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

Recruiting Phase 2 Interventional Study
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 Laryngeal Squamous Cell Carcinoma Laryngectomy; Status Laryngeal Cancer Laryngeal Neoplasms
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
140 (estimated)
Sponsor
University of Leipzig · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Male and female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of squamous cell carcinoma (SCC) of…
Contacts

Andreas Dietz, MD PhD

+493419721700

Andreas.Dietz@medizin.uni-leipzig.de

CONTACT

Susanne Wiegand, MD PhD

+493419721700

susanne.wiegand@medizin.uni-leipzig.de

CONTACT