Recruitment

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