CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
Pembrolizumab +2 moredrug
Likely dose
Pembrolizumab 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/NCT04489888
NCT04489888Phase 4Completed
CompareCT.gov

A Phase 4, Single-arm, Open-label Clinical Study of Pembrolizumab (MK-3475) to Evaluate the Efficacy and Safety of MK-3475 Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE B10).

Merck Sharp & Dohme LLC·interventional·Posted Jul 28, 2020·Updated Jun 19, 2025

In Brief

A Phase 4 clinical trial evaluating Pembrolizumab, Carboplatin, and 1 other intervention for Squamous Cell Carcinoma of Head and Neck. Completed, enrolled 101 participants across 35 sites in 5 countries.

Detailed Summary

The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of Head and Neck
CountriesArgentina, Australia, Brazil, Canada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJul 28, 2020
Enrollment StartOct 27, 2020
Primary CompletionFeb 20, 2023
Study CompletionJun 28, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.9 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle

Carboplatindrug

Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle

Paclitaxeldrug

At investigator's choice, paclitaxel 100 mg/m\^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each 21-day cycle