Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Immune System Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Skin Neoplasms

Head and Neck Neoplasms

Sarcoma

Lung Neoplasms

Hypersensitivity

Gastrointestinal Neoplasms

Digestive System Neoplasms

Urogenital Neoplasms

Neoplasms, Unknown Primary

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Neoplasm Metastasis

Neoplastic Processes

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Atezolizumab

Immunomodulating Agents

Pancrelipase

Pancreatin

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Cohort of participants whose primary tumour type is breast.

Cohort of participants whose primary tumour type is lung.

Cohort of participants whose primary tumour type is gastrointestinal (including pancreas and hepatobiliary).

Cohort of participants whose primary tumour type is genitourinary.

Cohort of participants whose primary tumour type is gynecological.

Cohort of participants whose primary tumour type is sarcoma.

Cohort of participants whose primary tumour type is unknown.

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.

1200 mg by intravenous infusion every 3 weeks as tolerated

Janessa Laskin, MD

Daniel Renouf, MD, MPH

Daniel J Renouf, MD, MPH

Lillian Siu, MD

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.

Simon 2-stage design; 8 tumour-defined cohorts consisting of 8 to 24 participants each.

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

Canadian Atezolizumab Precision Targeting for Immunotherapy Intervention

From blood and tissue samples collected throughout the study, identify putative markers of sensitivity to atezolizumab based on the response to treatment of the participants in each tumour-defined cohort.

From blood and tissue samples collected throughout the study, identify putative primary and secondary resistance markers to atezolizumab based on the response to treatment of the participants in each tumour-defined cohort.

From blood and tissue samples collected throughout the study, identify putative germline predictors of adverse events or toxicities of interest to atezolizumab based on the response to treatment of the participants in each tumour-defined cohort.

Participant response to treatment as per RECIST 1.1. compared to the response to treatment as per the modified response evaluation criteria in solid tumours for immunotherapy trials (iRECIST) from screening until progression in each tumour-defined cohort.

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.

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.

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.

The length of time from the initiation of atezolizumab that participants in each tumour-defined cohort survive.

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.

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.

Spots Global Cancer Trial Database for precision targeting