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Phase 3 Study of Petosemtamab for Head and Neck Squamous Cell Carcinoma

This study is testing a drug called petosemtamab (also known as MCLA-158) for people with head and neck squamous cell carcinoma (HNSCC). This is a type of cancer that starts in the moist linings of the head and neck. Researchers want to see if petosemtamab works better than standard treatments chosen by your doctor, which could include cetuximab, methotrexate, or docetaxel. You may be able to join if you are 18 or older, have HNSCC that has spread or come back, and your cancer has worsened after previous treatments including anti-PD-1 therapy and platinum-based chemotherapy. The main goal is to see how long people live (Overall Survival) over about three years. The study is currently recruiting about 600 participants.

Study design
This is a phase 3, open-label (meaning you and your doctor will know which treatment you are receiving), randomized (meaning you are assigned to a treatment group by chance), controlled study involving multiple centers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 3 years to measure overall survival.

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NCT06496178

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merus B.V.
~600 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:PetosemtamabInvestigator's Choice

At a glance

Recruiting sites
213 of 218 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 3 years

Conditions

Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

218 sites across 54 states
France16
Germany13
South Korea12
United Kingdom12
Japan10
Brazil8
Italy8
Spain8

Who to contact

David Yao, MD
[email protected]
+1 617 401 4499
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed ICF before initiation of any study procedures.
Age ≥ 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
Documentation of p16 status (positive or negative) by local laboratory IHC for participants with primary oropharyngeal cancer.
A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
Measurable disease as defined by RECIST v1.1 by radiologic methods.
ECOG PS of 0 or 1
Life expectancy ≥ 12 weeks, as per investigator
Adequate organ function (as per protocol)

Exclusion

Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms 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.
Persistent Grade \>1 clinically significant toxicities related to prior antineoplastic therapies
History of hypersensitivity reaction to any of the excipients of treatment required for this study.
Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
Participants with known infectious diseases (as per protocol)
Pregnant or breastfeeding participants
Participant has a primary tumor site of nasopharynx (any histology).

What this trial measures

  • Overall Survival (OS)Up to approximately 3 years

    OS was defined as the time from randomization to death due to any cause.