Lenvatinib And Stereotactic radiothErapy With pembRolizumab in Metastatic Kidney Cancer Patients

Metastatic clear-cell renal cell carcinoma (ccRCC) is sensitive to therapy with lenvatinib and pembrolizumab. The CLEAR trial demonstrated positive outcomes even in patients with a low tumor burden. In a subset of patients with metastatic ccRCC, the presence of a low tumor burden suggests that incorporating stereotactic body radiotherapy (SBRT) into systemic therapy could be a strategy to enhance the anti-tumor response, while maintaining an acceptable toxicity profile. This study evaluates the contribution of SBRT in a subgroup of patients who have achieved stable disease while receiving lenvatinib and pembrolizumab.

Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed clear-cell renal cell carcinoma. * Presence of measurable lesions per RECIST 1.1. * Sum of diameters of target lesions ≤ 7 cm. * ECOG 0-2. * No prior systemic therapy for metastatic disease. Exclusion Criteria: * Uncontrolled comorbidities that preclude the use of TKI/IO or SBRT. * Prior SBRT to the lesions planned for irradiation, rendering re-irradiation unsafe. * Active autoimmune diseases requiring systemic immunosuppressants. * Symptomatic CNS metastases (patients with asymptomatic metastases may be included).