Skin Cancer
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 Study ID:
INCB 24360-201
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
The study design included an open-label, dose escalation phase followed by a blinded, randomized phase, which combined epacadostat (an oral IDO1 inhibitor) with an approved therapy and compared to approved therapy plus placebo in metastatic melanoma patients.
Only Phase 1 of the study, dose escalation phase, was conducted. The study was terminated due to a business decision.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Mar 2012 - Dec 2016
TYPE
Interventional
PHASE
Phase 1/Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
Tampa, FL, US
Status
Recruiting
Location
Chicago, IL, US
Status
Recruiting
Location
Los Angeles, CA, US
Status
Recruiting
Location
Philadelphia, PA, US
Status
Recruiting
Location
Pittsburgh, PA, US
Status
Not yet recruiting
Location
Miami, FL, US
Status
Recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Male or female subjects, aged 18 years or older with unresectable or metastatic melanoma.
- A life expectancy of >12 weeks.
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.)
Protocol Summary
Incyte Study ID:
INCB 24360-201
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Interventions:
Drug
Enrollment:
50
Primary Outcome
Open
Secondary Outcome
Open