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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07223541
Phase
PHASE2
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab 350 MG Intravenous Solution — DRUG
    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.
  • Fianlimab 1600 MG Intravenous Solution — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2031

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab + Fianlimab
    Cemiplimab, 350 mg, IV, and Fianlimab 1600 mg, IV, q3w for 1 year. 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.
  • Active Comparator: Cemiplimab
    Cemiplimab 350 mg, IV, Q3W for 1 year. 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.

Primary Outcome Measure

Proportion of patients with progression-free survival of oligo-metastatic clear cell renal cell carcinoma (ccRCC) patients following stereotactic body radiation therapy (SBRT) and up to one-year of treatment with cemiplimab or cemiplimab plus fianlimab. [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Adanma Ayanambakkam, MD
[email protected]
405-271-4022
Adanma Ayanambakkam, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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