A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Roche

Status and phase: Enrolling; Phase 3

Conditions: Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03768063

2023-506184-34-00 (Registry Identifier)

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 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.

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). 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)

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: Pemetrexed

Drug: Alectinib

Drug: Atezolizumab

Drug: Cabozantinib

Drug: Venetoclax

Drug: Paclitaxel

Drug: Bevacizumab

Drug: Cobimetinib

Drug: Vemurafenib

Drug: FAP IL2V

Drug: Rucaparib

Drug: Enzalutamide

Drug: Emactuzumab

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: Paclitaxel

Drug: Cobimetinib

Drug: Sunitinib

Drug: Vemurafenib

Drug: Pembrolizumab

Drug: Enzalutamide

Drug: Niraparib