MedPath

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

Phase 1
Terminated
Conditions
Melanoma
Interventions
Registration Number
NCT01604889
Lead Sponsor
Incyte Corporation
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
136
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Epacadostat 25 mgEpacadostat25 mg BID in combination with ipilimumab
Epacadostat 300 mgEpacadostat300 mg twice daily (BID) in combination with ipilimumab
Epacadostat 300 mgipilimumab300 mg twice daily (BID) in combination with ipilimumab
Placebo in combination with ipilimumabPlacebo-
Placebo in combination with ipilimumabipilimumab-
Epacadostat 25 mgipilimumab25 mg BID in combination with ipilimumab
Epacadostat 50 mgEpacadostat50 mg BID in combination with ipilimumab
Epacadostat 50 mgipilimumab50 mg BID in combination with ipilimumab
Epacadostat 75 mgEpacadostat75 mg once a day (QD) in combination with ipilimumab
Epacadostat 75 mgipilimumab75 mg once a day (QD) in combination with ipilimumab
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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).
© Copyright 2025. All Rights Reserved by MedPath