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OncoMatch/Clinical Trials/NCT04273061

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

Is NCT04273061 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Atezolizumab for breast cancer.

Phase 2RecruitingBritish Columbia Cancer AgencyNCT04273061Data as of May 2026

Treatment: AtezolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Non-Small Cell Lung Carcinoma

Colorectal Cancer

Gastric Cancer

Hepatocellular Carcinoma

Pancreatic Cancer

Cholangiocarcinoma

Esophageal Carcinoma

Sarcoma

Head and Neck Squamous Cell Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: anti-PD-1/PD-L1 therapy

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.

Cannot have received: any approved or investigational agent

Exception: GnRH analogues may continue

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. Participants receiving gonadotropin releasing hormone (GnRH) analogues may continue to receive treatment while participating in CAPTIV-8.

Lab requirements

Blood counts

ANC ≥ 1500/µL without G-CSF; WBC > 2500/µL; lymphocyte count ≥ 500/µL; platelet count ≥ 100,000/µL without transfusion; hemoglobin ≥ 9.0 g/dL (transfusion/erythropoietic support allowed)

Kidney function

Serum creatinine ≤ 1.5 × ULN

Liver function

AST, ALT, and ALP ≤ 2.5 × ULN (≤ 5 × ULN with liver or bone metastases); serum bilirubin ≤ 1.5 × ULN (≤ 3 × ULN with Gilbert's syndrome)

Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 28 days prior to the first study treatment: ... (see full criteria for details)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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