Clinical trialNCT05327686RecruitingPhase 2Interventional

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

SponsorNRG OncologyEnrollment240Metastatic Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Unresectable Renal Cell Carcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

William A Hall
NRG Oncology
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

328 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Shankar Siva
Recruiting

Canada

University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Suspended
Chu de Quebec-L'Hotel-Dieu de Quebec (hdq)
Québec, Quebec, Canada
Isabelle Thibault
Recruiting

Ireland

Beacon Hospital
Dublin, Co Dublin, Ireland
Alina M. Mihai
Recruiting
Saint Lukes Hospital
Dublin, Co Dublin, Ireland
Pierre Thirion
Recruiting

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Active, not recruiting
Kingman Regional Medical Center
Kingman, Arizona, United States
John A. Ellerton
Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mark Waddle
Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sanjay Maraboyina
Recruiting
Pcr Oncology
Arroyo Grande, California, United States
John A. Ellerton
Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, United States
Leslie Ballas
Recruiting
Mills-Peninsula Medical Center
Burlingame, California, United States
Christopher U. Jones
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Active, not recruiting
Uc San Diego Health System - Encinitas
Encinitas, California, United States
Tyler M. Seibert
Recruiting
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Shera Feinstein
Recruiting
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Tyler M. Seibert
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Leslie Ballas
Recruiting
Los Angeles General Medical Center
Los Angeles, California, United States
Lauren A. Lukas
Recruiting
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Lauren A. Lukas
Recruiting
Memorial Medical Center
Modesto, California, United States
Christopher U. Jones
Recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Shera Feinstein
Recruiting
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Christopher U. Jones
Recruiting
Sutter Roseville Medical Center
Roseville, California, United States
Christopher U. Jones
Recruiting
Sutter Medical Center Sacramento
Sacramento, California, United States
Christopher U. Jones
Recruiting
Uc San Diego Medical Center - Hillcrest
San Diego, California, United States
Tyler M. Seibert
Recruiting
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Steven N. Seyedin
Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Active, not recruiting
Mills Health Center
San Mateo, California, United States
Christopher U. Jones
Recruiting
Ridley-Tree Cancer Center
Santa Barbara, California, United States
Christopher U. Jones
Recruiting
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Christopher U. Jones
Recruiting
Uchealth University of Colorado Hospital
Aurora, Colorado, United States
Corbin Eule
Recruiting
Uchealth - Cherry Creek
Denver, Colorado, United States
Corbin Eule
Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, United States
Corbin Eule
Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, United States
Corbin Eule
Recruiting
Uchealth Greeley Hospital
Greeley, Colorado, United States
Corbin Eule
Recruiting
Uchealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
Corbin Eule
Recruiting
Uchealth Lone Tree Health Center
Lone Tree, Colorado, United States
Corbin Eule
Recruiting
Medical Center of the Rockies
Loveland, Colorado, United States
Corbin Eule
Recruiting
Beebe Medical Center
Lewes, Delaware, United States
Gregory A. Masters
Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, United States
Gregory A. Masters
Recruiting

288 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Avelumab →Axitinib →Cabozantinib →Ipilimumab →Lenvatinib →Nivolumab →Pembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Feb 2023
Primary completion: 15 Jun 2028
Completion: 15 Jun 2033
Last update posted: 17 Aug 2026
Registered enrollment: 240
Registry id: NCT05327686

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.