Atezolizumab + Bevacizumab for Kidney Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, Atezolizumab (an immunotherapy drug) and Bevacizumab, to determine their effectiveness in treating advanced non-clear cell kidney cancer, including types like papillary or chromophobe kidney cancer. The goal is to see if this combination can slow the disease's progression. Candidates for this study include those with advanced kidney cancer that cannot be surgically removed and who are willing to provide a tumor sample. Participants will receive the drugs through an IV every three weeks, and the study will monitor the treatment's effectiveness and safety. As a Phase 2 trial, this study measures how well the treatment works in an initial, smaller group of people, offering a chance to contribute to important research.

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

The trial requires stopping certain medications before starting. You must stop taking small molecule kinase inhibitors 2 weeks before and any anti-cancer therapy 4 weeks before joining. Some medications like plaquenil must be stopped 2 weeks prior, and certain immunosuppressive drugs must be stopped 2 weeks before the first dose.

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

Studies have shown that the combination of atezolizumab and bevacizumab is generally well-tolerated in patients with kidney cancer. More than a quarter of patients treated with these drugs experienced tumor shrinkage, and the side effects remained manageable. While some patients did encounter side effects, they were not severe enough to halt treatment.

In another study, patients receiving the atezolizumab and bevacizumab combination experienced a longer time before cancer progression compared to those on a different treatment. This suggests that the combination is effective and relatively safe for patients.

Overall, past research indicates that this treatment is fairly safe for people with advanced kidney cancer, with side effects that can usually be managed. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for kidney cancer?

Researchers are excited about Atezolizumab and Bevacizumab for kidney cancer because they work differently from traditional treatments like sunitinib or pazopanib. Atezolizumab is an immunotherapy drug that boosts the body's immune system to attack cancer cells, while Bevacizumab is an angiogenesis inhibitor that cuts off the blood supply tumors need to grow. This combination targets both the immune system and blood vessel growth, offering a potentially more comprehensive approach to fighting kidney cancer.

What evidence suggests that the combination of Atezolizumab and Bevacizumab might be an effective treatment for advanced non-clear cell kidney cancer?

Research has shown that using atezolizumab and bevacizumab together, as studied in this trial, can benefit people with kidney cancer. One study showed that this combination reduced the risk of disease progression or death. Another study found that patients lived longer without cancer progression compared to those taking sunitinib. Atezolizumab boosts the immune system to fight cancer, while bevacizumab stops the growth of blood vessels that feed tumors. These findings suggest this combination could effectively treat advanced kidney cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Toni Choueiri, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. roche.com roche.com/media/releases/med-cor-2017-12-11

Phase III IMmotion151 study showed Roche's Tecentriq ... Phase III IMmotion151 study showed Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) reduced the risk of disease worsening or death for ...

2. actionkidneycancer.org actionkidneycancer.org/patient-reported-outcomes-with-atezolizumab-plus-bevacizumab-in-metastatic-kidney-cancer/

Patient-reported outcomes with atezolizumab plus ... In this study, the patients treated with atezolizumab plus bevacizumab had longer progression-free survival compared with patients treated with sunitinib.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7051851/

Results of a Multicenter Phase II Study of Atezolizumab ... In this multicenter phase II trial, we evaluated atezolizumab combined with bevacizumab in patients with advanced renal cell carcinoma (RCC) with variant ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03024437

Study Details | NCT03024437 | Atezolizumab in ... This study will assess the immunomodulatory activity of entinostat in patients with advanced renal cell carcinoma receiving the PD-L1 inhibitor atezolizumab ...

5. urotoday.com urotoday.com/conference-highlights/asco-gu-2017/asco-gu-2017-kidney-cancer/94183-asco-gu-2017-phase-ii-study-supports-potential-for-genentech-s-tecentriq-atezolizumab-plus-avastin-bevacizumab-for-people-with-locally-advanced-or-metastatic-renal-cell-carcinoma-session-highlights.html

Phase II Study Supports Potential For Genentech's TECENTRIQ ... “These Phase II results support the scientific rationale for potentially combining TECENTRIQ and Avastin in people with this type of kidney cancer,” said Sandra ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283821000038

Efficacy and Safety of Atezolizumab Plus Bevacizumab ... Tumors shrank in more than one-quarter of patients treated with this combination, and side effects were manageable. Introduction. Both immune checkpoint ...

7. roche.com roche.com/media/releases/med-cor-2017-06-03

Roche presents new data for TECENTRIQ® (atezolizumab) ... Specifically, TECENTRIQ plus Avastin resulted in an Overall Response Rate (ORR) of 26% in all-crossover patients (28% in crossover post- ...