects
FG0063 subjects
FG00783 subjects
FG008176 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG00214 subjects
FG00313 subjects
FG0046 subjects
FG0053 subjects
FG0063 subjects
FG00783 subjects
FG008176 subjects
Type
Comment
Reasons
Participants Decision: Consent Withdrawal from Study and Follow-up
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG00711 subjects
FG00825 subjects
Death
FG0002 subjects
FG0014 subjects
FG00210 subjects
FG0036 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0034 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Completed 100 Day Safety Follow-up Period
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Reason not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The safety population included all participants enrolled in the study who received at least 1 dose of epacadostat, nivolumab, or an applicable chemotherapy regimen.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
BG008
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG00214
BG00313
BG0046
BG0053
BG0063
BG00783
BG008176
BG009307
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
BG00050.0± 26.00
BG00162.5± 12.41
BG00257.5± 13.27
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
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
Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT > 3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
The Phase 1, Part 1 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG0003
OG0016
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT > 3 × upper limit of normal (ULN) and concurrent total bilirubin > 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
The Phase 1, Part 2 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
The Phase 1, Parts 1 and 2 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Primary
Phase 2: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR per RECIST v 1.1 was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Data is reported as per dose received by the participants with a particular cancer type. CR per Cheson criteria was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR per Cheson criteria was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.
The Phase 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported per cancer type in this outcome measure.
Posted
Number
percentage of participants
From first dose up end of the study (up to approximately 6 years)
ID
Title
Description
OG000
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
OG001
Primary
Phase 2: Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.
The Phase 2 Full Analysis Population includes all participants enrolled in the study who take at least 1 dose of study drug. The data is reported per cancer type in this outcome measure.
Posted
Median
95% Confidence Interval
months
From first dose up end of the study (up to approximately 6 years)
ID
Title
Description
OG000
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Primary
Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma
OS rate is defined as the proportion of participants alive 9 months after the start of treatment.
The Phase 2 Full Analysis Population includes all participants enrolled in the study who take at least 1 dose of study drug. The data is reported for participants with Glioblastoma cancer type for this outcome measure.
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG000
Secondary
Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters.
The Phase 1, Part 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose up end of the study (up to approximately 6 years)
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Secondary
Phase 1, Part 1: ORR Per RECIST v1.1 for Participants With Solid Tumors; Per Cheson Criteria for Participants With B-cell NHL; and Per RANO and mRANO Criteria for Participants With GBM
ORR was defined as percentage of participants having CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Per Cheson criteria, CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR: at least a 50% decrease in SPD of up to 6 of the largest dominant nodes or nodal masses. Per RANO criteria, CR: Complete disappearance of all enhancing measurable and non-measurable disease sustained. PR: at least ≥50% decrease compared with baseline in the SOD of all measurable enhancing lesions sustained.
The Phase 1, Part 1 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Posted
Number
percentage of participants
From first dose up end of the study (up to approximately 6 years)
Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
The Phase 1, Part 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported only for responders for this outcome measure.
Posted
Median
95% Confidence Interval
months
From first dose up end of the study (up to approximately 6 years)
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Secondary
Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first.
The Phase 1, Part 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Posted
Median
95% Confidence Interval
months
From first dose up end of the study (up to approximately 6 years)
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
DOR is defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of the participant's death and first overall response of PD. CR was defined as disappearance of all target lesions. PR was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. PD was defined as at least a 20% increase in the SOD of target lesions.
The Phase 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported only for responders and per cancer type for this outcome measure.
Posted
Median
95% Confidence Interval
months
From first dose up end of the study (up to approximately 6 years)
ID
Title
Description
OG000
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
Duration of disease control is the time from the first dose to the first objective response of PD, or death, whichever occurs first, for participants who reported a best overall response of SD or better. PD was defined as at least a 20% increase in the SOD of target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters.
The Phase 2 Full Analysis Population includes all participants enrolled in the study who received at least 1 dose of study drug. The data is reported per cancer type in this outcome measure. Overall number analyzed are the participants who had best overall response of stable disease or better.
Posted
Median
95% Confidence Interval
months
From first dose up end of the study (up to approximately 6 years)
ID
Title
Description
OG000
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Secondary
Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug. Adverse events of grade 5 which result in death are called as fatal AEs.
The Phase 2 Safety population includes all participants enrolled in the study who received at least 1 dose of study drug.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
OG001
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
Time Frame
up to approximately 39 months for Phase 1 and up to approximately 35 months for Phase 2
Description
The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug .
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 and participants with melanoma I/O-relapsed and melanoma I/O-refractory enrolled in this arm received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q4W on Days 1 and Day 29 of each 8-week cycle.
52
83
40
83
81
83
EG008
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg
Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
97
176
89
176
173
176
EG009
Total
Total
182
307
148
307
302
307
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected83 at risk
EG0080 events0 affected176 at risk
EG0091 events1 affected307 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Adrenocortical insufficiency acute
Endocrine disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Arterial haemorrhage
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Asthenia
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Brain compression
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Brain neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cauda equina syndrome
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Central nervous system infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Drug reaction with eosinophilia and systemic symptoms
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Embolism
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Exsanguination
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Fatigue
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Flushing
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gait disturbance
General disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Headache
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hemianopia homonymous
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected14 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypotension
Vascular disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Influenza
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lipase increased
Investigations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Lung infection
Infections and infestations
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 22
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected14 at risk
EG003
Metastases to peritoneum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D001254
Astrocytoma
D005910
Glioma
D018302
Neoplasms, Neuroepithelial
D009375
Neoplasms, Glandular and Epithelial
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077594
Nivolumab
C000613752
epacadostat
D004358
Drug Therapy
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D013812
Therapeutics
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0053 subjects
FG0062 subjects
FG00751 subjects
FG00897 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0085 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00711 subjects
FG00825 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
1 subjects
FG0050 subjects
FG0061 subjects
FG0073 subjects
FG00811 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0075 subjects
FG00812 subjects
61.6
± 10.67
BG00464.3± 6.38
BG00567.7± 6.43
BG00670.3± 11.37
BG00756.7± 13.82
BG00862.6± 12.12
BG00960.7± 12.33
11
BG0035
BG0041
BG0051
BG0061
BG00746
BG00877
BG009145
Male
BG0001
BG0015
BG0023
BG0038
BG0045
BG0052
BG0062
BG00737
BG00899
BG009162
0
BG0030
BG0040
BG0050
BG0060
BG0076
BG00811
BG00917
Not Hispanic or Latino
BG0003
BG0015
BG00214
BG00313
BG0046
BG0053
BG0063
BG00777
BG008159
BG009283
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0086
BG0097
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0083
BG0093
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0091
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0072
BG0084
BG0097
White
BG0003
BG0016
BG00213
BG00313
BG0045
BG0053
BG0063
BG00776
BG008160
BG009282
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0060
BG0075
BG0088
BG00914
13
0
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with 5-FU/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Pemetrexed /Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
OG006
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
OG006
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG00026
OG00118
OG00250
OG0037
OG0047
OG00558
OG00629
OG00731
OG00833
Title
Denominators
Categories
Title
Measurements
OG0001.78(1.74 to 1.81)
OG0011.64(1.35 to 3.52)
OG002NA(9.51 to NA)Median and upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
OG0031.76(0.46 to NA)Upper limit of 95% CI was not estimable due to low number of participants with events.
OG0042.55(0.59 to NA)Upper limit of 95% CI was not estimable due to low number of participants with events.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Units
Counts
Participants
OG0006
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00050.0
OG00133.3
OG002100.0
Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Units
Counts
Participants
OG0003
OG0011
OG0023
Title
Denominators
Categories
Title
Measurements
OG0003.82(3.75 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG001NA(NA to NA)The median value can't be reported for a single participant due to the risk of patient re-identification.
OG0023.93(2.76 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants with select solid tumor types received epacadostat 100 mg BID in combination with nivolumab 360 mg, IV, Q2W, on Day 1 of each 21-day cycle along with Paclitaxel/Platinum chemotherapy regimen IV. Participants were de-escalated to epacadostat 50 mg BID if 100 mg was not tolerated.
Units
Counts
Participants
OG0006
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG0005.72(2.07 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0012.83(1.35 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0026.10(4.84 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
OG006
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG0001
OG0010
OG00231
OG0031
OG0042
OG00512
OG0064
OG0078
OG0080
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, lower and upper limit of 95% CI was not estimable for 1 participant.
OG002NA(NA to NA)Median, lower and upper limit of 95% CI was not estimable due to low number of participants with events.
OG003NA(NA to NA)Median, lower and upper limit of 95% CI was not estimable for 1 participant.
OG004NA(NA to NA)Median and 95% CI was not estimable due to low number of participants with events.
OG005NA(1.94 to NA)Median and upper limit of 95% CI was not estimable due to low number of participants with events.
OG0063.93(3.13 to 5.53)
OG007NA(7.37 to NA)Median and upper limit of 95% CI was not estimable due to low number of participants with events.
Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
OG006
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG0004
OG0014
OG00239
OG0032
OG0043
OG00519
OG0069
OG00717
OG0088
Title
Denominators
Categories
Title
Measurements
OG0003.72(2.86 to NA)Upper limit of 95% CI was not estimable due to low number of participants with events.
OG0014.57(3.52 to 10.26)
OG002NA(NA to NA)Median, lower and upper limit of 95% CI was not estimable due to low number of participants with events.
OG003NA(NA to NA)Median, lower and upper limit of 95% CI was not estimable due to low number of participants with events.
OG004NA(3.19 to NA)Median, and upper limit of 95% CI was not estimable due to low number of participants with events.
OG005NA(9.11 to NA)Median, and upper limit of 95% CI was not estimable due to low number of participants with events.
OG0065.86(3.52 to 7.47)
OG00710.89(4.84 to NA)Upper limit of 95% CI was not estimable due to low number of participants with events.
OG0083.72(3.49 to 5.59)
Participants with select solid tumor types received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
Units
Counts
Participants
OG00083
OG001176
Title
Denominators
Categories
Participants with Treatment Emergent Adverse Events