At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Iza-bren (drug), Cisplatin (drug), Gemcitabine (drug), Carboplatin (drug)
- How long the study runs
- Study runs about 98 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a phase 2/3 study for people with urothelial cancer (a cancer of the bladder and urinary system) that has spread or cannot be removed, and that got worse during or after treatment with immunotherapy (Anti-PD-(L)1) drugs. It compares a study drug called izalontamab brengitecan against platinum-based chemotherapy. The sponsor is Bristol-Myers Squibb.
Who can take part
- Confirmed advanced urothelial cancer shown by tissue testing
- Able to receive platinum-based chemotherapy
- Already had Anti-PD-(L)1 immunotherapy treatment for advanced or spread cancer, either combined with or after another systemic therapy
- If immunotherapy was only given around surgery, the cancer came back within 12 months of the last dose
- At least one tumour that can be measured on scans (RECIST v1.1)
- Good daily functioning (Eastern Cooperative Oncology Group performance status 0–1)
Who may not be able to
- Platinum-based chemotherapy within the past 12 months
- More than 2 previous treatment regimens
- Previous treatment with an antibody-drug conjugate targeting EGFR or HER3
- Previous treatment with a topoisomerase 1 inhibitor
- Active, untreated cancer spread to the brain
- Other criteria in the study plan may also apply
What taking part involves
- • Receiving either the study drug izalontamab brengitecan or platinum-based chemotherapy
Time commitment: Number of visits, how long the study lasts, and what taking part involves: Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 470
- Started
- 2025-09-30
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for urothelial cancer
- • Phase2/Phase3 - 470 participants
- • A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with urothelial cancer
Where?
- • Glasgow - Local Institution - 0243
- • London - St Bartholomew's Hospital
- • London - Royal Marsden Hospital (Sutton)
- • Sheffield - Local Institution - 0230
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ histologically confirmed advanced urothelial carcinoma
- ✓ relapsed within 12 months of the last dose of the treatment
- ✓ ≥ 1 measurable lesion per RECIST v1
- ✓ Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Treatments you must NOT have had:
- ✗ \>2
What the study is looking for
- ✓Participants must have confirmed by a biopsy advanced urothelial carcinoma.
- ✓Participants must be eligible to receive platinum-based drug treatment.
- ✓Participants must be Anti-PD-(L)1-experienced (in that has grown locally or that has spread setting), either in combination...
- ✓Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the...
- ✓Participants must have ≥ 1 measurable lesion per (standard scan measurements).
Who cannot take part
- ✗Participants must not have platinum-based drug treatment 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.
See the full criteria
Where Is This Study? (4 UK sites)
Local Institution - 0243
Glasgow G12 0YN, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Local Institution - 0230
Sheffield S10 2SJ, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT