Atezolizumab + Bevacizumab for Kidney Cancer

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Immunosuppressants, Warfarin, Clopidogrel, others

Disqualifiers: Autoimmune disease, Brain metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 9

Duration: Up to 32 months

65 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying the combination of Atezolizumab and Bevacizumab as a possible treatment for Advanced Non-Clear Cell Kidney Cancer.

Research Team

Toni Choueiri, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with advanced non-clear cell kidney cancer, including various subtypes like Papillary RCC and Chromophobe RCC. Participants must have measurable disease, be in relatively good health (ECOG ≤ 2), able to follow study procedures, and use effective contraception. Excluded are those with recent significant cardiovascular events, organ transplants, active infections like HIV or hepatitis B/C, certain allergies or hypersensitivities to trial drugs' components, other cancers within the last two years (with exceptions), brain metastases unless stable for at least four weeks.

Inclusion Criteria

Agreement to use highly effective forms of contraception for a specified period after the last dose of atezolizumab or bevacizumab

Signed informed consent form

My blood and organ tests meet the required health standards.

Exclusion Criteria

I have had a recent blood clot but am stable on blood thinners.

My brain metastases are treated and stable.

I have a history of autoimmune diseases or specific lung conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Atezolizumab and Bevacizumab intravenously every 3 weeks

Up to 32 months

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 32 months

Every 6 months

Treatment Details

Interventions

• Atezolizumab
• Bevacizumab

Trial Overview The trial is testing a combination of Atezolizumab and Bevacizumab as potential treatments for advanced non-clear cell kidney cancer. It aims to see how well these drugs work together in treating this specific type of cancer.

Participant Groups

Group I: Bevacizumab And Atezolizumab Combination Experimental Treatment 2 Interventions

1200 mg of Atezolizumab intravenously x 3 weeks 15 mg/kg of Bevacizumab intravenously x 3 weeks. One cycle will be 3 weeks in duration.

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD