CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Intravenous MK-3475/ Intravesical BCGdrug
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/NCT02324582
NCT02324582Phase 1Completed
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Phase I Study of MK-3475 in Combination With BCG for Patients With High Risk Superficial Bladder Cancer

Southern Illinois University·interventional·Posted Dec 24, 2014·Updated Sep 3, 2024

In Brief

A Phase 1 clinical trial evaluating Intravenous MK-3475/ Intravesical BCG for Bladder Cancer. Completed, enrolled 18 participants across 3 sites.

Detailed Summary

This is a single center Phase I safety and efficacy study of MK-3475 therapy used in combination with bladder infused BCG treatment for patients, 18 years or older, with high risk superficial bladder cancer (cancer not yet involving the muscle of the bladder wall) who have had removal of their bladder tumor. Patients will be enrolled to a single treatment group of a fixed dose of MK 3475 and BCG.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 24, 2014
Enrollment StartJun 1, 2015
Primary CompletionNov 18, 2021
Study CompletionMar 27, 2023
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.5 years ago

Interventions

Intravenous MK-3475/ Intravesical BCGdrug

6 cycles (each cycle is 21 days) of pembrolizumab will be given over 9 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.