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

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ClinicalTrials.gov Identifier: NCT03777657
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE December 17, 2018
Last Update Posted Date November 13, 2019
Actual Study Start Date  ICMJE December 13, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • Progression-free survival - defined as the time from the date of randomization to the date of the first objectively documented tumor progression [ Time Frame: Up to 27 months ]
  • Overall Survival - defined as the time from the date of randomization to the date of death due to any cause [ Time Frame: Up to 43 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03777657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • Overall response rate - defined as the proportion of patients whose best overall response is complete response or partial response per Response Evaluation Criteria in Solid Tumors v1.1 [ Time Frame: Up to 43 months ]
  • Duration of response - defined as the time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first [ Time Frame: Up to 43 months ]
  • Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  • Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  • Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (at Screening or baseline, at every cycle through Cycle 6, then every other cycle thereafter until PD, and at EOT) [ Time Frame: Up to 43 months ]
  • The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 [ Time Frame: Up to 43 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastric, or Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • Drug: Tislelizumab (BGB-A317) combined with oxaliplatin and capecitabine or Tislelizumab (BGB-A317) combined with Cisplatin and 5-FU
    Tislelizumab (BGB-A317) + Oxaliplatin + Capecitabine: Subjects will be treated with BGB A317 200 mg IV on Day 1, cisplatin 80 mg/m² IV on Day 1, and 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21- day cycle. Tislelizumab (BGB-A317) + Cisplatin + 5- FU: Subjects will be treated with BGB A317 200 mg IV on Day 1, oxaliplatin 130 mg/m² IV on Day 1, and capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle.
  • Drug: Placebo combined with oxaliplatin and capecitabine or Placebo combined with Cisplatin and 5-FU
    Placebo + Oxaliplatin + Capecitabine: Subjects will be treated with Placebo 200 mg IV on Day 1, cisplatin 80 mg/m² IV on Day 1, and 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. Placebo + Cisplatin + 5-FU: Subjects will be treated with Placebo 200 mg IV on Day 1, oxaliplatin 130 mg/m² IV on Day 1, and capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle
Study Arms  ICMJE
  • Experimental: Tislelizumab (BGB-A317) + chemotherapy
    Patients received Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
    Intervention: Drug: Tislelizumab (BGB-A317) combined with oxaliplatin and capecitabine or Tislelizumab (BGB-A317) combined with Cisplatin and 5-FU
  • Placebo Comparator: Placebo + chemotherapy
    Patients receive placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
    Intervention: Drug: Placebo combined with oxaliplatin and capecitabine or Placebo combined with Cisplatin and 5-FU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2018)
720
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE China,   France,   Italy,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03777657
Other Study ID Numbers  ICMJE BGB-A317-305
2018-000312-24 ( EudraCT Number )
CTR20181841 ( Registry Identifier: Center for drug evaluation, CFDA )
JapicCTI-194799 ( Registry Identifier: Japic )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Crystal Denlinger, MD Fox Chase Cancer Center
PRS Account BeiGene
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP