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A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03783442
Recruitment Status : Active, not recruiting
First Posted : December 21, 2018
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Cisplatin Drug: Oxaliplatin Drug: Fluorouracil (5-FU) Drug: Capecitabine Drug: Paclitaxel Drug: Tislelizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 649 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Actual Study Start Date : December 11, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tislelizumab + chemotherapy

Tislelizumab administered with chemotherapy doublet:

Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

 Drug: Cisplatin
60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)

Drug: Oxaliplatin
130 mg/m^2 IV on Day 1 Q3W

Drug: Fluorouracil (5-FU)
750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Capecitabine
1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Paclitaxel
175 mg/m^2 IV on Day 1 Q3W

Drug: Tislelizumab
200 mg IV Q3W
Active Comparator: Placebo + chemotherapy

Placebo administered with chemotherapy doublet:

Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

 Drug: Cisplatin
60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)

Drug: Oxaliplatin
130 mg/m^2 IV on Day 1 Q3W

Drug: Fluorouracil (5-FU)
750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Capecitabine
1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Paclitaxel
175 mg/m^2 IV on Day 1 Q3W

Drug: Placebo
Placebo to match Tislelizumab


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 40 months from date of the first participant randomization ]
    OS is defined as the time from the date of randomization until the date of death due to any cause


Other Outcome Measures:
  1. Progression-Free Survival (PFS) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first

  2. Objective Response Rate (ORR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1

  3. Overall survival (OS) in the PD-L1 score ≥ 10% subgroup [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    OS is defined as the time from the date of randomization until the date of death due to any cause

  4. Duration of Response (DOR) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
    DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first

  5. Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  6. Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  7. Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L) [ Time Frame: Approximately 40 months from date of the first participant randomization ]
  8. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Approximately 40 months from date of the first participant randomization ]

Eligibility Criteria
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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

Participants with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy, chemo-radiation therapy or surgery) was given.

Key Inclusion Criteria:

  1. Pathologically (histologically) confirmed diagnosis of ESCC
  2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

Key Exclusion Criteria:

  1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
  4. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
  6. Evidence of complete esophageal obstruction not amenable to treatment
  7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
  8. Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
  9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)

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

Contacts and Locations
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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): NCT03783442


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Liyun Li, MD BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03783442    
Other Study ID Numbers: BGB-A317-306
2018-000587-28 ( EudraCT Number )
CTR20181013 ( Other Identifier: Center for drug evaluation, CFDA )
JapicCTI-194741 ( Registry Identifier: Japic )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
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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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Paclitaxel
Fluorouracil
Capecitabine
Oxaliplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs