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Petosemtamab

Phase 3

Head and Neck Squamous Cell Carcinoma | Small molecule | Oncology |Merus N.V.|Last Updated: Jul 16, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,300
FDA Designations
BREAKTHROUGH_THERAPYFAST_TRACK
Clinical trial landscape

Petosemtamab · 2 trials · 1 indication

Phase 3 2
NCT06525220A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)Head and Neck Squamous Cell Carcinoma
RECRUITING700 Analytics
NCT06496178A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)Head and Neck Squamous Cell Carcinoma
RECRUITING600 Analytics
PHASE3RECRUITING
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Head and Neck Squamous Cell Carcinoma
NCT06525220700
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PHASE3RECRUITING
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)
Head and Neck Squamous Cell Carcinoma
NCT06496178600
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
Up to approximately 3 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR)
Up to approximately 2 years
Secondary Endpoints
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR
Up to approximately 2 years
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR
Up to approximately 2 years
Clinical benefit rate per RECIST v1.1 as assessed by BICR
Up to approximately 2 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Petosemtamab + PembrolizumabEXPERIMENTALCombination Therapy
PembrolizumabACTIVE_COMPARATORMonotherapy
MCLA-158EXPERIMENTAL -
Investigator's ChoiceACTIVE_COMPARATOR -
Interventions
NameTypeDescription
PetosemtamabDRUGMCLA-158
PembrolizumabDRUGHumanized Antibody
Investigator's ChoiceDRUGCetuximab
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites205

Inclusion Criteria: 1. Signed ICF before initiation of any study procedures 2. Age ≥ 18 years at signing of ICF 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. 4. The eligible HNSCC primary tumor location...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileCroatiaCzechiaFranceGermanyGreeceHungaryIsraelItalyJapanLithuaniaMalaysiaMexicoNetherlandsPolandPortugalSouth KoreaSpainTaiwanThailandTurkey (Türkiye)United KingdomSwitzerland
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Recent Changes (Last 90 Days)
LOWJul 17, 2026NCT06496178lastUpdatePostDate: changed
LOWJul 17, 2026NCT06496178lastUpdatePostDate: changed
LOWJul 17, 2026NCT06496178lastUpdatePostDate: changed
LOWJun 3, 2026NCT06496178lastUpdatePostDate: changed
LOWJun 3, 2026NCT06496178lastUpdatePostDate: changed
LOWJun 2, 2026NCT06525220lastUpdatePostDate: changed
LOWJun 2, 2026NCT06525220lastUpdatePostDate: changed
LOWJun 2, 2026NCT06525220lastUpdatePostDate: changed
LOWMay 26, 2026NCT06496178Enrollment: 500 → 600
LOWMay 26, 2026NCT06525220primaryCompletionDate: changed
LOWMay 24, 2026NCT06496178studyFirstPostDate: changed
LOWMay 24, 2026NCT06525220studyFirstPostDate: changed