Bevacizumab + Atezolizumab for Cancer

Recruiting at 268 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

382 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Atezolizumab (Tecentriq) when used with Bevacizumab for cancer?

Atezolizumab has shown effectiveness in treating advanced bladder cancer, with improved response rates and survival compared to other treatments. Additionally, combining Atezolizumab with Bevacizumab has shown enhanced anticancer activity in ovarian cancer and may improve outcomes in non-small cell lung cancer by boosting the immune response against tumors. ^{1 2 3 4 5}

Is the combination of Bevacizumab and Atezolizumab safe for humans?

The combination of Bevacizumab and Atezolizumab has been evaluated for safety in patients with ovarian cancer and advanced hepatocellular carcinoma, showing a favorable safety profile in these studies. ^{1 2 3 6 7}

How is the drug combination of Bevacizumab and Atezolizumab unique for cancer treatment?

The combination of Bevacizumab and Atezolizumab is unique because it targets two different pathways to enhance the body's immune response against cancer. Atezolizumab blocks PD-L1, a protein that helps cancer cells hide from the immune system, while Bevacizumab inhibits VEGF, a protein that promotes blood vessel growth in tumors, potentially improving the effectiveness of the immune response. ^{1 2 3 4 8}

What is the purpose of this trial?

This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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 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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Clinical Activity of Atezolizumab Plus Bevacizumab in Patients with Ovarian Cancer: A Phase Ib Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Atezolizumab (Tecentriq®): Activity, indication and modality of use in advanced or metastatic urinary bladder carcinoma]. [2019]