Combining Stereotactic Radiation with Immune Therapy for Advanced Kidney Cancer
Official title: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
Run by NRG Oncology · NCT05327686 · Data updated 2026-11-12
This study is testing whether adding a special type of radiation therapy to standard immune treatment can help people with advanced kidney cancer live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | NRG Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, nivolumab, ipilimumab, avelumab, pembrolizumab, Axitinib, cabozantinib, lenvatinib, immunotherapy |
| Locations | 348 sites (Birmingham, Alabama and 347 other locations) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | June 15, 2028 |
| Study ends | June 15, 2033 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT05327686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with pathologically confirmed metastatic or unresectable renal cell carcinoma who are not recommended for immediate surgery.
✕Probably not a fit
Patients with early-stage renal cell carcinoma or those who are candidates for immediate cytoreductive nephrectomy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial investigates the effectiveness of adding stereotactic ablative radiation therapy (SABR) to standard immunotherapy in patients with unresectable or metastatic renal cell carcinoma. The study aims to determine if this combination improves outcomes such as progression-free survival compared to immunotherapy alone. Participants will receive high-precision radiation targeting the primary tumor alongside immune-boosting treatments like monoclonal antibodies. The trial will also assess safety, toxicity, and overall survival rates among the different treatment arms.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with advanced renal cell carcinoma.
How similar studies have gone: Other studies have shown promise in combining radiation with immunotherapy, suggesting potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
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Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States Recruiting -
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States Recruiting -
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States Recruiting -
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States Recruiting -
Highlands Oncology Group
Springdale, Arkansas, United States Recruiting -
Tower Cancer Research Foundation
Beverly Hills, California, United States Recruiting
Show 44 more locations
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Mills-Peninsula Medical Center
Burlingame, California, United States Recruiting -
UC San Diego Health System - Encinitas
Encinitas, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
UC San Diego Moores Cancer Center
La Jolla, California, United States Recruiting -
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States Recruiting -
Los Angeles General Medical Center
Los Angeles, California, United States Recruiting -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Memorial Medical Center
Modesto, California, United States Recruiting -
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States Recruiting -
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States Recruiting -
Sutter Roseville Medical Center
Roseville, California, United States Recruiting -
Sutter Medical Center Sacramento
Sacramento, California, United States Recruiting -
UC San Diego Medical Center - Hillcrest
San Diego, California, United States Recruiting -
UCSF Medical Center-Mission Bay
San Francisco, California, United States Recruiting -
Mills Health Center
San Mateo, California, United States Recruiting -
Ridley-Tree Cancer Center
Santa Barbara, California, United States Recruiting -
Sutter Pacific Medical Foundation
Santa Rosa, California, United States Recruiting -
UCHealth University of Colorado Hospital
Aurora, Colorado, United States Recruiting -
UCHealth - Cherry Creek
Denver, Colorado, United States Recruiting -
Poudre Valley Hospital
Fort Collins, Colorado, United States Recruiting -
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States Recruiting -
UCHealth Greeley Hospital
Greeley, Colorado, United States Recruiting -
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States Recruiting -
UCHealth Lone Tree Health Center
Lone Tree, Colorado, United States Recruiting -
Medical Center of the Rockies
Loveland, Colorado, United States Recruiting -
Beebe Medical Center
Lewes, Delaware, United States Recruiting -
Beebe South Coastal Health Campus
Millville, Delaware, United States Recruiting -
Helen F Graham Cancer Center
Newark, Delaware, United States Recruiting -
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States Recruiting -
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States Recruiting -
Beebe Health Campus
Rehoboth Beach, Delaware, United States Recruiting -
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States Recruiting -
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States Recruiting -
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States Recruiting -
Mayo Clinic in Florida
Jacksonville, Florida, United States Recruiting -
Moffitt Cancer Center at Speros
Land O' Lakes, Florida, United States Recruiting -
Miami Cancer Institute
Miami, Florida, United States Recruiting -
Mount Sinai Medical Center
Miami Beach, Florida, United States Recruiting -
Memorial Hospital West
Pembroke Pines, Florida, United States Recruiting -
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States Recruiting -
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting
+298 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: William A Hall — NRG Oncology
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.