A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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).
Yes
Lance Leopold, M.D.
Study Director
Incyte Corporation
United States: Food and Drug Administration
INCB 24360-201
NCT01604889
March 2012
February 2015
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Philadelphia, Pennsylvania 19104 |