A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

April 15, 2026 updated by: Incyte Corporation

The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients.

Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
    • Florida
      • Miami, Florida, United States
      • Tampa, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
  • A life expectancy of >12 weeks.
  • Laboratory ranges and medical criteria met, as defined within the protocol.
  • Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
  • For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.

Exclusion Criteria:

  • Pregnant or nursing women.
  • Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
  • Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
  • Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
  • Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
  • Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epacadostat 300 mg
300 mg twice daily (BID) in combination with ipilimumab
Drug: Epacadostat
Other Names:
  • INCB024360
Drug: ipilimumab
ipilimumab 3 mg/kg intravenous (IV)
Experimental: Epacadostat 25 mg
25 mg BID in combination with ipilimumab
Drug: Epacadostat
Other Names:
  • INCB024360
Drug: ipilimumab
ipilimumab 3 mg/kg intravenous (IV)
Experimental: Epacadostat 50 mg
50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
Drug: Epacadostat
Other Names:
  • INCB024360
Drug: ipilimumab
ipilimumab 3 mg/kg intravenous (IV)
Experimental: Epacadostat 75 mg
75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM).
Drug: Epacadostat
Other Names:
  • INCB024360
Drug: ipilimumab
ipilimumab 3 mg/kg intravenous (IV)
Experimental: Epacadostat 100 mg
100 mg twice daily (BID) in combination with ipilimumab
Drug: Epacadostat
Other Names:
  • INCB024360
Drug: ipilimumab
ipilimumab 3 mg/kg intravenous (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
Time Frame: Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).
Baseline and minimally every 3 weeks until discontinuation or death (estimated timeframe to be 29 months from first patient enrolled to last patient discontinued or dead).
Phase 2: Overall survival.
Time Frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death).
Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe to be 29 months from first patient enrolled to last patient death).

Secondary Outcome Measures

Outcome Measure
Time Frame
Preliminary efficacy as assessed by tumor response.
Time Frame: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
Evaluation of progression free survival.
Time Frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).
Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Lance Leopold, M.D., Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2012

Primary Completion (Actual)

December 27, 2016

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

May 9, 2012

First Submitted That Met QC Criteria

May 22, 2012

First Posted (Estimated)

May 24, 2012

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 24360-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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