Actively Recruiting
A Randomized Phase II Trial of Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Oligo-Metastatic Clear Cell Renal Cell Carcinoma
Led by University of Oklahoma · Updated on 2026-03-02
72
Participants Needed
1
Research Sites
104 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
Researchers are studying the safety and effects of the PD-1 inhibitor cemiplimab, alone or combined with the LAG-3 inhibitor fianlimab, in patients with oligometastatic clear cell renal cell carcinoma who have completed radiation therapy. This phase II trial aims to understand the impact of these immune checkpoint inhibitors on this patient group after standard stereotactic body radiation therapy SBRT. Eligible patients first receive SBRT to their primary tumor andor metastatic sites, delivered in 1 to 5 fractions over 1 to 2 weeks. After radiation, patients are randomly assigned to one of two groups one receives cemiplimab plus fianlimab, while the other receives cemiplimab alone. Both treatments are given intravenously every 3 weeks for up to one year or until disease recurrence, unacceptable side effects, or other health issues intervene. During the study, participants will have regular treatment visits every 3 weeks for up to 17 cycles. Researchers will monitor safety, disease progression, and response to treatment through clinical assessments. The main outcome is progression-free survival over one year, with additional measures including treatment-related adverse events, response rates, disease control locally and distantly, duration of response, and overall survival. The total study duration extends through treatment and follow-up periods as specified.
CONDITIONS
Brief 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.
- Patient must have a biopsy or pathological diagnosis of clear cell renal cell carcinoma.
- Patient must have between 1 and 5 measurable metastatic lesions as per RECIST v1.1.
- Patients with untreated brain metastasis smaller than 2 cm and minimal neurological symptoms are eligible.
- Patients with treated brain metastases up to three lesions without progression are eligible.
- All tumor sites must be suitable for stereotactic body radiation therapy (SBRT).
- Patients with prior or concurrent malignancies not interfering with study assessments are eligible.
- Patients with cardiac disease should be NYHA class 2B or better.
- Women of childbearing potential must have a pregnancy test within 14 days before randomization.
- Patient must be willing and able to sign informed consent.
- Patient must have ECOG Performance Status between 0 and 2.
- Adequate organ and bone marrow function per protocol.
- HIV-infected patients on effective therapy with undetectable viral load within 6 months are eligible.
- Patients with controlled hepatitis B or C infections are eligible.
- Patients with prior radiation without progression are allowed; prior nephrectomy or metastasectomy is allowed.
You will not qualify if you...
- Patients with untreated brain metastases larger than 2 cm or significant neurological deficits not suitable for surgery.
- Patients with non-clear cell renal cell carcinoma histology.
- Patients with metastases invading the gastrointestinal tract.
- Patients with more than 2 liver metastases or liver lesions causing obstructive jaundice.
- Patients who have received prior combination systemic therapy for metastatic RCC.
- Patients who received immune checkpoint inhibitors or similar therapies within the last 12 months, except certain adjuvant pembrolizumab cases.
- Patients with active autoimmune disease requiring systemic treatment or high-dose corticosteroids.
- Patients with more than one prior systemic therapy for metastatic disease.
- Patients with active tuberculosis.
- Patients with uncontrolled high blood pressure.
- Patients who had major surgery within 30 days before randomization.
- Patients with serious non-healing wounds or fractures within 30 days.
- Patients with major arterial thrombotic events within 180 days.
- Patients with moderate or severe liver impairment.
- Patients with untreated pulmonary embolism or deep vein thrombosis.
- Patients with unstable cardiac arrhythmia within 180 days.
- Patients with recent abdominal or gastrointestinal complications.
- Patients with inflammatory bowel disease or connective tissue diseases contraindicating radiation.
- Pregnant or breastfeeding women.
- Patients not using effective contraception during and 6 months after treatment.
- Patients with myocarditis or elevated troponin levels above twice the upper limit.
- Patients with active infections requiring therapy.
- Patients with recent systemic treatment for autoimmune diseases, except certain exceptions.
- Patients with uncontrolled infections or immune deficiencies.
- Patients allergic to study drugs or excipients.
- Patients who received live vaccines within 30 days before treatment.
- Women of childbearing potential without negative pregnancy test.
Research Team
I
Ingrid Block
L
Lead Nurse
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