OncoMatch/Clinical Trials/NCT06935188
Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC
Is NCT06935188 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dalpicilib combined with cetuximab and cetuximab for recurrent/metastatic head and neck squamous cell carcinoma.
Treatment: Dalpicilib combined with cetuximab · cetuximab — This study is a single center, randomized controlled, prospective phase II clinical trial to evaluate the efficacy and safety of cetuximab combined with dalpicilib compared to cetuximab monotherapy in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. The participants would receive cetuximab combined with dalpicilib or cetuximab monotherapy until termination criteria are met.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV negative (negative by IHC)
HPV viral testing determined to be negative, using the IHC method
Required: PD-L1 (CD274) expression testing required
Availability of tumor tissue ... for detection of PD-L1 and CDK4-related genes
Required: CDK4 testing required
Availability of tumor tissue ... for detection of PD-L1 and CDK4-related genes
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-pd-1 therapy
Cannot have received: anti-egfr monoclonal antibody (cetuximab)
Cannot have received: egfr tyrosine kinase inhibitor
Lab requirements
Blood counts
hemoglobin ≥ 100 g/L without transfusion or colony-stimulating factor support therapy, white blood cell count ≥ 4.0*10^9/L or neutrophil count ≥ 2.0*10^9/L, and platelet count ≥ 100*10^9/L
Kidney function
blood creatinine level below 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L
Liver function
serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal
Cardiac function
no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmias; no cardiac insufficiency
Normal major organ function within 2 weeks prior to treatment, i.e., meeting the following criteria：Bone marrow function: hemoglobin ≥ 100 g/L without transfusion or colony-stimulating factor support therapy, white blood cell count ≥ 4.0*10^9/L or neutrophil count ≥ 2.0*10^9/L, and platelet count ≥ 100*10^9/L; Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal; Renal: blood creatinine level below 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L; Urine protein <+, or if urine protein + then total 24-hour protein must be <500mg; Blood glucose: within normal range and/or with diabetes in treatment but under stable glycemic control; Pulmonary function: baseline FEV1 of at least 2L; if baseline FEV1 <2L then FEV1 >800ml expected post-surgery as assessed by a surgical specialist; Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmias; no cardiac insufficiency.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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