A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

Launched by MERUS N.V. · Jul 26, 2024

Keywords

ClinConnect Summary

This clinical trial is evaluating a new treatment approach for patients with head and neck cancer that has spread or come back after initial treatment. It compares two options: a combination of two medications, petosemtamab and pembrolizumab, versus pembrolizumab alone. This study is for adults aged 18 and older who have a specific type of head and neck cancer that can be tested for a protein called PD-L1. Participants should not have received any prior treatment for their cancer in its advanced stage and need to have measurable disease that can be monitored.

If you decide to participate, you will receive either the combination treatment or pembrolizumab alone, and the study will monitor your health and any side effects closely. To be eligible, you must meet certain health criteria, such as having good organ function and a life expectancy of at least 12 weeks. This trial is currently recruiting participants, and it’s important to discuss with your doctor if you meet the eligibility requirements and if this study is a good option for you.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed ICF before initiation of any study procedures
• • 2. Age ≥ 18 years at signing of ICF
• • 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent.
• • 4. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
• • 5. HNSCC patients eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD-L1, CPS ≥1.
• • 6. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting
• • 7. A new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
• • 8. Measurable disease per Investigator assessment as defined by RECIST v1.1 by radiologic methods
• • 9. ECOG Performance Status (PS) of 0-1
• • 10. Life expectancy ≥ 12 weeks, as per investigator assessment.
• • 11. Left ventricular ejection fraction (LVEF) ≥50% or ≥ institutional normal limit, whichever is higher, by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
• • 12. Adequate organ function as defined per protocol.
• • 13. 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:
• • 1. 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
• • 2. Known leptomeningeal involvement
• • 3. Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
• • 4. Requirement for immunosuppressive medication
• • 5. Major surgery or radiotherapy within 3 weeks of randomization
• • 6. 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
• • 7. History of hypersensitivity reaction to any of the excipients of petosemtomab or pembrolizumab.
• • 8. 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
• • 9. History of prior malignancies within the last 5 years, with the exception of excised local cancer
• • 10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
• • 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
• • 12. Patients with known infectious diseases as per protocol.
• • 13. Pregnant or breastfeeding patients.
• • 14. 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
• • 15. 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
• • 16. The patient has had an allogeneic tissue/solid organ transplant.
• • 17. Patient has a primary tumor site of nasopharynx, or sinonasal carcinoma (any histology)
• • Other protocol defined inclusion/exclusion criteria may apply.