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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 : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 21, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE December 11, 2018
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03783442 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Double-blinded
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma (ESCC)
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm A
    Tislelizumab + chemotherapy
    Interventions:
    • Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
    • Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
    • Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel
  • Active Comparator: Arm B
    Placebo + chemotherapy
    Interventions:
    • Drug: Platinum (cisplatin or oxaliplatin) + Fluorouracil (5-FU)
    • Drug: Platinum (cisplatin or oxaliplatin) + capecitabine
    • Drug: Platinum (cisplatin or oxaliplatin) + paclitaxel
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 19, 2018)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 Australia,   Belgium,   China,   Czechia,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03783442
Other Study ID Numbers  ICMJE BGB-A317-306
2018-000587-28 ( EudraCT Number )
CTR20181013 ( Other Identifier: Center for drug evaluation, CFDA )
JapicCTI-194741 ( Registry Identifier: Japic )
Has Data Monitoring Committee Yes
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
Study Director: Virginia Paton, Pharm.D. BeiGene
PRS Account BeiGene
Verification Date October 2019

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