Condition: Squamous Cell Carcinoma of Head and Neck · Hypopharyngeal Squamous Cell Carcinoma · Laryngeal Squamous Cell Carcinoma Stage III · Sponsor: University of Leipzig
ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with PD-L1-expression within tumor tissue biopsy, calculated as CPS ≥ 1 curable by total laryngectomy. Induction chemotherapy (IC) with Docetaxel and Cisplatin (TP) followed by radiation will be compared to additional PD-1 inhibition. Patients will be selected after short induction early response evaluation after the first cycle IC (IC-1) aiming on larynx organ-preservation by additional 2 cycles IC followed by radiotherapy (69.6 Gy) for responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥ 30%. Nonresponders (ETSS \< 30% or progressing disease) will receive total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation according to the recommendation of the clinics multidisciplinary tumor board. However, Patients randomized into the intervention arm starting day 1 will receive 200 mg Pembrolizumab (MK-3475) i.v. in 3-week cycle (q3w) for 17 cycles (12 months). Treatment with pembrolizumab will continue in the experimental arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent from subsequent decision on adjuvant therapy after TL.
This description comes directly from the study's public registry record.
Andreas Dietz, MD PhD · +493419721700 · Andreas.Dietz@medizin.uni-leipzig.de
Susanne Wiegand, MD PhD · +493419721700 · susanne.wiegand@medizin.uni-leipzig.de
Always discuss trial participation with your own doctor first.
| Universitätsklinikum Mannheim, Klinik für Hals-Nasen-Ohrenheilkunde Theodor-Kutzer-Ufer 1-3 | Mannheim, Baden-Würtemberg, Germany | Recruiting |
| Universitätsklinikum Ulm / Ulm University Medical Center, Klinik für Hals- Nasen-Ohrenheilkunde und Kopf-Halschirurgie, Frauensteige 12 | Ulm, Baden-Würtemberg, Germany | Recruiting |
| Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Ismaninger Straße 22 | München, Bavaria, Germany | Not Yet Recruiting |
| Universität Regensburg, Klinik und Poliklinik für Strahlentherapie Franz-Josef-Strauss-Allee 11 | Regensburg, Bavaria, Germany | Recruiting |
| Universitätsklinikum Würzburg, Klinik für Hals-, Nasen-, Ohrenheilkunde, Josef-Schneider-Straße 8 | Würzburg, Bavaria, Germany | Recruiting |
| Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin, Charlottenstr. 72 | Potsdam, Brandenburg, Germany | Not Yet Recruiting |
| Universitätsklinikum Köln, Klinik für Hals-, Nasen-, Ohrenheilkunde, Kerpener Str. 62 | Cologne, North Rhine-Westphalia, Germany | Not Yet Recruiting |
| University of Leipzig, Department für Kopf- und Zahnmedizin, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Liebigstrasse 12 | Leipzig, Saxon, Germany | Recruiting |
| Universitätsklinikum Jena Klinik für Hals-, Nasen- und Ohrenheilkunde, Am Klinikum 1 | Jena, Thuringia, Germany | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06137378