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NCT Number: NCT06496178

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 37, Buenos Aires, Argentina

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About this study

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. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 participants 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 participants with primary oropharyngeal cancer.
  • A baseline new tumor sample unless the participant 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 radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
  • Known leptomeningeal involvement
  • Any systemic anticancer therapy within 4 weeks prior to randomization.
  • Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
  • Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
  • History of hypersensitivity reaction to any of the excipients of treatment required for this study.
  • 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 localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
  • 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
  • Participants with known infectious diseases (as per protocol)
  • Pregnant or breastfeeding participants
  • Participant has a primary tumor site of nasopharynx (any histology).

Treatment and study plan

Petosemtamab

Drug

MCLA-158

Investigator's choice

Drug

Cetuximab

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 3 years

    OS was defined as the time from randomization to death due to any cause.

Secondary outcomes

  1. Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review

    Time frame: Up to approximately 2 years

    ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.

  2. Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review

    Time frame: Up to approximately 2 years

    PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

  3. Duration of Response (DOR) as Assessed by Blinded Independent Central Review

    Time frame: Up to approximately 2 years

    For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.

  4. Objective Response Rate (ORR) as Assessed by Investigator Review

    Time frame: Up to approximately 2 years

    ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.

  5. Progression Free Survival (PFS) as Assessed by Investigator Review

    Time frame: Up to approximately 2 years

    PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.

  6. Duration of Response (DOR) as Assessed by Investigator Review

    Time frame: Up to approximately 2 years

    For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of the first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.

  7. Time to Response (TTR) as Assessed by Blinded Independent Central Review

    Time frame: Up to approximately 2 years

    For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.

  8. Time to Response (TTR) as Assessed by Investigator Review

    Time frame: Up to approximately 2 years

    For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1.

  9. Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review

    Time frame: Up to approximately 2 years

    CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1

  10. Clinical Benefit Rate (CBR) as Assessed by Investigator Review

    Time frame: Up to approximately 2 years

    CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1

  11. Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to 30 days post-last dose

    An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one TEAE is presented.

  12. Number of Participants who Experienced At Least One Serious TEAE

    Time frame: Up to 30 days post-last dose

    An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one serious TEAE is presented.

  13. Number of Participants who Discontinued Study Treatment Due to TEAEs

    Time frame: Up to 30 days post-last dose

    An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who discontinued study treatment due to TEAEs is presented.

  14. Number of Participants who had Dose Modification Due to TEAEs

    Time frame: Up to 30 days post-last dose

    An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who had dose modification due to TEAEs is presented.

  15. Mean Change From Baseline in EORTC QLQ-C30

    Time frame: Up to approximately 2 years

    For the EORTC QLQ-C30, the functional scales, the symptom scales, the specific single items, and the global health and quality of life scale, will be computed according to EORTC QLQ-C30 Scoring Manual. Mean change from baseline is presented.

  16. Mean Change From Baseline in EORTC QLQ-H&N43

    Time frame: Up to approximately 2 years

    For the EORTC QLQ-H&N43, the multi-item scales and the single-items will be computed according to EORTC QLW-HN43 Scoring Manual. Mean change from baseline is presented.

  17. Mean Change From Baseline in EuroQol EQ-5D-5L

    Time frame: Up to approximately 2 years

    For the EuroQol EQ-5D-5L, the 5 domains and the visual analog scale will be summarized. Mean change from baseline will be presented.

  18. Scores in the Patient Global Impression of Change (PGIC) scale

    Time frame: Up to approximately 2 years

    For the PGIC scale, overall improvement since beginning treatment will be summarized.

  19. Concentrations Predose and at End of Infusion

    Time frame: Up to first 6 cycles

    Predose and end of infusion plasma concentrations as measured from all individual plasma concentrations.

  20. Pharmacokinetic parameters

    Time frame: Up to first 6 cycles

    Clearance of plasma and central volume of distribution based on population PK model

  21. Incidence of anti-drug antibody (ADA)

    Time frame: Up to 30 days post-last dose

    The frequency and proportion of participants developing anti-drug antibodies.

Study contacts

Contact information is provided by the study sponsor or research team.

David Yao, MD

CONTACT

[email protected]

+1 617 401 4499

Eduardo Pennella, MD

CONTACT

[email protected]

+1 617 401 4499

Sponsors and collaborators

Lead sponsor

Merus B.V.

Industry

Registry information

Official study title

A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 11, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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