OncoMatch/Clinical Trials/NCT06869473
Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19.
Is NCT06869473 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cetuximab/avelumab for head and neck squamous cell carcinoma (hnscc).
Treatment: Cetuximab/avelumab — This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%. The trial will include adult patients with confirmed R/M HNSCC, who have not previously received systemic therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels. Participants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects. The study aims to answer several key questions: Can this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe and well-tolerated? In addition to the treatment itself, participants will be asked to provide blood and tumor tissue samples for translational research, helping scientists better understand how biomarkers influence treatment response. Regular follow-up assessments will also be conducted to monitor disease progression and overall health. By testing this innovative treatment sequence, researchers hope to bridge the gap between different PD-L1 subgroups, potentially offering a more effective and personalized approach for patients with R/M HNSCC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) CPS ≥ 1 and ≤ 19 (CPS ≥ 1 and ≤ 19)
PD-L1 CPS≥1≤19 (assessment allowed either on primary and/or recurrent/metastatic site of disease)
Disease stage
Required: Stage IV
Confirmed R/M HNSCC (i.e. oral cavity, oropharynx, larynx, hypopharynx) not suitable for curative loco-regional therapy. Measurable disease according to RECIST Criteria 1.1.6.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: Systemic therapy completed more than 6 months prior as part of multimodal curative treatment for locally advanced disease is allowed
Subjects should not have had prior systemic therapy administered in the R/M HNSCC setting. Systemic therapy that was completed more than 6 months prior to signing consent, if given as a part of multimodal curative treatment for locally advanced disease, is allowed.
Cannot have received: chemotherapy
Previous chemotherapy...administered for R/M setting of HNSCC is not allowed.
Cannot have received: biological therapy (cetuximab)
Previous...biological therapy (i.e. Cetuximab)...administered for R/M setting of HNSCC is not allowed.
Cannot have received: immunotherapy
Previous...immunotherapy administered for R/M setting of HNSCC is not allowed.
Lab requirements
Blood counts
neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL
Kidney function
creatinine clearance ≥ 30 mL/min
Liver function
total bilirubin level < 1.5 X ULN (except for known medical reason not interfering with liver function, such as Gilbert syndrome), AP, GGT <3 x ULN and AST and ALT levels ≤ 2.5 × ULN
Adequate bone marrow function: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL. Adequate liver function: total bilirubin level < 1.5 X ULN (except for known medical reason not interfering with liver function, such as Gilbert syndrome), AP, GGT <3 x ULN and AST and ALT levels ≤ 2.5 × ULN. Adequate renal function: calculated or analyzed creatinine clearance ≥ 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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