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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Iza-bren
  • Cisplatin
  • Gemcitabine
  • Carboplatin

Treatment groups

470 Participants
are divided into 5 treatment groups

Sponsors and collaborators