A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

BeiGene

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Metastatic Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: 5-fluorouracil (5-FU); Drug: Cisplatin; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Subcutaneous Tislelizumab; Drug: Intravenous Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07043400

2024-519474-39-00 (EU Trial (CTIS) Number)

BGB-A317-316

Details and patient eligibility

About

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

Enrollment: 351 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma.
• No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
• At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.
• Must be able to provide tumor tissues for biomarker assessment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.
• Adequate organ function.
• Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.
• Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.

Exclusion criteria

• Squamous cell or undifferentiated or other histological type gastric cancer (GC)
• Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.
• Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 2 patient groups

Arm A: Tislelizumab Subcutaneous + Chemotherapy

Experimental group

Description:

Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Treatment:

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Subcutaneous Tislelizumab

Drug: Capecitabine

Drug: 5-fluorouracil (5-FU)

Drug: Cisplatin

Arm B: Tislelizumab Intravenous Infusion + Chemotherapy

Active Comparator group

Description:

Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis.

Treatment:

Drug: Intravenous Tislelizumab

Drug: Oxaliplatin

Drug: Leucovorin

Drug: Capecitabine

Drug: 5-fluorouracil (5-FU)

Drug: Cisplatin