Spots Global Cancer Trial Database for Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC)

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Trial Identification

Brief Title: Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC)

Official Title: Phase 2, Open-label, Two Cohort, Multicenter Trial for Sequential Treatment of High Dose Cabozantinib or Cabozantinib Plus Nivolumab on/After Progression on Cabozantinib Monotherapy in Advanced Renal Cell Carcinoma (Seq-Cabo)

Study ID: NCT05931393

Conditions

RCC

Renal Cell Carcinoma

Interventions

Cabozantinib 80 MG

Cabozantinib 40Mg Tab

Nivolumab

Study Description

Brief Summary: The goal of this clinical trial is to learn about the effects of a higher dose of cabozantinib or the effects of cabozantinib-nivolumab combination in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment. The study will have two parts or "cohorts". * Cohort 1: cabozantinib 80mg daily * Cohort 2: cabozantinib 40mg daily with nivolumab The cohort assignment will be determined by investigator, based on how much cabozantinib the participant is able to safely receive.

Detailed Description: This is a multi-center, open-label, 2 cohort, phase II study to assess the efficacy of cabozantinib dose escalation and cabozantinib/nivolumab combination at the time of progression on/after cabozantinib monotherapy. The study will enroll subjects with advanced RCC (defined as locally advanced, unresectable or metastatic) who have disease progression on/after cabozantinib monotherapy in any line of treatment