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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01604889
• Other study ID #: INCB 24360-201
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Est. completion date: December 27, 2016

Study information

• Verified date: March 2019
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: December 27, 2016
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Epacadostat

• Placebo
Placebo
• ipilimumab
ipilimumab 3 mg/kg IV
• ipilimumab
Doses to be determined following the completion of Phase I of the study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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).