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

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Melanoma

Treatments: Drug: Epacadostat; Drug: Placebo; Drug: ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01604889

INCB 24360-201

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 5 patient groups, including a placebo group

Epacadostat 300 mg

Experimental group

Description:

300 mg twice daily (BID) in combination with ipilimumab

Treatment:

Drug: ipilimumab

Drug: ipilimumab

Drug: Epacadostat

Placebo in combination with ipilimumab

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: ipilimumab

Drug: ipilimumab

Epacadostat 25 mg

Experimental group

Description:

25 mg BID in combination with ipilimumab

Treatment:

Drug: ipilimumab

Drug: ipilimumab

Drug: Epacadostat

Epacadostat 50 mg

Experimental group

Description:

50 mg BID in combination with ipilimumab

Treatment:

Drug: ipilimumab

Drug: ipilimumab

Drug: Epacadostat

Epacadostat 75 mg

Experimental group

Description:

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

Treatment:

Drug: ipilimumab

Drug: ipilimumab

Drug: Epacadostat