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

Phase 1

Completed

• Conditions: Neoplasms by Site
• Interventions: Biological: Denenicokin; Biological: Nivolumab

• Registration Number: NCT01629758
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558	Denenicokin	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 1-Arm B: BMS-982470 (3 times/week) + BMS-936558	Nivolumab	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 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558	Nivolumab	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 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558	Denenicokin	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
Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558	Denenicokin	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 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558	Nivolumab	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

Primary Outcome Measures

Name	Time	Method
Safety, as measured by the rate of adverse events and serious adverse events	Approximately up to 4.5 years

Secondary Outcome Measures

Name	Time	Method
Efficacy as measured by tumor assessment (RECIST)	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)	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)
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

Trial Locations

Locations (5)

Oncology Research Associates, Pllc D/B/A; 🇺🇸 Scottsdale, Arizona, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States