Who is eligible to participate?
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 new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
– Measurable disease per Investigator assessment 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% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
– Adequate organ function as defined per protocol.
– HIV-positive patients are eligible only if the cluster of differentiation 4 (CD4+) count is ≥ 300/µl, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy
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 prior to randomization
– Known leptomeningeal involvement
– Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
– Requirement for immunosuppressive medication
– Major surgery or radiotherapy within 3 weeks of randomization
– Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baseline except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies
– History of hypersensitivity reaction to any of the excipients of petosemtamab 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 prior to randomization
– History of prior malignancies within the last 5 years, with the exception of excised local 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
– Patients with known infectious diseases as per protocol.
– Pregnant or breastfeeding patients.
– The patient has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy of prednisone >10 mg/day or equivalent, or any other form of immunosuppressive therapy
– 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
– The patient has had an allogeneic tissue/solid organ transplant.
– Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)
– Other protocol defined inclusion/exclusion criteria may apply.
Register your interest
To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au.
Study location
Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane
