A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

Bristol-Myers Squibb78 sites in 9 countries437 target enrollmentJune 21, 2019

ConditionsRenal Cell Carcinoma

InterventionsNivolumab Ipilimumab Ipilimumab placebo

DrugsNivolumab Ipilimumab

Overview

Phase: Phase 3
Intervention: Nivolumab
Conditions: Renal Cell Carcinoma
Sponsor: Bristol-Myers Squibb
Enrollment: 437
Locations: 78
Primary Endpoint: Objective response rate (ORR) by BICR
Status: Active, not recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

Registry

clinicaltrials.gov

Start Date

June 21, 2019

End Date

March 11, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
•Inclusion Criteria:
•Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.
•Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).
•Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria.
•No prior systemic therapy for RCC
•Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC).

Exclusion Criteria

•Any active central nervous system (CNS) metastases.
•Active, known, or suspected autoimmune disease.
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways
•Other protocol-defined inclusion/exclusion criteria apply

Arms & Interventions

Nivolumab + ipilimumab

Intervention: Nivolumab

Nivolumab + ipilimumab

Intervention: Ipilimumab

Nivolumab + ipilimumab placebo

Intervention: Ipilimumab placebo

Outcomes

Primary Outcomes

Objective response rate (ORR) by BICR

Time Frame: Up to 23 months

Progression free survival (PFS) by blinded independent central review (BICR)

Time Frame: Up to 34 months

Secondary Outcomes

Overall survival (OS)(Up to 4 years)
Progression Free Survival (PFS) by investigator(Up to 4 years)
Duration of response (DoR) by BICR(Up to 4 years)
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests(Up to 4 years)
Objective response rate (ORR) based on GEP signatures(Up to 4 years)
PFS by BICR based on PD-L1 expression(Up to 4 years)
Overall response rate (ORR) by investigator(Up to 4 years)
Incidence of drug-related AEs(Up to 4 years)
Incidence of clinically significant changes in clinical laboratory results: Serology tests(Up to 4 years)
OS based on GEP signatures(Up to 4 years)
OS based on programmed cell death protein ligand-1 (PD-L1) expression(Up to 4 years)
ORR by BICR based on PD-L1 expression(Up to 4 years)
Disease control rate (DCR) by investigator(Up to 4 years)
Progression free survival secondary objective (PFS2) by investigator(Up to 4 years)
Disease control rate (DCR) by BICR(Up to 4 years)
Incidence of drug-related SAEs(Up to 4 years)
PFS based on gene expression (GEP) signatures(Up to 4 years)
Time to objective response (TTR) by investigator(Up to 4 years)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to 4 years)
Duration of response (DoR) by investigator(Up to 4 years)
Time to objective response (TTR) by BICR(Up to 4 years)
Incidence of Adverse Events (AEs)(Up to 4 years)
Incidence of Severe Adverse Events (SAEs)(Up to 4 years)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 4 years)