A Phase 3 interventional study of Cetuximab and avelumab in HNSCC, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.
This open-label, randomized, controlled, multicenter phase III study will include 688 patients with LA SCCHN (420 fit for HD cisplatin and 268 unfit for HD cisplatin), histologically confirmed who had not received previous treatment for this setting. The study is designed with the primary objective of demonstrating that treatment with avelumab in combination with cetuximab-RT is superior to SOC Cisplatin-RT or cetuximab-RT alone in terms of PFS. Randomization will assign the 2 treatment arms of each cohort with a 1:1 ratio. In each cohort (fit for cisplatin and unfit for cisplatin), the randomization will be stratified for the 2 most established prognostic factors N stage (N0-N1 vs N2-3) and p16 expression (OPC p16+ versus OPC p16- or non OPC). All patients will be followed until death or at least 60 months.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 707 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
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Written informed consent
Criteria for determining if a patient is fit for receiving high dose cisplatin:
Exclusion Criteria:
Lead-in phase (Day-8) : no treatment Concomitant radiotherapy phase : Radiotherapy by IMRT + cisplatin 100mg/m2 Maintenance phase : no treatment until follow-up phase
Drug: Cisplatin · Radiation: IMRT
Lead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase : Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months
Drug: Cetuximab · Drug: avelumab · Radiation: IMRT
Lead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months
Drug: Cetuximab · Drug: avelumab · Radiation: IMRT
Lead-in phase (Day-8): Cetuximab 400mg/m2 Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 Maintenance phase : no treatment until follow-up phase
Drug: Cetuximab · Radiation: IMRT
Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.
IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks. Avelumab will start on Day-8 together with cetuximab and subsequently every 2 weeks during the course of RT. Avelumab with be continued every 2 weeks for an additional 12 months following RT.
100 mg/m² IV after hyperhydration and at a maximal rate of 1 mg/min, on days 1, 22, 43.
RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique. RT dose to the GTV will be 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions). Prophylactic dose will be 52.8 Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
Progression free survival
Time between randomization and the first event among progression (per modified Response Evaluation Criteria in Solid Tumors (RECIST) version v1.1) and death, whatever the cause of death.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 74 months
Safety: acute adverse events graded by NCI CTCAE v4.03
Time frame: From date of randomization to end of study, assessed up to 74 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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