RecruitingPhase 2NCT06699602

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma

A Pilot Phase II Study of Neoadjuvant Cemiplimab + Fianlimab in Patients With Locally Advanced Clear Cell Renal Cell Carcinoma Undergoing Nephrectomy


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

10 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The researchers are doing this study to find out whether it is practical (feasible) to give cemiplimab and fianlimab before a nephrectomy and whether it causes any delays with surgery in people with kidney cancer. The researchers will also look at whether cemiplimab and fianlimab given before a nephrectomy is a safe and effective treatment approach and if there is a change in the size of the tumor following immunotherapy prior to planned surgery.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving two immunotherapy drugs — cemiplimab and fianlimab — before surgery can help shrink kidney cancer tumors and improve outcomes for people with high-risk, non-metastatic clear cell renal cell carcinoma who are planned for surgical removal of the kidney. **You may be eligible if...** - You are 18 years or older - You are planned to have your kidney removed (nephrectomy) for high-risk, non-metastatic clear cell renal cell carcinoma - Your cancer has not spread to distant organs (regional lymph node involvement is acceptable) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have previously received immunotherapy or targeted therapy for kidney cancer - You have active autoimmune disease - You have significant organ dysfunction 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCemiplimab

cemiplimab IV flat

DRUGFianlimab

fianilmab IV flat


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT06699602


Related Trials