Solid TumorsPhase 1/2NCT03347123

A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)

A Phase 1/2 study testing Epacadostat, Nivolumab and Ipilimumab in people with Solid Tumors, run by Incyte Corporation at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in participant with advanced or metastatic malignancies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: Epacadostat, Nivolumab and Ipilimumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 5 sitesUnited States
Study dates: 21 Mar 2018to 29 Jan 2021
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

During Phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment.
During Phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
Presence of measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Expected survival of ≥ 12 weeks.

Who cannot join

Laboratory and medical history parameters not within the Protocol-defined range.
Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
Previous radiotherapy within 7 days of Cycle 1 Day 1.
Known active central nervous system metastases and/or carcinomatous meningitis.
Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.
Active infection requiring systemic therapy.
Any active or inactive autoimmune disease or syndrome

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Duke University Medical Center
Durham, North Carolina, 27710
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
John Wayne Cancer Institute
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)

Conditions: Solid Tumors
Being tested: Epacadostat, Nivolumab, Ipilimumab, Lirilumab
Keywords: Epacadostat, nivolumab, ipilimumab, lirilumab, solid tumor, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), IDO inhibitor
Medical subject headings: Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck

What participants receive

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

EpacadostatDrug
Also called INCB024360
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
NivolumabDrug
Also called Opdivo®, BMS-936558
Nivolumab at the protocol-specified dose and schedule.
IpilimumabDrug
Also called Yervoy®, BMS-734016
Ipilimumab at the protocol-specified dose and schedule.
LirilumabDrug
Also called IPH2102, BMS-986015
Lirilumab at the protocol-specified dose and schedule.

Study groups in NCT03347123
Study group	Role	What they receive
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID	Experimental	Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Ipilimumab
Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID	Experimental	Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Ipilimumab
Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID	Experimental	Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Lirilumab
Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID	Experimental	Participants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Lirilumab
Phase 2: Dose Expansion: Treatment Group A: Cohort A1	Experimental	Participants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Ipilimumab
Phase 2: Dose Expansion: Treatment Group A: Cohort A2	Experimental	Participants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Ipilimumab
Phase 2: Dose Expansion: Treatment Group B: Cohort B1	Experimental	Participants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase. Receives: Drug: Epacadostat; Drug: Nivolumab; Drug: Lirilumab

What is being measured

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

Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs)
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Measured: Screening through up to 100 days after end of treatment, up to approximately 24 months
Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)

Secondary outcomes (6)

Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1
ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 1: Duration of Response (DOR)
DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 1: Progression-free Survival (PFS)
PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Duration of Response (DOR)
DOR was defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Progression-free Survival (PFS)
PFS was defined as the time from the start of combination therapy until the earliest date at which progression criteria are met as determined by investigator evaluation of radiographic disease assessment per RECIST v1.1, or date of death due to any cause. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.
Measured: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Measured: Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months

Timeline

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

21 Mar 201829 Jan 2021

First posted20 Nov 2017
Study start21 Mar 2018
Primary completion29 Jan 2021
Study completion29 Jan 2021

Why it stopped: A business decision made by Incyte after analysis of data from a sister study.

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 Solid TumorsStudies 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: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03347123
Sponsor's protocol ID: INCB 24360-208 (ECHO-208)
Other IDs: 2017-001743-12, 2017
Status last verified: Feb 2022
First submitted: 14 Nov 2017
Last updated: 28 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
ClinicalTrials.gov ID: NCT03347123
Acronym / sponsor ID: INCB 24360-208 (ECHO-208)
Conditions: Solid Tumors
Keywords: Epacadostat, nivolumab, ipilimumab, lirilumab, solid tumor, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: A business decision made by Incyte after analysis of data from a sister study.
Enrolment: 11 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 21 Mar 2018 (actual)
Primary completion: 29 Jan 2021 (actual)
Study completion: 29 Jan 2021 (actual)
First posted: 20 Nov 2017 (actual)
Results: Posted 28 Feb 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: IpilimumabParticipants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: IpilimumabParticipants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of each 14 day cycle and ipilimumab 1 mg/kg intravenous (IV) every 6 weeks thereafter on Day 1 of every third treatment cycle until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: LirilumabParticipants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 50 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: LirilumabParticipants with advanced or metastatic solid tumor who have received no more than 2 prior treatment regimens received epacadostat 100 mg BID orally in combination with nivolumab 240 mg on day 1 of every 14 day cycle and lirilumab 240 mg IV every 4 weeks until disease progression or occurrence of unacceptable drug-related toxicities or discontinuation or up to 24 months.
Phase 2: Dose Expansion: Treatment Group A: Cohort A1	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: IpilimumabParticipants with unresectable or metastatic melanoma (MEL) were planned to be included in this cohort, who did not receive prior systemic therapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
Phase 2: Dose Expansion: Treatment Group A: Cohort A2	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: IpilimumabParticipants with advanced or metastatic non-small cell lung cancer (NSCLC) were planned to be included in this cohort, who have received no more than 1 prior line of platinum-based chemotherapy for advanced or metastatic disease to receive epacadostat in combination with nivolumab and ipilimumab at the MTD/PAD determined from dose escalation phase.
Phase 2: Dose Expansion: Treatment Group B: Cohort B1	Experimental	Drug: Epacadostat, Drug: Nivolumab, Drug: LirilumabParticipants with recurrent or metastatic serotonin norepinephrine reuptake inhibitor (SCCHN) were planned to be included in this cohort, who received no more than 1 prior line of platinum-based chemotherapy for recurrent or metastatic disease to receive epacadostat in combination with nivolumab and lirilumab at the MTD/PAD determined from dose escalation phase.

Who may qualify

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

Key inclusion criteria (5 listed)

During Phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment.
During Phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
Presence of measurable disease per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Expected survival of ≥ 12 weeks.

Key exclusion criteria (7 listed)

Laboratory and medical history parameters not within the Protocol-defined range.
Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
Previous radiotherapy within 7 days of Cycle 1 Day 1.
Known active central nervous system metastases and/or carcinomatous meningitis.
Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.

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
EpacadostatAlso: INCB024360Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.	Drug	Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID, Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID, Phase 2: Dose Expansion: Treatment Group A: Cohort A1, Phase 2: Dose Expansion: Treatment Group A: Cohort A2, Phase 2: Dose Expansion: Treatment Group B: Cohort B1
NivolumabAlso: Opdivo®, BMS-936558Nivolumab at the protocol-specified dose and schedule.	Drug	Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID, Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID, Phase 2: Dose Expansion: Treatment Group A: Cohort A1, Phase 2: Dose Expansion: Treatment Group A: Cohort A2, Phase 2: Dose Expansion: Treatment Group B: Cohort B1
IpilimumabAlso: Yervoy®, BMS-734016Ipilimumab at the protocol-specified dose and schedule.	Drug	Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID, Phase 2: Dose Expansion: Treatment Group A: Cohort A1, Phase 2: Dose Expansion: Treatment Group A: Cohort A2
LirilumabAlso: IPH2102, BMS-986015Lirilumab at the protocol-specified dose and schedule.	Drug	Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID, Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID, Phase 2: Dose Expansion: Treatment Group B: Cohort B1

Primary outcome

Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs)
Time frame: Screening through up to 100 days after end of treatment, up to approximately 24 months
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment. AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
ORR was defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

6 secondary outcomes

Phase 1: Objective Response Rate (ORR) Based on RECIST v1.1
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 1: Duration of Response (DOR)
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 1: Progression-free Survival (PFS)
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Duration of Response (DOR)
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Progression-free Survival (PFS)
Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)
Phase 2: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Screening through up to 100 days for treatment Group A and 150 days for treatment Group B after end of treatment, up to approximately 24 months

Results and safety

Results posted to the registry on 28 Feb 2022, 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: Dose Escalataion: Treatment Group A: Cohort 1 Epacadostat 50 mg BID	5	0
Phase 1: Dose Escalation: Treatment Group A: Cohort 2 Epacadostat 100 mg BID	6	0
Phase 1: Dose Escalation: Treatment Group B: Cohort 1 Epacadostat 50 mg BID	0	0
Phase 1: Dose Escalation: Treatment Group B: Cohort 2 Epacadostat 100 mg BID	0	0
Phase 2: Dose Expansion: Treatment Group A: Cohort A1	0	0
Phase 2: Dose Expansion: Treatment Group A: Cohort A2	0	0
Phase 2: Dose Expansion: Treatment Group B: Cohort B1	0	0

Primary outcome: Phase 1: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs)

Time frame: Screening through up to 100 days after end of treatment, up to approximately 24 months. Number. Unit: percentage of participants

Measure	Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID n = 5	Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID n = 6
Value	100	100

Population analysed: Safety population included all participants enrolled in the study who received at least 1 dose of combination therapy. Treatment group B was excluded from this analysis as no participants were enrolled.

Primary outcome: Phase 2: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Time frame: Every 8 weeks for the first 12 months and then every 12 weeks thereafter up to end of treatment (Up to Month 24)

Population analysed: As the study was terminated early due to business decision, with lack of enrollment, the data for this outcome measure was not collected and analyzed as planned.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through up to 100 days after end of treatment, up to approximately 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Dose Escalation: Treatment Group A: Cohort 1 Epacadostat 50 mg BID	2 of 5 (40%)	5 of 5 (100%)	1 of 5
Phase 1: Dose Esclataion: Treatment Group A: Cohort 2 Epacadostat 100 mg BID	3 of 6 (50%)	6 of 6 (100%)	2 of 6
Total	5 of 11 (45.5%)	11 of 11 (100%)	3 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Solid Tumors

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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.

Medical Monitor Consultant for Incyte study director

Incyte Corporation

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Epacadostat, Nivolumab and Ipilimumab in people with Solid Tumors, run by Incyte Corporation at 5 sites in United States.

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 7 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: stopped early, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 28 Feb 2022). 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: Percentage of Participants With At Least One Treatment Emergent Adverse Events (TEAEs) (time frame: Screening through up to 100 days after end of treatment, up to approximately 24 months). The study lists 2 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 NCT03347123.

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 28 Feb 2022.