Informations générales (source: ClinicalTrials.gov)
A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma
Interventional
Phase 3
Merus B.V. (Voir sur ClinicalTrials)
juin 2024
mars 2029
04 juin 2026
This is a phase 3 open-label, randomized, controlled, multicenter study to compare
petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and
third-line treatment of incurable metastatic/recurrent disease.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 09/06/2026 18:05:04 | Contacter | ||
Critères
Tous
- Signed ICF before initiation of any study procedures.
- Age ≥ 18 years at signing of ICF.
- Histologically previously confirmed HNSCC with evidence of metastatic or locally
advanced disease not amenable to standard therapy with curative intent.
- HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing
therapy.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx,
and larynx.
- Documentation of p16 status (positive or negative) by local laboratory IHC for
participants with primary oropharyngeal cancer.
- A baseline new tumor sample unless the participant has an available tumor sample as
an FFPE block with sufficient material.
- Measurable disease as defined by RECIST v1.1 by radiologic methods.
- ECOG PS of 0 or 1
- Life expectancy ≥ 12 weeks, as per investigator
- Adequate organ function (as per protocol)
Exclusion Criteria:
- Central nervous system metastases that are untreated or symptomatic, or require
radiation, surgery, or continued steroid therapy to control symptoms within 14 days
prior to randomization.
- Known leptomeningeal involvement
- Any systemic anticancer therapy within 4 weeks prior to randomization.
- Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to
randomization.
- Persistent Grade >1 clinically significant toxicities related to prior
antineoplastic therapies
- History of hypersensitivity reaction to any of the excipients of treatment required
for this study.
- 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 of study entry
- History of prior malignancies with the exception of localized cancer with curative
resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin 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
- Participants with known infectious diseases (as per protocol)
- Pregnant or breastfeeding participants
- Participant has a primary tumor site of nasopharynx (any histology).