IRB #

STUDY00020148

Title

A Randomized, Double-Blind, Controlled Phase 3 Study of
Cabozantinib in Combination with Nivolumab and Ipilimumab
versus Nivolumab and Ipilimumab in Subjects with Previously
Untreated Advanced or Metastatic Renal Cell Carcinoma of
Intermediate or Poor Risk

Principal Investigator

Christopher Ryan

Study Purpose

The objective of this study is to evaluate the efficacy and safety of cabozantinib in combination with nivolumab and ipilimumab versus placebo in combination nivolumab and ipilimumab in previously untreated subjects with intermediate- and poor-risk advanced or metastatic RCC.

Medical Condition(s)

Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of
Intermediate or Poor Risk

Eligibility Criteria

Age eighteen years or older on the day of consent with histologically confirmed advanced or metastatic renal cell carcinoma with a clear-cell component, including subjects who also have a sarcomatoid feature. Further exams, tests, and procedures will be done to confirm eligibility.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive study drug as long as you are seeing clinical benefit.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
Email: trials@ohsu.edu

Sponsor

Exelixis, Inc.

Recruitment End

10/01/2022

Compensation Provided

No


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