European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]

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.

NCT Number	NCT06137378
Lead Sponsor	University of Leipzig Collaborators: University of Göttingen, University of Jena, University of Cologne, University of Ulm, University of Regensburg, Wuerzburg University Hospital, Technical University of Munich, Ernst von Bergmann Hospital, Universitätsmedizin Mannheim, University of Kiel
Conditions	Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma Stage III, Laryngeal Squamous Cell Carcinoma Stage IV, Squamous Cell Carcinoma of Larynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Larynx Stage III, Squamous Cell Carcinoma of the Larynx Stage IV +4 more
Enrollment	140 participants
Start Date	2024-04-17
Primary Completion	2028-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2024-09-20