drugset / Trial / NCT05014828
To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked. A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.
Timeline
- Start
- 2021-09-18
- Primary completion
- 2023-10-20
- Completion
- 2024-07-10
Publications
- Background BGB-A317-212: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors. Poster No: 2610 presented at ASCO, Chicago, IL, May 31-June 4, 2024
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 400 mg | Intravenous |