CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Cabozantinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03149822
NCT03149822Phase 2Completed
CompareCT.gov

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

University of Colorado, Denver·interventional·Posted May 11, 2017·Updated Mar 13, 2025

In Brief

A Phase 2 clinical trial evaluating Cabozantinib and Pembrolizumab for Metastatic Renal Cell Carcinoma. Completed, enrolled 45 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Renal Cell Carcinoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 11, 2017
Enrollment StartSep 28, 2017
Primary CompletionDec 14, 2022
Study CompletionFeb 16, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.1 years ago

Interventions

Cabozantinibdrug

Pharmaceutical form: tablets Route of administration: oral

Pembrolizumabdrug

Pharmaceutical form: solution Route of administration: injection