Phase 2 Study Comparing CB839 & Cabo vs. Placebo & Cabo in Adv RCC
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Cabozantinib (CB-Cabo) vs. Placebo with Cabozantinib (Pbo-Cabo) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)
IRAS ID
245733
Contact name
Lisa Pickering
Contact email
Sponsor organisation
Calithera Biosciences Inc
Eudract number
2018-000363-91
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This research is to determine if CB-839, given together with cabozantinib is able to stop or reduce the rate of cancer growth in patients with advanced renal cell carcinoma (kidney cancer) better than cabozantinib alone. The study is placebo-controlled, randomized and double-blinded. Participants will be randomised at a 1:1 ratio. Approximately 298 participants are expected to be enrolled in this study across all countries. This study will run in the EU, the USA, Australia and New Zealand. All participants in the study must be 18 years of age or older and be diagnosed with advanced or metastatic clear cell kidney cancer. Subjects will receive study treatment as long as they continue to experience clinical benefit in the opinion of the Investigator or until there is unacceptable toxicity or the need for subsequent systemic anticancer treatment. The Study Protocol does not specify an end date and can be in excess of 19 cycles, each cycle lasting approximately 28 days.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1172
Date of REC Opinion
8 Aug 2018
REC opinion
Further Information Favourable Opinion