OncoMatch/Clinical Trials/NCT06525220

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

Is NCT06525220 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Petosemtamab and Pembrolizumab for head and neck squamous cell carcinoma.

Phase 3RecruitingMerus B.V.NCT06525220Data as of May 2026

Treatment: Petosemtamab · Pembrolizumab — This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) cps ≥1 (cps ≥1)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic anticancer therapy

Exception: administered in the incurable recurrent or metastatic setting

HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting

Cannot have received: systemic anticancer therapy or investigational drug

Exception: within 4 weeks or 5 half-lives, whichever is shorter, before randomization

Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization

Lab requirements

Blood counts

Adequate organ function as defined per protocol.

Kidney function

Adequate organ function as defined per protocol.

Liver function

Adequate organ function as defined per protocol.

Cardiac function

Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

Adequate organ function as defined per protocol. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Site 164 · Mobile, Alabama
Site 36 · La Jolla, California
Site 27 · Los Angeles, California
Site 16 · Palo Alto, California
Site 19 · Newark, Delaware

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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