NCT07223541

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All eligible patients will undergo standard of care SBRT to primary tumor (if present) and/or all metastatic tumor sites prior to randomization. During radiotherapy, patients will receive 1 to 5 fractions delivered over 1-2 weeks. Then patients will be randomized at 1:1 ratio to the two arms: * ARM A: Cemiplimab, 350 mg, IV, and Fianlimab 1600 mg, IV, q3w for 1 year, * ARM B: Cemiplimab 350 mg, IV, Q3W for 1 year. Immune check point inhibition will occur within 3 weeks (+/-1 week) of completion of SBRT Patients will undergo treatment with the study drug(s) every 3 weeks for a maximum of 17 cycles (approximately 12 months) or until disease recurrence, unacceptable toxic effects, or intercurrent illness preventing further administration.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab 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.
DRUG	Fianlimab 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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2029-08-01
• Completion: 2031-08-01
• First posted: 2025-11-03
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study