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The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years |
|
| Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558 | Experimental | Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years |
|
| Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558 | Experimental | Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denenicokin | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as measured by the rate of adverse events and serious adverse events | Approximately up to 4.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by tumor assessment (RECIST) | Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 using Best overall response (BOR), Objective response rate (ORR), Duration of Response (DOR), Progression-Free Survival Rate (PFSR) | Week 6 of for the first 4 cycles, Week 6 of alternate cycle starting with cycle 6, End of Treatment (2 years) and approximately every 12 weeks during follow-up (approximately 1 year) |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
All subjects will have locally advanced or metastatic solid tumors
For Part 2 (Cohort Expansion):
At least 1 lesion with measurable disease
Only subjects with tumor samples that are PD-L1 positive or negative are eligible
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 | ||
| Yale University School Of Medicine |
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| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab | Biological |
|
|
| Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558 | Up to 2 years + 100 days post-treatment follow-up |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |