drugset / Trial / NCT04887831
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in participants receiving first-line treatment for advanced/metastatic urothelial carcinoma.
Timeline
- Start
- 2021-06-04
- Primary completion
- 2023-04-07
- Completion
- 2024-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trilaciclib | Unknown | 240 mg/m2 | Intravenous |
| Background | Avelumab | Monoclonal antibody | 800 mg | Intravenous |
| Background | Carboplatin | Small molecule | 4.5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |