Skip to main content
MedPathMedPath Home
Clinical Trials/2023-509711-83-00
2023-509711-83-00
Active, not recruiting
Phase 3

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

Bristol Myers Squibb International Corporation23 sites in 7 countries265 target enrollmentStarted: April 10, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 3
Status
Active, not recruiting
Enrollment
265
Locations
23
Primary Endpoint
Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in the treatment of Kidney cancer in patients with previously untreated, advanced, or cancer that has spread

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants

Progression Free Survival (PFS) per blinded independent central review (BICR) of Arm A versus Arm C in all randomized participants

Secondary Outcomes

  • Overall Survival (OS) of Arm A versus Arm C
  • Objective Response Rate (ORR)
  • Incidence of adverse events (AEs)
  • Incidence of Serious Adverse Events (SAEs)

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

GSM-CT

Scientific

Bristol Myers Squibb International Corporation

Study Sites (23)

Loading locations...

Similar Trials

Completed
Phase 2
A Study of Nivolumab and Nivolumab Combinations in Recurrent and Metastatic Colon Cancer
2024-516004-42-01Bristol Myers Squibb International Corporation143
Active, not recruiting
Phase 3
A Clinical Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
2023-506576-27-00Janssen - Cilag International170
Completed
Phase 2
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.
2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
Recruiting
Not Applicable
Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease
NCT07272499Ruijin Hospital25
Recruiting
Not Applicable
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma
NCT07270835The First Affiliated Hospital of Soochow University40