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.
Terminated
Sponsor no longer pursuing trilaciclib for the indication.
This PHASE2 trial investigates Bladder Cancer and Chemotherapy-induced Neutropenia and is currently terminated or withdrawn. G1 Therapeutics, Inc. leads this study, which shows 20 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
20 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE2
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Oct 2025 — Present [monthly]
Terminated PHASE2
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Sep 2025 — Oct 2025 [monthly]
Terminated PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
▶ Show 15 earlier versions
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Apr 2024 — Jul 2024 [monthly]
Terminated PHASE2
Status: Active Not Recruiting → Terminated
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Oct 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
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Feb 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
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Nov 2022 — Feb 2023 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Jul 2022 — Nov 2022 [monthly]
Recruiting PHASE2
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May 2022 — Jul 2022 [monthly]
Recruiting PHASE2
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Apr 2022 — May 2022 [monthly]
Recruiting PHASE2
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Mar 2022 — Apr 2022 [monthly]
Recruiting PHASE2
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Feb 2022 — Mar 2022 [monthly]
Recruiting PHASE2
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Jan 2022 — Feb 2022 [monthly]
Recruiting PHASE2
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Dec 2021 — Jan 2022 [monthly]
Recruiting PHASE2
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Nov 2021 — Dec 2021 [monthly]
Recruiting PHASE2
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Oct 2021 — Nov 2021 [monthly]
Recruiting PHASE2
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Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Jun 2021 — Sep 2021 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- G1 Therapeutics, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .