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

A Phase 1 Dose Escalation Study of BMS-982470 (Recombinant Interleukin-21, rIL-21) in Combination With BMS-936558 (Anti-PD-1) in Subjects With Advanced or Metastatic Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01629758

Enrollment

Registered

2012-06-28

Start date

2012-06-30

Completion date

2014-12-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms by Site

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.

Interventions

BIOLOGICALDenenicokin

BIOLOGICALNivolumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026