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

Purpose

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.

Conditions

  • Metastatic Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Tislelizumab Subcutaneous + Chemotherapy 		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.
  • Drug: Subcutaneous Tislelizumab
    Administered by subcutaneous injection
    Other names:
    • BGB-A317
  • Drug: Cisplatin
    Administered by intravenous infusion
  • Drug: Leucovorin
    Administered by intravenous infusion
  • Drug: 5-fluorouracil (5-FU)
    Administered by intravenous infusion
  • Drug: Oxaliplatin
    Administered by intravenous infusion
  • Drug: Capecitabine
    Administered orally
Active Comparator
Arm B: Tislelizumab Intravenous Infusion + Chemotherapy 		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.
  • Drug: Intravenous Tislelizumab
    Administered by intravenous infusion
    Other names:
    • BGB-A317
    • TEVIMBRA®
  • Drug: Cisplatin
    Administered by intravenous infusion
  • Drug: Leucovorin
    Administered by intravenous infusion
  • Drug: 5-fluorouracil (5-FU)
    Administered by intravenous infusion
  • Drug: Oxaliplatin
    Administered by intravenous infusion
  • Drug: Capecitabine
    Administered orally

Recruiting Locations

Ironwood Cancer and Research Centers
Chandler, Arizona 85224-5665

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

Bioresearch Partners Holding Hialeah Hospital
Hialeah, Florida 33013-3804

Orlando Health Ufhealth Cancer Center
Orlando, Florida 32806-2134

Northwestern University
Chicago, Illinois 60611

Hope and Healing Cancer Services
Hinsdale, Illinois 60521-0509

University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160-8500

New England Cancer Specialists
Westbrook, Maine 04092

St Louis Cancer Care, Llp
Bridgeton, Missouri 63044

Nebraska Hematology Oncology
Lincoln, Nebraska 68506-7548

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169-3321

Hunterdon Hematology Oncology
Flemington, New Jersey 08822-4603

Summit Medical Group
Florham Park, New Jersey 07932-1049

Oregon Oncology Specialists
Salem, Oregon 97301

Md Anderson Cancer Center
Houston, Texas 77030-3907

Northwest Medical Specialties
Tacoma, Washington 98405

Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico 00935

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

BeOne Medicines
1-877-828-5568
clinicaltrials@beonemed.com

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.