Melanoma Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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-PD-1, anti- 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 is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT01604889

Recruitment Status:

Terminated

Sponsor:

Incyte Corporation

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There is 1 Location for this study

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Los Angeles California, , United States

Miami Florida, , United States

Tampa Florida, , United States

Chicago Illinois, , United States

Durham North Carolina, , United States

Philadelphia Pennsylvania, , United States

Pittsburgh Pennsylvania, , United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT01604889

Recruitment Status:

Terminated

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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