OncoMatch/Clinical Trials/NCT06137378
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
Is NCT06137378 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies KEYTRUDA® for squamous cell carcinoma of head and neck.
Treatment: KEYTRUDA® — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) cps ≥1 (cps ≥1)
Disease stage
Required: Stage III, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory receptor on T or NK cells (e.g., CTLA-4, OX 40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents.
Cannot have received: radiation therapy
Has received prior radiotherapy.
Lab requirements
Blood counts
adequate organ function as defined in the (Table 4) of the protocol
Kidney function
adequate organ function as defined in the (Table 4) of the protocol
Liver function
adequate organ function as defined in the (Table 4) of the protocol
Have adequate organ function as defined in the (Table 4) of the protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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