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
China420 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 range18 Years – 75 Years
SexALL
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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.
✓. Adequate organ function before randomization:
Exclusion criteria
✕. 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
✕
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