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

NCT05286619 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-10-15

No results posted yet for this study

Summary

This is an open-label, single-arm, Phase 2 study of pembrolizumab plus platinum and gemcitabine (PG) in subjects with recurrent or metastatic head and neck cancer squamous cell carcinoma (R/M HNSCC). Evaluable 63 subjects with R/M HNSCC will be enrolled for examination of the efficacy and safety of the combination of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle, up to 35 cycles) in combination with platinum (either cisplatin at 35 mg/m2 IV using a split-dose regimen on Day 1 and Day 8 or carboplatin at AUC 5 IV on Day 1 of each 3-week cycle, up to 6 cycles) and gemcitabine at 1250 mg/m2 IV on Day 1 and 8 of each 3-week cycle, for up to 6 cycles as first-line treatment. This study will be conducted in conformance with Good Clinical Practices. Specific procedures to be performed during the trial, as well as their prescribed timelines and associated visit windows, are outlined in the protocol.

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

Sponsors & Collaborators

  • Cancer Research Malaysia

    collaborator OTHER

  • Kuala Lumpur General Hospital

    collaborator OTHER_GOV

  • National Cancer Institute, Malaysia

    collaborator OTHER_GOV

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • My Starfish Foundation

    collaborator UNKNOWN

  • Yayasan Sime Darby

    collaborator UNKNOWN

  • Yayasan PETRONAS

    collaborator UNKNOWN

  • University of Malaya

    lead OTHER

Principal Investigators

  • Wan Zamaniah Wan Ishak, MBBS, MD · University of Malaya

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2025-12-31
Completion
2028-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286619 on ClinicalTrials.gov