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

  • STATUS
    Recruiting
  • End date
    May 9, 2024
  • participants needed
    90
  • sponsor
    G1 Therapeutics, Inc.
Updated on 9 September 2021
cancer
carboplatin
avelumab
gemcitabine
metastatic bladder cancer
bladder cancer
bladder tumor
platinum-based chemotherapy

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 patients receiving first-line treatment for advanced/metastatic bladder cancer.

Description

Patients 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.

Patients enrolled in the study will be eligible to receive 4-6 cycles of platinum-based chemotherapy, and patients 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) 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.

Patients will be followed for survival approximately every 3 months after receiving the last dose of study medication.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Transitional cell carcinoma, Chemotherapy-induced Neutropenia, Metastatic Bladder Cancer, Chemotherapy Induced Neutropenia, Myelosuppression Adult, Bladder Carcinoma, Metastatic Bladder Carcinoma, Urothelial Carcinoma, carcinoma of the bladder, bladder tumor
Treatment cisplatin, carboplatin, Gemcitabine, Avelumab, Trilaciclib
Clinical Study IdentifierNCT04887831
SponsorG1 Therapeutics, Inc.
Last Modified on9 September 2021

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