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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
Must not have
Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1
Major surgical procedure < 28 days before cycle 1, day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from study enrollment
Awards & highlights

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.
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.
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 below
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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.
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any immune-weakening medications in the last 2 weeks.
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I have not had major surgery in the last 28 days.
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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.
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I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.
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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.
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I am not pregnant or breastfeeding.
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I am not taking strong drugs that affect liver enzyme CYP450 3A4 or 1A2, or I can stop them before starting the study treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease control rate (DCR)
Duration of response (DOR)
Incidence of adverse events
+4 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
pneumonia
4%
cranial nerve VI palsy
4%
pyelonephritis
4%
colon cancer
4%
bradycardia
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
~5540
Bone Scan
2015
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2740
Erlotinib
2011
Completed Phase 4
~2290
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Positron Emission Tomography
2011
Completed Phase 2
~2200
Atezolizumab
2017
Completed Phase 3
~5850
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,935 Total Patients Enrolled
Ramaprasad SrinivasanPrincipal InvestigatorNational Cancer Institute LAO

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04981509 — Phase 2
Renal Cell Carcinoma Research Study Groups: Treatment (bevacizumab, atezolizumab, erlotinib)
Renal Cell Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04981509 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981509 — Phase 2
~6 spots leftby Dec 2024
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