OncoMatch/Clinical Trials/NCT05286619
A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)
Is NCT05286619 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Cisplatin for recurrent/metastatic head and neck squamous cell carcinoma.
Treatment: Pembrolizumab · Cisplatin · Carboplatin · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Metastatic disease required
measurable disease based on RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Exception: Systemic therapy completed >6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
Subject may not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or antiPDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to start of study treatment.
Cannot have received: radiotherapy
Exception: A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Lab requirements
Blood counts
ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
Creatinine ≤1.5 × ULN
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Have adequate organ function as defined in the following table (Table 3)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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