Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Merus N.V. (Voir sur ClinicalTrials)
septembre 2024
juillet 2030
04 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:06 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Site 101 - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Site 105 - 75005 - Paris - France | Contact (sur clinicalTrials) | ||||
| Site 54 - 76038 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Site 55 - 34298 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Site 56 - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Site 57 - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Site 59 - 31100 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Site 64 - 54519 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Site 66 - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Site 72 - 69378 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Site 79 - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Site 87 - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
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
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.