B-cell MalignanciesPhase 1/2NCT02327078

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

A Phase 1/2 study testing Nivolumab, Epacadostat and Chemotherapy in people with B-cell Malignancies and Colorectal Cancer (CRC), run by Incyte Corporation at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: B-cell Malignancies, Colorectal Cancer (CRC), Head and Neck Cancer
What is being tested?: Nivolumab, Epacadostat and Chemotherapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 307 participants
Where: 24 sitesin 2 countries
Study dates: 26 Nov 2014to 16 Jun 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States22 sites

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Texas Oncology Research
Austin, Texas, 78705
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Duke University Medical Center
Durham, North Carolina, 27710
The University of Kansas Clinical Research Center
Fairway, Kansas, 66205
Sanford Research
Fargo, North Dakota, 58122
MD Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
USC Norris Cancer Center
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Cancer Center
New York, New York, 10016
Columbia University, Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Sanford Research
North Sioux City, South Dakota, 57104
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15232
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
UCSF - University of California San Francisco
San Francisco, California, 94115
Wake Forest Medical Center Boulevard
Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom2 sites

The Christie NHS Foundation Trust
Manchester, M20 4BX
Oxford University Hospitals NHS Trust
Oxford, OX3 7LJ

Other trials in United Kingdom

About this study

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)

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).

Conditions: B-cell Malignancies, Colorectal Cancer (CRC), Head and Neck Cancer, Lung Cancer, Lymphoma, Melanoma
Being tested: Nivolumab, Epacadostat, Chemotherapy
Medical subject headings: Colorectal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Lymphoma, Melanoma, Ovarian Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabDrug
specified dose and dosing schedule
EpacadostatDrug
oral twice daily continuous at the protocol-defined dose
ChemotherapyDrug
Specified dose on specified days

Study groups in NCT02327078
Study group	Role	What they receive
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 Receives: 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 Receives: 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. Receives: 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. Receives: 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). Receives: Drug: Nivolumab; Drug: Epacadostat; Drug: Chemotherapy
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). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Nivolumab; Drug: Epacadostat

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 9

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to approximately 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 201416 Jun 2020

First posted30 Dec 2014 (estimated)
Study start26 Nov 2014
Primary completion16 Jun 2020
Study completion16 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for B-cell MalignanciesStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02327078
Sponsor's protocol ID: INCB 24360-204 / ECHO-204
Other IDs: 2016-002423-29, 2016
Status last verified: Aug 2025
First submitted: 1 Dec 2014
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

All B-cell Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02327078
Acronym / sponsor ID: INCB 24360-204 / ECHO-204
Conditions: B-cell Malignancies, Colorectal Cancer (CRC), Head and Neck Cancer, Lung Cancer, Lymphoma, Melanoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: 26 Nov 2014 (actual)
Primary completion: 16 Jun 2020 (actual)
Study completion: 16 Jun 2020 (actual)
First posted: 30 Dec 2014 (estimated)
Results: Posted 26 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W
Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.
Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum	Experimental	Drug: Nivolumab, Drug: Epacadostat, Drug: ChemotherapyEpacadostat 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).
Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum	Experimental	Drug: Epacadostat, Drug: ChemotherapyEpacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Pemetrexed/Platinum (Carboplatin orCisplatin+Pemetrexed) administered intravenously (IV).
Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum	Experimental	Drug: Epacadostat, Drug: ChemotherapyEpacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Paclitaxel/Platinum(Carboplatin+Cisplatin+Paclitaxel)administered intravenously (IV).
Phase 2 Epacadostat 100mg BID + Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 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).
Phase 2 Epacadostat 300mg BID + Nivolumab	Experimental	Drug: Nivolumab, Drug: EpacadostatEpacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nivolumabspecified dose and dosing schedule	Drug	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
Epacadostatoral twice daily continuous at the protocol-defined dose	Drug	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
ChemotherapySpecified dose on specified days	Drug	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

Primary outcome

Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 42
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.
Phase 1, Part 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 42
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.
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
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.
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)
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.
Phase 2: Progression Free Survival (PFS)
Time frame: From first dose up end of the study (up to approximately 6 years)
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.
Phase 2: Overall Survival (OS) Rate of Proportion With Glioblastoma
Time frame: Month 9
OS rate is defined as the proportion of participants alive 9 months after the start of treatment.

7 secondary outcomes

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)
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)
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)
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)
Phase 2: Duration of Response
Time frame: 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)
Time frame: 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
Time frame: up to approximately 35 months

Results and safety

Results posted to the registry on 26 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg	3	0
Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg	6	0
Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg	14	0
Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg	13	0
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum	6	0
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum	3	0
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum	3	0
Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg	83	0
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg	176	0

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

Time frame: Day 42. Count of participants. Unit: Participants

Measure	Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg n = 3	Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg n = 6	Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg n = 14	Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg n = 13
Value	0	0	0	0

Population analysed: The Phase 1, Part 1 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.

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

Time frame: Day 42. Count of participants. Unit: Participants

Measure	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum n = 6	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum n = 3	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum n = 3
Value	0	0	0

Population analysed: The Phase 1, Part 2 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg n = 3	Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg n = 6	Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg n = 14	Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg n = 13	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum n = 6	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum n = 3	Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum n = 3
Value	3	6	14	13	6	3	3

Population analysed: 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.

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer n = 26	Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL n = 18	Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive) n = 50	Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed) n = 7	Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory) n = 7	Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC n = 58	Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer n = 29	Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN n = 31	Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma n = 33
Value	3.8	0.0	62.0	28.6	28.6	20.7	13.8	25.8	0.0

Population analysed: 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.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to approximately 39 months for Phase 1 and up to approximately 35 months for Phase 2. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg	3 of 6 (50%)	6 of 6 (100%)	4 of 6
Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg	4 of 14 (28.6%)	14 of 14 (100%)	11 of 14
Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg	4 of 13 (30.8%)	13 of 13 (100%)	7 of 13
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + 5-FU/Platinum	4 of 6 (66.7%)	6 of 6 (100%)	4 of 6
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Pemetrexed/ Platinum	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Phase 1, Part 2: Epacadostat 100 mg + Nivolumab 360 mg + Paclitaxel/ Platinum	2 of 3 (66.7%)	3 of 3 (100%)	2 of 3
Phase 2: Epacadostat 100 mg + Nivolumab 240/480 mg	40 of 83 (48.2%)	81 of 83 (97.6%)	52 of 83
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg	89 of 176 (50.6%)	173 of 176 (98.3%)	97 of 176
Total	148 of 307 (48.2%)	302 of 307 (98.4%)	182 of 307

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for B-cell Malignancies

RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lance Leopold study director

Incyte Corporation

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Epacadostat and Chemotherapy in people with B-cell Malignancies and Colorectal Cancer (CRC), run by Incyte Corporation at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Day 42). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02327078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.