Actively Recruiting
Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
Led by University of Oklahoma · Updated on 2026-03-02
72
Participants Needed
1
Research Sites
289 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older.
- Diagnosed with clear cell renal cell carcinoma confirmed by biopsy or pathology.
- Have between 1 and 5 metastatic lesions measurable by imaging within 45 days before randomization.
- Untreated brain metastasis smaller than 2 cm with minimal neurological symptoms or treated brain metastasis with no progression.
- Radiation oncologist confirms all tumor sites can receive stereotactic body radiation therapy (SBRT).
- Prior or concurrent cancers that do not affect safety or treatment assessment are allowed.
- Cardiac function classified as class 2B or better by New York Heart Association standards.
- Negative pregnancy test for patients who can become pregnant within 14 days before randomization.
- Able and willing to provide informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ and bone marrow function.
- HIV patients on effective treatment with undetectable viral load within 6 months are eligible.
- Hepatitis B virus patients with undetectable viral load on therapy are eligible; testing not required if no history.
- Hepatitis C patients on treatment with undetectable viral load are eligible; testing not required if no history.
- Prior radiation to sites allowed if no progression; prior nephrectomy or metastasectomy allowed.
You will not qualify if you...
- Untreated brain metastasis larger than 2 cm with significant neurological deficits and not suitable for surgery.
- Renal cell carcinoma with variant histology.
- Metastasis invading gastrointestinal tract.
- More than 2 liver metastases or liver lesions causing obstructive jaundice.
- Prior combination systemic therapy for metastatic renal cell carcinoma.
- Immune or checkpoint inhibitor therapy within last 12 months (exceptions apply).
- Active autoimmune disease requiring systemic treatment or high-dose corticosteroids.
- More than one prior systemic therapy for metastatic disease.
- Active tuberculosis.
- Uncontrolled high blood pressure (systolic >190 mmHg or diastolic >110 mmHg).
- Major surgery within 30 days before randomization.
- Serious untreated wounds, ulcers, or fractures within 30 days before randomization.
- Recent arterial thrombotic events within 180 days.
- Moderate or severe liver impairment.
- Untreated pulmonary embolism or deep vein thrombosis.
- Unstable cardiac arrhythmia within 180 days.
- Recent history of abdominal fistula, perforation, abscess, bowel obstruction, or gastric outlet obstruction.
- History of or active inflammatory bowel disease.
- History of connective tissue disease or conditions contraindicating radiation therapy.
- Pregnant or breastfeeding.
- Not using effective contraception during study and for 6 months after.
- History of myocarditis.
- Elevated troponin levels above twice the normal limit at baseline.
- Recent or active serious infections requiring antibiotics.
- Recent systemic treatment for autoimmune diseases within 2 years.
- Uncontrolled infections including HIV, HBV, or HCV.
- Known allergies to study drugs or their ingredients.
- Live vaccine within 30 days before starting study medication.
- Fertile women not permanently sterile must have negative pregnancy test at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
I
Ingrid Block
CONTACT
L
Lead Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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