Canadian Atezolizumab Precision Targeting for Immunotherapy Intervention

Who is this study for? Adult patients with Incurable Solid Tumors
What treatments are being studied? Atezolizumab
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than or equal to 18 years at the time of signature of informed consent.

• Participants with an incurable solid tumour who have undergone whole genome and transcriptome analysis (WGTA) as part of Personalized OncoGenomics (POG) or equivalent program.

• a. Participants must have had successful sequencing of their tumour, been formally reviewed by the POG (or POG-approved) genome analysts and found to have CAPTIV-8 factors identified (including Immune, Burden, Variant (IBV) score ≥ 5), been reviewed at the Molecular Tumour Board (MTB) (or site equivalent), and allocated to a specific tumour-defined cohort (that is open for enrolment) with a final opinion documented.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Participants must have measurable disease, as defined by RECIST 1.1.

• Life expectancy of at least 12 weeks.

• Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 28 days prior to the first study treatment:

‣ Absolute neutrophil count (ANC) ≥ 1500 cells/µL without granulocyte colony- stimulating factor support.

⁃ White blood cell (WBC) counts \> 2500/µL.

⁃ Lymphocyte count ≥ 500/µL.

⁃ Serum albumin ≥ 2.5 g/dL.

⁃ Platelet count ≥ 100,000/µL without transfusion (without transfusion within 2 weeks of laboratory test used to determine eligibility).

⁃ Hemoglobin ≥ 9.0 g/dL, participants may be transfused or receive erythropoietic treatment to meet this criterion.

⁃ International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × Upper Limit of Normal (ULN). This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation must have an INR or aPTT within therapeutic limits for at least 1 week prior to enrolment.

⁃ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 × ULN with the following exceptions: i) Participants with documented liver metastases: AST and/or ALT ≤ 5 × ULN. ii) Participants with documented liver or bone metastases: ALP ≤ 5 × ULN.

⁃ Serum bilirubin ≤ 1.5 × ULN. Participants with known Gilbert's syndrome who have serum bilirubin level ≤ 3 × ULN may be enrolled.

‣ Serum creatinine ≤ 1.5 × ULN.

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than 1% (one percent) per year during the treatment period and for at least 5 months after the last dose of atezolizumab.

• For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures that result in a failure rate of less than 1% (one percent) per year, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose of atezolizumab.

• Asymptomatic participants with treated or untreated CNS lesions are eligible provided that all of the following criteria are met:

‣ Measurable disease, per RECIST 1.1, must be present.

⁃ The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.

⁃ The participant has not undergone stereotactic radiotherapy within 7 days prior to the initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.

⁃ The participant has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.

• Ability to give informed consent for the study procedures defined in this protocol.

Locations
Other Locations
Canada
University Health Network / Princess Margaret Cancer Centre
WITHDRAWN
Toronto
BC Cancer
RECRUITING
Vancouver
Contact Information
Primary
Janessa Laskin, MD
jlaskin@bccancer.bc.ca
800-663-3333
Backup
Daniel Renouf, MD, MPH
drenouf@bccancer.bc.ca
800-663-3333
Time Frame
Start Date: 2020-06-17
Estimated Completion Date: 2027-10
Participants
Target number of participants: 200
Treatments
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.
Sponsors
Collaborators: Hoffmann-La Roche
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov

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