Étude de phase II du traitement combiné au magrolimab chez des patients atteints d'un carcinome épidermoïde de la tête et du cou

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : II
Étape du traitement : Traitements combinés
Date d'ouverture : 07/09/2021
Date clôture : 31/07/2025
Promoteur : Gilead Sciences
Progression du cancer: À distance
Résumé :

The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC).

Domaines/spécialités :
  • Cancer de la tête et du cou
Pathologies :
  • Tumeur maligne de siège mal défini de la tête, de la face et du cou - Cim10 : C760
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Critères d’inclusion :

Key Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies

Safety Run-in Cohort 1 and Phase 2 Cohorts 1

  • Should not have had prior systemic therapy administered in the recurrent or metastatic setting.
  • Eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Nasopharynx is not included.
  • HNSCC per protocol specified inclusion criteria regardless of PD-L1 status

Safety Run-in Cohort 2 and Phase 2 Cohort 3

  • Histologically or cytologically confirmed locally advanced/mHNSCC regardless of PD-L1 status with at least 1 and no more than 2 lines of prior systemic anticancer therapy in the locally advanced/metastatic setting
Critères d’exclusion :

Key Exclusion Criteria:

  • Active central nervous system (CNS) disease (individuals with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)
  • History of (noninfectious) pneumonitis that required steroids or current pneumonitis

Safety Run-in Cohort 1, Pre-expansion Safety Run-in Cohort for Magrolimab + Pembrolizumab (if Applicable), and Phase 2 Cohorts 1 and 2

  • Prior treatment with any of the following:

    • Anti-programmed cell death protein 1 or anti-PD-L1 checkpoint inhibitors
    • Anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitors

Safety Run-in Cohort 2 and Phase 2 Cohort 3

  • Progressive disease within 6 months of completion of curatively intended systemic treatment for locally advanced/mHNSCC
  • Prior treatment with a taxane

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Nom : LEVEQUE
Prénom : Nathalie
Téléphone : 03 45 34 80 68
Email : nleveque@cgfl.fr

Référentiels Oncologik

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