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 (Jun 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
Treatments studied
Immunotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT04857164 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 any tested is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify