Actively Recruiting

Phase 2
Age: 12Years +
All Genders
NCT04981509

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

65

Participants Needed

13

Research Sites

290 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hereditary leiomyomatosis and renal cell cancer with confirmed renal cell carcinoma or confirmed sporadic papillary renal cell carcinoma
  • Advanced renal cell cancer with measurable disease meeting specified size criteria
  • No more than two prior VEGF-targeting regimens and no prior bevacizumab or PD-1/PD-L1 inhibitor therapy for advanced disease
  • Age 12 years or older
  • ECOG performance status of 0, 1, or 2 (Karnofsky score of 60% or higher)
  • Adequate blood counts and liver function within specified limits
  • Glomerular filtration rate (GFR) of at least 30 mL/min/1.73 m2 with creatinine thresholds for pediatric patients
  • Controlled HIV, hepatitis B, or hepatitis C infection as specified
  • Treated brain metastases stable for at least 3 months
  • No prior or concurrent invasive malignancy likely to interfere with study
  • Cardiac function classified as New York Heart Association class 2B or better
  • Agreement to use effective contraception during and for 6 months after treatment
  • Ability to provide tumor tissue samples or consent to biopsy
  • Ability to understand and sign informed consent or have a legally authorized representative
Not Eligible

You will not qualify if you...

  • Prior systemic therapy for kidney cancer within 4 weeks or 5 half-lives before treatment start
  • Radiotherapy for kidney cancer within 2 weeks before treatment
  • Major surgery within 28 days before treatment start with unhealed wounds
  • Unresolved toxicities from prior cancer treatments above grade 1 except alopecia or correctable electrolyte abnormalities
  • Recent treatment with other investigational agents, systemic immunostimulants, or immunosuppressive medications within specified timeframes
  • Uncorrected hypercalcemia and use of bisphosphonates for symptomatic hypercalcemia
  • History of autoimmune diseases except stable autoimmune hypothyroidism, controlled type 1 diabetes, or certain skin conditions
  • History of lung diseases including pneumonitis or active pneumonitis
  • Untreated latent or active tuberculosis
  • Severe infections requiring hospitalization within 4 weeks before treatment
  • Recent live attenuated vaccine within 4 weeks before treatment or planned during study
  • Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, or psychiatric conditions
  • Poorly controlled hypertension despite treatment
  • Prior bone marrow or solid organ transplant
  • Severe allergic reactions to similar drugs
  • Recent major cardiovascular or gastrointestinal events within 6 months
  • Significant proteinuria exceeding specified thresholds
  • Pregnancy or breastfeeding
  • Serious non-healing wounds, ulcers, or recent bone fractures
  • Use of strong CYP450 inhibitors or inducers
  • Inability to stop tobacco or nicotine use during treatment
  • Significant vascular disease or recent bleeding disorders
  • Recent use of high-dose aspirin or clopidogrel except stable therapeutic anticoagulation or prophylactic anticoagulants allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

2

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

3

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

6

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Suspended

7

NCI - Center for Cancer Research

Bethesda, Maryland, United States, 20892

Actively Recruiting

8

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

9

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

Active, Not Recruiting

10

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

Active, Not Recruiting

11

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

12

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

13

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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