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Brief Title: Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma
Official Title: A Phase I Dose Escalation Study of BMS-982470 (Recombinant Interleukin 21, rIL-21) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma
Study ID: NCT01489059
Brief Summary: The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone
Detailed Description: Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Oncology Research Associates, Pllc D/B/A, Scottsdale, Arizona, United States
Ucla Hematology/Oncology., Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc, Tampa, Florida, United States
Indiana University Health Melvin And Bren Simon Cancer Center, Indianapolis, Indiana, United States
University Of Louisville Medical Center, Inc., Dba, Louisville, Kentucky, United States
Portland Providence Medical Center, Portland, Oregon, United States
Md Anderson Can Cnt, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Local Institution, San Juan, , Puerto Rico
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR