臨床研究等提出・公開システム

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 (STAR-221)

Randomized Phase 3 Trial of Domvanalimab + Zimberelimab + Chemotherapy vs. Nivolumab + Chemotherapy in Adults with Advanced Upper Gastrointestinal Tract Adenocarcinoma (STAR-221)

Nasermoaddeli Ali

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

k-ryu@taiho.co.jp

Ryu Kiyo

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3293-2455

k-ryu@taiho.co.jp

Not Recruiting

April. 27, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Age >= 18 years at the time of signing the informed consent.
2. 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.
3. Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
4. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
5. At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

1. 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.
2. Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
3. Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
4. Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
5. Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

Both

Locally Advanced Unresectable or Metastatic Gastric, GEJ, and Esophageal Adenocarcinoma

Safety Run-in Phase :
- Domvanalimab 1600 mg + zimberelimab 480 mg once every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX* once every 2 weeks (Q2W), andor
- Domvanalimab 1200 mg + zimberelimab 360 mg once every 3 weeks (Q3W) in addition to chemotherapy with CAPOX** Q3W.
Global Enrollment Phase :
Experimental Arm:
- Domvanalimab 1600 mg + zimberelimab 480 mg every 4 weeks (Q4W) in addition to chemotherapy with FOLFOX every 2 weeks (Q2W), or
- Domvanalimab 1200 mg + zimberelimab 360 mg every 3 weeks (Q3W) in addition to chemotherapy with CAPOX Q3W.
Comparator Arm:
- Nivolumab 240 mg Q2W + FOLFOX Q2W or
- Nivolumab 360 mg Q3W + CAPOX Q3W.
*FOLFOX: oxaliplatin, levofolinate calcium, fluorouracil
**CAPOX: capecitabine and oxaliplatin

Overall survival [ Time Frame: From randomization until death from any cause ]

+81-72-366-0221

Mar. 28, 2023

Yes

We will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

United States/Australia/Georgia/Hong Kong/Lithuania/Mexico/Romania/United Kingdom