A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma

Official Title

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma

Summary:

This is a Phase III, multicentre, open-label, three-arm, randomized study in participants with unresectable locally advanced or metastatic colorectal cancer (CRC) who have received at least two prior regimens of cytotoxic chemotherapy for metastatic disease. The study compares regorafenib, a standard of care therapy in this setting, to cobimetinib plus atezolizumab and atezolizumab monotherapy.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression-free Survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
  • Percentage of Participants with Investigator-assessed Objective Response of Complete Response (CR) or Partial Response (PR) per RECIST Version 1.1
  • Duration of Response (DOR) based on RECIST Version 1.1
  • Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 questionnaire (EORTC QLQ-C30) score

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society