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

NCT07223541 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Adanma Ayanambakkam, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2029-08-31
Completion
2031-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223541 on ClinicalTrials.gov