CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 297 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/NCT01848834
NCT01848834Phase 1Completed
CompareCT.gov

A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors

Merck Sharp & Dohme LLC·interventional·Posted May 8, 2013·Updated Jun 28, 2021

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab for Cancer and Solid Tumor. Completed, enrolled 297 participants.

Detailed Summary

This study is being done to investigate the safety, tolerability and anti-tumor activity of pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC) (Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer (Cohort C), or advanced gastric cancer (Cohort D). Additionally, for Cohort D, data is presented for Asian Pacific (AP) participants. Only participants with programmed cell death-ligand 1 (PD-L1) expressing tumors were enrolled in Cohorts A, B, C and D. Participants in Cohort B2 were enrolled irrespective of PD-L1 status. The primary study hypothesis is that pembrolizumab is safe and well-tolerated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Solid Tumor
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 8, 2013
Enrollment StartMay 7, 2013
Primary CompletionApr 26, 2016
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.2 years ago

Interventions

Pembrolizumabbiological

IV infusion