Cabozantinib Plus Pembrolizumab as First-Line Therapy for Cisplatin-Ineligible Advanced Urothelial Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Utah
Study ID
NCT03534804
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib is administered at 40 mg oral daily
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks.

Study Details

This is an open label, non-randomized phase 2 study of the combination of pembrolizumab and cabozantinib to assess overall response rate (ORR), progression free survival at 6 months (PFS6), and overall survival (OS) in patients with metastatic urothelial carcinoma (UC) ineligible for cisplatin.

Key Dates

Start date
Sep 18, 2018
Status verified
Nov 2024
Primary completion
Aug 2, 2023
Completion
Apr 15, 2024

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib and Pembrolizumab, all patients

Primary Outcome Measure

Count of Participants With Response Measured by RECIST 1.1 [ Time Frame: From baseline disease assessment to best response disease assessment, measured up to 28 months. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Tampa, FL

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By specialty
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By research site
Moffitt Cancer Center· Tampa, FLWinship Cancer Institute, Emory University· Atlanta, GAHuntsman Cancer Institute· Salt Lake City, UT

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