Comparing Petosemtamab with Pembrolizumab for head and neck squamous cell carcinoma

Exclusion

• −History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab.
• −Known leptomeningeal involvement
• −Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Requirement for immunosuppressive medication
• −Clinically significant toxicities related to prior anticancer therapies that have not returned to ≤ Grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → except for Grade ≤2- myalgia, neuropathy, alopecia, and any prior therapy related endocrinopathies
• −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 protocolProtocolThe detailed plan a study must follow.Read more →.
• −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 siteTrial siteA hospital or clinic where a study is actually run.Read more → of nasopharynx, or sinonasal carcinoma (any histology)
• −Other protocol defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
• −Pregnant or breastfeeding patients.
• −Central nervous system metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to controlControl groupThe group a new treatment is measured against.Read more → symptoms within 21 days prior to randomization
• −Major surgery or radiotherapy within 3 weeks of randomization