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) (eVOLVE-HNSCC)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
décembre 2023
mai 2030
04 octobre 2024
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 sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Research Site - 31059 - Toulouse Cedex 09 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44805 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 84918 - Avignon Cedex 09 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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 within 12 weeks prior to randomization.
- 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 within 12 weeks prior to randomization.
- 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. Residual disease that needs further treatment with curative intent after
definitive cCRT administration;
2. LA-HNSCC that was resected before definitive cCRT
3. 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.
- Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks
(84 days) prior to randomization.