The trial is taking place at:
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A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Roche logo

Roche

Status and phase

Enrolling
Phase 3

Conditions

Cancer

Treatments

Drug: Niraparib
Drug: Pembrolizumab
Drug: Enzalutamide
Drug: FAP IL2V
Drug: Vemurafenib
Drug: Sunitinib
Drug: Paclitaxel
Drug: Rucaparib
Drug: Cobimetinib
Drug: Bevacizumab
Drug: Venetoclax
Drug: Emactuzumab
Drug: Cabozantinib
Drug: Pemetrexed
Drug: Atezolizumab
Drug: Alectinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03768063
BO40729

Details and patient eligibility

About

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 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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) * 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Parallel Assignment

Masking

None (Open label)

1,000 participants in 3 patient groups

Atezolizumab Monotherapy
Experimental group
Description:
Participants will receive atezolizumab by intravenous infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Treatment:
Drug: Atezolizumab
Combined Agents with Atezolizumab
Experimental group
Description:
Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Treatment:
Drug: Alectinib
Drug: Atezolizumab
Drug: Pemetrexed
Drug: Emactuzumab
Drug: Cabozantinib
Drug: Venetoclax
Drug: Bevacizumab
Drug: Cobimetinib
Drug: Rucaparib
Drug: Paclitaxel
Drug: Vemurafenib
Drug: FAP IL2V
Drug: Enzalutamide
Drug: Niraparib
Comparator Treatment
Active Comparator group
Description:
Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.
Treatment:
Drug: Pemetrexed
Drug: Venetoclax
Drug: Cobimetinib
Drug: Paclitaxel
Drug: Sunitinib
Drug: Vemurafenib
Drug: Pembrolizumab
Drug: Enzalutamide
Drug: Niraparib

Trial contacts and locations

192

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Central trial contact

Reference Study ID Number: BO40729 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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