A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)

PHASE2RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

September 22, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2028

Conditions
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Pembrolizumab

Pembrolizumab 200mg will be administered on Day 1 every 3 weeks for up to 24months

DRUG

Cisplatin

Cisplatin at 35 mg/m2 IV using a split dose regimen on Day 1 and Day 8 of each 3-week cycle, up to 6 cycles.

DRUG

Carboplatin

Carboplatin at AUC 5 IV on Day 1 of each 3-week cycle, up to 6 cycles.

DRUG

Gemcitabine

Gemcitabine 1250mg/m2 IV on Day 1 and Day 8 of each 3-week cycle, up to 6 cycles

Trial Locations (1)

59100

RECRUITING

University Malaya Medical Centre, Kuala Lumpur

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Cancer Research Malaysia

OTHER

collaborator

Kuala Lumpur General Hospital

OTHER_GOV

collaborator

National Cancer Institute, Malaysia

OTHER_GOV

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

My Starfish Foundation

UNKNOWN

collaborator

Yayasan Sime Darby

UNKNOWN

collaborator

Yayasan PETRONAS

UNKNOWN

lead

University of Malaya

OTHER