NCT04887831

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: G1 Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomly assigned (1:1) to receive standard of care platinum-based chemotherapy (with or without the addition of trilaciclib) administered intravenously (IV) in 21-day cycles followed by standard of care avelumab maintenance therapy (with or without the addition of trilaciclib) administered IV in 14-day cycles. Participants enrolled in the study will be eligible to receive 4-6 cycles of platinum-based chemotherapy, and participants without progressive disease (PD) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) after platinum-based chemotherapy will be eligible to receive avelumab maintenance therapy until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever comes first. Participants will be followed for survival approximately every 3 months after receiving the last dose of study medication.

Conditions

• Urothelial Carcinoma
• Bladder Cancer
• Myelosuppression Adult
• Chemotherapy-induced Neutropenia
• Metastatic Bladder Cancer

Interventions

Type	Name	Description
DRUG	Trilaciclib	Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered.
DRUG	Gemcitabine	Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle
DRUG	Cisplatin	Cisplatin administered IV on Day 1 of each 21-day cycle
DRUG	Carboplatin	Carboplatin administered IV on Day 1 of each 21-day cycle
DRUG	Avelumab	Avelumab administered IV on Day 1 of each 14-day maintenance cycle

Timeline

• Start date: 2021-06-04
• Primary completion: 2023-04-07
• Completion: 2024-03-01
• First posted: 2021-05-14
• Last updated: 2025-09-08
• Results posted: 2025-08-17

Locations

34 sites across 5 countries: United States, France, Georgia, Hungary, Spain

Regulatory

• FDA-regulated drug study