RecruitingPhase 2NCT07188896

A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)

A Randomized Phase 2 Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)


Sponsor

Brian Rini

Enrollment

120 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing several immunotherapy combinations for people with advanced kidney cancer (renal cell carcinoma) who have never received treatment before. It is testing whether different combinations of immune-boosting drugs can improve outcomes compared to the current standard. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic kidney cancer with a clear cell type - You have never received any systemic (whole-body) treatment for kidney cancer - Your cancer can be measured on imaging scans - You are well enough to participate (Karnofsky score of 70% or higher) - You have adequate organ function **You may NOT be eligible if...** - You have already received treatment (including adjuvant or neoadjuvant therapy) for kidney cancer - Your cancer has spread to the brain and is not controlled - You have an active autoimmune disease requiring immune-suppressing medication - You have serious lung inflammation or 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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Interventions

DRUGFianlimab

Fianlimab will be co-administered by IV.

DRUGIpilimumab

Ipilimumab will be administered by IV.

DRUGNivolumab

Nivolumab will be administered by IV. Maintenance nivolumab will then be administered by IV.

DRUGCemiplimab

Cemiplimab will co-administered by IV.


Locations(1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

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NCT07188896