Clinical trial NCT05112965: An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 90 days after the final dose of study treatment (up to approximately 4 years)
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Up to 90 days after the final dose of study treatment (up to approximately 4 years)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center
state: Hubei
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: Changchun Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha City
country: China
facility: Hunan Cancer Hospital
city: Fuzhou
country: China
facility: The 900th Hospital of PLA joint service support force
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Tianjin
country: China
facility: The 2nd Hospital of Tianjin Medical University
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: