RecruitingPhase 2NCT04322955

CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition

Cyto-KIK; TRIAL (CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy (Nivolumab) and Targeted Kinase Inhibition (Cabozantinib)


Sponsor

Mark Stein

Enrollment

48 participants

Start Date

Jun 22, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney, will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether removing the primary kidney tumor through surgery, combined with immunotherapy and a targeted drug, can improve outcomes for people with advanced kidney cancer that has spread to other parts of the body. Researchers want to know if taking out the main tumor first helps these combination treatments work better. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with kidney cancer (clear cell type) that has spread to other organs - You have not yet received any treatment for your metastatic kidney cancer - Your primary tumor in the kidney is measurable on scans - You are in good physical condition (ECOG 0–1) - You are using effective contraception if you are of childbearing potential **You may NOT be eligible if...** - You have already received treatment for metastatic kidney cancer - You have a non-clear cell type of kidney cancer - Your organ function (blood, liver, kidney, heart) does not meet minimum levels - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCabozantinib

2 x 20 mg capsules taken orally daily

DRUGNivolumab

480mg IV on first day of each 28-day cycle

PROCEDURECytoreductive nephrectomy

Surgery removing as much tumor tissue as possible, possibly including surrounding tissues.


Locations(4)

The Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Columbia University Irving Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04322955


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