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

Sponsor

Incyte Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT01604889

Collaborator

(none)

136

Enrollment

Locations

Arms

57.9

Actual Duration (Months)

19.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Epacadostat Drug: Placebo Drug: ipilimumab Drug: ipilimumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 27, 2016

Actual Study Completion Date :

Dec 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epacadostat 300 mg 300 mg twice daily (BID) in combination with ipilimumab	Drug: Epacadostat Other Names: INCB024360 Drug: ipilimumab Doses to be determined following the completion of Phase I of the study
Placebo Comparator: Placebo in combination with ipilimumab	Drug: Placebo Placebo Drug: ipilimumab ipilimumab 3 mg/kg IV
Experimental: Epacadostat 25 mg 25 mg BID in combination with ipilimumab	Drug: Epacadostat Other Names: INCB024360 Drug: ipilimumab Doses to be determined following the completion of Phase I of the study
Experimental: Epacadostat 50 mg 50 mg BID in combination with ipilimumab	Drug: Epacadostat Other Names: INCB024360 Drug: ipilimumab Doses to be determined following the completion of Phase I of the study
Experimental: Epacadostat 75 mg 75 mg once a day (QD) in combination with ipilimumab	Drug: Epacadostat Other Names: INCB024360 Drug: ipilimumab Doses to be determined following the completion of Phase I of the study

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
A life expectancy of >12 weeks.
Laboratory ranges and medical criteria met, as defined within the protocol.
Subject may have received more than 1 prior regimen of systematic treatment for unresectable or metastatic melanoma.
For Phase 2 period of the study only, Subjects must have archival tumor tissue available and collected with the prior 6 months or accessible disease for pre-treatment, study biopsy.

Exclusion Criteria:

Pregnant or nursing women.
Current investigational trial participation with another investigational product or subjects who have received any anticancer medications within 21 days prior to screening (6 weeks for mitomycin-C or nitrosoureas.)
Subjects receiving monoamine oxidase inhibitors (MAOI)s; subjects who have ever had Serotonin Syndrome after receiving one or more serotonergic drugs.
Subjects who have received prior immune checkpoint inhibitors (eg anti-CTLA-4, anti-PD-1, anti- PD-L1 and others) who have had Grade 3 or 4 hepatotoxicity, immune colitis requiring infliximab, endocrine toxicity not controlled by replacement, any other Grade 4 immune adverse events (AEs) or ocular toxicity
Subjects with protocol-specified active autoimmune process except vitiligo or thyroiditis.
Subjects with concurrent conditions that would jeopardize the safety of the safety of the subject or compliance with the protocol.

Contacts and Locations

Locations

	City	State	Country
1	Los Angeles	California	United States
2	Miami	Florida	United States
3	Tampa	Florida	United States
4	Chicago	Illinois	United States
5	Durham	North Carolina	United States
6	Philadelphia	Pennsylvania	United States
7	Pittsburgh	Pennsylvania	United States

Sponsors and Collaborators

Incyte Corporation

Investigators

Study Director: Lance Leopold, M.D., Incyte Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Incyte Corporation

ClinicalTrials.gov Identifier:

NCT01604889

Other Study ID Numbers:

INCB 24360-201

First Posted:

May 24, 2012

Last Update Posted:

Mar 26, 2019

Last Verified:

Mar 1, 2019

Keywords provided by Incyte Corporation

Melanoma, Skin Cancer, Oncology

Additional relevant MeSH terms:

Melanoma

Ipilimumab

Study Results

No Results Posted as of Mar 26, 2019