SAMURAI Trial: Radiation with Immunotherapy for Kidney Cancer
This study, called the SAMURAI trial, is testing if adding radiation therapy to the main tumor, using a method called stereotactic ablative radiation therapy (SABR), helps patients with kidney cancer that has spread or cannot be removed by surgery. You would receive either SABR plus standard immunotherapy (avelumab and axitinib, or cabozantinib) or immunotherapy alone. The study aims to see if this combination improves how long patients live without their cancer growing or spreading further. To join, you must have kidney cancer that has spread or cannot be surgically removed, and be at least 18 years old. The study is currently unclear about its recruitment status and plans to enroll 240 participants.
- Study design
- This is an interventional study with a planned enrollment of 240 participants. The phase of the study is not specified.
- What's involved
- You would undergo biospecimen collection (blood tests) and bone scans. You would also receive either avelumab (given intravenously) and axitinib (taken by mouth), or cabozantinib (taken by mouth).
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be followed from randomization up to 8 years to measure nephrectomy and radiographic progression-free survival.
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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
Recruiting
PHASE2Ages 18+InterventionalTreatmentNRG OncologyInvestigator-initiated
~240 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AvelumabAxitinibBiospecimen CollectionBone ScanCabozantinibComputed Tomography
At a glance
Recruiting sites
284 of 328 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nephrectomy and radiographic progression-free survival (nrPFS)
Measured over From randomization to last follow-up, up to 8 years
Conditions
Where it's being run
328 sites across 39 statesPennsylvania39
Wisconsin34
Illinois30
California21
Minnesota20
Ohio19
Michigan15
North Carolina15
Study leadership
- William A Hall · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration
Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:
History/physical examination within 45 days prior to registration
CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration
Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors)
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 measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor
Patient not recommended for or refused immediate cytoreductive nephrectomy
Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen
Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging
Age \>= 18
Karnofsky performance status \>= 60 within 45 days prior to registration
Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)
Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration)
Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration)
Calculated (Calc.) creatinine clearance \>= 30 mL/min (within 45 days prior to registration)
Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault Equation
For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR \>= 30 mL/min/1.73m\^2 will be considered adequate
Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) (within 45 days prior to registration)
Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present (within 45 days prior to registration)
Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load
The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion
Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment
Patients with untreated or unstable brain metastases or cranial epidural disease
Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
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)
Severe, active comorbidity defined as follows:
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
History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies
Active tuberculosis (purified protein derivative \[PPD\] response without active tuberculosis \[TB\] is allowed)
Uncontrolled hypertension (systolic blood pressure \[BP\] \>= 190 mmHg or diastolic BP \> 110 mmHg)
Major surgery requiring hospital admission =\< 28 days prior to registration
Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration
Any arterial thrombotic (ST elevation myocardial infarction \[STEMI\], non-ST elevation myocardial infarction \[NSTEMI\], cerebrovascular accident \[CVA\], etc) events within 180 days prior to registration
Active New York (NY) Heart Association class 3-4 heart failure symptoms
Moderate or severe hepatic impairment (Child-Pugh B or C)
Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis \> 30 days prior to registration is allowed)
Unstable cardiac arrhythmia within 180 days prior to registration
History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration
History of or active inflammatory bowel disease
Malabsorption syndrome within 45 days prior to registration
Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =\< 45 days prior to registration
What this trial measures
- Nephrectomy and radiographic progression-free survival (nrPFS)From randomization to last follow-up, up to 8 years
Nephrectomy and radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, nephrectomy, death, or last negative evaluation (censored). nrPFS rates are estimated using the Kaplan-Meier method. Progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST).