IRB #

STUDY00019991

Title

[NCI CIRB] A031704 - PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

Principal Investigator

Christopher Ryan

Study Purpose

The purpose of this study is to determine if adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong the life of patients with advanced kidney cancer. The study is also trying to determine if this approach is better or worse than the usual approach.

Medical Condition(s)

Renal Cell Carcinoma

Eligibility Criteria

1- Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.

2- Measurable Disease

3- No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents; No prior previous systemic therapy for renal cell carcinoma; No cancer therapy less than 28 days prior to registration

4- Over the age of 18 years

5- Not pregnant or nursing

6- Laboratory values within range

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

5 years from registration

Minors Included

No

Contact

Knight Information Line - trials@ohsu.edu or 503-494-1080

Sponsor

Alliance

Recruitment End

05/31/2023

Compensation Provided

No


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