RecruitingEarly Phase 1NCT05188118

Rapid Sequencing of Approved Therapies in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

A Pilot, Rapid Sequencing of First Line Cabozantinib, Ipilimumab and Nivolumab, and Lenvatinib and Everolimus in Patients with Metastatic or Unresectable Clear Cell Renal Cell Carcinoma

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

20 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma

Summary

This is a pilot, single-center, single-arm study where 20 patients with metastatic or unresectable clear cell renal cell carcinoma will receive same sequential treatment strategy (Cabozantinib for 12 weeks, then proceed with Ipilimumab plus Nivolumab immunotherapy x4 over 12 weeks, then subsequent therapies depending on treatment response for another 12 weeks \[Nivolumab for CR/PR/SD, Cabozantinib or Lenvatinib/Everolimus for PROG\]).

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a strategy of quickly cycling through multiple approved therapies — including cabozantinib, nivolumab, ipilimumab, lenvatinib, and everolimus — in patients with advanced or metastatic clear cell kidney cancer (renal cell carcinoma) who have not yet received treatment for their advanced disease. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic clear cell kidney cancer - You have not previously received systemic treatment for advanced disease - You are in good health (ECOG 0 or 1) with a life expectancy of at least 12 weeks - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have previously been treated with cabozantinib, nivolumab, ipilimumab, or any other systemic therapy for advanced kidney cancer - You have active brain metastases - You have uncontrolled heart conditions, recent stroke or heart attack, or active autoimmune disease - You are pregnant or breastfeeding - You have active inflammatory bowel disease 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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