A Phase 1/2 interventional study of Epacadostat and ipilimumab in Melanoma, sponsored by Incyte Corporation. Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Incyte Corporation · Phase 1/2, Interventional, and Treatment
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 50 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25 mg BID in combination with ipilimumab
Drug: Epacadostat · Drug: ipilimumab
50 mg BID in combination with ipilimumab. 50 mg BID Int indicates 50 mg BID daily 2 weeks on and 1 week off.
Drug: Epacadostat · Drug: ipilimumab
75 mg once a day (QD) in combination with ipilimumab. 75 mg total daily dose indicates 50 mg every day before noon (QAM ) and 25 mg every day after noon (QPM).
Drug: Epacadostat · Drug: ipilimumab
100 mg twice daily (BID) in combination with ipilimumab
Drug: Epacadostat · Drug: ipilimumab
300 mg twice daily (BID) in combination with ipilimumab
Drug: Epacadostat · Drug: ipilimumab
Also known as: INCB024360
ipilimumab 3 mg/kg intravenous (IV)
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).
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Incyte Corporation