Short-Term Intensified Pembrolizumab and Tivozanib for High-Risk Renal Cell Carcinoma

What is the Purpose of this Study?

The purpose of this study is to evaluate whether the addition of a drug called tivozanib to another drug, pembrolizumab, is better than the usual approach (pembrolizumab alone) for treating advanced kidney cancer. Specifically, researchers aim to determine whether adding tivozanib to the usual treatment can prevent the cancer from returning and prolong life for patients with kidney cancer who have had all disease removed by surgery and/or radiation or ablation. Pembrolizumab is an immunotherapy that allows the body’s immune system to work against tumor cells. Participants will be randomly assigned to 1 of 2 groups. One group will receive the usual drug alone (pembrolizumab), and the other group will receive tivozanib plus pembrolizumab. Tivozanib is a medication that targets blood vessels and is approved by the U.S. Food and Drug Administration (FDA) for kidney cancer that has not been removed by surgery, but its use in this study is considered investigational.


Eligibility

  • * • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)
  • * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted
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Where can I participate?

  • CS Cancer at Beverly Hills : Maria Tarallo
  • CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer


More about this Clinical Trial

What is the full name of this clinical trial?

A032201: Short TeRm Intensified Pembrolizumab and Tivozanib for High-risk renal cell carcinoma IRB#4368

Study Details
Disease Type/Condition

Kidney

Principal Investigator

Figlin, Robert

Co-Investigators

Andrew Horodner, David Chan, David Hoffman, Edwin Posadas, Hugo Hool, Jeremy Lorber, Jun Gong, Justin Wayne Tiulim, Kevin Scher, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

III

IRB Number

STUDY00004368

ClinicalTrials.gov ID

NCT06661720

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org
Study Detail
Disease Type/Condition

Kidney

Principal Investigator

Figlin, Robert

Age Group

Adult

Phase

III

IRB Number

A032201

ClinicalTrials.gov ID

NCT06661720

Key Eligibility
ClinicalTrials.gov

Contact
Name

Maria Tarallo

Email
Maria.Tarallo@cshs.org