Urothelial Cancer
Conditions
Keywords
Bladder cancer
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
Interventions
DRUGIza-bren
Specified dose on specified days
DRUGCisplatin
Specified dose on specified days
DRUGGemcitabine
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507 | Approximately 3 months | — |
| Phase 3: Progression-Free Survival (PFS) | Up to 5 years | Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) |
| Phase 3: Overall Survival (OS) | Up to 5 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Objective Response (OR) | Up to 5 years | Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator |
| Phase 2: PFS | Up to 5 years | Assessed using RECIST v1.1 by investigator |
| Phase 2: Duration of Response (DOR) | Up to 5 years | Assessed using RECIST v1.1 by investigator |
| Phase 2: Time to Response (TTR) | Up to 5 years | Assessed using RECIST v1.1 by investigator |
| Phase 2: OS | Up to 5 years | — |
| Phase 2: Iza-bren antibody-drug conjugate (ADC) concentration | Up to 5 years | — |
| Phase 2: Iza-bren total antibody concentration | Up to 5 years | — |
| Phase 2: Iza-bren Ed-04 payload concentration | Up to 5 years | — |
| Phase 2: Iza-bren observed concentration at end of infusion (Ceoi) | Up to 5 years | — |
| Phase 2: Iza-bren trough observed concentration (Ctrough) | Up to 5 years | — |
| Phase 3: OR | Up to 5 years | As per RECIST v1.1 by BICR |
| Phase 3: DoR | Up to 5 years | As per RECIST v1.1 by BICR |
| Phase 3: TTR | Up to 5 years | As per RECIST v1.1 by BICR |
| Phase 3: Time until definitive deterioration in the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QoL) scale | Up to 5 years | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed