NCT02327078 · REGISTRY CONDITION SEARCH

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2025-08-14

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

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outcome · POSTED

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

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outcome · POSTED

Phase 2: Progression Free Survival (PFS)

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outcome · POSTED

Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma

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outcome · POSTED

Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC

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outcome · POSTED

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

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outcome · POSTED

Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC

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outcome · POSTED

Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC

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outcome · POSTED

Phase 2: Duration of Response

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outcome · POSTED

Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)

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outcome · POSTED

Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab
type
EXPERIMENTAL
description
Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab
type
EXPERIMENTAL
description
Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab
type
EXPERIMENTAL
description
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab
type
EXPERIMENTAL
description
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).
intervention Names
Drug: Nivolumab
Drug: Epacadostat
Drug: Chemotherapy
label
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum
type
EXPERIMENTAL
description
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).
intervention Names
Drug: Epacadostat
Drug: Chemotherapy
label
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum
type
EXPERIMENTAL
description
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).
intervention Names
Drug: Epacadostat
Drug: Chemotherapy
label
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum
type
EXPERIMENTAL
description
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).
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 2 Epacadostat 100mg BID + Nivolumab
type
EXPERIMENTAL
description
Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).
intervention Names
Drug: Nivolumab
Drug: Epacadostat
label
Phase 2 Epacadostat 300mg BID + Nivolumab
type
EXPERIMENTAL

interventions

arm Group Labels
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 2 Epacadostat 100mg BID + Nivolumab
Phase 2 Epacadostat 300mg BID + Nivolumab
description
specified dose and dosing schedule
name
Nivolumab
type
DRUG
arm Group Labels
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
description
oral twice daily continuous at the protocol-defined dose
name
Epacadostat
type
DRUG
arm Group Labels
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
description
Specified dose on specified days
name
Chemotherapy
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 307
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
Day 42
description
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.
measure
Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
Day 42
description
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.
measure
Phase 1, Parts 1 and 2: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
time Frame
up to approximately 39 months
description
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.
measure
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
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
Phase 2: Progression Free Survival (PFS)
time Frame
From first dose up end of the study (up to approximately 6 years)
description
OS rate is defined as the proportion of participants alive 9 months after the start of treatment.
measure
Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma
time Frame
Month 9

secondary Outcomes

description
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.
measure
Phase 1, Part 2: ORR Per RECIST v1.1 and for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
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
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
Phase 1, Part 2: Duration of Response (DOR) for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
time Frame
From first dose up end of the study (up to approximately 6 years)
description
PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first.
measure
Phase 1, Part 2: PFS for Participants With Advanced or Metastatic SCCHN and Advanced or Metastatic NSCLC
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
Phase 2: Duration of Response
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
Phase 2: Duration of Disease Control, Defined as CR, PR, and Stable Disease (SD)
time Frame
From first dose up end of the study (up to approximately 6 years)
description
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.
measure
Phase 2: Safety and Tolerability Measured by the Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and Fatal Treatment Emergent AEs
time Frame
up to approximately 35 months

Full study description

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).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice