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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)

Study acronym: PIPER
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 15, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Collaborators: 4 to 7v5
  2. Primary completion date: Jun 2026 to Dec 2025
    • Study completion date: Jun 2027 to Dec 2028
    • Secondary endpoints reordered
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2022 to Sep 22, 2022
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05286619
Lead Sponsor University of Malaya
Collaborators: Cancer Research Malaysia, Kuala Lumpur General Hospital, National Cancer Institute, Malaysia, Merck Sharp & Dohme LLC, My Starfish Foundation, Yayasan Sime Darby, Yayasan PETRONAS
Conditions
(from sponsor)		 Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov