The trial is taking place at:
L

Leicester Royal Infirmary | Hope Trials Facility

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A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study (UmbrellaMAX)

Roche logo

Roche

Status and phase

Enrolling
Phase 3

Conditions

Cancer

Treatments

Drug: Tiragolumab
Drug: Ipatasertib
Drug: Atezolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05862285
BX44273
2023-504263-16-00 (Other Identifier)
2022-003414-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 study treatment or comparator agent 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Roche IMP(s) Monotherapy
Experimental group
Description:
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.
Treatment:
Drug: Atezolizumab
Drug: Ipatasertib
Roche Combined Agents
Experimental group
Description:
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.
Treatment:
Drug: Atezolizumab
Drug: Tiragolumab

Trial contacts and locations

22

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Central trial contact

Reference Study ID Number: BX44273 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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