OncoMatch/Clinical Trials/NCT04857164
Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China
Is NCT04857164 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab combined with Chemotherapy for head and neck squamous cell carcinoma.
Treatment: Pembrolizumab combined with Chemotherapy — This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection
Disease stage
Metastatic disease required
Recurrent and/or metastatic HNSCC without indications for local radical treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Exception: treatment for locally advanced disease as part of multimodal treatment completed >6 months before first trial medication
Have received systemic chemotherapy, but does not include treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the end of this treatment must be more than 6 months after the first trial medication)
Cannot have received: anti-PD-1 therapy
Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway
Cannot have received: anti-PD-L1 therapy
Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway
Cannot have received: anti-PD-L2 therapy
Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway
Cannot have received: anti-CTLA-4 therapy
Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway
Cannot have received: immunotherapy
Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway
Cannot have received: cetuximab (cetuximab)
Received cetuximab treatment within 6 months before the first administration
Lab requirements
Blood counts
Neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90g/L
Kidney function
Serum creatinine ≤1.5×ULN or Ccr ≥50ml/min (carboplatin) or ≥60ml/min (cisplatin)
Liver function
ALT and AST ≤ 3×ULN (no liver mets), ≤5×ULN (with liver mets); TBIL ≤1.5×ULN (Gilbert ≤3×ULN)
Cardiac function
LVEF ≥50%
The main organs function normally, that is, they meet the following standards: ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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