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Monoclonal Antibodies

Petosemtamab for Head and Neck Cancer

Phase 3
Recruiting
Research Sponsored by Merus N.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at signing of ICF
HNSCC patients progressed on or after anti-PD-1 therapy and platinum-containing therapy
Must not have
Patient has a primary tumor site of nasopharynx (any histology)
Known leptomeningeal involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare two treatments for head and neck cancer patients in the second or third stage of treatment for advanced cancer that cannot be cured.

Who is the study for?
This trial is for individuals with head and neck squamous cell carcinoma (HNSCC) who have already undergone treatment but the cancer has returned or spread. Participants should be suitable for second- or third-line therapy, meaning they've tried at least one other treatment that didn't work.
What is being tested?
The study is testing a new medication called Petosemtamab against a treatment chosen by the investigator, which could be any standard therapy deemed appropriate. It's an open-label study, so everyone knows what treatment they're getting, and it's randomized to compare outcomes fairly.
What are the potential side effects?
While specific side effects of Petosemtamab are not listed here, treatments for HNSCC often include risks like fatigue, nausea, skin reactions, dry mouth or throat issues due to inflammation in mucous membranes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My head or neck cancer worsened after treatment with anti-PD-1 and platinum drugs.
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My head or neck cancer is in my throat, mouth, or voice box.
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My throat cancer's p16 status is documented.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My throat or mouth cancer has spread and cannot be cured with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer originates from the nasopharynx.
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My cancer has spread to the lining of my brain and spinal cord.
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I do not have any serious illnesses like uncontrolled infections or significant lung, metabolic, or mental health issues.
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I do not have brain metastases needing urgent treatment.
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I have lasting side effects from cancer treatment that affect my daily life.
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I have not had a heart attack or serious heart issues in the last 6 months.
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I need oxygen therapy all the time or have trouble breathing even when resting.
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I do not have any known infectious diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Overall Survival (OS)
Secondary study objectives
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review
Clinical Benefit Rate (CBR) as Assessed by Investigator Review
Concentrations Predose And at End of Infusion
+15 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MCLA-158Experimental Treatment1 Intervention
Group II: Investigator's ChoiceActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Merus N.V.Lead Sponsor
9 Previous Clinical Trials
2,222 Total Patients Enrolled
~333 spots leftby Feb 2028
Unbiased ResultsWe believe in providing patients with all the options.
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