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

Bristol-Myers Squibb33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasms by Site

Interventions

DenenicokinBIOLOGICAL

NivolumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Oncology Research Associates, Pllc D/B/A

Scottsdale, Arizona, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Safety, as measured by the rate of adverse events and serious adverse events

Time frame: Approximately up to 4.5 years

Secondary Outcomes

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)

Time frame: 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)

Immunogenicity as measured by incidence of specific antidrug antibodies (ADA) to BMS-98470 and BMS-936558

Time frame: Up to 2 years + 100 days post-treatment follow-up

Data from ClinicalTrials.gov

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