A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Registration Number
- NCT06525220
- Lead Sponsor
- Merus N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria:<br><br> 1. Signed ICF before initiation of any study procedures<br><br> 2. Age = 18 years at signing of ICF<br><br> 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent<br> disease not amenable to local therapy with curative intent.<br><br> 4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx,<br> and larynx.<br><br> 5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors<br> expressing PD-L1, CPS =1.<br><br> 6. HNSCC patients should not have had previous systemic therapy administered in the<br> incurable recurrent or metastatic setting<br><br> 7. A baseline new tumor sample unless the patient has an available tumor sample as an<br> FFPE block with sufficient material.<br><br> 8. Measurable disease as defined by RECIST v1.1 by radiologic methods.<br><br> 9. ECOG Performance Status (PS) of 0-1<br><br> 10. Life expectancy = 12 weeks, as per investigator assessment.<br><br> 11. Left ventricular ejection fraction (LVEF) =50% or = institutional normal limit,<br> whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.<br><br> 12. Adequate organ function as defined per protocol.<br><br>Exclusion Criteria:<br><br> 1. Central nervous system metastases that are untreated or already treated but<br> symptomatic, or require radiation, surgery, or continued steroid therapy to control<br> symptoms within 21 days of study entry.<br><br> 2. Known leptomeningeal involvement<br><br> 3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment<br><br> 4. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment<br><br> 5. Persistent Grade >1 clinically significant toxicities related to prior cancer<br> therapies (except for alopecia); stable sensory neuropathy Grade =2 National Cancer<br> Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 is<br> allowed.<br><br> 6. History of hypersensitivity reaction to any of the excipients of petosemtomab or<br> pembrolizumab.<br><br> 7. Unstable angina; history of congestive heart failure of Class II-IV New York Heart<br> Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment; or<br> history of myocardial infarction within 6 months of study entry<br><br> 8. History of prior malignancies, with the exception of excised local cancer, or<br> treated cancer deemed at low risk for recurrence with no evidence of disease for =3<br> years<br><br> 9. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen<br> therapy<br><br> 10. Current serious illness or medical conditions including, but not limited to,<br> uncontrolled active infection, clinically significant pulmonary, metabolic or<br> psychiatric disorders<br><br> 11. Patients with known infectious diseases as per protocol.<br><br> 12. Pregnant or breastfeeding patients.<br><br> 13. The patient has a diagnosis of immunodeficiency or is receiving systemic steroid<br> therapy or any form of immunosuppressive therapy within 7 days prior to the first<br> dose<br><br> 14. The patient has an active autoimmune disease that has required systemic immune<br> suppressive treatment in the past 2 years; replacement therapy is not considered<br> immune suppressive treatment.<br><br> 15. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any<br> histology)<br><br>Other protocol defined inclusion/exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR;Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) per RECIST v1.1 as assessed by BICR;Duration of Response (DOR) per RECIST v1.1 as assessed by BICR;Incidence and Severity of AEs and SAEs