OncoMatch/Clinical Trials/NCT05327686
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
Is NCT05327686 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for metastatic renal cell carcinoma.
Treatment: Avelumab · Axitinib · Cabozantinib · Ipilimumab · Lenvatinib · Nivolumab · Pembrolizumab — This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Disease stage
Required: Stage III, IV (AJCC v8)
Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) ... measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor
Prior therapy
Cannot have received: systemic therapy for metastatic renal cell carcinoma
Exception: systemic therapy initiated > 90 days before registration is excluded; prior chemotherapy for a different cancer is allowed if completed > 3 years prior to registration
Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
Cannot have received: radiotherapy to the kidney
Exception: if would result in overlap of radiation therapy fields treatment of the primary tumor
Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
Lab requirements
Blood counts
Hemoglobin >= 8 g/dL (transfusions allowed); Platelet count >= 50,000/mm^3; ANC >= 1500/mm^3
Kidney function
Calculated creatinine clearance >= 30 mL/min (Cockcroft-Gault or CKD-EPI formula for African American patients); GFR >= 30 mL/min/1.73m^2 for African American patients
Liver function
Total bilirubin <= 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); AST and ALT <= 3 x ULN or < 5 x ULN if hepatic metastases present
Hemoglobin >= 8 g/dL (transfusions are allowed); Platelet count >= 50,000/mm^3; ANC >= 1500/mm^3; Calculated (Calc.) creatinine clearance >= 30 mL/min; Total bilirubin <= 1.5 x ULN (except Gilbert Syndrome < 3.0 mg/dL); AST and ALT <= 3 x ULN or < 5 x ULN if hepatic metastases present
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- PCR Oncology · Arroyo Grande, California
- Mills-Peninsula Medical Center · Burlingame, California
- City of Hope Comprehensive Cancer Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify