RecruitingPhase 2NCT05286619

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

Sponsor

University of Malaya

Enrollment

63 participants

Start Date

Sep 22, 2022

Study Type

INTERVENTIONAL

Conditions

Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests pembrolizumab (an immunotherapy drug) combined with platinum-based chemotherapy and gemcitabine as a first-line treatment for people with head and neck squamous cell carcinoma (HNSCC) — cancers of the mouth, throat, or voice box — that has come back or spread and cannot be cured with local treatments. **You may be eligible if...** - You are 18 or older with confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx) - You have not previously received chemotherapy for your recurrent or metastatic disease (systemic therapy more than 6 months ago as part of initial treatment for local disease is allowed) - Your overall health is good **You may NOT be eligible if...** - Your primary tumor is in the nasopharynx - You have had prior immunotherapy (anti-PD-1 or similar) for this cancer - You have active autoimmune disease, immune deficiency, or serious infection - You are pregnant or breastfeeding - You have had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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

DRUGCisplatin

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.

DRUGCarboplatin

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

DRUGGemcitabine

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

Locations(1)

University Malaya Medical Centre

Kuala Lumpur, Malaysia

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NCT05286619

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