Cancer
Conditions
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.
Interventions
DRUGIpatasertib
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.
DRUGTiragolumab
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.
DRUGAtezolizumab
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 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.
DRUGBevacizumab
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.
DRUGEntrectinib
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.
DRUGInavolisib
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.
DRUGDivarasib
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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 * Concurrent participation in any therapeutic clinical trial (other than the parent study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium, Canada, China, Costa Rica, France, Greece, Japan, Mexico, Poland, Russia, South Korea, Taiwan, Thailand, United Kingdom
Contacts
CONTACTReference Study ID Number: BX44273 https://forpatients.roche.com/
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed