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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03149822
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Pharmaceutical form: tablets Route of administration: oral
  • Pembrolizumab — DRUG
    Pharmaceutical form: solution Route of administration: injection

Study Details

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.

Key Dates

Start date
Sep 28, 2017
Status verified
Mar 2025
Primary completion
Dec 14, 2022
Completion
Feb 16, 2024

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 40mg
    Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
  • Experimental: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 60mg
    Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.
  • Experimental: Phase 2: Pembrolizumab 200 mg plus Cabozantinib at the RP2D
    Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.

Primary Outcome Measure

Efficacy of Pembrolizumab and Cabozantinib Based on Objective Response Rate [ Time Frame: Beginning of study to end of study, up to 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado DenverAuroraColorado80045-
Memorial Hospital CentralColorado SpringsColorado80909-
Poudre Valley HospitalFort CollinsColorado80528-
Highlands Ranch HospitalHighlands RanchColorado80129-
UCHealth Lone Tree Medical CenterLone TreeColorado80124-

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