Informations générales (source: ClinicalTrials.gov)
A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
décembre 2023
septembre 2030
09 mai 2026
The main purpose of this study is to assess the efficacy and safety of volrustomig
compared to observation in participants with unresected locally advanced head and neck
squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive
concurrent chemoradiotherapy (cCRT).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | France NGUYEN | 09/06/2026 17:30:06 | Contacter | ||
Critères
Tous
- Histologically or cytologically documented locally advanced squamous cell carcinoma
of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of
metastatic disease (i.e. M0).
- Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of
the American Joint Committee on Cancer (AJCC) staging manual (tumor, node,
metastasis (TNM) staging system).
- Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with
curative intent prior to randomization.
Exclusion Criteria:
- Histologically/cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria
including participants with squamous cell carcinoma of unknown primary or
non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1
primary tumors are not eligible for the study.
- Participants with any of the following:
1. LA-HNSCC that was resected before definitive cCRT
2. LA-HNSCC that was treated and is recurrent at the time of screening
- Participants who have received radiotherapy (RT) alone as definitive local therapy
for LA-HNSCC.