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A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma

NCT01604889 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Epacadostat

DRUG

ipilimumab

ipilimumab 3 mg/kg intravenous (IV)

Sponsors & Collaborators

Principal Investigators

  • Lance Leopold, M.D. · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-29
Primary Completion
2016-12-27
Completion
2017-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604889 on ClinicalTrials.gov