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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: Iza-bren
    Specified dose on specified days
    Other names:
    • BMS-986507
    • BL-B01D1
    • Izalontamab brengitecan
Experimental
Arm B
  • Drug: Iza-bren
    Specified dose on specified days
    Other names:
    • BMS-986507
    • BL-B01D1
    • Izalontamab brengitecan
Active Comparator
Arm C
  • Drug: Cisplatin
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
Experimental
Arm D
  • Drug: Iza-bren
    Specified dose on specified days
    Other names:
    • BMS-986507
    • BL-B01D1
    • Izalontamab brengitecan
Active Comparator
Arm E
  • Drug: Cisplatin
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days

Recruiting Locations

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Matthew Galsky, Site 0086
212-824-8583

University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Paul Viscuse, Site 0158
434-924-9333

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.