Last updated 9 days ago
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab Vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
500 patients around the world
Available in Chile, Argentina
This is a Phase 3 randomized, open-label study to evaluate the efficacy and safety of
petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or
metastatic PD-L1+ HNSCC. HNSCC patients should not have had previous systemic therapy
administered in the recurrent or metastatic setting, although previous systemic therapy
as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6
months after the last platinum-containing therapy dose. Previous treatments with anti
PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who
have received cetuximab with radiotherapy as a local treatment and PD was >1 year after
the last dose of cetuximab are eligible.
Merus N.V.
500Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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 Performance Status (PS) of 0-1.Life expectancy ≥ 12 weeks, as per investigator assessment.Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.Adequate organ function as defined per protocol.
- 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 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 cancer therapies (except for alopecia); stable sensory neuropathy Grade ≤2 National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is allowed.History of hypersensitivity reaction to any of the excipients of petosemtomab 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 of study entry.History of prior malignancies, with the exception of excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3 years.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 systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose.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.Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology).
SponsorMerus N.V.
Conditions
Squamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06525220
