Cancer
Conditions
Brief summary
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.
Interventions
DRUGAtezolizumab
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, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
DRUGBevacizumab
Bevacizumab will be administered as directed per the parent study.
DRUGAlectinib
Alectinib will be administered as directed per the parent study.
DRUGCobimetinib
Cobimetinib will be administered as directed per the parent study.
DRUGVemurafenib
Vemurafenib will be administered as directed per the parent study.
DRUGFAP IL2V
FAP IL2V will be administered as directed per the parent study.
DRUGVenetoclax
Venetoclax will be administered as directed per the parent study.
DRUGEnzalutamide
Enzalutamide will be administered as directed per the parent study.
DRUGPembrolizumab
Pembrolizumab will be administered as directed per the parent study.
DRUGSunitinib
Sunitinib will be administered as directed per the parent study.
DRUGNiraparib
Niraparib will be administered as directed per the parent study.
DRUGCabozantinib
Cabozantinib will be administered as directed per the parent study.
DRUGPemetrexed
Pemetrexed will be administered as directed per the parent study.
DRUGPaclitaxel
Paclitaxel will be administered as directed per the parent study.
DRUGEmactuzumab
Emactuzumab will be administered as directed per the parent study.
DRUGRucaparib
Rucaparib will be administered as directed per the parent study.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for continuing atezolizumab-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 * Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. 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 roll-over 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 this extension study * Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient * Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this 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 this extension study (if applicable). Exception: Participants who permanently discontinued atezolizumab from parent studies that permit participants to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study. * Ongoing serious adverse event(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 * Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or 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 this extension study and for the period after the last dose of study treatment specified in the designated referenced safety information (RSI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) | Day 1 up to maximum 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0 | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Treatment Duration | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Total Dose Received | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Number of Treatment Cycles | Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
Countries
Australia, Belgium, Brazil, Bulgaria, Chile, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Italy, Japan, Mexico, Poland, Romania, Russia, South Korea, Spain, Thailand, Ukraine, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed