Clinical Research Directory

MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas

This Phase II study will evaluate toripalimab plus axitinib in adults with previously untreated, synchronous metastatic non-clear cell renal cell carcinoma and renal medullary carcinomas whose primary kidney tumor remains in place and whose baseline tumor biopsy contains a tertiary lymphoid structure. All participants will receive toripalimab and axitinib for approximately 12 weeks. At Week 12, an independent multidisciplinary team will review treatment response, overall disease burden, fitness for surgery, technical resectability, and participant preference. Deferred cytoreductive nephrectomy will be performed only when it has an independent clinical indication; it is not mandatory and is not assigned at random. Participants who do not undergo surgery will remain in the study for clinical follow-up. The study will estimate the proportion of eligible surgical participants who remain free of progression or death 24 weeks after surgery and will evaluate whether the functional state of tertiary lymphoid structures in the treated primary tumor is associated with control of residual metastatic disease. Peripheral blood will be used to track T-cell and B-cell receptor clonotypes. Postoperative blood for this purpose will be collected only at 3 months, and disease progression.