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A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer

PHASE3RECRUITING

This is Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

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Study details:

This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.

In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was \>1 year after the last dose of cetuximab are eligible.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Signed ICF before initiation of any study procedures

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.

The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.

HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting

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 Performance Status (PS) of 0-1

Life expectancy ≥ 12 weeks, as per investigator assessment.

Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.

Adequate organ function as defined per protocol.

Exclusion criteria

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

Any systemic anticancer therapy within 4 weeks of the first dose of study treatment

Major surgery or radiotherapy within 3 weeks of the first dose of study treatment

Persistent Grade >1 clinically significant toxicities related to prior cancer therapies (except for alopecia); stable sensory neuropathy Grade ≤2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed.

History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.

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 excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3 years

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

Patients with known infectious diseases as per protocol.

Pregnant or breastfeeding patients.

The patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose

The patient has an active autoimmune disease that has required systemic immune suppressive treatment in the past 2 years; replacement therapy is not considered immune suppressive treatment.

Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-09-25

Primary completion: 2028-01-01

Study completion finish: 2030-07-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06525220

Intervention or treatment

DRUG: Petosemtamab

DRUG: Pembrolizumab

Conditions

• Head and Neck Squamous Cell Carcinoma

Image related to Head and Neck Squamous Cell Carcinoma

Condition: Head and Neck Squamous Cell Carcinoma
DRUG: Petosemtamab and other drugs
Blacktown, New South Wales, Australia
Sponsor: Merus N.V.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Site 11

Research sites nearby

Select from list below to view details:

Site 11
Blacktown, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Petosemtamab + Pembrolizumab Combination Therapy	DRUG: Petosemtamab MCLA-158
ACTIVE_COMPARATOR: Pembrolizumab Monotherapy	DRUG: Pembrolizumab Humanized Antibody

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR	Not Specified	Up to approximately 2 years
Overall Survival (OS)	Not Specified	Up to approximately 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR	Not Specified	Up to approximately 2 years
Duration of Response (DOR) per RECIST v1.1 as assessed by BICR	Not Specified	Up to approximately 2 years
Incidence and Severity of AEs and SAEs	To evaluate safety and tolerability of petosemtamab in combination with pembrolizumab	Up to 30 days post-last dose

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer