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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-12-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epacadostat 300 mg

300 mg twice daily (BID) in combination with ipilimumab

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Doses to be determined following the completion of Phase I of the study

Placebo in combination with ipilimumab

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

ipilimumab

Intervention Type DRUG

ipilimumab 3 mg/kg IV

Epacadostat 25 mg

25 mg BID in combination with ipilimumab

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Doses to be determined following the completion of Phase I of the study

Epacadostat 50 mg

50 mg BID in combination with ipilimumab

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Doses to be determined following the completion of Phase I of the study

Epacadostat 75 mg

75 mg once a day (QD) in combination with ipilimumab

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

ipilimumab

Intervention Type DRUG

Doses to be determined following the completion of Phase I of the study

Interventions

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Epacadostat

Intervention Type DRUG

Placebo

Intervention Type DRUG

ipilimumab

ipilimumab 3 mg/kg IV

Intervention Type DRUG

ipilimumab

Doses to be determined following the completion of Phase I of the study

Intervention Type DRUG

Other Intervention Names

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INCB024360

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No