Bevacizumab + Atezolizumab for Cancer

Not currently recruiting at 309 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: Atezolizumab

Must not be taking: Anti-cancer treatments

Disqualifiers: Unresolved toxicities, Uncontrolled disease, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of atezolizumab (Tecentriq), a cancer treatment, either alone or with other drugs, in individuals who participated in a previous study. The goal is to determine if continuing these treatments benefits patients after the original study concludes. The trial seeks participants from a Genentech or Roche-sponsored study who still benefit from atezolizumab but lack local access. Potential participants must have benefited from atezolizumab and be unable to access it outside the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of this treatment for others.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems focused on continuing or transitioning treatments from a previous study, so it's best to discuss your specific medications with the trial team.

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

Research has shown that atezolizumab, whether used alone or with bevacizumab, is generally safe. When used by itself, some patients experienced immune-related side effects, such as lung inflammation (pneumonitis), but this occurred in only 3% of patients in one study, indicating that the treatment is usually well-tolerated.

When combined with bevacizumab, the treatment has also proven to be safe and effective. Several studies have shown that this combination is safe for patients with certain types of liver cancer. Specifically, one study reported that the combination was well-tolerated and had strong effects against tumors.

In summary, both atezolizumab alone and with bevacizumab have been thoroughly studied. The evidence suggests they are generally safe, with side effects that most patients can manage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because atezolizumab, known for its role as an immune checkpoint inhibitor, offers a different approach compared to traditional chemotherapy or radiation therapies for cancer. Atezolizumab works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. When combined with bevacizumab, an angiogenesis inhibitor, the duo targets both the blood vessels that feed tumors and the tumor cells themselves, potentially enhancing treatment effectiveness. This dual-action approach could offer improved outcomes for patients, making it a promising option compared to existing therapies.

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

Research has shown that atezolizumab, one of the treatments in this trial, extends survival in people with advanced lung cancer when used alone. In one study, patients lived for a median of 19.2 months, marking a significant improvement. In this trial, some participants will receive atezolizumab monotherapy, while others will receive a combination of atezolizumab with other agents, including bevacizumab. Studies indicate that combining atezolizumab with bevacizumab yields even better results, with a median survival of 23.1 months and a high response rate, meaning many patients experience tumor shrinkage or halted growth. These treatments have demonstrated promising results in extending life and controlling cancer progression. ^{1 6 7 8 9}

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 cancer patients who were part of a previous Genentech/Roche Atezolizumab study and are still benefiting from the treatment. They must not have access to this medication commercially, should start the extension within 7 days after their last dose in the parent study, and cannot have unresolved severe side effects or other treatments interfering.

Inclusion Criteria

I am eligible to continue or switch to atezolizumab therapy as my current study ends.

I stopped or can continue atezolizumab as per my previous study's rules and can get it commercially.

I am still benefiting from my current cancer treatment as determined by my doctor.

Exclusion Criteria

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

I had to stop a previous study treatment due to lasting side effects.

Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (± 7 days) allowed in the parent study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Extension Treatment

Participants continue to receive atezolizumab monotherapy or combination therapy as per the parent study protocol until disease progression or other specified conditions

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab

Trial Overview The trial continues treatment with Atezolizumab alone or combined with Bevacizumab for those previously enrolled in related studies. It's an open-label, non-randomized extension to assess long-term outcomes without changing the original dosing regimen until disease progression or unacceptable toxicity.

How Is the Trial Designed?

Group I: Combined Agents with Atezolizumab Experimental Treatment 2 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 continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.

Group III: Comparator Treatment Active Control 1 Intervention

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 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]

The combination of bevacizumab and atezolizumab in patients with metastatic non-small cell lung cancer (NSCLC) showed a significant increase in disease control rate (DCR) from 35.7% after atezolizumab alone to 87.5% after adding bevacizumab, indicating enhanced treatment efficacy.

The treatment was well-tolerated, with only 25% of patients experiencing treatment-related adverse events, all of which were mild (grade 1 or 2), suggesting a favorable safety profile for this combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab Plus Atezolizumab After Progression on Atezolizumab Monotherapy in Pretreated Patients With NSCLC: An Open-Label, Two-Stage, Phase 2 Trial. Lee, J., Koh, J., Kim, HK., 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 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]

In a multicenter study of 121 patients with advanced hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab (Ate/Bev), the objective response rate was 24% and the disease control rate was 76%, demonstrating real-world efficacy similar to phase III trial results.

The most common severe side effect was an increase in aspartate aminotransferase levels (10.7%), and factors like elevated baseline neutrophil-to-lymphocyte ratio were linked to poorer progression-free and overall survival, indicating the need for careful monitoring in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. Cheon, J., Yoo, C., Hong, JY., et al.[2022]

In a phase Ib study involving 20 patients with platinum-resistant ovarian cancer, the combination of atezolizumab and bevacizumab demonstrated a safety profile consistent with the individual drugs, with 95% experiencing treatment-related adverse events, but no grade 5 events reported.

The treatment resulted in a 15% overall response rate, with some patients achieving durable responses lasting up to 18.9 months, and a disease control rate of 55%, indicating potential efficacy in managing this challenging cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of Atezolizumab Plus Bevacizumab in Patients with Ovarian Cancer: A Phase Ib Study. Moroney, JW., Powderly, J., Lieu, CH., et al.[2021]

In a phase 3 study involving 692 patients with metastatic nonsquamous non-small-cell lung cancer (NSCLC), the combination of atezolizumab, bevacizumab, and chemotherapy significantly improved median progression-free survival to 8.3 months compared to 6.8 months with bevacizumab and chemotherapy alone.

The addition of atezolizumab also led to a longer median overall survival of 19.2 months versus 14.7 months in the control group, demonstrating its efficacy across various genetic backgrounds and PD-L1 expression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. Socinski, MA., Jotte, RM., Cappuzzo, F., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. Finn, RS., Qin, S., Ikeda, M., et al.[2021]

Citations

1. 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 ...

2. 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.

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0169500223009170

Results of the IFCT-1905 CLINATEZO real-world study Atezolizumab plus chemotherapy improves overall survival in 1st-line treatment of extensive SCLC. IFCT-1905 CLINATEZO studied consecutive patients receiving ...

5. tecentriq.com tecentriq.com/sclc/results/how-tecentriq-may-help.html

Imagine if you had more time to live your life Median overall survival (OS) was 12.3 months for patients taking TECENTRIQ® (atezolizumab. Patients who received TECENTRIQ with chemotherapy† had a 30% reduced ...

6. 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 ...

7. 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 ...

8. 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% ( ...

9. tecentriq-hcp.com tecentriq-hcp.com/hcc/patient-reported-outcomes.html

Patient-reported outcomes - TECENTRIQ-HCP.com Important Safety Information · TECENTRIQ can cause immune-mediated pneumonitis. · Immune-mediated pneumonitis occurred in 3% (83/2616) of patients receiving ...