CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 103 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/NCT02821000
NCT02821000Phase 1Completed
CompareCT.gov

A Phase Ib Study of Pembrolizumab (MK-3475) in Chinese Subjects With Locally Advanced or Metastatic Melanoma (Keynote-151)

Merck Sharp & Dohme LLC·interventional·Posted Jul 1, 2016·Updated May 30, 2024

In Brief

A Phase 1 clinical trial evaluating Pembrolizumab for Melanoma. Completed, enrolled 103 participants.

Detailed Summary

The purpose of this study is to determine the safety, tolerability, and objective response rate (ORR) of pembrolizumab (MK-3475) in Chinese participants with locally advanced or metastatic melanoma, with disease progression following first line chemotherapy or targeted therapy. ORR will be based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). With Amendment 6 (effective date 18-Mar-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and may be enrolled in an extension study to continue protocol-defined assessments and treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 1, 2016
Enrollment StartJul 8, 2016
Primary CompletionDec 27, 2017
Study CompletionNov 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.0 years ago

Interventions

Pembrolizumabbiological

Intravenous infusion