Phase 2 Bladder Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
All groups generally require:
- Having a confirmed diagnosis of advanced or spreading cancer of the urinary tract (such as the bladder, kidneys, ureters, or urethra) that cannot be removed by surgery
- Having at least one area of cancer that can be measured on a scan
- Being well enough to carry out daily activities, measured on a standard fitness scale (confirm with trial site for your specific group)
- Having a tumor sample tested by the trial's central lab showing a certain level of a protein called HER2 (required for most groups — confirm with trial site)
Depending on which group you are assigned to:
- Having received only 1 or 2 prior cancer treatments, including at least one platinum-based chemotherapy (Groups A, B)
- Having received no prior treatment for advanced/spreading urinary tract cancer, or having had early-stage treatment that finished more than 12 months ago (Groups C, E)
- Having received specific prior treatments including platinum chemotherapy, an immune checkpoint therapy, and a drug called enfortumab vedotin — this group is for patients treated in Japan (Group D)
- Having received 1 or 2 prior treatments including enfortumab vedotin (alone or combined with pembrolizumab), with the last dose given at least 90 days before starting this trial (Group G)
- Being considered suitable by your doctor to receive platinum-based chemotherapy (Groups C, E)
Who may not be able to join:
- Having a known allergy to the study drugs (disitamab vedotin, and/or pembrolizumab depending on the group)
- Having received any cancer treatment within 2 weeks before starting the trial
- Still experiencing side effects from previous cancer treatment that have not reduced to a mild or resolved level (except for certain hair loss)
- Having previously been treated with HER2-targeted therapies (all groups) or certain chemotherapy-linked drugs called MMAE-based antibody-drug combinations, such as enfortumab vedotin (Groups A, B, C, E)
- Having had major surgery within the past 4 weeks that you have not fully recovered from
- Having nerve damage affecting feeling or movement in your hands or feet at a moderate or severe level before starting the trial (confirm with trial site for your specific group, as the threshold differs)
- Having a history of severe (Grade 3 or higher) non-blood-related side effects from previous cancer treatment (Groups D, E)
- Having an immune system disorder, or currently taking high-dose steroids or other immune-suppressing medications (Groups C, E)
- Having previously received certain immune system-targeting treatments, such as CAR-T cell therapy or CTLA-4 inhibitors (Group C)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Phone: 1-800-718-1021
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G); Incidence of adverse events (AEs) (Cohorts D and E); Incidence of dose alterations (Cohorts D and E); Incidence of laboratory abnormalities (Cohorts D and E); Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E); Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E); Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E); PK parameter - Max...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.