Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 13, 2018
End Date:August 2022
Contact:Cici Zhang
Email:han.zhang@beigene.com
Phone:+86 010-68445306

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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

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
(1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal
junction (GEJ) adenocarcinoma.


Inclusion Criteria:

1. Able to provide written informed consent and can understand and comply with the
requirements of the study

2. Adult patients (≥ 18 years of age or acceptable age according to local regulations,
whichever is older) at the time of voluntarily signing informed consent

3. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have
histologically confirmed adenocarcinoma

4. At least 1 measurable lesion as defined per RECIST v1.1 as determined by investigator
assessment.

5. 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 6 months.

6. Patients must be able to provide tumor tissues.

7. ECOG PS ≤ 1 within 7 days prior to randomization

8. Adequate organ function as indicated by the following laboratory values ≤ 7 days prior
to randomization:

9. Females of childbearing potential must have a negative urine or serum pregnancy test
within 7 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.

10. 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.

Exclusion Criteria:

1. Patient has squamous cell or undifferentiated or other histological type GC

2. 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.

3. Active autoimmune diseases or history of autoimmune diseases that may relapse.

4. Any active malignancy ≤ 2 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).

5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
drainage within 7 days prior to randomization (The cytological confirmation of any
effusion is permitted).

6. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2

7. Any condition that requires systemic treatment with either corticosteroids (> 10 mg
daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days
before randomization.

8. With 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 (beyond acute phase) without any
concerns about recurrence. Patients with severe but stable radiation-induced
pneumonitis may be required to undergo routine pulmonary function studies

9. With severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy, including tuberculosis infection, etc.

10. A known history of HIV infection

11. Patients with untreated chronic hepatitis B virus (HBV) or HBV carriers at screening
or patients with active Hepatitis C virus (HCV) infection should be excluded.

12. Prior 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

13. Prior allogeneic stem cell transplantation or organ transplantation

14. A history of severe hypersensitivity reactions to other monoclonal antibodies or any
components of study treatment

15. Known dihydropyrimidine dehydrogenase (DPD) deficiency

16. 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 protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
19
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Chapel Hill, North Carolina 27514
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450 West Drive
Chapel Hill, North Carolina 27599
Principal Investigator: Autumn McRee
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Carolyn Britten
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Columbus, Ohio 43210
Principal Investigator: John Hays
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Nashville, Tennessee 37203
Principal Investigator: Johanna Bendell
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Paul Oberstein
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Newnan, Georgia 30265
Principal Investigator: Eyal Meiri
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8303 Dodge Street
Omaha, Nebraska 68114
(402) 354–4000
Principal Investigator: Timothy Huyck
Nebraska Methodist Hospital Methodist Hospital is a general medical and surgical hospital in Omaha, NE....
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Philadelphia, Pennsylvania 19107
Principal Investigator: James Posey
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Sacramento, California 95817
Principal Investigator: May Cho
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7901 Frost Street
San Diego, California 92123
858-939-3400
Principal Investigator: Charles Redfern
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Temple, Texas 76508
Principal Investigator: Lucas Wong
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Tulsa, Oklahoma 74133
Principal Investigator: Asha Karippot
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300 South 6th Avenue
West Reading, Pennsylvania 19611
(610) 988-8000
Principal Investigator: Terrence Cescon
Reading Hospital At Reading Health System, advancing your health and wellness is our mission. When...
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1202 Medical Center Drive
Wilmington, North Carolina 28401
Principal Investigator: James McGrath
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Zion, Illinois 60099
Principal Investigator: Ashwin Sheelvanth
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