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Trial Summary

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 676 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio (~338 per treatment arm) at approximately 180 sites.

Acronym:

COSMIC-313

ACTRN/NCT /ethics:

NCT03937219

Scientific 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

Sponsor / Cooperative group:

Exelixis

Trial & Patient Characteristics

Cancer TypeKidney
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream Renal Cell Carcinoma
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date25/06/2019
Anticipated End Date1/06/2024

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorProfessor Hsing Tan
Recruitment StatusRecruiting
HospitalCalvary North Adelaide Hospital
Clinical Trial CoordinatorJulie Rowe
Emailjulie.rowe@calvarycare.org.au
Phone08 8239 9536
Principal InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting