RecruitingPhase 2NCT07223541

Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma

A Randomized Phase II Trial of Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Oligo-Metastatic Clear Cell Renal Cell Carcinoma


Sponsor

University of Oklahoma

Enrollment

72 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to test the safety of PD-1 inhibitor cemiplimab with or without LAG-3 inhibitor fianlimab, and see what effects (good and bad) of cemiplimab either alone or combined with fianlimab has on patients with oligometastatic clear cell renal cell carcinoma after completion of radiation therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a second immunotherapy drug (fianlimab) to an existing immunotherapy drug (cemiplimab) after targeted radiation therapy improves outcomes for patients with advanced clear cell kidney cancer (clear cell renal cell carcinoma) that has spread to other areas. The radiation is intended to stimulate the immune system before immunotherapy. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with clear cell kidney cancer confirmed by biopsy - You have between 1 and 5 metastatic tumors that are measurable on scans - All of your tumor sites (including the primary tumor, if present) are able to receive stereotactic body radiation therapy (SBRT) - You have not yet received systemic cancer treatment for this diagnosis **You may NOT be eligible if...** - You have already received systemic treatment for kidney cancer - You have more than 3 treated brain metastases, or brain metastases larger than 2 cm - You have active autoimmune disease requiring systemic treatment - You are unable to receive radiation therapy or immunotherapy for medical reasons 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

DRUGCemiplimab 350 MG Intravenous Solution

Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology. By binding to PD-1, cemiplimab (Libtayo) has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

DRUGFianlimab 1600 MG Intravenous Solution

Fianlimab is a recombinant fully human monoclonal antibody (based on IgG4 isotype) targeting the immune checkpoint receptor LAG-3 on T cells and was invented using Regeneron's proprietary Veloc Immune® technology.


Locations(1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

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NCT07223541


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