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A Phase 3 Trial in Metastatic Untreated Renal Cell (Kidney) Cancer [Nivolumab and Ipilimumab Followed by Nivolumab vs. Cabozantinib with Nivolumab]

This study is being done to answer the following question: Can we prolong life for patients with advanced kidney cancer, by adding a drug called cabozantinib to another treatment after receiving the standard treatment? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced kidney cancer. The usual approach is defined as care most people get for advanced kidney cancer.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study involves physical exams, EKG, vital signs, blood draws for labs and research, a variety of imaging procedures that include CT and PET scans, submission of biopsy tissue, paper questionnaires, oral study drug, and study drug injections.

Incentives

Ipilimumab, nivolumab, and cabozantinib will be supplied at no charge while you take part in this study.

Total length of participation:
5yrs

Looking for Specific Volunteers

Able to participate:

You have a diagnosis of metastatic renal cell cancer.

Not eligible if:

You have an autoimmune disease that requires continued therapy.
You have unstable CNS disease from your cancer or are requiring treatment for CNS disease.
You have received treatment for your renal cell carcinoma.
You have received prior treatment with immunotherapy within the last year.
You have had surgery within 28 days of entering the study.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Tracy Rose
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Kidney)
Kidneys and Liver

IRB Number

19-1668

ClinicalTrials.gov

NCT03793166

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