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RecruitingLast updated: 22 January 2025

This study is recruiting people with head and neck squamous cell carcinoma (HNSCC) that haven't responded to other treatments to compare the effectiveness of an experimental antibody (called petosemtamab) compared to other treatmentsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Head and Neck Cancers Head and Neck

Age

People18+

Clinical summary

Summary

This clinical trial is comparing Petosemtamab, which is an experimental bispecific antibody, with the Investigator's choice of treatment in people with head and neck squamous cell carcinoma (HNSCC) as a second- and third-line treatment for their incurable metastatic or recurrent disease.

To be eligible, people with HNSCC must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. People 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.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive Petosemtamab.

In the Active Comparator Arm, participants will receive the Investigator's choice of either:

  • Cetuximab targeted therapy,
  • Methotrexate chemotherapy or
  • Docetaxel chemotherapy

Conditions

This trial is treating people with head and neck squamous cell carcinoma that is incurable, metastatic or recurrent

Eligibility

Inclusion

  • 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 patients 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 patients with primary oropharyngeal cancer.
  • 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 PS of 0 or 1
  • Life expectancy ≥ 12 weeks, as per investigator
  • Adequate organ function (as per protocol)

Exclusion

  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 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 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 excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease
  • 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
  • Patient has a primary tumor site of nasopharynx (any histology).

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Merus N.V.

Scientific 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

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