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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07106762
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iza-bren — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days

Study Details

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

Key Dates

Start date
Sep 30, 2025
Status verified
Jun 2026
Primary completion
Jan 26, 2029
Completion
Nov 18, 2033

Study Design

Enrollment
470 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Experimental: Arm B
  • Active Comparator: Arm C
  • Experimental: Arm D
  • Active Comparator: Arm E

Primary Outcome Measure

Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 [ Time Frame: Approximately 3 months ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (35)

FacilityCityStateZIPSite coordinators
Local Institution - 0167GilbertArizona85234
Site 0167
Local Institution - 0162FullertonCalifornia92835
Site 0162
Palo Alto Center-Palo Alto Medical Foundation Research InstitutePalo AltoCalifornia94304
Nitin Rohatgi, Site 0252
000-000-0000
Sutter Health - Sutter Institute for Medical ResearchSacramentoCalifornia95816
Nitin Rohatgi, Site 0163
000-000-0000
University of California Davis (UC Davis) Comprehensive Cancer CenterSacramentoCalifornia95817
Mamta Parikh, Site 0139
916-734-3772
Pacific Hematology Oncology AssociatesSan FranciscoCalifornia94115
Nitin Rohatgi, Site 0251
000-000-0000
Sutter Santa RosaSanta RosaCalifornia95403
Nitin Rohatgi, Site 0254
000-000-0000
Rocky Mountain Cancer Centers, LLPDenverColorado80218
Manojkumar Bupathi, Site 0185
303-418-7639
Local Institution - 0245DillonColorado80435-
Shaw Cancer CenterEdwardsColorado81632
Erin Schwab, Site 0191
970-569-7608
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Jean Hoffman-Censits, Site 0250
267-760-5194
Local Institution - 0247MiamiFlorida33176
Site 0247
University of Kentucky Chandler Medical CenterLexingtonKentucky40536
Zin Myint, Site 0193
859-323-2964
Johns Hopkins HospitalBaltimoreMaryland21287
Jean Hoffman-Censits, Site 0232
267-760-5194
Local Institution - 0195BostonMassachusetts02215
Site 0195
Karmanos Cancer InstituteDetroitMichigan48201
Yusra Shao, Site 0168
000-000-0000
Local Institution - 0248BuffaloNew York14203-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Matthew Galsky, Site 0086
212-824-8583
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Jonathan Rosenberg, Site 0088
646-422-4461
Cleveland ClinicClevelandOhio44195
Shilpa Gupta, Site 0192
216-296-5457
Fairview HospitalClevelandOhio44111
Shilpa Gupta, Site 0256
216-296-5457
The James Outpatient Care West CampusColumbusOhio43221
Lingbin Meng, Site 0161
502-424-8792
Cleveland Clinic - Hillcrest HospitalMayfield HeightsOhio44124
Shilpa Gupta, Site 0257
216-296-5457
Local Institution - 0141PortlandOregon97239
Site 0141
Local Institution - 0084NashvilleTennessee37232
Site 0084
SCRI Oncology PartnersNashvilleTennessee37203
Benjamin Garmezy, Site 0186
713-444-7804
Texas Oncology - West TexasAbileneTexas79606
Srikar Malireddy, Site 0249
940-691-8271
Local Institution - 0187AustinTexas78705
Site 0187
Intermountain Medical CenterMurrayUtah84107
David Gill, Site 0111
913-568-7449
St George Regional Hospital Cancer CenterSt. GeorgeUtah84790
David Gill, Site 0253
913-568-7449
University of Virginia Health SystemCharlottesvilleVirginia22903
Paul Viscuse, Site 0158
434-924-9333
Local Institution - 0188NorfolkVirginia23502
Site 0188
Local Institution - 0200SeattleWashington98101
Site 0200
Local Institution - 0255SeattleWashington98109
Site 0255
Local Institution - 0259SeattleWashington98195
Site 0259

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