Combining Tislelizumab with Chemotherapy for Urothelial Carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial evaluates the effectiveness and safety of tislelizumab in combination with chemotherapy agents (cisplatin or carboplatin plus gemcitabine) compared to a placebo with the same chemotherapy regimen. The study involves approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not previously received systemic therapy. It is designed as a multicenter, randomized, double-blind, placebo-controlled trial to ensure robust results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University First Hospital
  Beijing, Beijing, China Recruiting
• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing, China Recruiting
• Fifth Medical Center of Pla General Hospital
  Beijing, Beijing, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing, China Recruiting
• Chongqing Cancer Hospital
  Chongqing, Chongqing, China Recruiting
• Southwest Hospital
  Chongqing, Chongqing, China Recruiting

Study contacts

• Principal investigator: Dingwei Ye, MD — Fudan University
• Study coordinator: BeiGene
• Email: clinicaltrials@beigene.com
• Phone: +1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.