PhIIIRandTriaEribulinW/GemcitabineVsStandCarTxMetaUrothelialCaRefracOrIneligAntiPD1/PDL1Therp

Cancer
Nataliya Mar
A Phase III Randomized Trial of Eribulin with Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy
Urinary Bladder

Study Description

This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.

Eligibility

Inclusion Criteria:

  • Participant must have evidence of metastatic urothelial carcinoma based on CT or MRI within 28 days prior to registration
  • Participant must have had progression of disease following prior therapy at the discretion of the treating investigator
  • Participant must have completed any planned surgery or radiation therapy prior to registration
  • Participant must be on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration if they are known to have human immunodeficiency virus (HIV)-infection
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