Description:
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second
line treatment in participants with advanced unresectable/metastatic ESCC that has progressed
during or after first line therapy.
Title
- Brief Title: A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
BGB-A317-302
- SECONDARY ID:
2017-003699-30
- SECONDARY ID:
CTR20171026
- NCT ID:
NCT03430843
Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | Tislelizumab |
Paclitaxel | | Investigator chosen chemotherapy |
Docetaxel | | Investigator chosen chemotherapy |
Irinotecan | | Investigator chosen chemotherapy |
Purpose
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second
line treatment in participants with advanced unresectable/metastatic ESCC that has progressed
during or after first line therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Tislelizumab | Experimental | Tislelzumab on Day 1, given every 21 days | |
Investigator chosen chemotherapy | Active Comparator | Paclitaxel will be administered on Day 1, given every 21 days or on a weekly schedule.
OR docetaxel will be administered on Day 1, given 21 days. OR irinotecan will be administered on Days 1, 8, given 21 days. | - Paclitaxel
- Docetaxel
- Irinotecan
|
Eligibility Criteria
Key Inclusion Criteria:
1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
2. Tumor progression during or after first-line treatment for advanced unresectable /
metastatic ESCC
3. At least one measurable/evaluable lesion by RECIST v1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to
randomization
5. Adequate End organ function
Key Exclusion Criteria:
1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable
ESCC
2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula
within 6 months prior to randomization
3. Apparent tumor invasion into organs located adjacent to the esophageal disease site
(eg, aorta or respiratory tract) at an increased risk of fistula in the study
treatment assessed by investigator
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent
drainage
5. Received prior therapies targeting PD-1 or PD-L1
6. Prior malignancy active within the previous 2 years (exceptions include the tumor
under investigation in this trial, and locally recurring cancers that have undergone
curative treatment, such as resected basal or squamous cell skin cancer, superficial
bladder cancer or carcinoma in situ of the prostate, cervix or breast)
7. Active brain or leptomeningeal metastasis.
8. Has active autoimmune disease or history of autoimmune diseases at high risk for
relapse
9. Known history of, or any evidence of interstitial lung disease, non-infectious
pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or
uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases,
etc
10. Known history of Human Immunodeficiency Virus (HIV)
11. Has cardiovascular risk factors
12. Pregnant or breastfeeding woman.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) in the Intention-to-Treat (ITT) Analysis Set |
Time Frame: | approximately 2 years from date of first randomization |
Safety Issue: | |
Description: | Length of time from study treatment initiation to death of any cause |
Secondary Outcome Measures
Measure: | Overall survival (OS) in the PDL-1 Positive Analysis Set |
Time Frame: | Up to 2 years from date of first randomization |
Safety Issue: | |
Description: | Length of time from study treatment initiation to death of any cause |
Measure: | Overall response rate (ORR) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria |
Measure: | Progression-free survival (PFS) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death |
Measure: | Duration of response (DOR) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | 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 |
Measure: | Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | HRQoL as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus Cancer Module (EORTC QLQ-OES18) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing adverse events (AEs) |
Time Frame: | From the first dose date to 30 days after the last dose date |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing immune-related AEs |
Time Frame: | From the first dose date to 90 days after the last dose date |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing serious adverse events (SAEs) |
Time Frame: | From the first dose date to 30 days after the last dose date |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- Unresectable
- metastatic
- second-line
- squamous
- esophagus
- chemotherapy
- paclitaxel
- docetaxel
- irinotecan
Last Updated
March 5, 2021