CALGB 90802: Randomized phase III trial comparing everolimus plus placebo versus everolimus plus bevacizumab for advanced renal cell carcinoma progressing after treatment with tyrosine kinase inhibitors

Study Status

Open to Enrollment

Study Description

This is a clinical trial for men and women with advanced kidney cancer (renal cell carcinoma).

The trial is studying giving everolimus together with bevacizumab to see how well it works compared to everolimus alone in treating people with advanced kidney cancer that progressed after first-line therapy.

Everolimus has been shown to stop the growth of cancer cells in some people and is approved by the FDA for the treatment of advanced kidney cancer that has not responded to at least one prior treatment. Bevacizumab is an antibody that blocks a protein called “vascular endothelial growth factor” (VEGF), and it can slow the growth of new blood vessels in tumors. Bevacizumab is FDA-approved for the treatment of advanced kidney cancer in combination with interferon. . Everolimus and bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor. Bevacizumab used in combination with everolimus is considered experimental.

Study participants will be randomly assigned to one of two study groups:

  • Group 1 will receive everolimus
  • Group 2 will receive everolimus and bevacizumab

Participants will take the study treatment for as long as their kidney cancer is responding to or is stabilized by the drugs and they do not have any severe side effects from the drugs

Disease Status and/or Stage

Advanced Kidney Cancer

Sponsor

CALGB

Key Eligibility

  • Age 18 and older
  • Renal cell carcinoma (kidney cancer)
  • Metastatic or unresectable disease
  • Must have been treated with at least 1 prior VEGFR tyrosine kinase inhibitor and have progressed or have been intolerant to treatment
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

Protocol ID

CALGB 90802

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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