A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (NCT05862285) — China Trial Details

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Ipatasertib →Tiragolumab →Atezolizumab →Tiragolumab and Atezolizumab →Bevacizumab →Entrectinib →Inavolisib →Divarasib →Giredestrant →

Ipatasertib: Ipatasertib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Tiragolumab: Tiragolumab in combination with atezolizumab will be administered at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Atezolizumab: Atezolizumab will be administered as a monotherapy and in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants' discontinuation from the parent study.

Tiragolumab and Atezolizumab: Tiragolumab and Atezolizumab in fixed dose combination administered intravenously (IV) at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Bevacizumab: Bevacizumab will be administered as a monotherapy or in combination with atezolizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Entrectinib: Entrectinib will be administered as a monotherapy at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Inavolisib: Inavolisib will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Divarasib: Divarasib will be administered as a monotherapy or in combination with atezolizumab or bevacizumab at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Giredestrant: Giredestrant will be administered as a monotherapy or in combination at the same dose, schedule, and with the same administration guidelines that were in effect at the time of participants discontinuation from the parent study.

Study summary

The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP\[s\]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

No

Inclusion Criteria: * Eligible for continuing Roche IMP-based therapy at the time of roll-over 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 the Roche IMP-based therapy or comparator at the time of roll-over from the parent study as assessed by the investigator * Ability to comply with the extension study protocol, per Investigator's judgement Exclusion Criteria: * Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study * Study treatment or comparator agent is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant * 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 all study treatment(s) or comparator agent(s) 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 SAE(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. Potential participants with an ongoing SAE that has not resolved to baseline level or Grade 1 may be enrolled at the investigator's discretion, provided the event is deemed clinically stable and the investigator documents that the potential clinical benefit outweighs the risk to the potential participant. * Concurrent participation in any therapeutic clinical trial (other than the parent study)

Primary outcome measure(s)

Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) — Up to approximately 10 years
Number and Severity of Participants With Selected Adverse Events Assessed as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 — Up to approximately 10 years

Trial sites (85)

Facility	City	Region	Status
GHdC Site Les Viviers	Charleroi	Belgium	Completed
AZ Groeninge	Kortrijk	Belgium	Active Not Recruiting
UZ Leuven Gasthuisberg	Leuven	Belgium	Completed
UZ Leuven Gasthuisberg	Leuven	Belgium	Active Not Recruiting
Princess Margaret Cancer Center	Toronto	Ontario	Recruiting
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology	Wuhan	Hubei	Recruiting
First Affiliated Hospital of Medical College of Xi'an Jiaotong University	XI 'an City, Shaanxi Province	Shaanxi	Recruiting
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting
Beijing Cancer Hospital	Beijing	China	Recruiting
the First Hospital of Jilin University	Changchun	China	Recruiting
West China Hospital of Sichuan University	Chengdu	China	Recruiting
Cancer Center of Guangzhou Medical University	Guangzhou	China	Recruiting
Nanfang Hospital, Southern Medical University	Guangzhou	China	Recruiting
Zhejiang People's Hospital	Hangzhou	China	Recruiting
Sir Run Run Shaw Hospital Zhejiang University	Hangzhou	China	Recruiting
Zhejiang Cancer Hospital	Hangzhou	China	Recruiting
Harbin Medical University Cancer Hospital	Harbin	China	Recruiting
The Second Affiliated Hospital of Anhui Medical University	Hefei	China	Recruiting
Meizhou People's Hospital	Meizhou	China	Recruiting
The 1st Affiliated Hospital of Nanchang Unversity	Nanchang	China	Recruiting
Jiangsu Province Hospital of Chinese Medicine	Nanjing	China	Recruiting
Shanghai Chest Hospital	Shanghai	China	Recruiting
Fudan University Shanghai Cancer Center	Shanghai	China	Recruiting
Shanghai Geriatric Medical Center	Shanghai	China	Recruiting
Tianjin Cancer Hospital	Tianjin	China	Recruiting
First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an	China	Recruiting
Xi'an International Medical Center Hospital	Xi'an	China	Recruiting
The First Affiliated Hospital of Xiamen University	Xiamen	China	Recruiting
The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	China	Recruiting
Henan Cancer Hospital	Zhengzhou	China	Recruiting
Clinica CIMCA	San José	Costa Rica	Active Not Recruiting
ICIMED Instituto de Investigación en Ciencias Médicas	San José	Costa Rica	Active Not Recruiting
AP-HM- Hôpital de La Timone	Marseille	Bouches-du-Rhône	Recruiting
Institut Bergonie	Bordeaux	France	Recruiting
Centre Francois Baclesse	Caen	France	Recruiting
Institut de Cancérologie de Bourgogne	Dijon	France	Recruiting
Centre Leon Berard	Lyon	France	Recruiting
Hopital de la Timone	Marseille	France	Recruiting
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque	Montpellier	France	Recruiting
CHU de Nantes - Hotel Dieu	Nantes	France	Recruiting

+ 45 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

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