Phase 2Terminated
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab (PRESERVE3)
A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)
- Sponsor
- G1 Therapeutics, Inc. (Industry)
- Enrollment
- 92 enrolled
- Conditions
- Urothelial Carcinoma; Bladder Cancer; Myelosuppression Adult; Chemotherapy-induced Neutropenia; Metastatic Bladder Cancer
- Interventions
- Trilaciclib; Gemcitabine; Cisplatin; Carboplatin; Avelumab
- Ages
- adults, older adults
- Registry
- NCT04887831, EUCTR2021-000205-24
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of Participants With Progression-Free Survival (PFS) During Overall Study
History
Last registry update
Results first posted
Study completion
Primary completion
Started
Registered