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

Sponsor
British Columbia Cancer Agency
Study ID
NCT04273061
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    1200 mg by intravenous infusion every 3 weeks as tolerated

Study Details

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.

Key Dates

Start date
Jun 17, 2020
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Breast Cohort
    Cohort of participants whose primary tumour type is breast.
  • Experimental: Lung Cohort
    Cohort of participants whose primary tumour type is lung.
  • Experimental: GI Cohort
    Cohort of participants whose primary tumour type is gastrointestinal (including pancreas and hepatobiliary).
  • Experimental: GU Cohort
    Cohort of participants whose primary tumour type is genitourinary.
  • Experimental: Gyne Cohort
    Cohort of participants whose primary tumour type is gynecological.
  • Experimental: Sarcoma Cohort
    Cohort of participants whose primary tumour type is sarcoma.
  • Experimental: Primary Unknown Cohort
    Cohort of participants whose primary tumour type is unknown.
  • Experimental: Other Cohort
    Cohort of participants whose primary tumour type is not classified as one of the other study arms. This cohort includes participants with cancers from the head and neck, skin, or rare cancers.

Primary Outcome Measure

Overall response rate (ORR) in each tumour-defined cohort, as defined by RECIST 1.1 [ Time Frame: From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months. ]

Central Contacts

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