Cabozantinib with Nivolumab and Ipilimumab in Untreated Metastatic RCC
Research type
Research Study
Full title
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
IRAS ID
263485
Contact name
Thomas Powles
Contact email
Sponsor organisation
Exelixis, Inc.
Eudract number
2018-004567-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND NUMBER: , 140,521
Duration of Study in the UK
2 years, 1 months, 27 days
Research summary
This study evaluates the efficacy and safety of anti-cancer medication cabozantinib in combination with two other anti-cancer drugs nivolumab and ipilimumab compared to a treatment with just nivolumab and ipilimumab in previously untreated subjects with intermediate- or poor-risk advanced or metastatic kidney cancer (Renal Cell Carcinomas (RCC)).
Cabozantinib, nivolumab and ipilimumab are approved drugs for RCC. However, a combination of these three drugs is not yet approved but is attractive because of the potential for improved clinical outcomes for all patients. Further evaluation of cabozantinib in combination with nivolumab and ipilimumab in previously untreated RCC patients of intermediate-or poor-risk is warranted.
Exelixis, the company sponsoring this trial, will be organising and funding this study. Approximately 676 eligible participants with intermediate- or poor-risk advanced or metastatic RCC will be randomized in a 1:1 ratio (~338 per treatment arm) at approximately 150 sites globally. Participants will remain for approximately 15 to 21 months on study including 3 months of safety follow-up. They will be followed until death, withdrawal of consent or Sponsors decision to no longer collect survival data.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1263
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion