S1937: A Phase III Randomized Trial of Eribulin with or Without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

About this Study

Study compares the usual chemotherapy treatment to eribulin alone to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread to other places in the body (metastatic).

Sponsor Protocol ID:S1937
IRB Number:2021-0584
Actively Enrolling
Phase 3
July 12, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Histologically or cytologically proven urothelial carcinoma in a metastatic site
  • Evidence of metastatic urothelial carcinoma based on CT or MRI within 28 day prior to registration
  • Must have had progression of disease following prior therapy
  • Must have received any planned surgery prior to registration
  • Must be on effective anti-retroviral therapy and undetectable viral load at most recent viral load test and within 6 months prior to registration, if they are known to have HIV infection
  • Must have undetectable hepatitis B viral load within 28 days prior to registration if patient has known chronic hepatitis B virus infection

Exclusion Criteria
  • Must not require immediate central nervous system (CNS) specific treatment if they have active brain metastases or leptomeningeal disease
  • Must not have progressed within 3 months following last dose of gemcitabine, if previously received gemcitabine
  • Must not have unresolved toxicities from prior surgeries or radiation therapy at the time of registration
  • Pregnant or breast-feeding

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Henegan, John C, M.D.
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