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Monoclonal Antibodies
Bevacizumab for Renal Cell Carcinoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response Rate
Secondary outcome measures
1-Year Overall Survival
1-Year Overall Survival by Histological Subgroup
1-Year Overall Survival by International Metastatic Renal Cell Carcinoma Risk Group
+16 moreTrial 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
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,807 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,624 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what medical conditions is bevacizumab usually prescribed?
"Bevacizumab is generally used to treat non-small cell lung carcinoma but has been known to be effective in postoperative, recurrent non-squamous cases and recurrent platinum-sensitive epithelial ovarian cancer."
Answered by AI
Has the federal government okayed Bevacizumab for public use?
"There is limited clinical data indicating the safety of bevacizumab, so it scored a 2 on our scale."
Answered by AI
Does the recruitment for this clinical trial remain active?
"According to the data provided by clinicaltrials.gov, this trial is no longer accepting applications as it was last updated on March 28th 2022 and initially posted on July 1st 2016. However, there are still an abundance of research studies that require participants - 1040 at present."
Answered by AI
Can you provide a summary of the research that has been conducted in regard to Bevacizumab?
"Bevacizumab was first investigated in 2004 at the Memorial Sloan Kettering Basking Ridge facility. Since that time, 1078 trials have been concluded and 621 are still active with many being hosted from Boston, Massachusetts."
Answered by AI
How many individuals have thus far enrolled in this experiment?
"At this time, recruitment for this trial is not active. The study was first published on July 1st 2016 and last modified two months ago. However, there are currently 419 trials admitting patients with kidney neoplasms and 621 studies looking to enroll people in Bevacizumab therapies."
Answered by AI
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