Stopped: Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
Timeframe: 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.
Timeframe: 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).