A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerus B.V.
About this trial
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.
Eligibility criteria
Qualifiers
Signed ICF before initiation of any study procedures
Age ≥ 18 years at signing of ICF
Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Disqualifiers
Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days prior to randomization
Known leptomeningeal involvement
Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
Requirement for immunosuppressive medication
Trial design
Treatments tested in this trial
- Petosemtamab
- Pembrolizumab
Treatment groups
700 Participants
are divided into 2 treatment groupsLocations
205Argentina
Site 170C1113AAE, CABA Argentina
Site 37C1125ABD, CABA Argentina
Site 96C1118AAT, CABA Argentina
Site 31X5008HHW, Córdoba Argentina
Sponsors and collaborators
Merus B.V.
Lead sponsor
Source ClinicalTrials.gov