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Closed (no longer recruiting)Last updated: 29 August 2023

COSMIC-313: This phase III trial is combining a targeted cancer treatment and immunotherapy treatment to see how this combination impacts survival outcomes for people whose renal cell carcinoma (a type of cancer) has spread to other parts of the bodyA 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

Clinical summary

Summary

Eligible participants will be randomised to receive either cabozantinib or a placebo, in combination with nivolumab and ipilimumab for four doses, followed by further dose(s) of nivolumab and cabozantinib/placebo treatment.

Conditions

This trial is treating patients with renal cell carcinoma (a type of cancer).

Cancer

Urinary System Cancers Urinary System

Age

People18+

Phase

III

Trial Acronym

COSMIC-313

More information

Trial Identifiers

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Commercial Sponsor

Exelixis

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

Eligibility

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.