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
Investigating the Effectiveness of Investigational Medicine in Metastatic or Recurrent Head and Neck Cancer
G
Greg Durm, MD
Primary Investigator
Recruiting
18 years - 100 years
All
Phase
3
2 Locations
Brief description of 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.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
Conditions:Squamous Cell Carcinoma of Head and Neck, Cancer
Age:
18 years - 100 years
Gender: All
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 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 Criteria:
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).
Updated on
26 Aug 2025.
Study ID: CTO-MCLA-158-CL02, 24485
This study investigates the effectiveness and safety of an investigational medication compared to the investigator's choice of monotherapy treatment in patients with head and neck squamous cell carcinoma (HNSCC) that is incurable, metastatic, or recurrent. HNSCC is a type of cancer that occurs in the squamous cells lining the head and neck region, and metastatic means the cancer has spread to other parts of the body. The purpose of this study is to provide a second- and third-line treatment option for patients who have already been treated with anti-PD-1 therapy and platinum-containing therapy.
In this study, patients will be randomly assigned to receive either the investigational medication or a treatment chosen by their doctor, which is a standard practice in clinical trials to compare different treatments. Participants will undergo various procedures to assess the safety and effectiveness of the treatment, including regular monitoring and imaging tests. These procedures help researchers understand how well the treatment works and its impact on the patient's health.
Who can participate: Adults aged 18 years and older with previously confirmed head and neck squamous cell carcinoma that is metastatic or locally advanced and not treatable with curative intent can participate. Eligible participants must have progressed on or after anti-PD-1 therapy and platinum-containing therapy, and they must meet specific health criteria, including adequate organ function and measurable disease.
Study details: Participants will be randomly assigned to receive either the investigational medication or a standard treatment chosen by their doctor. Participants must provide a baseline tumor sample or have an available sample for analysis.
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