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

NCT07223541 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OU-SCC-LAG-BOOST
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Clear Cell Renal Cell Carcinoma

Keywords

Stereotactic body radiation therapy (SBRT); Oligo metastatic; ctDNA

Outcome Measures

Primary Outcomes (1)

• 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.

  Comparison of the 1-year progression-free survival between patients with oligo-metastatic ccRCC treated with cemiplimab alone versus those treated with both cemiplimab and fianlimab following SBRT.

  1 year

Secondary Outcomes (7)

• Proportion of TRAEs for assessment of the overall safety profile of cemiplimab and fianlimab in patients with oligo-metastatic ccRCC.

  1 year

• Evaluation of the objective response rate (ORR) of cemiplimab and fianlimab

  1 year

• Evaluation of the rates of local disease control in patients in response to SBRT with cemiplimab and fianlimab

  1 year

• Evaluation of the rates of distant disease control in patients in response to SBRT with cemiplimab and fianlimab

  1 year

• Evaluation of duration of response in patients in response to SBRT with cemiplimab and fianlimab

  1 year

Study Arms (2)

Cemiplimab + Fianlimab

EXPERIMENTAL

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.

Drug: Cemiplimab 350 MG Intravenous Solution; Drug: Fianlimab 1600 MG Intravenous Solution

Cemiplimab

ACTIVE COMPARATOR

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.

Drug: Cemiplimab 350 MG Intravenous Solution

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.

Also known as: Libtayo

Cemiplimab; Cemiplimab + Fianlimab

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.

Cemiplimab + Fianlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be \>= 18 years of age.
• Patient must have a biopsy/pathologically (histologically or cytologically) proven diagnosis of clear cell renal cell carcinoma (ccRCC) prior to randomization.
• Patient must have at least 1 and not more than 5 metastatic lesions measurable by RECIST v1.1, with imaging obtained within 45 days prior to randomization.
• Patients with untreated brain metastasis measuring \<2cm in diameter (intracranial RANO-BM measurable disease required) and with minimal neurological symptoms. Patients with treated brain metastasis are eligible for the trial as long as they have had three or fewer brain metastasis without signs of progression of disease on post-treatment MRI of the brain as per RANO for Brain Metastases (RANO-BM) guidelines.
• Patient must have documentation from a radiation oncologist confirming that all sites (metastases and primary tumor, if present) are amenable to stereotactic body radiation therapy (SBRT).
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, 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.
• All patients of childbearing potential must have a serum test within 14 days prior to randomization to rule out pregnancy.
• Patient must have the ability to understand and the willingness to sign a written informed consent document.
• Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
• Patients must have adequate organ and bone marrow function per protocol.
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study.
• For patients with history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If no previous history, testing for HBV is not required for entry onto the study.
• For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. If no previous history, testing for HCV is not required for entry onto the study.
• Patients with prior radiation to sites but without evidence of progression will be allowed, however these RT-treated sites will not be treated on study. Patients who have had a prior nephrectomy can be included in the study, patients with prior metastasectomy are also eligible for the study.

You may not qualify if:

• Patients with untreated brain metastasis \>2cm, significant neurological deficits and unamenable to surgical resection.
• Patient with variant histology renal cell carcinoma.
• Patient with metastasis invading gastrointestinal tract (such as esophagus, stomach, intestines, colon, rectum).
• Patients with more than 2 liver metastatic lesions, or liver lesions resulting in obstructive jaundice.
• Patient who have received any prior combination systemic therapy for metastatic RCC (including immune checkpoint inhibitors, tyrosine kinase inhibitors or combinations)
• 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
• Patients with active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Patients with no more than 1 prior systemic therapy for metastatic disease.
• Patients with active tuberculosis per protocol.
• Patients with uncontrolled hypertension (systolic blood pressure \[BP\] \> 190mmHg or diastolic BP \> 110mmHg).
• Patients requiring major surgery within 30 days prior to randomization.
• Patients with any serious (requiring hospital stay or long-term rehab) non-healing wound, ulcer, or bone fracture within 30 days prior to randomization.
• Patients with any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-STEMI \[NSTEMI\], cerebrovascular accident \[CVA\], etc.) events within 180 days prior to randomization.
• Patients with moderate or severe hepatic impairment (child-Pugh B or C).
• Patients with untreated pulmonary embolism (PE) or deep-vein thrombosis (DVT) is not allowed.

Sponsors & Collaborators

• University of Oklahoma: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Adanma Ayanambakkam, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Block

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Lead Nurse

CONTACT

405-271-8777; SCC-IIT-Office@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 3, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)