Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

ClinicalTrials.gov ID: NCT03783078

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Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT03783078
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Merck Sharp & Dohme LLC; Industry
Enrollment: 55 participants

Conditions and interventions

Conditions

Merkel Cell Carcinoma

Interventions

Pembrolizumab (MK-3475) Drug

Drug

Eligibility (public fields only)

Age range: 12 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 25, 2019 (Actual)
Primary completion: Feb 15, 2022 (Actual)
Completion: Feb 15, 2024 (Actual)
Last update posted: May 28, 2025

2019 – 2024

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0006)	New York	New York	10016	—
Icahn School of Medicine at Mount Sinai ( Site 0004)	New York	New York	10029	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03783078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 28, 2025 · Synced Nov 13, 2026