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

RecruitingPhase 2/3

IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2/3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 470 · Started: Sep 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07106762

Locations in the U.S.

ArizonaLocal Institution - 0167, Gilbert (Not yet recruiting)
CaliforniaLocal Institution - 0162, Fullerton (Not yet recruiting)
Palo Alto Center-Palo Alto Medical Foundation Research Institute, Palo Alto
Sutter Health - Sutter Institute for Medical Research, Sacramento
University of California Davis (UC Davis) Comprehensive Cancer Center, Sacramento
Pacific Hematology Oncology Associates, San Francisco
Sutter Santa Rosa, Santa Rosa
ColoradoRocky Mountain Cancer Centers, LLP, Denver
Shaw Cancer Center, Edwards
District of ColumbiaSibley Memorial Hospital, Washington D.C.
FloridaMiami Cancer Institute at Baptist Health, Inc., Miami
KentuckyUniversity of Kentucky Chandler Medical Center, Lexington
MarylandJohns Hopkins Hospital, Baltimore
MassachusettsLocal Institution - 0195, Boston (Not yet recruiting)
MichiganKarmanos Cancer Institute, Detroit
New YorkIcahn School of Medicine at Mount Sinai, New York
Memorial Sloan Kettering Cancer Center, New York
OhioCleveland Clinic, Cleveland
Fairview Hospital, Cleveland
The James Outpatient Care West Campus, Columbus
Cleveland Clinic - Hillcrest Hospital, Mayfield Heights
OregonLocal Institution - 0141, Portland (Not yet recruiting)
TennesseeLocal Institution - 0084, Nashville (Not yet recruiting)
SCRI Oncology Partners, Nashville
TexasTexas Oncology - West Texas, Abilene
Local Institution - 0187, Austin (Not yet recruiting)
UtahIntermountain Medical Center, Murray
St George Regional Hospital Cancer Center, St. George
VirginiaUniversity of Virginia Health System, Charlottesville
Local Institution - 0188, Norfolk (Not yet recruiting)
WashingtonFred Hutchinson Cancer Center, Seattle
Local Institution - 0200, Seattle (Not yet recruiting)
University of Washington Medical Center - Montlake, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.