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

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06525220

    Intervention or treatment

    DRUG: Petosemtamab

    DRUG: Pembrolizumab

    Conditions

    • Head and Neck Squamous Cell Carcinoma

    Find a site

    Closest Location:

    Site 11

    Research sites nearby

    Select from list below to view details:

    • Site 11

      Blacktown, New South Wales, Australia

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICRNot SpecifiedUp to approximately 2 years
    Overall Survival (OS)Not SpecifiedUp to approximately 3 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICRNot SpecifiedUp to approximately 2 years
    Duration of Response (DOR) per RECIST v1.1 as assessed by BICRNot SpecifiedUp to approximately 2 years
    Incidence and Severity of AEs and SAEsTo evaluate safety and tolerability of petosemtamab in combination with pembrolizumabUp to 30 days post-last dose

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    References

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

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