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

Recruiting now · Phase 3

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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+ head and neck squamous cell carcinoma.

Key facts

Study ID: NCT06525220
Run by: Merus B.V.
People needed: 700
Starts: 2024-09-25
Expected to finish: 2030-07-01
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 new tumor biopsy, unless the patient has an available archival tumor sample with sufficient material
Measurable disease per Investigator assessment 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% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Adequate organ function as defined per protocol.
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

You may not qualify if…

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
Known leptomeningeal involvement
Any systemic anticancer therapy or investigational drug within 4 weeks or 5 half-lives, whichever is shorter, before randomization
Requirement for immunosuppressive medication
Major surgery or radiotherapy within 3 weeks of randomization
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
History of hypersensitivity reaction to any of the excipients of petosemtamab 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 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 protocol.
Pregnant or breastfeeding patients.
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 site of nasopharynx, or sinonasal carcinoma (any histology)
Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

Site 164 — Mobile, Alabama, United States (enrolling)
Site 27 — Los Angeles, California, United States (enrolling)
Site 36 — La Jolla, California, United States (enrolling)
Site 19 — Newark, Delaware, United States (enrolling)
Site 108 — Washington D.C., District of Columbia, United States (enrolling)
Site 14 — Fort Myers, Florida, United States (enrolling)
Site 16 — Palo Alto, California, United States (enrolling)
Site 8 — Orlando, Florida, United States (enrolling)
Site 21 — St. Petersburg, Florida, United States (enrolling)
Site 20 — West Palm Beach, Florida, United States (enrolling)
Site 171 — Atlanta, Georgia, United States (enrolling)
Site 197 — Chicago, Illinois, United States (enrolling)
Site 50 — Chicago, Illinois, United States (enrolling)
Site 2 — Louisville, Kentucky, United States (enrolling)
Site 162 — Baton Rouge, Louisiana, United States (enrolling)
Site 155 — Minneapolis, Minnesota, United States (enrolling)
Site 168 — St Louis, Missouri, United States (enrolling)
Site 94 — Hackensack, New Jersey, United States (enrolling)
Site 6 — Albuquerque, New Mexico, United States (enrolling)
Site 113 — Durham, North Carolina, United States (enrolling)
Site 118 — Winston-Salem, North Carolina, United States (enrolling)
Site 191 — Cleveland, Ohio, United States (enrolling)
Site 43 — Philadelphia, Pennsylvania, United States (enrolling)
Site 153 — Philadelphia, Pennsylvania, United States (enrolling)
Site 154 — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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