OncoMatch/Clinical Trials/NCT05446467
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
Is NCT05446467 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies pembrolizumab+cisplatin + 5-FU for head and neck squamous cell carcinoma.
Treatment: pembrolizumab+cisplatin + 5-FU — A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced 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) expression (CPS PD-L1 immunohistochemical examination (22C3 DAKO) required; no threshold specified)
Have sufficient tumour tissue samples available for CPS PD-L1 immunohistochemical examination (22C3 DAKO)
Excluded: HPV p16 positive
HPV p16 positive oropharyngeal cancer [excluded]
Disease stage
Required: Stage III, IV A (AJCC 8th edition)
Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon)... Patients with local advanced head and neck squamous cell carcinoma stage T4B and/or N3 [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: any disease-related therapy
Exception: diagnostic biopsies on primary lesions
Lab requirements
Blood counts
ANC≥1.5×10^9 /L, platelets ≥100×10^9 /L, Hb≥ 90 g/L, WBC ≥3.0×10^9 /L before enrollment, no blood transfusion and bleeding tendency within 7 days
Kidney function
Serum creatinine ≤1.5 or creatinine clearance >50 mL/min
Liver function
ALT, AST and ALP ≤ 2.5 × ULN; Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN
No abvious signs of hematological disorders, ANC≥1.5×10^9 /L, platelets ≥100×10^9 /L, Hb≥ 90 g/L,WBC ≥3.0×10^9 /L before enrollment, no blood transfusion and bleeding tendency within 7 days; ALT,AST and ALP ≤ 2.5 × ULN; Serum bilirubin ≤ 1.5 × ULN, for patients with known Gilbert disease, serum bilirubin ≤ 3 x ULN; Serum creatinine ≤1.5 or creatinine clearance>50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05446467 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 expression is a required biomarker for enrollment.
Are patients with HPV alterations eligible?
No. HPV p16 positive is an exclusion criterion.
What disease stage is eligible?
Stage III or IV A is required.
Is there an age limit?
Yes. Patients must be 85 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