Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Arcus Biosciences, Inc. (Voir sur ClinicalTrials)
novembre 2022
février 2027
02 novembre 2025
This randomized Phase 3 open-label study will compare the efficacy of the T-cell
immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT)
monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1)
monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1
monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of
participants with locally advanced unresectable or metastatic gastric, gastroesophageal
junction (GEJ), and esophageal adenocarcinoma.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Val�rie BOIGE | 11/04/2024 11:50:46 | Contacter | ||
Critères
Tous
- 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 status of 0-1.
- At least one measurable target lesion per Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1.
Key Exclusion Criteria:
- 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:
- 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.
- 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.
- History of prior solid-organ transplantation, including allogenic bone marrow
transplantation.
- 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 completion of neoadjuvant or adjuvant
therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.