A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03430843|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Squamous Cell Carcinoma (ESCC)||Drug: BGB-A317 Drug: Paclitaxel, or Docetaxel, or Irinotecan||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma|
|Actual Study Start Date :||January 23, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
BGB-A317 will be administered with 200 mg intravenous dosing (IV) on Day1, given every 21 days.
Other Name: Tislelizumab
Active Comparator: Investigator chosen chemotherapy
Paclitaxel will be administered at a dose of 135-175 mg /m² IV, Day 1, given every 21 days or 80-100mg/m2 IV given on a weekly schedule.
OR docetaxel will be administered at a dose of 75 mg/m2 IV, Day 1, given 21 days.
OR irinotecan will be administered at a dose of 125mg/m2 IV, Day 1, 8, given 21 days.
Drug: Paclitaxel, or Docetaxel, or Irinotecan
One of the following three single-agent chemotherapies as determined by the Investigator Paclitaxel, or Docetaxel, or Irinotecan
- Overall survival (OS) [ Time Frame: approximately 2 years from date of first randomization ]Length of time from study treatment initiation to death of any cause
- Overall response rate (ORR) [ Time Frame: 2 years ]Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
- Progression-free survival (PFS) [ Time Frame: 2 years ]The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
- Duration of response (DOR) [ Time Frame: 2 years ]The interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause
- The Health-Related Quality of Life Questionnaire [ Time Frame: 2 years ]
- Safety will be analyzed through the incidence of adverse events. [ Time Frame: From the first dose date to 30 days after the last dose date ]
- Safety will be analyzed through the incidence of immune-related adverse events. [ Time Frame: From the first dose date to 90 days after the last dose date ]
- Safety will be analyzed through the incidence of serious adverse events. [ Time Frame: From the first dose date to 30 days after the last dose date ]
- Safety will be analyzed through the incidence of laboratory abnormalities. [ Time Frame: From the first dose date to 30 days after the last dose date ]
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): NCT03430843
|Contact: Virginia Paton, Senior Director||1 (877) firstname.lastname@example.org|
|Contact: Sarah Shaoemail@example.com|
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