A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
- Conditions
- Cancer
- Interventions
- Registration Number
- NCT05862285
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roche IMP(s) Monotherapy Ipatasertib Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche IMP(s) Monotherapy Atezolizumab Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche IMP(s) Monotherapy Bevacizumab Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche IMP(s) Monotherapy Entrectinib Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche IMP(s) Monotherapy Inavolisib Participants will continue to receive Roche IMP(s) monotherapy as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche Combined Agents Tiragolumab Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche Combined Agents Atezolizumab Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche Combined Agents Tiragolumab and Atezolizumab Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche Combined Agents Bevacizumab Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first. Roche Combined Agents Inavolisib Participants will continue to receive Roche IMP(s) in combination with other agent(s) as per parent protocol, until disease progression, loss of clinical benefit as judged by the investigator, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participants non-compliance, if local access becomes available or study termination by the Sponsor, whichever occurs first.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Clinica CIMCA
🇨🇷San José, Costa Rica
GHdC Site Les Viviers
🇧🇪Charleroi, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Princess Margaret Cancer Center
🇨🇦Toronto, Ontario, Canada
ICIMED Instituto de Investigación en Ciencias Médicas
🇨🇷San José, Costa Rica
Institut de Cancérologie de Bourgogne
🇫🇷Dijon, France
Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
🇫🇷Montpellier, France
Institut de cancerologie du Gard
🇫🇷Nimes, France
ICO - Site René Gauducheau
🇫🇷Saint Herblain, France
Yokohama City University Medical Center
🇯🇵Kanagawa, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Centro Medico Culiacan SA de CV
🇲🇽Culiacan, Sinaloa, Mexico
Medical Care & Research
🇲🇽Mérida, Yucatan, Mexico
Consultorio de Especialidad en Urologia Privado
🇲🇽Durango, Mexico
Moscow City Oncology Hospital #62
🇷🇺Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
Russian Scientific Center of Roentgenoradiology
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
P.A. Herzen Oncological Inst.
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Chang Gung Memorial Hospital - Linkou
🇨🇳Taoyuan, Taiwan
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital
🇹🇭Chiangmai, Thailand
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Royal Marsden Hospital - Surrey
🇬🇧Surrey, United Kingdom