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

Summary

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.

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
• Laryngeal Squamous Cell Carcinoma
• Laryngectomy; Status
• Laryngeal Cancer
• Laryngeal Neoplasms

Interventions

BIOLOGICAL

KEYTRUDA®

200 mg KEYTRUDA® i. v. in 3-week cycle (q3w)

Sponsors & Collaborators

• University of Göttingen

  collaborator OTHER

• University of Jena

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• University of Ulm

  collaborator OTHER

• University of Regensburg

  collaborator OTHER

• Wuerzburg University Hospital

  collaborator OTHER

• Technical University of Munich

  collaborator OTHER

• Ernst von Bergmann Hospital

  collaborator OTHER

• Universitätsmedizin Mannheim

  collaborator OTHER

• University of Kiel

  collaborator OTHER

• University of Leipzig

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2028-12-31

Completion

2030-12-31

FDA Drug

Yes

Countries

• Germany

Study Locations