OncoMatch/Clinical Trials/NCT07223541
Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
Is NCT07223541 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab 350 MG Intravenous Solution and Fianlimab 1600 MG Intravenous Solution for clear cell renal cell carcinoma.
Treatment: Cemiplimab 350 MG Intravenous Solution · Fianlimab 1600 MG Intravenous Solution — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: combination systemic therapy for metastatic RCC
Patient who have received any prior combination systemic therapy for metastatic RCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors or combinations)
Cannot have received: checkpoint inhibitor or immune therapies
Exception: adjuvant pembrolizumab >12 months ago and no radiographic progression within 12 months from last dose
Patients who have received any check point inhibitor or immune therapies (i.e. Vaccine or other immune-oncology agent) within the last 12 months. Patients who have previously been treated for non-metastatic RCC with adjuvant pembrolizumab can be included if over 12 months since last dose and they have not had radiographic progression within 12 months from the last dose of pembrolizumab
Lab requirements
Blood counts
adequate organ and bone marrow function per protocol
Liver function
Patients with moderate or severe hepatic impairment (child-Pugh B or C) excluded
Cardiac function
NYHA class 2B or better; unstable cardiac arrhythmia within 180 days prior to randomization excluded; history of myocarditis excluded; troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline per protocol excluded
Patients with known history or current symptoms of cardiac disease...should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients with moderate or severe hepatic impairment (child-Pugh B or C) [excluded]. Patients must have adequate organ and bone marrow function per protocol. Patients with unstable cardiac arrhythmia within 180 days prior to randomization [excluded]. Patients with history of myocarditis [excluded]. Patients with troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline per protocol [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Oklahoma Health Sciences Center · Oklahoma City, Oklahoma
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