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Melanoma drug combo study halted before full results

NCT ID NCT01604889

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs, ipilimumab and epacadostat, in people with advanced melanoma that could not be removed by surgery or had spread. The goal was to see if adding epacadostat to standard treatment improved survival. However, the study was stopped early for business reasons, and only the first safety phase was completed. About 50 adults took part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

50 people

The number who actually took part.

Started

Mar 2012

Finished

Jan 2017

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma neoplasm skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • Study site

    Los Angeles, California, United States

  • Study site

    Miami, Florida, United States

  • Study site

    Tampa, Florida, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Pittsburgh, Pennsylvania, United States

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