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

• Status: Terminated
• Trial end date: 2016-12-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Antibodies, Monoclonal; Ipilimumab

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.