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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+ Head and Neck Squamous Cell Carcinoma

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

Jauhari Shekeab

Genmab, US, Inc.

777 Scudders Mill Rd, Plainsboro, New Jersey 08536, United States of America

USenquiries@merus.nl

Ito Yoshikazu

Medpace Japan KK

1-5-8, Jingumae, Shibuya-ku, Tokyo

+81-70-3972-0234

RSJapan1@medpace.com

Not Recruiting

Mar. 07, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Signed ICF before initiation of any study procedures
2. Age 18 years or older 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 or more.
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 week or longers, as per investigator assessment.
11. Left ventricular ejection fraction (LVEF) 50% or higher, or above 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/microliter or more, viral load is undetectable, and the patient is currently receiving highly active antiretroviral therapy.

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 under Grade 1 or baseline (except for Grade 2 or more myalgia, neuropathy, alopecia) and any prior therapy related endocrinopathies
7. History of hypersensitivity reaction to any of the excipients of petosemtamab 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 more than 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)

Both

Recurrent/metastatic PD-L1+ head and neck squamous cell carcinoma

Study participants will be randomly assigned to a study group to receive either petosemtamab plus pembrolizumab or pembrolizumab in this study.

petosemtamab plus pembrolizumab treatment:
Petosemtamab is administered intravenously once every 2 weeks at the prescribed dose. And pembrolizumab is administrated intravenously once every 6 week at a prescribed dose.

pembrolizumab monotherapy treatment:
Pembrolizumab is administrated intravenously once every 6 week at a prescribed dose.

- Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR [Time Frame: Up to approximately 2 years]
- Overall Survival (OS) [Time Frame: Up to approximately 3 years]

Jan. 29, 2025

No

United States/United Kingdom/Thailand/Taiwan/Spain/South Korea/Netherlands/Italy/Israel/Greece/Germany/France/Chile/Canada/Belgium/Australia/Argentina/Poland