Advanced Kidney Cancer Study: Fianlimab and Cemiplimab Combinations

This study is for people with advanced kidney cancer (renal cell carcinoma). It's testing different combinations of medicines: fianlimab, cemiplimab, ipilimumab, and nivolumab. You would be randomly assigned to one of three groups. Two groups will receive fianlimab and cemiplimab, with one of those groups also receiving ipilimumab. The third group will receive the standard treatment of ipilimumab and nivolumab. The main goal is to see how many people respond to the treatments after two years. To join, you need to be at least 18 years old and have a good performance status, meaning you can do most daily activities. The study is currently unclear about its recruitment status and plans to enroll 120 participants.

Study design
This is a randomized Phase 2 study with three groups, enrolling 120 participants. You would be randomly assigned to one of the treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 2 years, which suggests follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07188896

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brian Rini
~120 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:FianlimabIpilimumabNivolumabCemiplimab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over 2 years
Advanced Renal Cell Carcinoma (aRCC)
Metastatic Renal Cell Carcinoma ( mRCC)
Clear Cell Renal Cell Carcinoma (ccRCC)
3 sites across 3 states
District of Columbia1
Tennessee1
Wisconsin1
  • Brian Rini, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt-Ingram Cancer Center

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  • Objective Response Rate (ORR)2 years

    ORR is defined as confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.