Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity

Official Title

Canadian Atezolizumab Precision Targeting for Immunotherapy Intervention

Summary:

This study will investigate the effects of atezolizumab on select cancer types in people whose analysis of tumour DNA and RNA indicates they may be sensitive to atezolizumab. This study aims to determine if the information from the cancer genome analysis corresponds with the effects of atezolizumab on individuals and their cancer. This is a Phase 2 study, which is undertaken after preliminary safety testing on a drug is completed, and will involve approximately 200 participants. Participants are assigned to one of 8 cohorts based on their primary tumour type: breast, lung, gastrointestinal (GI), primary unknown, genitourinary (GU), sarcoma, gynecological, and 'other' cancer types. Participants in all cohorts will receive the same dose of atezolizumab (1200 mg every 3 weeks). In the first stage for each cohort, 8 participants will be enrolled and if no participants respond to treatment, enrollment to that cohort will be closed. If 1 or more participants respond to treatment, up to 16 additional participants will be enrolled to that cohort. Participants continue on treatment until they no longer may benefit from the treatment or they decide to stop treatment.

Trial Description

Primary Outcome:

  • Overall response rate (ORR) in each tumour-defined cohort, as defined by RECIST 1.1
Secondary Outcome:
  • Progression-free survival (PFS) in each tumour-defined cohort from the initiation of atezolizumab
  • Clinical benefit rate (CBR) in each tumour-defined cohort at the 18-week follow-up scan
  • Overall survival (OS) in each tumour-defined cohort from the initiation of atezolizumab
  • Quality-adjusted survival in each tumour-defined cohort from the initiation of atezolizumab
  • Duration of response (DoR) in each tumour-defined cohort

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