60 Participants Needed

Atezolizumab + Tiragolumab + Ipatasertib for Cancer

(UmbrellaMAX Trial)

Recruiting at 31 trial locations
RS
Overseen ByReference Study ID Number: BX44273 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Must be taking: Roche IMP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug combination Atezolizumab, Tiragolumab, and Ipatasertib for cancer?

The combination of tiragolumab and atezolizumab has shown effectiveness in treating solid cancers, including non-small cell lung cancer, in multiple trials. Additionally, atezolizumab has demonstrated promising results when combined with other treatments in various cancers, suggesting potential benefits when used with ipatasertib.12345

Is the combination of Atezolizumab, Tiragolumab, and Ipatasertib generally safe for humans?

Atezolizumab, a part of the treatment, can cause immune-related side effects like skin rash, liver issues, and thyroid problems, but these are usually manageable. Serious side effects like kidney injury and low platelet count are rare. There is no specific safety data available for the combination with Tiragolumab and Ipatasertib.16789

What makes the drug combination of atezolizumab, tiragolumab, and ipatasertib unique for cancer treatment?

This drug combination is unique because it combines immune checkpoint inhibitors (atezolizumab and tiragolumab) with ipatasertib, which targets cancer cell growth pathways, potentially enhancing the immune response against cancer cells and offering a novel approach compared to standard treatments.1251011

What is the purpose of this trial?

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.

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for cancer patients who were part of a previous Genentech or Roche study and are still benefiting from the treatment but can't get it outside the study. They must start this extension within 7 days after their last dose in the original study and be able to follow this new study's rules.

Inclusion Criteria

My current Roche treatment is working as determined by my doctor.
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
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
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Exclusion Criteria

Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
Concurrent participation in any therapeutic clinical trial (other than the parent study)
I haven't received any cancer treatments not allowed in the main study before starting this extension study.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive Roche investigational medicinal product (IMP) monotherapy or in combination with other agents as per parent protocol

Until disease progression or other specified criteria

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue treatment with Roche IMP(s) if they do not have local access to the study treatment

Long-term

Treatment Details

Interventions

  • Ipatasertib
Trial Overview The trial continues treatment with Atezolizumab, Tiragolumab, Ipatasertib, or combinations thereof for participants previously receiving these drugs. It aims to provide ongoing access to these medications when they're not available commercially.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Roche IMP(s) MonotherapyExperimental Treatment5 Interventions
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.
Group II: Roche Combined AgentsExperimental Treatment5 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Adagrasib combined with pembrolizumab shows promising efficacy for patients with newly diagnosed non-small cell lung cancer with a KRASG12C mutation, achieving overall response rates of 49% and 57% in two separate trials.
This drug combination demonstrated a favorable safety profile, exhibiting lower liver toxicity compared to other combinations of checkpoint inhibitors and targeted therapies.
Frontline Promise for Adagrasib-Pembrolizumab Combination.[2023]
Atezolizumab combined with chemotherapy showed promising efficacy in treating advanced, treatment-naïve non-small-cell lung cancer (NSCLC), with overall response rates of 36% to 68% across different chemotherapy regimens in a study of 76 patients.
The treatment was generally well tolerated, although common severe side effects included neutropenia and anemia, indicating a manageable safety profile for this combination therapy.
Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer.Liu, SV., Camidge, DR., Gettinger, SN., et al.[2022]
In a phase 3 trial involving 501 patients with unresectable hepatocellular carcinoma, the combination of atezolizumab and bevacizumab significantly improved overall survival (67.2% at 12 months) and progression-free survival (6.8 months) compared to sorafenib.
The treatment with atezolizumab-bevacizumab showed a lower risk of death (hazard ratio 0.58) and similar rates of severe adverse events compared to sorafenib, indicating a favorable safety profile despite some instances of grade 3 or 4 hypertension.
Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.Finn, RS., Qin, S., Ikeda, M., et al.[2021]

References

Frontline Promise for Adagrasib-Pembrolizumab Combination. [2023]
Long-term survival follow-up of atezolizumab in combination with platinum-based doublet chemotherapy in patients with advanced non-small-cell lung cancer. [2022]
Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. [2021]
Tiragolumab Impresses in Multiple Trials. [2021]
Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. [2022]
Managing adverse effects of immunotherapy. [2018]
Possible atezolizumab-associated acute kidney injury and immune thrombocytopenia. [2022]
[Management of Toxicities of Immune Checkpoint Inhibitors]. [2017]
A phase II study of atezolizumab for pretreated advanced/recurrent non-small cell lung cancer with idiopathic interstitial pneumonias: rationale and design for the TORG1936/AMBITIOUS study. [2022]
A phase I study of the combination of atezolizumab, tiragolumab, and stereotactic body radiation therapy in patients with metastatic multiorgan cancer. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Safety and Clinical Activity of Atezolizumab Plus Ipilimumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Results From a Phase 1b Trial. [2022]
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