Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Neoplasms by Site

Treatments: Biological: Denenicokin; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629758

CA220-008

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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):

  • Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma

• At least 1 lesion with measurable disease

• Only subjects with tumor samples that are PD-L1 positive or negative are eligible

Exclusion Criteria:

• Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
• Inadequate liver or kidney function
• History of autoimmune Disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Denenicokin

Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Denenicokin

Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Biological: Denenicokin