July 13 2022
Randomized Phase IIStereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
Currently, there is no well-established treatment for the primary tumor in patients with metastatic renal cell cancer (RCC) that are not candidates for surgery. Clinical trials are underway to define the role of cytoreductive nephrectomy when combined with immunotherapy, but many patients with metastatic RCC may not be eligible for upfront surgical resection. NRG-GU012, also known as the “SAMURAI” study, was designed to test a potential alternative treatment directed at the primary renal tumor for patients with metastatic RCC, who are not ideal candidates for surgery upfront.
“The NRG-GU012 trial will use stereotactic ablative radiotherapy (SABR) to treat the primary tumor in patients with advanced metastatic RCC who are also receiving immunotherapy. Our goal is to see if the addition of SABR helps to enhance the effectiveness of the immunotherapy treatment, ultimately translating to improved survival outcomes,” stated William A. Hall, MD, of the Medical College of Wisconsin, and the Principal Investigator of NRG-GU012.
Eligible patients include those with any RCC histology, with metastatic disease, not having received prior systemic therapy for advanced RCC. Patients will be stratified by International Metastatic RCC Database Consortium risk group, planned immunotherapy type, and histology. Following stratification, patients on NRG-GU012 will be randomly assigned (1:2) to either receive the standard immunotherapy treatment alone or to receive the standard immunotherapy treatment combined with SABR to the primary tumor (42 Gy in 3 fractions).
The primary aim of NRG-GU012 is to determine whether the addition of SABR treatment to the primary tumor to immunotherapy improves outcomes compared to immunotherapy alone via the endpoints of nephrectomy and radiographic progression-free survival. Additionally, NRG-GU012 will aim to assess the safety, toxicity, tolerability, objective response rate, overall survival, time to subsequent second-line therapy or death, rate of cytoreductive nephrectomy, and treatment-free survival in patients who discontinue therapy for any reason other than radiographic disease progression between both treatment arms. There are several exploratory objectives on NRG-GU012, including identifying prognostic and predictive biomarkers of response to SABR with immunotherapy.
“While SABR has been proven to be a safe treatment for primary RCC tumors based on multiple single-institution studies, this would be the first randomized trial of radiation therapy in the National Clinical Institute (NCI) National Clinical Trials Network (NCTN) for advanced RCC,” added Rana McKay, MD, the University of California, San Diego Moores Cancer Center and the Co-Principal Investigator of NRG-GU012. “This trial is very significant as it has the ability to enlighten researchers on the potential benefit of SABR primary cytoreduction in metastatic RCC patients who are receiving immunotherapy.”
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website