MCLA-158-CL03 - 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.

Studio Clinico

Patologia: Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Prima linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Petosemtamab + Pembrolizumab
Combination Therapy

Trattamento di controllo: 

Pembrolizumab
Monotherapy

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-510323-30-00

Data di inserimento: 17.06.2026

Promotore

Merus B.V.

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -