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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03777657
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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.

Condition or disease Intervention/treatment Phase
Gastric, or Gastroesophageal Junction Adenocarcinoma Drug: Tislelizumab Drug: Placebo Drug: Cisplatin Drug: Oxaliplatin Drug: Capecitabine Drug: 5-FU Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab (BGB-A317) + chemotherapy
Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
Drug: Tislelizumab
200 mg IV on Day 1 during each 21-day cycle
Other Name: BGB-A317

Drug: Cisplatin
80 mg/m² IV on Day 1 during each 21-day cycle

Drug: Oxaliplatin
130 mg/m² IV on Day 1 during each 21-day cycle

Drug: Capecitabine
1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle

Drug: 5-FU
800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle

Placebo Comparator: Placebo + chemotherapy
Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
Drug: Placebo
Placebo to match zanubrutinib on Day 1 during each 21-day cycle

Drug: Cisplatin
80 mg/m² IV on Day 1 during each 21-day cycle

Drug: Oxaliplatin
130 mg/m² IV on Day 1 during each 21-day cycle

Drug: Capecitabine
1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle

Drug: 5-FU
800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 48 months ]
    The time from the date of randomization to the date of death due to any cause


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 30 months ]
    The time from the date of randomization to the date of the first objectively documented tumor progression

  2. Overall response rate (ORR) [ Time Frame: Up to 48 months ]
    The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1

  3. Duration of response (DOR) [ Time Frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months ]
    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

  4. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) [ Time Frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months ]
  5. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30) [ Time Frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months ]
  6. Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L) [ Time Frame: Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months ]
  7. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Up to 48 months ]
  8. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Up to 48 months ]
  9. Disease control rate (DCR) [ Time Frame: Up to 48 Months ]
    Proportion of complete response + partial response + stable disease

  10. clinical benefit rate (CBR) [ Time Frame: Up to 48 Months ]
    Proportion of complete response + partial response + durable stable disease

  11. time to response (TTR) [ Time Frame: Up to 48 Months ]
    Time from randomization to the first determination of an objective response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
  2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants 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.
  3. ECOG PS ≤ 1 within 7 days prior to randomization
  4. Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization

Key Exclusion Criteria:

  1. Has squamous cell or undifferentiated or other histological type GC
  2. Active leptomeningeal disease or uncontrolled brain metastasis
  3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  4. 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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777657


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 166 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Jin Wang, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03777657    
Other Study ID Numbers: BGB-A317-305
2018-000312-24 ( EudraCT Number )
CTR20181841 ( Registry Identifier: Center for drug evaluation, CFDA )
JapicCTI-194799 ( Registry Identifier: Japic )
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Capecitabine
Oxaliplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action