Trials / Terminated
TerminatedNCT01604889
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Epacadostat | |
| DRUG | Placebo | Placebo |
| DRUG | ipilimumab | ipilimumab 3 mg/kg IV |
| DRUG | ipilimumab | Doses to be determined following the completion of Phase I of the study |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2016-12-27
- Completion
- 2016-12-27
- First posted
- 2012-05-24
- Last updated
- 2019-03-26
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01604889. Inclusion in this directory is not an endorsement.