Description:
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.
Title
- Brief Title: A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CA209-8Y8
- SECONDARY ID:
2018-004695-35
- NCT ID:
NCT03873402
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | Opdivo | Nivolumab + ipilimumab |
| Ipilimumab | Yervoy | Nivolumab + ipilimumab |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab + ipilimumab | Experimental | | |
| Nivolumab + ipilimumab placebo | Experimental | | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression free survival (PFS) by blinded independent central review (BICR) |
| Time Frame: | Up to 34 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Overall survival (OS) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall response rate (ORR) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Disease control rate (DCR) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DoR) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to objective response (TTR) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival (PFS) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Progression free survival secondary objective (PFS2) by investigator |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Disease control rate (DCR) by BICR |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DoR) by BICR |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Time to objective response (TTR) by BICR |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Adverse Events (AEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of drug-related AEs |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of Severe Adverse Events (SAEs) |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of drug-related SAEs |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Hematology tests |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Coagulation tests |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of clinically significant changes in clinical laboratory results: Serology tests |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | PFS based on gene expression (GEP) signatures |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Objective response rate (ORR) based on GEP signatures |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | OS based on GEP signatures |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | OS based on programmed cell death protein ligand-1 (PD-L1) expression |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | ORR by BICR based on PD-L1 expression |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | PFS by BICR based on PD-L1 expression |
| Time Frame: | Up to 4 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
October 19, 2020
