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

NCT05112965 | Active Not Recruiting Phase 3

• 1 other identifier: YO42713
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)

  Up to approximately 4 years

Secondary Outcomes (2)

• Percentage of Participants With Serious Adverse Events (SAEs)

  Up to 90 days after the final dose of study treatment (up to approximately 4 years)

• Percentage of Participants With Adverse Events of Special Interest (AESIs)

  Up to 90 days after the final dose of study treatment (up to approximately 4 years)

Study Arms (3)

Atezolizumab Monotherapy

EXPERIMENTAL

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.

Drug: Atezolizumab

Combined Agents with Atezolizumab

EXPERIMENTAL

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.

Drug: Atezolizumab; Drug: Bevacizumab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Enzalutamide

Comparator Treatment

ACTIVE COMPARATOR

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.

Drug: Bevacizumab; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Enzalutamide

Interventions

Pemetrexed DRUG

Pemetrexed will be administered as directed per the parent study.

Combined Agents with Atezolizumab; Comparator Treatment

Paclitaxel DRUG

Paclitaxel will be administered as directed per the parent study.

Combined Agents with Atezolizumab; Comparator Treatment

Enzalutamide DRUG

Enzalutamide will be administered as directed per the parent study.

Also known as: Xtandi

Combined Agents with Atezolizumab; Comparator Treatment

Atezolizumab 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.

Also known as: Tecentriq

Atezolizumab Monotherapy; Combined Agents with Atezolizumab

Bevacizumab DRUG

Bevacizumab will be administered as directed per the parent study.

Also known as: Avastin

Combined Agents with Atezolizumab; Comparator Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

Location

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

Wuhan, Hubei, 430022, China

Location

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Changchun Cancer Hospital

Changchun, 130000, China

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

Hunan Cancer Hospital

Changsha, 410013, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Jiangsu Cancer Hospital

Nanjing, 211100, China

Location

Shanghai Chest Hospital

Shanghai, 200000, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

The 2nd Hospital of Tianjin Medical University

Tianjin, 300211, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

atezolizumab; Bevacizumab; Pemetrexed; Paclitaxel; enzalutamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 9, 2021
• Study Start: December 1, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (17)