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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
ipilimumab 3 mg/kg intravenous (IV)
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Chicago, Illinois, United States
Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
Time frame: 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.
Time frame: 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).
Preliminary efficacy as assessed by tumor response.
Time frame: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
Evaluation of progression free survival.
Time frame: Measured every 4 weeks until the 50th death occurs, then follow-up is measured every 3 months (estimated timeframe is that patients will progress after 11 months).
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Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States