CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 374 enrolled
Drug / intervention
pembrolizumabbiological
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/NCT02335424
NCT02335424Phase 2Completed
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A Phase II Clinical Trial of Pembrolizumab (MK-3475) in Subjects With Advanced/Unresectable or Metastatic Urothelial Cancer

Merck Sharp & Dohme LLC·interventional·Posted Jan 9, 2015·Updated Mar 2, 2023

In Brief

A Phase 2 clinical trial evaluating pembrolizumab for Urothelial Cancer. Completed, enrolled 374 participants.

Detailed Summary

This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. The primary study objective is to determine the objective response rate (ORR) in all participants and by programmed cell death ligand 1 (PD-L1) status. With Amendment 4, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Cancer
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 9, 2015
Enrollment StartFeb 24, 2015
Primary CompletionJun 19, 2018
Study CompletionFeb 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.5 years ago

Interventions

pembrolizumabbiological

IV infusion