NCT06496178 · Merus N.V.
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
What this study is about
This is a phase 3 where both patients and doctors know the treatment given, randomly assigned, controlled, conducted at multiple hospitals study to compare petosemtamab vs investigator's choice treatment given alone in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
View original scientific description
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.
Interventions
DRUG
Petosemtamab
MCLA-158
DRUG
Investigator's Choice
Cetuximab
DRUG
Investigator's Choice
Methotrexate
DRUG
Investigator's Choice
Docetaxel
Primary outcome measures
Overall Survival (OS)
Time frame: Up to approximately 3 years
OS was defined as the time from randomization to death due to any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 patients 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 patients with primary oropharyngeal cancer.
- A baseline new tumor sample unless the patient 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 criteria
- Central nervous system metastases that are untreated or symptomatic, or require radiati
Where
- Mobile, Alabama
- Prescott, Arizona
- Scottsdale, Arizona
- Duarte, California
- La Jolla, California
- Orange, California
- Palo Alto, California
- Sacramento, California
- San Francisco, California
- Lone Tree, Colorado
- Washington D.C., District of Columbia
- Fort Myers, Florida
And 43 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations