Description:
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is
safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal
cell carcinoma
Title
- Brief Title: A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
- Official Title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
CA209-9ER
- SECONDARY ID:
2017-000759-20
- NCT ID:
NCT03141177
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Doublet |
Cabozantinib | Cabometyx | Doublet |
Sunitinib | Sutent | Monotherapy |
Ipilimumab | Yervoy, BMS-734016 | Triplet |
Purpose
The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is
safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal
cell carcinoma
Trial Arms
Name | Type | Description | Interventions |
---|
Doublet | Experimental | Nivolumab and Cabozantinib | |
Monotherapy | Active Comparator | Sunitinib | |
Triplet | Experimental | Nivolumab, Ipilimumab, Cabozantinib
*Enrollment to the triplet arm was discontinued by protocol amendment | |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histological confirmation of RCC with a clear-cell component, including participants
who may also have sarcomatoid features
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC
Stage IV) RCC
- No prior systemic therapy for RCC with the following exception:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such
therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence
occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy
Exclusion Criteria:
- Any active CNS metastases
- Any active, known or suspected autoimmune disease
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
randomization
- Participants who have received a live/attenuated vaccine within 30 days of first
treatment
Other protocol defined inclusion/exclusion criteria could 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) per blinded independent central review (BICR) |
Time Frame: | Up to 29 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) |
Time Frame: | up to 29 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of AEs leading to discontinuation |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Deaths |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities |
Time Frame: | Up to 40 months |
Safety Issue: | |
Description: | |
Measure: | Change from baseline in Laboratory values |
Time Frame: | Up to 40 Months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
February 12, 2021