Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 55
Summary
- Conditions
- Metastatic Renal Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Masking Description: Open-LabelPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
Primary Objectives To determine the efficacy based on objective response rate [ORR = complete response (CR) + partial response (PR)] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma.. Secondary Objectives To chara...
Primary Objectives To determine the efficacy based on objective response rate [ORR = complete response (CR) + partial response (PR)] of pembrolizumab and cabozantinib when administered in combination in subjects with locally advanced or metastatic renal cell carcinoma.. Secondary Objectives To characterize dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) for the combination. To assess other measures of anti-tumor activity of the combination of pembrolizumab and cabozantinib in subjects with locally advanced or metastatic renal cell carcinoma.
Tracking Information
- NCT #
- NCT03149822
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Elaine Lam, MD University of Colorado, Denver