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Monoclonal Antibodies

Petosemtamab + Pembrolizumab 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

Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent

Must not have

Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days of study entry

Known leptomeningeal involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days post-last dose

Awards & highlights

Summary

"This trial is comparing the effectiveness and safety of petosemtamab plus pembrolizumab versus pembrolizumab alone as the first treatment for recurrent or metastatic head and neck cancer

Who is the study for?

This trial is for adults with a type of cancer called PD-L1+ recurrent or metastatic head and neck squamous cell carcinoma. Participants must be receiving their first round of treatment for this condition.

What is being tested?

The study compares two treatments: one group receives Petosemtamab plus Pembrolizumab, while the other gets only Pembrolizumab. It's designed to see which combination is more effective as a first-line treatment.

What are the potential side effects?

Possible side effects include immune-related reactions such as skin rash, colitis, hepatitis, endocrine disorders; infusion reactions; fatigue; nausea; and an increased risk of infections.

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 throat cancer has spread or returned and cannot be cured with surgery or radiation.

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My head or neck cancer is in my throat, mouth, or voice box.

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My head/neck cancer is eligible for a specific therapy because it shows a certain protein.

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I have head and neck cancer and haven't received systemic therapy for incurable or metastatic stages.

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I am fully active or can carry out light work.

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My heart's pumping ability is normal or above.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain metastases are either untreated, still causing symptoms, or need more treatment.

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My cancer has spread to the lining of my brain and spinal cord.

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I haven't had cancer treatment in the last 4 weeks.

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I haven't had major surgery or radiotherapy in the last 3 weeks.

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I have lasting side effects from cancer treatment, but no severe nerve pain.

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I am allergic to ingredients in petosemtomab or pembrolizumab.

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I do not have recent serious heart issues or untreated heart rhythm problems.

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I need oxygen therapy all the time due to difficulty breathing.

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I do not have any serious illness like uncontrolled infections or significant lung, metabolic, or mental health issues.

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I do not have any infectious diseases as listed in the protocol.

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I have an immune system disorder or have been on steroids or immune-weakening drugs recently.

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My cancer originates in the nasopharynx or sinonasal area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post-last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post-last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post-last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence and Severity of AEs and SAEs

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Petosemtamab + PembrolizumabExperimental Treatment2 Interventions

Combination Therapy

Group II: PembrolizumabActive Control1 Intervention

Monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2070

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merus N.V.Lead Sponsor

9 Previous Clinical Trials

2,268 Total Patients Enrolled

~333 spots leftby Jan 2028

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