RecruitingPhase 2NCT05263050

Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors

GU-187: Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors


Sponsor

Fox Chase Cancer Center

Enrollment

111 participants

Start Date

Jan 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an alternative dosing schedule for a cancer drug called cabozantinib in people with kidney cancer (renal cell carcinoma) or a specific type of slow-growing tumor called a neuroendocrine tumor (NET). The goal is to see if a different schedule reduces side effects while keeping the drug effective. **You may be eligible if...** - You have been diagnosed with advanced kidney cancer (any type, including sarcomatoid) - Or you have been diagnosed with a well-differentiated neuroendocrine tumor (Grade 1–3, any primary site) - You may or may not have received prior treatment depending on which study group (cohort) you join - Your general health is adequate for cancer treatment **You may NOT be eligible if...** - You have previously received cabozantinib (for some cohorts) - You have uncontrolled high blood pressure or serious heart conditions - You are pregnant or breastfeeding - You have significant bleeding problems or recent blood clots 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

Cabozantinib initiated at 40 mg daily. Dose-escalate or de-escalate based on pre-specified criteria and at set dosing schedules

DRUGNivolumab

Nivolumab injection is to be administered as an IV infusion at a dose of 480 mg on day 1 of each cycle


Locations(1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

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NCT05263050


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