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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. 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: NCT03783442
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

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 ESCC.

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

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Study Type : Interventional
Estimated Enrollment : 622 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 : March 30, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab + chemotherapy
Tislelizumab administered with chemotherapy doublet (any of the two available chemotherapy drug combinations) for up to 24 months
Drug: Cisplatin
60 to 80 mg/m2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)

Drug: Capecitabine
1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Paclitaxel
175 mg/m2 IV on Day 1 Q3W

Drug: Fluorouracil (5-FU)
750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Oxaliplatin
30 mg/m2 IV on Day 1 Q3W

Drug: Tislelizumab
200 mg IV Q3W

Active Comparator: Placebo + chemotherapy
Placebo administered with chemotherapy doublet (any of the two available chemotherapy drug combinations) for up to 24 months
Drug: Cisplatin
60 to 80 mg/m2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)

Drug: Capecitabine
1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Paclitaxel
175 mg/m2 IV on Day 1 Q3W

Drug: Fluorouracil (5-FU)
750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Oxaliplatin
30 mg/m2 IV on Day 1 Q3W

Drug: Placebo
Placebo to match Tislelizumab




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the blinded independent review committee (BIRC) per RECIST v1.1 or death, whichever occurs first [ Time Frame: Approximately 31 months from date of the first participant randomization ]
  2. Overall Survival (OS) - defined as the time from the date of randomization until the date of death due to any cause [ Time Frame: Approximately 31 months from date of the first participant randomization ]

Other Outcome Measures:
  1. Objective Response Rate (ORR) - defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by BIRC per RECIST v1.1 [ Time Frame: Approximately 31 months from date of the first participant randomization ]
  2. Duration of Response (DOR)- defined as the time from the first determination of an objective response until the first documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes first [ Time Frame: Approximately 31 months from date of the first participant randomization ]
  3. 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 31 months from date of the first participant randomization ]
  4. 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 31 months from date of the first participant randomization ]
  5. 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 31 months from date of the first participant randomization ]
  6. Number of participants experiencing Adverse Events (AEs) [ Time Frame: Approximately 31 months from date of the first participant randomization ]
  7. Number of participants experiencing Serious Adverse Events (SAEs) [ Time Frame: Approximately 31 months from date of the first participant randomization ]


Information from the National Library of Medicine

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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 with a treatment free interval of at least 6 months after definitive treatment.

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.


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


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

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Sumei Liu, MD BeiGene
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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: September 16, 2020
Last Verified: September 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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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
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
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