CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 600 target
Drug / intervention
Petosemtamab +3 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Histologically confirmed metastatic or locally advanced HNSCC not amenable to standard curative therapy
  • ✓Progressed on or after anti-PD-1 therapy and platinum-containing therapy
  • ✓Primary tumor from oropharynx, oral cavity, hypopharynx, or larynx
  • ✓p16 status documented for oropharyngeal cancer
Key exclusion· 13
  • ✕Untreated or symptomatic CNS metastases requiring intervention within 14 days prior to randomization
  • ✕Known leptomeningeal involvement
  • ✕Any systemic anticancer therapy within 4 weeks prior to randomization
  • ✕Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization

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

Search/NCT06496178
NCT06496178Phase 3RecruitingHigh Momentum
CompareCT.gov

A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Merus B.V.·interventional·Posted Jul 11, 2024·Updated Jun 3, 2026

In Brief

A Phase 3 clinical trial evaluating Petosemtamab and Investigator's Choice for Head and Neck Squamous Cell Carcinoma. Currently recruiting, targeting 600 participants across 216 sites in 24 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

Study Details

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

Timeline

Phase 3Recruiting
20252026202720282029
First PostedJul 11, 2024
Enrollment StartJun 25, 2024
Primary CompletionFeb 1, 2028
Study CompletionMar 1, 2029
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 2.0 years agoPrimary completion in 1.6 years

Interventions

Petosemtamabdrug

MCLA-158

Investigator's Choicedrug

Cetuximab

Investigator's Choicedrug

Methotrexate

Investigator's Choicedrug

Docetaxel