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)

PHASE4CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

October 27, 2020

Primary Completion Date

February 20, 2023

Study Completion Date

June 28, 2024

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
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

Trial Locations (35)

2000

Hospital Provincial del Centenario ( Site 0304), Rosario

2800

Orange Health Services ( Site 0106), Orange

3065

St Vincents Hospital Melbourne ( Site 0101), Fitzroy

4215

Gold Coast University Hospital ( Site 0103), Southport

4814

The Townsville Hospital ( Site 0105), Douglas

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0262), Mineola

14215

Erie County Medical Center-Head & Neck Surgery and Plastic & Reconstructive Surgery ( Site 0268), Buffalo

15232

UPMC Hillman Cancer Center ( Site 0253), Pittsburgh

19090

Abington Hospital - Asplundh Cancer Center ( Site 0229), Willow Grove

19718

Helen F. Graham Cancer Center & Research Institute ( Site 0214), Newark

23219

Virginia Commonwealth University ( Site 0233), Richmond

27103

Novant Health Forsyth Medical Center ( Site 0266), Winston-Salem

28204

Novant Health Presbyterian ( Site 0261), Charlotte

29414

Charleston Oncology ( Site 0231), Charleston

32207

Baptist MD Anderson Cancer Center ( Site 0215), Jacksonville

32806

Orlando Health, Inc. ( Site 0216), Orlando

55101

Regions Hospital ( Site 0227), Saint Paul

63110

Washington University School of Medicine ( Site 0240), St Louis

06510

Yale-New Haven Hospital-Yale Cancer Center ( Site 0265), New Haven

T4000IAK

Centro Medico San Roque ( Site 0302), San Miguel de Tucumán

C1012AAR

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0303), Buenos Aires

C1426ABP

Fundación Respirar ( Site 0306), Buenos Aires

C1426ANZ

Instituto Medico Especializado Alexander Fleming ( Site 0301), Buenos Aires

60336-232

Centro Regional Integrado de Oncologia ( Site 0403), Fortaleza

30110-022

CETUS Hospital Dia Oncologia ( Site 0400), Belo Horizonte

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 0404), Natal

98700-000

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0406), Ijuí

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0402), São Paulo

01321-001

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0401), São Paulo

01509-900

A.C. Camargo Cancer Center ( Site 0405), São Paulo

T2N 4N2

Tom Baker Cancer Center ( Site 0014), Calgary

A1B 3V6

Dr. H. Bliss Murphy Cancer Centre ( Site 0001), St. John's

K7L 2V7

Cancer Centre of Southeastern Ontario at Kingston General Hospital ( Site 0004), Kingston

M5G 2M9

Princess Margaret Cancer Centre ( Site 0005), Toronto

J1H 5N4

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0003), Sherbrooke

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter