Terminated PHASE2 INTERVENTIONAL 2-arm NCT04887831

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.

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

Interventions Avelumab Carboplatin Cisplatin Gemcitabine Trilaciclib

Updated 19 times since 2021 Last updated: Aug 26, 2025 Started: Jun 4, 2021 Primary completion: Apr 7, 2023 Completion: Mar 1, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor no longer pursuing trilaciclib for the indication.

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This PHASE2 trial investigates Bladder Cancer and Chemotherapy-induced Neutropenia and is currently terminated or withdrawn. G1 Therapeutics, Inc. leads this study, which shows 19 recorded versions since 2021 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

19 versions recorded

Oct 2025 — Present [monthly]

Terminated PHASE2
Sep 2025 — Oct 2025 [monthly]

Terminated PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE2
Apr 2024 — Jul 2024 [monthly]

Terminated PHASE2

Status: Active Not Recruiting → Terminated

▶ Show 14 earlier versions

Oct 2023 — Apr 2024 [monthly]

Active Not Recruiting PHASE2
Feb 2023 — Oct 2023 [monthly]

Active Not Recruiting PHASE2
Nov 2022 — Feb 2023 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting
Jul 2022 — Nov 2022 [monthly]

Recruiting PHASE2
May 2022 — Jul 2022 [monthly]

Recruiting PHASE2
Apr 2022 — May 2022 [monthly]

Recruiting PHASE2
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE2
Feb 2022 — Mar 2022 [monthly]

Recruiting PHASE2
Jan 2022 — Feb 2022 [monthly]

Recruiting PHASE2
Dec 2021 — Jan 2022 [monthly]

Recruiting PHASE2
Nov 2021 — Dec 2021 [monthly]

Recruiting PHASE2
Oct 2021 — Nov 2021 [monthly]

Recruiting PHASE2
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Jun 2021 — Sep 2021 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

G1 Therapeutics, Inc.

Data source: G1 Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Badalona, Spain , Baltimore, United States , Barcelona, Spain , Batumi, Georgia , Bordeaux, France , Budapest, Hungary , Chapel Hill, United States , Coeur d'Alene, United States , Fort Myers, United States and 19 more locations