Brief Title
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
Official Title
A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed
to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin +
gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately
420 participants with locally advanced or metastatic urothelial carcinoma who have not
received prior systemic therapy.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Overall survival (OS) in the Intent to Treat (ITT) set
Secondary Outcome
Overall response rate (ORR) per RECIST v1.1 in ITT
Condition
Urothelial Carcinoma
Intervention
Tislelizumab
Study Arms / Comparison Groups
Tislelizumab in combination with chemotherapy
Description: Tislelizumab: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
420
Start Date
May 29, 2019
Completion Date
January 2024
Primary Completion Date
January 2024
Eligibility Criteria
Key Inclusion Criteria:
1. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form
(ICF)
2. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial
cancer (UC)
3. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
4. Have had no prior systemic chemotherapy for locally advanced or metastatic UC
5. Must be able to provide fresh or archival tumor tissues with an associated
pathological report.
6. Must have evaluable disease (either measurable or non-measurable) as defined per
RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
8. Adequate organ function before randomization:
Key Exclusion Criteria:
1. Received prior therapies targeting PD-1, PD-L1, PD-L2, CTLA4, or any other antibody or
drug specifically targeting T-cell co-stimulation or checkpoint pathways.
2. Any approved anticancer therapy within 28 days before randomization.
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
4. Participants with uncontrolled hypercalcemia
5. Participants with active autoimmune diseases or history of autoimmune diseases that
may relapse
6. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled
diseases
7. A known history of HIV infection.
8. Prior allogeneic stem cell transplantation or organ transplantation.
9. History of severe hypersensitivity reactions to other monoclonal antibodies.
10．History of allergic reactions to cisplatin, carboplatin, or other
platinum-containing compounds.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Dingwei Ye, MD, +1-877-828-5568, clinic[email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03967977
Organization ID
BGB-A317-310
Secondary IDs
CTR20190543
Responsible Party
Sponsor
Study Sponsor
BeiGene
Study Sponsor
Dingwei Ye, MD, Principal Investigator, Fudan University
Verification Date
December 2022