Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)
NRG Oncology
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria. SECONDARY OBJECTIVES: I. To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 hav…
Interventions
- BiologicalAvelumab
Given IV
- DrugAxitinib
Given PO
- ProcedureBiospecimen Collection
Undergo collection of blood
- ProcedureBone Scan
Undergo bone scan
- DrugCabozantinib
Given PO
- ProcedureComputed Tomography
Undergo CT
- BiologicalIpilimumab
Given IV
Locations (318)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- PCR OncologyArroyo Grande, California
- Mills-Peninsula Medical CenterBurlingame, California
- City of Hope Comprehensive Cancer CenterDuarte, California
- UC San Diego Health System - EncinitasEncinitas, California