RecruitingPhase 2NCT04981509

Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer

A Phase 2 Study of Bevacizumab, Erlotinib and Atezolizumab in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) Associated or Sporadic Papillary Renal Cell Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

65 participants

Start Date

Jun 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effects of combination therapy with bevacizumab, erlotinib, and atezolizumab in treating patients with hereditary leiomyomatosis and kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Bevacizumab is in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Combination therapy with bevacizumab, erlotinib, and atezolizumab may stabilize or shrink advanced hereditary leiomyomatosis and kidney cancer.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — bevacizumab (targets blood vessel growth), erlotinib (targets a specific cancer signal), and atezolizumab (an immunotherapy) — for people with advanced kidney cancer, specifically a rare papillary type. **You may be eligible if...** - You are 12 or older - You have advanced kidney cancer — either a rare genetic type (HLRCC) or sporadic papillary renal cell carcinoma confirmed by biopsy - Your cancer has at least one measurable tumor on scans - You have received no more than two prior treatments targeting blood vessel growth, and no prior bevacizumab or PD-1/PD-L1 immunotherapy - Your general health and organ function meet study thresholds **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have severe autoimmune or inflammatory conditions - You have already received bevacizumab or PD-1/PD-L1 immunotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given PO

BIOLOGICALBevacizumab

Given IV

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT without contrast

PROCEDUREComputed Tomography with Contrast

Undergo CT with contrast

DRUGErlotinib

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET

DRUGSodium Fluoride F-18

Given F-18 sodium fluoride


Locations(13)

UC San Diego Moores Cancer Center

La Jolla, California, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

NCI - Center for Cancer Research

Bethesda, Maryland, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04981509


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