CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 700 target
Drug / intervention
Petosemtamab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Histologically confirmed HNSCC with metastatic or locally recurrent disease not amenable to curative local therapy
  • ✓Primary tumor from oropharynx, oral cavity, hypopharynx, or larynx
  • ✓PD-L1 CPS ≥1 expressing tumors eligible for pembrolizumab 1L monotherapy
  • ✓No prior systemic therapy in incurable recurrent or metastatic setting
Key exclusion· 16
  • ✕Untreated or symptomatic CNS metastases, or requiring radiation/surgery/steroids within 21 days prior to randomization
  • ✕Known leptomeningeal involvement
  • ✕Nasopharynx or sinonasal carcinoma primary sites
  • ✕Requirement for immunosuppressive medication

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06525220
NCT06525220Phase 3RecruitingHigh Momentum
CompareCT.gov

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

Merus B.V.·interventional·Posted Jul 29, 2024·Updated Jun 2, 2026

In Brief

A Phase 3 clinical trial evaluating Petosemtamab and Pembrolizumab for Head and Neck Squamous Cell Carcinoma. Currently recruiting, targeting 700 participants across 205 sites in 28 countries.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Squamous Cell Carcinoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3Recruiting
202520262027202820292030
First PostedJul 29, 2024
Enrollment StartSep 25, 2024
Primary CompletionJan 1, 2028
Study CompletionJul 1, 2030
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 1.9 years agoPrimary completion in 1.5 years

Interventions

Petosemtamabdrug

MCLA-158

Pembrolizumabdrug

Humanized Antibody