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
Allocation: Part 1 Dose Escalation Phase: Non-randomized; Part 2 Cohort Expansion Phase: Randomized
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
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
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
Time frame: Within the first 63 days
Part 2 (Cohort Escalation): Safety and tolerability of the MTD dose for each of the schedules
Based on medical review of AE reports and the results of vital sign measurements, physical examinations, medical history, and clinical laboratory tests
Time frame: 84 days on treatment
Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response
Time frame: Baseline (Day 1), End of Treatment (EOT) [3 weeks after last dose of Ipilimumab], 3 and 6 months Follow-up
Area under the serum concentration-time curve from time zero to the last quantifiable concentration [AUC(0-T)] of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Area under the serum concentration-time curve in one dosing interval [AUC(TAU)] of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
The maximum observed serum concentration (Cmax) of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
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
Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab
Time frame: 1 time point each 3-week Cycle
The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Serum half-life (T-HALF) of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Apparent total body clearance (CLT) of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Apparent volume of distribution at steady state (Vss) of BMS-982470 and Ipilimumab
Time frame: 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3
Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies
Time frame: Up to 6 months following last dose