Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

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.

Eligibility

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.

Conditions2

Interventions4

Related trials

• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors — Mabwell (Shanghai) Bioscience Co., Ltd.
• A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer — Shanghai Jiao Tong University School of Medicine
• A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma — Renmin Hospital of Wuhan University
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

Browse More Trials