An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)

NCT ID: NCT05112965

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2026-06-30

Brief Summary

This is an open-label, multicenter, non-randomized extension study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and do not have access to the study treatment locally, continue to receive study treatment in this extension study.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atezolizumab Monotherapy

Participants will continue to receive atezolizumab monotherapy as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study at the time of participant discontinuation from the parent study closure.

Combined Agents with Atezolizumab

Participants will continue to receive atezolizumab with other agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study at the time of participant discontinuation from the parent study closure.

Bevacizumab

Intervention Type: DRUG

Bevacizumab will be administered as directed per the parent study.

Pemetrexed

Intervention Type: DRUG

Pemetrexed will be administered as directed per the parent study.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered as directed per the parent study.

Enzalutamide

Intervention Type: DRUG

Enzalutamide will be administered as directed per the parent study.

Comparator Treatment

Participants will continue to receive comparator agent(s) as per parent protocol, until disease progression or beyond if the participant continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; participant non-compliance; or study termination by the Sponsor, whichever occurs first.

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

Bevacizumab will be administered as directed per the parent study.

Pemetrexed

Intervention Type: DRUG

Pemetrexed will be administered as directed per the parent study.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered as directed per the parent study.

Enzalutamide

Intervention Type: DRUG

Enzalutamide will be administered as directed per the parent study.

Interventions

Atezolizumab

Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study at the time of participant discontinuation from the parent study closure.

Intervention Type: DRUG

Bevacizumab

Bevacizumab will be administered as directed per the parent study.

Intervention Type: DRUG

Pemetrexed

Pemetrexed will be administered as directed per the parent study.

Intervention Type: DRUG

Paclitaxel

Paclitaxel will be administered as directed per the parent study.

Intervention Type: DRUG

Enzalutamide

Enzalutamide will be administered as directed per the parent study.

Intervention Type: DRUG

Other Intervention Names

Tecentriq; Avastin; Xtandi

Eligibility Criteria

Inclusion Criteria

• Eligible for continuing or crossing over to 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
• 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 rollover from the parent study as assessed by the investigator
• Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
• For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
• For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria

• Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
• Study treatment is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
• Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (±7 days) allowed in the parent study
• 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 the 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 the extension study (if applicable)
• Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
• Ongoing serious adverse events that have 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 the extension study
• Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would 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 the extension study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Union Hospital of Tongji Medical College, Dept. of Cancer Center

Wuhan, Hubei, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Changchun Cancer Hospital

Changchun, , China

Jilin Cancer Hospital

Changchun, , China

Hunan Cancer Hospital

Changsha, , China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Jiangsu Cancer Hospital

Nanjing, , China

Shanghai Chest Hospital

Shanghai, , China

Tianjin Cancer Hospital

Tianjin, , China

The 2nd Hospital of Tianjin Medical University

Tianjin, , China

Zhejiang Cancer Hospital

Zhejiang, , China

Henan Cancer Hospital

Zhengzhou, , China

Countries

China

Other Identifiers

YO42713

Identifier Type: -

Identifier Source: org_study_id