Trial of Tremelimumab in Patients With Previously Treated Metastatic Urothelial Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Matthew Galsky
Study ID
NCT03557918
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles. Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria.

Study Details

This is a phase II trial designed to estimate the activity of single agent tremelimumab in subjects with metastatic urothelial cancer with disease progression despite prior treatment with PD-1/PD-L1 blockade. The primary endpoint is objective response rate and the study will employ a Simon's 2-stage design.

Key Dates

Start date
Nov 12, 2018
Status verified
Jun 2024
Primary completion
Dec 6, 2021
Completion
Jun 7, 2023

Study Design

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

Arms

  • Experimental: Tremelimumab
    Tremelimumab 750 mg IV Day 1 of each 28 day cycle. Up to 7 cycles.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to a maximum of 12 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
University of Kansas Medical Center Research Institute, Inc.WestwoodKansas66205-
Dana Farber- Partners Cancer Care, IncBostonMassachusetts02215-
Ichan School of Medicine at Mount SinaiNew YorkNew York10029-6542-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Huntsman Cancer Institute University of UtahSalt Lake CityUtah84112-

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Georgetown University· Washington D.C., DCWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Kansas Medical Center Research Institute, Inc.· Westwood, KSDana Farber- Partners Cancer Care, Inc· Boston, MAIchan School of Medicine at Mount Sinai· New York, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NC

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