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

NCT03149822 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-13

Study results available
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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.

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Cabozantinib

Pharmaceutical form: tablets Route of administration: oral

DRUG

Pembrolizumab

Pharmaceutical form: solution Route of administration: injection

Sponsors & Collaborators

Principal Investigators

  • Elaine Lam, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2022-12-14
Completion
2024-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03149822 on ClinicalTrials.gov