Clinical trial NCT01604889: A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Keywords: Melanoma, Skin Cancer, Oncology
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Number of patients with adverse events as a measure of Safety and Tolerability.
timeFrame: 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).
measure: Phase 2: Overall survival.
timeFrame: 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 outcomes:
measure: Preliminary efficacy as assessed by tumor response.
timeFrame: Baseline and every nine weeks (3 cycles) thereafter (estimated timeframe is that each patient will be on study for 11 months).
measure: Evaluation of progression free survival.
timeFrame: 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).
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold, M.D.
role: STUDY_DIRECTOR
References:
citation: Gibney GT, Hamid O, Lutzky J, Olszanski AJ, Mitchell TC, Gajewski TF, Chmielowski B, Hanks BA, Zhao Y, Newton RC, Maleski J, Leopold L, Weber JS. Phase 1/2 study of epacadostat in combination with ipilimumab in patients with unresectable or metastatic melanoma. J Immunother Cancer. 2019 Mar 20;7(1):80. doi: 10.1186/s40425-019-0562-8.