NCT04489888

A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)

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).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
DRUG	Carboplatin	Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
DRUG	Paclitaxel	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

Timeline

• Start date: 2020-10-27
• Primary completion: 2023-02-20
• Completion: 2024-06-28
• First posted: 2020-07-28
• Last updated: 2025-06-19
• Results posted: 2024-05-09

Locations

35 sites across 5 countries: United States, Argentina, Australia, Brazil, Canada

Regulatory

• FDA-regulated drug study