Recruiting
Phase 3

Roche IMP

Sponsor:

Hoffmann-La Roche

Code:

NCT05862285

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ipatasertib

Tiragolumab

Atezolizumab

Tiragolumab and Atezolizumab

Bevacizumab

Study Details

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.

Conditions

Cancer

Study ID

NCT05862285

Start date

Jun 1, 2023

Status verified date

Sep, 2026

Completion date

Mar 1, 2033

Anticipated

Primary completion date

Mar 1, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Roche IMP(s) Monotherapy

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.

experimental: Roche Combined Agents

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.

Interventions

Ipatasertib

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.

Tiragolumab

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.

Atezolizumab

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

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.

Bevacizumab

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.

Entrectinib

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.

Inavolisib

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.

Divarasib

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.

Primary outcome measure

  • Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s) [ Time Frame: 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 [ Time Frame: Up to approximately 10 years ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: BX44273 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-09-02.