Actively Recruiting
Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity
Led by British Columbia Cancer Agency · Updated on 2025-09-22
200
Participants Needed
2
Research Sites
380 weeks
Total Duration
On this page
Sponsors
B
British Columbia Cancer Agency
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigating the Effects of Atezolizumab in People Whose Tumour DNA or RNA Indicates Possible Sensitivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Incurable solid tumor with successful whole genome and transcriptome analysis reviewed by approved genome analysts
- Tumors with CAPTIV-8 factors including Immune, Burden, Variant (IBV) score 65
- Assigned to a specific tumor cohort open for enrollment
- ECOG performance status between 0 and 2
- Measurable disease as defined by RECIST 1.1
- Life expectancy of at least 12 weeks
- Adequate hematologic and organ function based on specified laboratory tests within 28 days before first treatment
- Women of childbearing potential must agree to abstinence or highly effective contraception during treatment and for 5 months after last dose
- Men must agree to abstinence or highly effective contraception and not donate sperm during treatment and for 5 months after last dose
- Asymptomatic with treated or untreated CNS lesions meeting specified safety criteria
- Ability to give informed consent for study procedures
You will not qualify if you...
- Prior treatment with monoclonal antibodies targeting PD-1/PD-L1 pathway
- Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days or five half-lives prior to enrollment
- Pregnancy or breastfeeding
- History of severe allergic or hypersensitivity reactions to antibodies or fusion proteins
- Known hypersensitivity to components of atezolizumab
- Active autoimmune disease within 2 years prior to enrollment, except controlled hypothyroidism or type I diabetes
- Severe dermatologic conditions with active symptoms beyond specified limits
- History or evidence of active pneumonitis or certain lung diseases
- Positive tests for HIV, active hepatitis B or C infection
- Active tuberculosis
- Severe infections requiring hospitalization within 2 weeks prior to treatment
- Significant cardiovascular disease or recent major surgery
- Prior allogeneic stem cell or solid organ transplant
- Recent treatment with systemic immunostimulatory or immunosuppressive agents
- Recent treatment with live attenuated vaccines
- Deemed unfit by treating clinician to proceed with the protocol
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Trial Site Locations
Total: 2 locations
1
BC Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
2
University Health Network / Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Withdrawn
Research Team
J
Janessa Laskin, MD
CONTACT
D
Daniel Renouf, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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