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
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase:
Randomized
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab
Based on the dose-limiting toxicity (DLT) rate
Within the first 63 days
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA220-007
NCT01489059
December 2011
November 2014
Name | Location |
---|---|
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Oncology Research Associates, Pllc D/B/A | Scottsdale, Arizona 85258 |
Portland Providence Medical Center | Portland, Oregon 97213 |
H. Lee Moffitt Cancer Center & Research Inst, Inc | Tampa, Florida 33612 |
University Of Louisville Medical Center, Inc., Dba | Louisville, Kentucky 40202 |
Md Anderson Can Cnt | Houston, Texas 77030-4009 |