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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
1200 mg by intravenous infusion every 3 weeks as tolerated
BC Cancer
Vancouver, British Columbia, Canada
RECRUITINGUniversity Health Network / Princess Margaret Cancer Centre
Toronto, Ontario, Canada
WITHDRAWNOverall response rate (ORR) in each tumour-defined cohort, as defined by RECIST 1.1
The proportion of participants in each tumour-defined cohort who have a complete response (CR) or partial response (PR) to treatment, 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.
Progression-free survival (PFS) in each tumour-defined cohort from the initiation of atezolizumab
The length of time from the first dose of atezolizumab until participants in each tumour-defined cohort have progressive disease (PD), as defined by RECIST 1.1.
Time frame: From the date of first dose until the date of confirmed progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.
Clinical benefit rate (CBR) in each tumour-defined cohort at the 18-week follow-up scan
The percentage of participants in each tumour-defined cohort who have a complete response (CR), partial response (PR), or stable disease (SD) response to treatment, as defined by RECIST 1.1, at the 18-week follow-up scan.
Time frame: From the date of the screening scan (within 28 days of first dose) until the date of the 18-week follow-up scan.
Overall survival (OS) in each tumour-defined cohort from the initiation of atezolizumab
The length of time from the initiation of atezolizumab that participants in each tumour-defined cohort survive.
Time frame: From the date of first dose until the date of death, assessed up to 54 months.
Quality-adjusted survival in each tumour-defined cohort from the initiation of atezolizumab
Survival time (from the initiation of atezolizumab) multiplied by quality of life. Participants' responses to health-related quality of life questions on the EQ-5D-3L questionnaire will be converted to utility weights using existing conversion scales that are based on patient and public valuations of the health states described by the EQ-5D-3L questionnaire.
Time frame: From the date of first dose until the treatment discontinuation visit (within 30 days of last dose), withdrawal, or date of death, whichever comes first, assessed up to 54 months.
Duration of response (DoR) in each tumour-defined cohort
The length of time from the first response to treatment (CR or PR) until participants in each tumour-defined cohort have progressive disease (PD), as defined by RECIST 1.1.
Time frame: From the date of the scan that shows the first response to treatment until the date of progression, withdrawal, or date of death, whichever comes first, assessed up to 54 months.
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