CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 55 enrolled
Drug / intervention
Pembrolizumab (MK-3475)drug
Likely dose
Pembrolizumab (MK-3475) 200 mgfrom 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/NCT03783078
NCT03783078Phase 3Completed
CompareCT.gov

A Phase 3 Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) as First Line Therapy in Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-913)

Merck Sharp & Dohme LLC·interventional·Posted Dec 20, 2018·Updated May 28, 2025

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab (MK-3475) for Merkel Cell Carcinoma. Completed, enrolled 55 participants across 22 sites in 8 countries.

Detailed Summary

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMerkel Cell Carcinoma
CountriesAustralia, Canada, France, Italy, New Zealand, Spain, Sweden, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 20, 2018
Enrollment StartFeb 25, 2019
Primary CompletionFeb 15, 2022
Study CompletionFeb 15, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.5 years ago

Interventions

Pembrolizumab (MK-3475)drug

200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) IV up to 35 administrations (approximately 2 years).