OncoMatch/Clinical Trials/NCT06856213
Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Is NCT06856213 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cetuximab and Paclitaxel for recurrent / metastatic head and neck squamous cell carcinoma.
Treatment: Cetuximab · Paclitaxel — Squamous cell carcinoma of the head and neck (SCCHN) arises from epithelial cells and occurs in the oral cavity, pharynx and larynx. SCCHN is the seventh most common cancer worldwide with an annual incidence of approximately 90.000 cases per year in Europe. Recurrent / metastatic SCCHN remains a grievous diagnosis and optimal treatment options after progression to first-line ICI treatment are not determined yet. Previous reports showed that cetuximab plus paclitaxel after progression to ICI therapy may have an enhanced activity as second line after ICI therapy ERBIOTAX is multi-center, open-label, randomized, non-comparative two-arm, phase 2 trial Investigator Initiated Study. The primary study aims is to evaluate the efficacy of weekly cetuximab combined with paclitaxel (Arm A) or cetuximab monotherapy (Arm B) after progression to pembrolizumab plus platinum / 5-FU. The efficacy of treatment will be assessed through objective response rate (ORR). Patients will be randomized in a 2:1 ratio to ERBITAX (cetuximab + paclitaxel) and cetuximab, respectively, assigning 2 patients to Arm A and 1 patient to Arm B out of 3 patients. No stratification for the randomization process is planned as this is a non-comparative study. A total of 65 evaluable patients will be included in the trial; 41 in Arm A and 24 in Arm B. The main hypothesis is that treatment with the cetuximab +/- paclitaxel regimen maybe more effective after immune checkpoint inhibitors (ICI) failure in patients with recurrent/metastatic head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy (pembrolizumab) — first-line for recurrent/metastatic disease
disease progression per RECIST 1.1 on or after receiving platinum / 5-FU and pembrolizumab as first-line therapy for recurrent/metastatic disease
Must have received: platinum-based chemotherapy — first-line for recurrent/metastatic disease
disease progression per RECIST 1.1 on or after receiving platinum / 5-FU and pembrolizumab as first-line therapy for recurrent/metastatic disease
Must have received: antimetabolite (5-FU) — first-line for recurrent/metastatic disease
disease progression per RECIST 1.1 on or after receiving platinum / 5-FU and pembrolizumab as first-line therapy for recurrent/metastatic disease
Cannot have received: taxane (paclitaxel)
Any previous treatment with paclitaxel and/or cetuximab in the recurrent or metastatic setting
Cannot have received: EGFR-targeted therapy (cetuximab)
Any previous treatment with paclitaxel and/or cetuximab in the recurrent or metastatic setting
Lab requirements
Blood counts
Absolute neutrophils > 1.5 x 10^9/L; Platelets > 100 x 10^9/L; Hemoglobin > 90 g/L
Kidney function
Creatinine or measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5xULN or ≥ 60 mL/min
Liver function
Bilirubin < 1.5 x ULN; AST and ALT < 2.5 x ULN
Patients must have adequate organ function as determined by the following... Hematology: Absolute neutrophils > 1.5 x 10^9/L; Platelets > 100 x 10^9/L; Hemoglobin > 90 g/L; Biochemistry: Bilirubin < 1.5 x ULN; AST and ALT < 2.5 x ULN; Creatinine or measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5xULN or ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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