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

  • STATUS
    Recruiting
  • End date
    Oct 23, 2024
  • participants needed
    200
  • sponsor
    British Columbia Cancer Agency
Updated on 23 July 2021
platelet count
cancer
total bilirubin
absolute neutrophil count
granulocyte colony stimulating factor
measurable disease
gilbert's syndrome
serum bilirubin
metastasis
neutrophil count
liver metastasis
g-csf
bone metastases
thromboplastin
solid tumour
sarcoma
metastatic cancer
atezolizumab
mammogram
lymphocyte count

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, Metastasis, Breast Cancer, Genitourinary Neoplasms, melanoma, Neoplasms, Unknown Primary, Lung Neoplasm, skin cancer, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Sarcoma, Bronchial Neoplasm, head and neck cancer, Metastatic Melanoma, All Solid Tumors, Liver Metastases, Bone Metastases, Gastrointestinal Diseases and Disorders, Solid Tumors, Breast Cancer Diagnosis, Brain Metastases, Gynecologic Cancer, Sarcoma (Pediatric), Lung Cancer, Malignant Melanoma, Lung Disease, Metastatic Cancer, Digestive System Neoplasms, Soft Tissue Sarcoma, Neoplasm Metastasis, Genitourinary Cancer, breast carcinoma, gastrointestinal cancer, sarcomas, soft tissue sarcomas, cancer, breast, cancer of the head and neck, tumor, unknown primary, skin cancers, gastrointestinal cancers, carcinoma lung, lung carcinoma
Treatment Atezolizumab
Clinical Study IdentifierNCT04273061
SponsorBritish Columbia Cancer Agency
Last Modified on23 July 2021

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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