Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Partici… (NCT03967977) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
China, Taiwan420 participantsStarted 2019-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female aged 18 to 75 years on the day of signing the Informed Consent Form (ICF)
. Histologically confirmed, inoperable, locally advanced, or metastatic urothelial cancer (UC)
. Must be eligible to receive cisplatin or carboplatin in the investigator's judgment
. Have had no prior systemic chemotherapy for locally advanced or metastatic UC
. Must be able to provide fresh or archival tumor tissues with an associated pathological report.
. Must have evaluable disease (either measurable or non-measurable) as defined per RECIST v1.1.
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival (OS) in the Intent to Treat (ITT) set
Timeframe: From first randomization up to 3.5 years, approximately
. 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.
. Any approved anticancer therapy within 28 days before randomization.
. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
. Participants with uncontrolled hypercalcemia
. Participants with active autoimmune diseases or history of autoimmune diseases that may relapse
. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled diseases
. A known history of HIV infection.
. Prior allogeneic stem cell transplantation or organ transplantation.