NCT03149822

Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma

Phase I/II Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II open-label study designed to evaluate the combination of pembrolizumab and cabozantinib in subjects with locally advanced, recurrent, or metastatic renal cell carcinoma. Sequential dose escalation of cabozantinib with standard dose pembrolizumab will occur in the phase I dose escalation part of the study to determine the recommended phase 2 dose (RP2D). Subsequently, subjects will receive cabozantinib at the RP2D in combination with pembrolizumab in the phase II dose expansion part of the study.

Detailed 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 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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Pharmaceutical form: tablets Route of administration: oral
DRUG	Pembrolizumab	Pharmaceutical form: solution Route of administration: injection

Timeline

• Start date: 2017-09-28
• Primary completion: 2022-12-14
• Completion: 2024-02-16
• First posted: 2017-05-11
• Last updated: 2025-03-13
• Results posted: 2023-10-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study