Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy

Official Title

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Keywords

Urothelial Cancer, Bladder cancer, Urinary Bladder Neoplasms, Cisplatin, Gemcitabine, Carboplatin, Iza-bren

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants must have histologically confirmed advanced urothelial carcinoma.
  • Participants must be eligible to receive platinum-based chemotherapy.
  • Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.
  • Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.
  • Participants must have ≥ 1 measurable lesion per RECIST v1.1.
  • Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

You CAN'T join if...

  • Participants must not have platinum-based chemotherapy exposure within 12 months.
  • Participants must not have received >2 prior regimens irrespective of the setting.
  • Participants must not have prior ADC therapy targeting EGFR or HER3.
  • Participants must not have prior therapy with topoisomerase 1 inhibitor.
  • Participants must not have active, untreated brain metastases.
  • Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • University of California Davis (UC Davis) Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Local Institution - 0251 not yet accepting patients
    San Francisco California 94115 United States
  • Local Institution - 0163 not yet accepting patients
    Sacramento California 95816 United States
  • Local Institution - 0162 not yet accepting patients
    Fullerton California 92835 United States
  • Local Institution - 0252 not yet accepting patients
    Palo Alto California 94304 United States
  • Intermountain Medical Center accepting new patients
    Murray Utah 84107 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07106762
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 470 study participants
Last Updated