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A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03783442
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : May 2, 2019
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 patients with advanced unresectable/metastatic ESCC.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma (ESCC) Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU) Drug: Platinum (cisplatin or oxaliplatin) + capecitabine Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Double-blinded
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 12, 2018
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : January 30, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A
Tislelizumab + chemotherapy
 Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • 5-FU 750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • Capecitabine 1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel

  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 or 2 Q3W

    • Depending on local guidelines, cisplatin may be given in 3 divided doses on Days 1, 2, and 3. The total dose given must be between 60 to 80 mg/m2 per cycle.
  • Paclitaxel 175 mg/m2 IV on Day 1 Q3W
Active Comparator: Arm B
Placebo + chemotherapy
 Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • 5-FU 750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 Q3W
  • Capecitabine 1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W

Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel

  • Cisplatin 60 to 80 mg/m2 OR oxaliplatin 130 mg/m2 IV on Day 1 or 2 Q3W

    • Depending on local guidelines, cisplatin may be given in 3 divided doses on Days 1, 2, and 3. The total dose given must be between 60 to 80 mg/m2 per cycle.
  • Paclitaxel 175 mg/m2 IV on Day 1 Q3W


Outcome Measures
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Primary Outcome Measures :
  1. PFS - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first [ Time Frame: Approximately 31 months from date of the first patient randomization ]
  2. 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 patient randomization ]

Other Outcome Measures:
  1. ORR - defined as the proportion of patients 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 patient randomization ]
  2. 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 patient randomization ]
  3. Health-Related Quality of Life (HRQoL) assessment of the patient'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 patient randomization ]
  4. Health-Related Quality of Life (HRQoL) assessment of the patient'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 patient randomization ]
  5. Health-Related Quality of Life (HRQoL) assessment of the patient'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 patient randomization ]
  6. The incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 [ Time Frame: Approximately 31 months from date of the first patient 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

Patients 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.

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.

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 PD-1, PD-L1 or PD-L2
  4. Patients 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 other indicators of severe malnutrition (Severe malnutrition may be determined using the Nutritional Risk Index (Shirasu, et al. 2018))
  8. Patients receiving chemotherapy doublet C (platinum and paclitaxel) must not have peripheral neuropathy ≥ Grade 2 at baseline
  9. Patients who recur after definitive surgery and are eligible for non-palliative radiation therapy and/or chemoradiotherapy.

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


Contacts
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Contact: Virginia Paton, Europe and United States 1 (877) 828-5568 clinicaltrials@beigene.com
Contact: Baochong Guo, Asia 1 (877) 828-5568 clinicaltrials@beigene.com

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Sponsors and Collaborators
BeiGene
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03783442     History of Changes
Other Study ID Numbers: BGB-A317-306
2018-000587-28 ( EudraCT Number )
China CT No. ( Other Identifier: CTR20181013 )
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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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
Cisplatin
Capecitabine
Oxaliplatin
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors