A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma
Date de révision : 14/05/2026
31 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 18/11/2024
Date de fin de recrutement : 18/11/2024
Critères :
Critères d'inclusion :
- Age >= 18 years at the time of signing the informed consent.
- Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
- Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
- At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Critères d'exclusion :
- Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to: 1. Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization, 2. Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization, 3. History of prior solid-organ transplantation, including allogenic bone marrow transplantation, 4. Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
- Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
- Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
- Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Sites des essais
Adresse
Centre Hospitalier Regional Et Universitaire De Brest
29200 Brest France
Institut Regional Du Cancer De Montpellier
34298 Montpellier Cedex 5 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".