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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112965
• Other study ID #: YO42713
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: YO42713 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• 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.
• Bevacizumab
Bevacizumab will be administered as directed per the parent study.
• Pemetrexed
Pemetrexed will be administered as directed per the parent study.
• Paclitaxel
Paclitaxel will be administered as directed per the parent study.
• Enzalutamide
Enzalutamide will be administered as directed per the parent study.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing City
China	Changchun Cancer Hospital	Changchun
China	Jilin Cancer Hospital	Changchun
China	Hunan Cancer Hospital	Changsha CITY
China	The 900th Hospital of PLA joint service support force	Fuzhou
China	Nanfang Hospital, Southern Medical University	Guangzhou
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Sir Run Run Shaw Hospital	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Shandong Cancer Hospital	Jinan
China	Jiangsu Cancer Hospital	Nanjing City
China	Shanghai Chest Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	The 2nd Hospital of Tianjin Medical University	Tianjin
China	Tianjin Cancer Hospital	Tianjin
China	Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center	Wuhan
China	Zhejiang Cancer Hospital	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)		Up to approximately 4 years
Secondary	Percentage of Participants With Serious Adverse Events (SAEs)		Up to 90 days after the final dose of study treatment (up to approximately 4 years)
Secondary	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)