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Monoclonal Antibodies
Triple Drug Therapy for Kidney Cancer
Phase 2
Recruiting
Led By Ramaprasad Srinivasan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must provide archival tissue block or unstained tumor tissue or be willing to undergo biopsy to collect samples for retrospective central pathology review
Patients must have received no more than two prior regimens targeting the VEGF pathway and no prior bevacizumab therapy in the metastatic/advanced setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from study enrollment
Awards & highlights
Study Summary
This trial is studying a combination of 3 drugs to treat patients with advanced hereditary leiomyomatosis and kidney cancer.
Who is the study for?
This trial is for individuals aged 12 or older with advanced kidney cancer, including hereditary leiomyomatosis and renal cell carcinoma. Participants must have measurable disease, acceptable organ function, no more than two prior VEGF-targeted treatments, and no recent use of certain medications or therapies. Those with treated brain metastases stable for at least 3 months can join. Pregnant women and tobacco users who cannot quit are excluded.Check my eligibility
What is being tested?
The study tests a combination therapy using bevacizumab (stops blood vessels from feeding tumors), erlotinib (blocks proteins that signal cancer cells to multiply), and atezolizumab (boosts the immune system to fight cancer). The goal is to see if this trio can stabilize or shrink advanced-stage kidney cancers.See study design
What are the potential side effects?
Potential side effects include high blood pressure, bleeding problems from bevacizumab; rash and diarrhea from erlotinib; fatigue, coughing up blood, shortness of breath due to lung inflammation from atezolizumab. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a tissue sample from my tumor or am willing to have a biopsy.
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I have had 2 or fewer treatments targeting VEGF but no bevacizumab for my advanced cancer.
Select...
I have been diagnosed with HLRCC or papillary renal cell carcinoma.
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I can take care of myself but might not be able to do heavy physical work.
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I am 12 years old or older.
Select...
My hepatitis B is under control with treatment.
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My kidney function, measured by GFR, is adequate.
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I had hepatitis C but have been treated and cured.
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I have advanced kidney cancer with at least one tumor that can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events
+4 moreSide effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (bevacizumab, atezolizumab, erlotinib)Experimental Treatment11 Interventions
Patients receive bevacizumab IV over 30-90 minutes and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Patients also receive erlotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT with or without contrast and MRI throughout the trial. Patients undergo collection of blood throughout the trial, and may undergo a biopsy during screening, as well as a brain MRI/CT scan with contrast, bone scan, and/or F-18 sodium fluoride PET scan as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Computed Tomography
2017
Completed Phase 2
~2720
Erlotinib
2011
Completed Phase 4
~2290
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Atezolizumab
2017
Completed Phase 3
~5860
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,789 Total Patients Enrolled
Ramaprasad SrinivasanPrincipal InvestigatorNational Cancer Institute LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin levels need to be within a certain range, unless you have Gilbert's disease.I haven't had radiotherapy for kidney cancer in the last 2 weeks.I can provide a tissue sample from my tumor or am willing to have a biopsy.I haven't taken any immune-weakening medications in the last 2 weeks.I have not had major surgery in the last 28 days.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.I haven't had any kidney cancer treatment in the last 4 weeks or within 5 half-lives of the last treatment, whichever is shorter.I have had 2 or fewer treatments targeting VEGF but no bevacizumab for my advanced cancer.I have been diagnosed with HLRCC or papillary renal cell carcinoma.I can take care of myself but might not be able to do heavy physical work.I am 12 years old or older.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I am not pregnant or breastfeeding.Your platelet count is at least 100,000 per microliter.Your liver function tests should not be too high, unless it's because of liver or bone cancer, as determined by the doctor in charge.Your alkaline phosphatase levels are not too high, unless it is related to liver or bone issues as determined by the study doctor.I am HIV positive, on treatment, and my viral load is undetectable.My hepatitis B is under control with treatment.My brain cancer has not worsened for 3 months after treatment, and I don't need high doses of steroids.I have another cancer, but it won't affect this trial's treatment.I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.My kidney function, measured by GFR, is adequate.I had hepatitis C but have been treated and cured.I am not taking strong drugs that affect liver enzyme CYP450 3A4 or 1A2, or I can stop them before starting the study treatment.You have enough infection-fighting white blood cells in your body.I have advanced kidney cancer with at least one tumor that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (bevacizumab, atezolizumab, erlotinib)
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.
How many test subjects are required for this experiment?
"That is correct. The clinical trial, which was first advertised on September 17th 2021, is still ongoing and actively recruiting patients. Up to 65 individuals will be accepted from 5 different locations."
Answered by AI
Could you please explain what other research has been conducted utilizing Bevacizumab?
"At this time, there are 686 ongoing clinical trials researching Bevacizumab with 161 in Phase 3. Although New york City has a considerable amount of research being conducted, there are 39243 locations operating clinical trials for Bevacizumab."
Answered by AI
Are there any dangers associated with Bevacizumab?
"While there is some supportive data, bevacizumab has not been shown to be effective. Our team rates it a 2 in terms of safety."
Answered by AI
Are there any unfilled positions in this clinical trial?
"That is correct, the available information does show that this study is still looking for patients to enroll. The 5 recruiting locations are listed on clinicaltrials.gov, where the trial was originally posted on September 17th, 2021 and last updated on November 15th, 2022."
Answered by AI
What ailment does Bevacizumab usually address?
"Bevacizumab is a medication typically used to treat recurrent platinum-resistant epithelial ovarian cancer. It has also shown efficacy against malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and disease progression after chemotherapy."
Answered by AI
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