Atezolizumab Continuation for Cancer

(IMbrella B Trial)

Not currently recruiting at 145 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: Atezolizumab

Must not be taking: Anti-cancer treatments

Disqualifiers: Pregnancy, Serious adverse events, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 21-day cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on continuing treatment with atezolizumab, a medication used in certain cancers, for patients who benefited from it in a prior study. It aims to provide ongoing access to this treatment for those unable to obtain it otherwise. Participants can continue with atezolizumab alone, combine it with other drugs, or switch to a similar (comparator) treatment. This trial is ideal for individuals who participated in a previous Genentech or Roche study and continue to benefit from atezolizumab but lack local access. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to the validation of a potentially life-changing treatment.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atezolizumab, also known as Tecentriq, is generally well-tolerated by cancer patients. In studies, patients taking atezolizumab alone or with other medications experienced side effects that were usually manageable. Reports indicate that these side effects are often mild or moderate and can be treated. This treatment has been used in other studies where patients lived for more than a year on average, suggesting it can be safely used for extended periods. Safety information from these studies supports its continued use, but like all treatments, some individuals may experience more serious reactions. Always discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Atezolizumab is unique because it harnesses the power of the immune system to fight cancer differently from traditional chemotherapy or radiation. Most treatments for cancer work by directly attacking cancer cells, but atezolizumab is an immunotherapy that blocks the PD-L1 protein, effectively taking the brakes off the immune system to allow it to recognize and destroy cancer cells more effectively. Researchers are excited about this approach because it offers a promising option for patients who may not respond well to conventional treatments, potentially leading to longer-lasting responses and fewer side effects. Additionally, when combined with other agents, atezolizumab might enhance the overall effectiveness of cancer treatment, offering new hope for improved outcomes.

What evidence suggests that this trial's treatments could be effective for cancer?

Studies have shown that atezolizumab effectively treats certain types of cancer. For patients with advanced non-small cell lung cancer (NSCLC), atezolizumab has been found to extend life compared to traditional chemotherapy. One study showed that patients had a 41% lower risk of death with atezolizumab than with chemotherapy. In this trial, participants may receive atezolizumab as monotherapy or in combination with other agents. When combined with other treatments, atezolizumab also shows promise, particularly in small cell lung cancer, where it has been linked to longer survival. These findings suggest that atezolizumab, alone or with other treatments, can be a valuable option for some cancer patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for patients who were part of a previous Genentech/Roche study and benefited from Atezolizumab or other cancer treatments. They must not have access to these drugs locally, be able to continue treatment without health risks, and agree to contraception if applicable. Pregnant women or those with unresolved serious side effects are excluded.

Inclusion Criteria

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

I am eligible to continue my current atezolizumab therapy or another study drug as per my initial study's protocol.

Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

Exclusion Criteria

Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study

The treatment I am considering is available and approved for my condition in my country.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive atezolizumab monotherapy or combination therapy as per the parent study protocol

21-day cycles

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive study treatment in this extension study following roll-over from the parent study

Until unacceptable toxicity or loss of clinical benefit

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab

Trial Overview The extension study allows participants who saw benefits from Atezolizumab alone or in combination with other drugs in prior trials to continue receiving them. It's open-label and multicenter, meaning both the researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: Combined Agents with Atezolizumab Experimental Treatment 14 Interventions

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.

Group II: Atezolizumab Monotherapy Experimental Treatment 1 Intervention

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.

Group III: Comparator Treatment Active Control 9 Interventions

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.

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

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Atezolizumab significantly improves overall survival in patients with metastatic non-small cell lung cancer (mNSCLC), with median survival times of 13.8 months in the atezolizumab group compared to 9.6 months in the docetaxel group in the OAK trial.

The treatment has an acceptable safety profile, with common side effects including fatigue and decreased appetite, and serious immune-related adverse events occurring in a small percentage of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer. Weinstock, C., Khozin, S., Suzman, D., et al.[2022]

Atezolizumab, a monoclonal antibody targeting PD-L1, showed a 23% response rate and a median overall survival of 15.9 months in 119 patients with metastatic urothelial cancer who were unfit for cisplatin, indicating its efficacy as a front-line treatment.

In patients whose tumors progressed after first-line chemotherapy, atezolizumab had a 15% response rate and a median overall survival of 7.9 months, with better outcomes (26% response rate) in those with high PD-L1 expression, demonstrating its potential effectiveness based on biomarker status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. Bernard-Tessier, A., Bonnet, C., Lavaud, P., et al.[2019]

Atezolizumab, an inhibitor of PD-L1, was found to be well tolerated in a phase 1-2 trial involving 90 children and young adults with refractory or relapsed solid tumors, with no fatal adverse events reported.

While only 5% of patients achieved an objective response, the study showed comparable serum concentrations of atezolizumab between children and young adults, suggesting potential for future research into optimizing immune checkpoint inhibitors for specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1-2 study. Geoerger, B., Zwaan, CM., Marshall, LV., et al.[2020]

Atezolizumab, an anti-PD-L1 therapy, was well tolerated in a study of 45 patients with advanced melanoma, showing that most side effects were mild (grade 1/2) and no treatment-related deaths occurred.

The treatment resulted in a 30% overall response rate and a median overall survival of 23 months, with certain biomarkers like PD-L1 expression and tumor mutational burden linked to better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Clinical Activity, and Biological Correlates of Response in Patients with Metastatic Melanoma: Results from a Phase I Trial of Atezolizumab. Hamid, O., Molinero, L., Bolen, CR., et al.[2020]

In the phase II IMvigor210 study, patients with advanced urothelial carcinoma who continued treatment with atezolizumab after initial tumor progression experienced a median overall survival of 8.6 months, compared to only 1.2 months for those who received no further treatment.

Continuing atezolizumab beyond RECIST v1.1 progression was associated with prolonged clinical benefit and did not result in additional safety concerns, suggesting that some patients may still respond positively to immunotherapy even after conventional signs of progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab in platinum-treated locally advanced or metastatic urothelial carcinoma: post-progression outcomes from the phase II IMvigor210 study. Necchi, A., Joseph, RW., Loriot, Y., et al.[2022]

Atezolizumab is an FDA-approved treatment for advanced bladder cancer that works by blocking the PD-L1/PD-1 immune checkpoint, enhancing T-cell immunity against tumors.

In clinical trials, atezolizumab showed a 15% objective response rate in patients whose cancer progressed after chemotherapy, and a 24% response rate in chemotherapy-naïve patients, with a favorable safety profile compared to other second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

Atezolizumab, an immune checkpoint inhibitor, has been shown to significantly prolong overall survival in patients with advanced non-small cell lung cancer (NSCLC) who have previously received chemotherapy, based on results from the phase II POPLAR and phase III OAK trials.

The treatment is particularly effective in patients with higher PD-L1 expression, demonstrating higher objective response rates, and it has a manageable safety profile with a low incidence of immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A Review in Previously Treated Advanced Non-Small Cell Lung Cancer. Blair, HA.[2020]

Atezolizumab is a monoclonal antibody that targets PD-L1, which is being developed for treating various blood cancers and solid tumors, showing promise in cancer immunotherapy.

It has already been approved in the US as a second-line treatment for urothelial carcinoma and is pending approval for non-small cell lung cancer, highlighting its potential efficacy in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

Atezolizumab combined with chemotherapy (ABCP or ACnP) has been shown to significantly improve progression-free survival (PFS) and overall survival (OS) in chemotherapy-naïve patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), based on the IMpower150 and IMpower130 studies.

Both treatment regimens (ABCP and ACnP) demonstrated manageable safety profiles, with most immune-related side effects being mild to moderate and reversible, making them promising first-line options for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab First-Line Combination Therapy: A Review in Metastatic Nonsquamous NSCLC. Dhillon, S., Syed, YY.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716834/

updated long-term efficacy of atezolizumab in a diverse ... In patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC), atezolizumab therapy improves survival with manageable safety.

2. tecentriq-hcp.com tecentriq-hcp.com/metastatic-nsclc/efficacy/impower110-clinical-trial-results.html

IMpower110 Clinical Trial Results - TECENTRIQ-HCP.com 41% reduction in the risk of death vs chemotherapy · Median PFS was 8.1 months with TECENTRIQ (95% CI, 6.8, 11.0) vs 5.0 months with platinum-based chemotherapy ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10074249/

Effectiveness and Safety of Atezolizumab Monotherapy in ... In this study, we evaluated the effectiveness and safety of atezolizumab monotherapy in a large real-world cohort to confirm the reproducibility of the results.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1917346

Atezolizumab for First-Line Treatment of PD-L1–Selected ... Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression.

5. onclive.com onclive.com/view/atezolizumab-monotherapy-falls-short-in-exploratory-os-analysis-in-untreated-locally-advanced-or-metastatic-urothelial-cancer

Atezolizumab Monotherapy Falls Short in Exploratory OS ... The 12- and 24-month OS rates with atezolizumab were 57.9% (95% CI, 52.7%-63.1%) and 34.5% (95% CI, 29.4%-39.5%) vs 54.6% (95% CI, 49.2%-59.9%) ...

6. tecentriq.com tecentriq.com/metastatic-nsclc/results/how-tecentriq-may-help.html

Effectiveness & Safety of TECENTRIQ® (atezolizumab) for ... Median overall survival (OS) was 19.2 months for patients taking TECENTRIQ® (atezolizumab. Median OS=the length of time from the start of treatment in a ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601751/

Clinical Review - Atezolizumab (Tecentriq) - NCBI At the final OS analysis (data cut-off date: January 24, 2019), the median survival follow-up time was 22.9 months. The median OS was 12.3 months (95% CI, 10.8 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32459597/

Safety and Patient-Reported Outcomes of Atezolizumab ... Conclusion: ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between ...

9. roche.com roche.com/media/releases/med-cor-2021-05-20

Pivotal Phase III data at ASCO show Roche's Tecentriq ... In the larger population of all randomised Stage II-IIIA study participants, Tecentriq reduced the risk of disease recurrence or death by 21% ( ...

10. tecentriq.com tecentriq.com/nsclc-after-surgery/results/how-tecentriq-may-help.html

TECENTRIQ may prevent your PD-L1+ non-small cell lung ... TECENTRIQ may prevent your PD-L1+ non-small cell lung cancer from coming back · More people were alive with TECENTRIQ than with best supportive care · Important ...