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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

Palo Alto Center-Palo Alto Medical Foundation Research Institute
Palo Alto, California 94304
Contact:
Nitin Rohatgi, Site 0252
000-000-0000

Sutter Health - Sutter Institute for Medical Research
Sacramento, California 95816
Contact:
Nitin Rohatgi, Site 0163
000-000-0000

University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Mamta Parikh, Site 0139
916-734-3772

Pacific Hematology Oncology Associates
San Francisco, California 94115
Contact:
Nitin Rohatgi, Site 0251
000-000-0000

Sutter Santa Rosa
Santa Rosa, California 95403
Contact:
Nitin Rohatgi, Site 0254
000-000-0000

Rocky Mountain Cancer Centers, LLP
Denver, Colorado 80218
Contact:
Manojkumar Bupathi, Site 0185
303-418-7639

Shaw Cancer Center
Edwards, Colorado 81632
Contact:
Erin Schwab, Site 0191
970-569-7608

Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Contact:
Jean Hoffman-Censits, Site 0250
267-760-5194

University of Kentucky Chandler Medical Center
Lexington, Kentucky 40536
Contact:
Zin Myint, Site 0193
859-323-2964

Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
Jean Hoffman-Censits, Site 0232
267-760-5194

Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Yusra Shao, Site 0168
000-000-0000

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

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Jonathan Rosenberg, Site 0088
646-422-4461

Fairview Hospital
Cleveland, Ohio 44111
Contact:
Shilpa Gupta, Site 0256
216-296-5457

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Shilpa Gupta, Site 0192
216-296-5457

The James Outpatient Care West Campus
Columbus, Ohio 43221
Contact:
Lingbin Meng, Site 0161
502-424-8792

Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124
Contact:
Shilpa Gupta, Site 0257
216-296-5457

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Benjamin Garmezy, Site 0186
713-444-7804

Texas Oncology - West Texas
Abilene, Texas 79606
Contact:
Srikar Malireddy, Site 0249
940-691-8271

Intermountain Medical Center
Murray, Utah 84107
Contact:
David Gill, Site 0111
913-568-7449

St George Regional Hospital Cancer Center
St. George, Utah 84790
Contact:
David Gill, Site 0253
913-568-7449

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

Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Rosa Nadal, Site 0255
206-606-1406

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.