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BeiGene BGB-A317-305: A randomized, double-blind, placebo-controlled, phase 3 clinical study comparing the efficacy and safety of tislelizumab (BGB-A317) plus platinum and fluoropyrimidine versus placebo plus platinum and fluoropyrimidine as first-line treatment in patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

Description

This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line therapy for locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this trial is to determine:

  • Progression-free survival, defined as the time from the date of randomization to the date of the first objectively documented tumor progression
  • Overall survival

Core eligibility

Note: This is only a partial list of eligibility criteria.

 

Including patients who:

  • Are able to provide written informed consent and can understand and comply with the requirements of the study
  • Are at least 18 years old or an acceptable age according to local regulations (whichever is older) at the time of voluntarily signing informed consent
  • Have locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
  • Have at least one measurable lesion as defined per RECIST v1.1
  • Have no previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer (Note: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least six months.)
  • Are able to provide tumor tissues.
  • Have ECOG PS ≤ 1 within seven days prior to randomization
  • Have adequate organ function as indicated by the following laboratory values ≤ 7 days prior to randomization:
    • Females of childbearing potential must have a negative urine or serum pregnancy test within seven days of randomization and 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 or placebo and 180 days after the last dose of chemotherapy
    • 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 or placebo and 180 days after the last dose of chemotherapy

Excluding patients who:

  • Have squamous cell, undifferentiated or other histological type GC
  • Have 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 ≥ four weeks before randomization.)
  • Have active autoimmune diseases or history of autoimmune diseases that may relapse.
  • Have any active malignancy ≤ two years before randomization, with the exception of the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
  • Have uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage within seven days prior to randomization (The cytological confirmation of any effusion is permitted.)
  • Have been diagnosed with gastric or GEJ adenocarcinoma that is HER2 positive
  • Have any condition that requires systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization
  • Have a history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc. (Note: Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable without concerns of recurrence. Patients with severe but stable radiation-induced pneumonitis may be required to undergo routine pulmonary function studies.)
  • Have severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
  • Have a history of HIV infection
  • Have untreated chronic hepatitis B virus (HBV) or are HBV carriers at screening or patients with active Hepatitis C virus (HCV) infection
  • Have had therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Have had allogeneic stem cell transplantation or organ transplantation
  • Have a history of severe hypersensitivity reactions to other monoclonal antibodies or any components of study treatment
  • Have known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Have underlying medical conditions or alcohol or drug abuse or dependence that, in the investigator's opinion, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or adverse events; or insufficient compliance during the study according to investigator's judgement.

Note: Other inclusion/exclusion criteria may apply.

     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Asha Karippot

Eyal Meiri