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

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    42
  • sponsor
    National Cancer Institute (NCI)
Updated on 27 June 2022

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 has spread to other places in 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.

Description

PRIMARY OBJECTIVE:

I. To assess the complete response (CR) rate according to standard Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients with 1) advanced renal cell cancer (RCC) associated with hereditary leiomyomatosis and renal cell cancer (HLRCC) and 2) advanced sporadic/non-HLRCC papillary renal cell cancer treated with a combination of bevacizumab, erlotinib, and atezolizumab.

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of the combination of bevacizumab, erlotinib, and atezolizumab.

II. To determine the objective response rate (ORR) as complete response (CR) + partial response (PR).

III. To determine disease control rate (DCR) - confirmed response, or stable disease (SD) lasting for at least 6 months.

IV. To assess progression-free survival time (PFS) according to RECIST 1.1. V. To assess overall survival (OS). VI. To assess the duration of response. VII. To assess response to treatment using immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST).

EXPLORATORY OBJECTIVES:

I. To evaluate immunologic modulation associated with the administered treatment regimen,

including

Ia. Peripheral immune subset analysis before and on treatment. Ib. Evaluation of relevant soluble factors before and on treatment. (e.g., cytokine profiles) Ic. Tumor tissue immune infiltration cells before and after treatment (immune microenvironment, CD8/CD4/CD3 cells, T-Cell receptor clonality).

Id. Evaluation of tissue PDL1/PD1 expression and their correlation with outcome.

II. To assess specific genomic alterations (including FH, NRF2 pathway) and determine if there is a correlation with clinical outcomes.

OUTLINE

Patients receive bevacizumab intravenously (IV) over 30-90 minutes and atezolizumab IV over 30-90 minutes on day 1 of each cycle. Patients also receive erlotinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months.

Details
Condition Advanced Papillary Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Hereditary Leiomyomatosis and Renal Cell Carcinoma, Recurrent Renal Cell Carcinoma, Sporadic Papillary Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8
Treatment bevacizumab, Erlotinib, Atezolizumab
Clinical Study IdentifierNCT04981509
SponsorNational Cancer Institute (NCI)
Last Modified on27 June 2022

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