A Phase 1/2 Randomized, Blinded, Placebo Controlled Study of Ipilimumab in Combination With INCB024360 or Placebo in Subjects With Unresectable or Metastatic Melanoma
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).
Lance Leopold, M.D.
United States: Food and Drug Administration
|Hinsdale, Illinois 60521|
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Philadelphia, Pennsylvania 19104|