Phase 2, Open-label, Single Cohort, Multicenter Trial for Sequential Treatment of High Dose Cabozantinib on/After Progression on Cabozantinib Monotherapy in Advanced Renal Cell Carcinoma (Seq-Cabo)
University of Texas Southwestern Medical Center
Summary
The goal of this clinical trial is to learn about the effects of a higher dose of ncabozantinib in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment.
Description
This is a multi-center, open-label, single cohort, phase II study to assess the efficacy of cabozantinib dose escalation 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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with advanced RCC (defined as locally advanced unresectable or metastatic) of any histology who progressed on/after cabozantinib monotherapy in any line of treatment. Patient must have cabozantinib sensitive disease (prior treatment with cabozantinib ≥ 6 months) 2. Ability to tolerate prior cabozantinib at 60mg PO daily with manageable toxicity profile at the respective doses, at investigator discretion 3. Prior PD-1 inhibitor/PD-L1 inhibitor allowed 4. Evidence of measurable disease per RECIST 1.1 5. For up to 5 patients opting into on-treatment biopsy, one of…
Interventions
- DrugCabozantinib 80 MG
cabozantinib 80mg daily
Location
- UT Southwestern Medical CenterDallas, Texas