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

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

  • Urothelial Cancer

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