An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)

Phase 1

Recruiting

• Conditions: Advanced Malignancies; MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104; MedDRA version: 20.0Level: LLTClassification code: 10064467Term: Urothelial carcinoma Class: 10029104; MedDRA version: 26.1Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864; MedDRA version: 27.0Level: LLTClassification code: 10027481Term: Metastatic melanoma Class: 10029104; MedDRA version: 27.0Level: LLTClassification code: 10052362Term: Metastatic colorectal cancer Class: 10029104; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10072740Term: Locally advanced breast cancer Class: 10029104

• Registration Number: CTIS2023-506184-34-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1099

Inclusion Criteria

Signed extension study Informed Consent Form, Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or, Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent, Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study, Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator, Able to comply with this extension study, in the investigator's judgment, Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential, Will comply with contraception criteria

Exclusion Criteria

Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study, Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient, Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study, Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable), Ongoing serious adverse event(s) that has not resolved to baseline level or Grade =1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study, Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications, Concurrent participation in any therapeutic clinical trial (other than the parent study), Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated RSI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide continued treatment with atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally;Secondary Objective: To identify any new safety signal related to atezolizumab or atezolizumab administered with combination agent(s) in patients who are currently eligible to receive treatment with atezolizumab and have demonstrated clinical benefit;Primary end point(s): Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.