NCT01604889|TerminatedPhase 1FDA Drug

Study Stopped

Further development of this compound with ipilimumab in the treatment of melanoma is no longer being pursued.

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

Incyte Corporation ClinicalTrials.gov

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1 other identifier

INCB 24360-201

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMay 2012

StartedMar 2012

CompletionJan 2017

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Mar 2012

Longer than P75 for phase_1

Geographic Reach

1 country

7 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

March 29, 2012

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed

15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2012

Completed

4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2016

Completed

24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.8 years

First QC Date

May 9, 2012

Last Update Submit

April 15, 2026

Conditions

Melanoma

Keywords

Melanoma, Skin Cancer, Oncology

Outcome Measures

Primary Outcomes (2)

Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
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.
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).

Secondary Outcomes (2)

Preliminary efficacy as assessed by tumor response.
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.
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).