ClinicaliQ Trial Snapshot
- A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 — Recruiting • Phase II • Oncology • NCT04879329.
- What is being tested: Disitamab vedotin (a HER2-targeted antibody-drug conjugate) as monotherapy or in combination with pembrolizumab (PD-L1 inhibitor) for HER2-expressing urothelial cancer, evaluating both efficacy and safety profiles.
- Patient eligibility overview: Participants must have histologically confirmed urothelial cancer with documented HER2 expression; specific disease stage and prior treatment history criteria apply (detailed in full protocol).
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the…
Eligibility Snapshot
- : Cohorts A and B * Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra * Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy * At least one measurable lesion by investigator assessment based on RECIST version 1.1. * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Cohort C * Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra * No prior systemic therapy for LA/mUC * Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy * At least one measurable lesion by investigator assessment based on RECIST v1.1. * Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation * HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample * ECOG performance status of 0, 1, or 2…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.