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

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Recruiting
participants needed

200
sponsor

British Columbia Cancer Agency

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Updated on 19 February 2024

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cancer

blood transfusion

breast cancer

platelet count

absolute neutrophil count

measurable disease

metastasis

atezolizumab

solid tumour

gilbert's syndrome

neutrophil count

lung cancer

sarcoma

liver metastasis

international normalized ratio

granulocyte colony stimulating factor

bone metastases

primary tumor

serum bilirubin

gastrointestinal cancer

thromboplastin

g-csf

aptt

head and neck cancer

serum bilirubin level

liver metastases

international normalised ratio

metastatic cancer

lymphocyte count

international normalized ratio (inr)

transcriptome analysis

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.

Details

Condition	Gastrointestinal Neoplasm, Pulmonary Disease, Connective and Soft Tissue Neoplasm, Solid Tumors, Metastasis, Brain Metastases, Breast Cancer, Breast Cancer, Genitourinary Neoplasms, melanoma, Metastatic Melanoma, melanoma, Neoplasms, Unknown Primary, Lung Neoplasm, skin cancer, skin cancer, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Sarcoma, Sarcoma, head and neck cancer, head and neck cancer, Metastatic Melanoma, Gynecologic Cancer, Solid Tumors, Brain Metastases
Age	18-100 years
Treatment	Atezolizumab
Clinical Study Identifier	NCT04273061
Sponsor	British Columbia Cancer Agency
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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
	Participants must have had successful sequencing of their tumour, been formally reviewed by the POG 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), 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/L without granulocyte colonystimulating factor support
	White blood cell (WBC) counts > 2500/L
	Lymphocyte count 500/L
	Serum albumin 2.5 g/dL
	Platelet count 100,000/L 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
	Ability to give informed consent for the study procedures defined in this protocol
Exclusion Criteria
	Any prior treatment with monoclonal antibodies targeting the Programmed Death 1/Ligand (PD-1/PD-L1) axis, including antibody-drug conjugates and other experimental agents
	Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days or five half-lives of the drug, whichever is longer, prior to enrollment
	Asymptomatic participants with treated or untreated central nervous system (CNS) lesions are eligible provided that all of the following criteria are met
	Measurable disease, per RECIST v1.1, must be present outside the CNS
	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 participants has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted
	Pregnancy or breastfeeding
	History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
	Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
	Active autoimmune disease at any point within the last 2 years prior to enrollment including but not limited to
	Myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjgren's syndrome, Guillain-Barr syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
	Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible for this study
	Participants with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study
	Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions
	Rash must cover less than 10% (ten percent) of body surface area (BSA)
	Disease is well controlled at baseline and only requiring low potency topical steroids
	No acute exacerbations of underlying condition within the last 12 months requiring treatment with either psoralen plus ultraviolet radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high potency or oral steroids
	History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
	Previous positive test for HIV (participants with a past history of/or symptoms of HIV are eligible only if serological tests are negative)
	Participants with known active hepatitis B virus (HBV; chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
	Active tuberculosis
	Severe infections within 2 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
	Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
	Major surgical procedure within 21 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
	Prior allogeneic stem cell or solid organ transplant
	Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
	Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial
	Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
	Participants who are otherwise felt by the treating clinician to be unfit to proceed with this protocol

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absolute neutrophil count

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gastrointestinal cancer

serum bilirubin level

liver metastases

international normalised ratio

metastatic cancer

lymphocyte count

international normalized ratio (inr)

transcriptome analysis

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