Recruiting
Phase 2
Phase 3

Izalontamab vs. Platinum-based Chemotherapy

Sponsor:

Bristol-Myers Squibb

Code:

NCT07106762

Conditions

Urothelial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iza-bren

Cisplatin

Gemcitabine

Carboplatin

Study Details

Brief summary:

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

Conditions

Urothelial Cancer

Study ID

NCT07106762

Start date

Sep 30, 2025

Status verified date

Jul, 2026

Completion date

Nov 18, 2033

Anticipated

Primary completion date

Jan 26, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

470 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

experimental: Arm B

active comparator: Arm C

experimental: Arm D

active comparator: Arm E

Interventions

Iza-bren

Specified dose on specified days

Cisplatin

Specified dose on specified days

Gemcitabine

Specified dose on specified days

Carboplatin

Specified dose on specified days

Primary outcome measure

  • Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 [ Time Frame: Approximately 3 months ]
  • Phase 3: Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]
  • Phase 3: Overall Survival (OS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Palo Alto Center-Palo Alto Medical Foundation Research Institute

Recruiting

Palo Alto, California, United States, 94304

Contacts

Nitin Rohatgi, Site 0252

000-000-0000

Sutter Health - Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

Contacts

Nitin Rohatgi, Site 0163

000-000-0000

University of California Davis (UC Davis) Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Mamta Parikh, Site 0139

916-734-3772

Pacific Hematology Oncology Associates

Recruiting

San Francisco, California, United States, 94115

Contacts

Nitin Rohatgi, Site 0251

000-000-0000

Sutter Santa Rosa

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Nitin Rohatgi, Site 0254

000-000-0000

Rocky Mountain Cancer Centers, LLP

Recruiting

Denver, Colorado, United States, 80218

Contacts

Manojkumar Bupathi, Site 0185

303-418-7639

Shaw Cancer Center

Recruiting

Edwards, Colorado, United States, 81632

Contacts

Erin Schwab, Site 0191

970-569-7608

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Jean Hoffman-Censits, Site 0250

267-760-5194

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

Rohan Garje, Site 0247

786-596-2000

University of Kentucky Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Zin Myint, Site 0193

859-323-2964

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jean Hoffman-Censits, Site 0232

267-760-5194

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Yusra Shao, Site 0168

000-000-0000

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Matthew Galsky, Site 0086

212-824-8583

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jonathan Rosenberg, Site 0088

646-422-4461

Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Shilpa Gupta, Site 0256

216-296-5457

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Shilpa Gupta, Site 0192

216-296-5457

The James Outpatient Care West Campus

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Lingbin Meng, Site 0161

502-424-8792

Cleveland Clinic - Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

Contacts

Shilpa Gupta, Site 0257

216-296-5457

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Benjamin Garmezy, Site 0186

713-444-7804

Texas Oncology - West Texas

Recruiting

Abilene, Texas, United States, 79606

Contacts

Srikar Malireddy, Site 0249

940-691-8271

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

David Gill, Site 0111

913-568-7449

St George Regional Hospital Cancer Center

Recruiting

St. George, Utah, United States, 84790

Contacts

David Gill, Site 0253

913-568-7449

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Paul Viscuse, Site 0158

434-924-9333

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Rosa Nadal, Site 0255

206-606-1406

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Rosa Nadal Rios, Site 0259

000-000-0000

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Christina Canil, Site 0021

613737770070185

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Srikala Sridhar, Site 0016

416-946-4501ext.2662

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Ramy Saleh, Site 0017

5149341934

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Bladder cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-07-29.