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Monoclonal Antibodies
Atezolizumab + Bevacizumab for Kidney Cancer
Phase 2
Waitlist Available
Led By Toni Choueiri, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hematologic and end-organ function as defined by specific laboratory results
Age ≥ 18 years
Must not have
History of autoimmune diseases or specific pulmonary conditions
Prior treatment with specific therapeutic antibodies or pathway targeting agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination treatment for advanced kidney cancer that has not responded to other treatments.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include allergic reactions to the drug components; increased risk of infection; high blood pressure; proteinuria which is excess protein in urine indicating kidney damage; bleeding issues; gastrointestinal complications such as fistulas or perforations; and potentially severe skin reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood and organ tests meet the required health standards.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of autoimmune diseases or specific lung conditions.
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I have been treated with drugs targeting specific cancer pathways.
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I have been treated with bevacizumab before.
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I have serious wounds, ulcers, or protein in my urine.
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I have had a major surgery or organ transplant recently.
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I have had issues like a hole in my stomach or throat, or a blockage in my intestines.
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I do not have serious heart disease or high blood pressure that is not well controlled.
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I have a history of stroke, vascular disease, or bleeding problems.
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I have had cancer other than kidney cancer within a specific timeframe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best Overall Response Rate
Secondary study objectives
1-Year Overall Survival
1-Year Overall Survival by Histological Subgroup
1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group
+16 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bevacizumab And Atezolizumab CombinationExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Atezolizumab
2016
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,172 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,371 Total Patients Enrolled
Toni Choueiri, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
207 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have been treated with drugs targeting specific cancer pathways.I have not taken any immune-weakening medications recently.My blood and organ tests meet the required health standards.My kidney cancer cannot be removed by surgery and is not the usual 'clear cell' type.I agree to provide tumor samples and undergo a biopsy if it's safe and possible.I have serious wounds, ulcers, or protein in my urine.I have had a major surgery or organ transplant recently.I am 18 years old or older.I have had issues like a hole in my stomach or throat, or a blockage in my intestines.I can follow the study's requirements and attend all follow-ups.I have recently been treated with targeted cancer drugs.I have been treated with bevacizumab before.I do not have serious heart disease or high blood pressure that is not well controlled.I have a history of stroke, vascular disease, or bleeding problems.I have not needed antibiotics for an infection recently.I can take care of myself but might not be able to do heavy physical work.I am currently taking or have recently taken certain medications.I have had cancer other than kidney cancer within a specific timeframe.I have not received a live vaccine recently.
Research Study Groups:
This trial has the following groups:- Group 1: Bevacizumab And Atezolizumab Combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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