Clareo Health | A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
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Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
