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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06935188 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-egfr monoclonal antibody, egfr tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require HPV?
Yes, HPV negative is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 expression testing required is a required biomarker for enrollment.
Does this trial require CDK4?
Yes, CDK4 testing required 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