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

Launched by BEIGENE · May 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for urothelial carcinoma, which is a type of cancer that affects the bladder and urinary system. The researchers want to find out if combining a medication called tislelizumab with chemotherapy (using either cisplatin or carboplatin along with gemcitabine) is more effective than chemotherapy alone. The trial will include about 420 participants who have not received any previous treatment for their advanced cancer.

To be eligible for this study, participants must be between 18 and 75 years old, have a confirmed diagnosis of locally advanced or metastatic urothelial carcinoma, and be suitable candidates for cisplatin or carboplatin chemotherapy. They should not have had any prior systemic chemotherapy for this type of cancer and must be able to provide tumor samples for testing. Throughout the trial, participants will receive either the combination treatment or a placebo (a substance with no active treatment) alongside chemotherapy. This trial is currently recruiting participants, and it aims to gather important information about the safety and effectiveness of this new treatment approach.

Gender

ALL

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.