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

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
Clinical.Trials@bms.com