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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Dose Escalation |
|
| Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Dose Escalation |
|
| Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab | Experimental | Cohort Expansion |
|
| Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab | Experimental | Cohort Expansion |
|
| Part 2 - Arm 3: Ipilimumab monotherapy | Active Comparator | Cohort Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-982470 (recombinant interleukin-21) | Biological | Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 | 84 days on treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BMS-982470 in combination with Ipilimumab as measured by objective response | 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 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Research Associates, Pllc D/B/A | Scottsdale | Arizona | 85258 | United States | ||
| Ucla Hematology/Oncology. |
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| BMS-982470 (recombinant interleukin-21) | Biological | Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response |
|
| BMS-982470 (recombinant interleukin-21) | Biological | Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response |
|
| BMS-982470 (recombinant interleukin-21) | Biological | Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response |
|
| Ipilimumab | Biological | Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response |
|
|
| Ipilimumab | Biological | Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response |
|
|
| Ipilimumab | Biological | Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response |
|
|
| 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 | 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 | 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 | 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 |
| Trough observed serum concentration (Cmin) of BMS-982470 and Ipilimumab | 1 time point each 3-week Cycle |
| The time of maximum observed serum concentration (Tmax) of BMS-982470 and Ipilimumab | 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 | 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 | 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 | 20 time points during Lead-In Cycle; Up to 11 time points during Cycle 3 |
| Incidence of BMS-984270 and Ipilimumab Anti-Drug Antibodies | Up to 6 months following last dose |
| Los Angeles |
| California |
| 90095 |
| United States |
| H. Lee Moffitt Cancer Center & Research Inst, Inc | Tampa | Florida | 33612 | United States |
| Indiana University Health Melvin And Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University Of Louisville Medical Center, Inc., Dba | Louisville | Kentucky | 40202 | United States |
| Portland Providence Medical Center | Portland | Oregon | 97213 | United States |
| Md Anderson Can Cnt | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Local Institution | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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