Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05911295 | Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | PHASE3 | ACTIVE NOT_RECRUITING | 412 | — | — | Sep 22, 2023 | Apr 30, 2029 | Apr 20, 2026 | 279 | United States, Argentina +22 |
| NCT04879329 | A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 | PHASE2 | RECRUITING | 372 | — | — | May 3, 2022 | Apr 14, 2029 | Apr 21, 2026 | 223 | United States, Argentina +10 |
The time from randomization to first documentation of disease progression per RECIST v1.1 by BICR, or to death due to any cause.
The time from date of randomization to date of death due to any cause.
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
To be summarized using descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Disitamab vedotin arm | EXPERIMENTAL | disitamab vedotin + pembrolizumab |
| Standard of care arm | ACTIVE_COMPARATOR | gemcitabine + cisplatin OR carboplatin |
| Cohort A - DV monotherapy for HER2-positive tumor types | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort B - DV monotherapy for HER2-low tumor types | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort C - Non-randomized combination therapy | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort C - Randomized combination therapy | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort C - Randomized monotherapy | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort D - DV monotherapy (Japan only) | EXPERIMENTAL | Disitamab vedotin monotherapy |
| Cohort E - DV combination therapy (Japan only) | EXPERIMENTAL | Disitamab vedotin + pembrolizumab |
| Cohort G - DV monotherapy | EXPERIMENTAL | Disitamab vedotin |
| Name | Type | Description |
|---|---|---|
| disitamab vedotin | DRUG | Given into the vein (IV; intravenous) every 2 weeks |
| pembrolizumab | DRUG | 400mg given by IV every 6 weeks |
| gemcitabine | DRUG | 1000 mg/m\^2 given by IV on days 1 and 8 of every 3-week cycle |
| cisplatin | DRUG | 70 mg\^2 given by IV on day 1 of every 3-week cycle |
| carboplatin | DRUG | Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of every 3-week cycle |
Inclusion Criteria: * Histopathological confirmation of locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra. * Measurable disease by investigator assessment per RECIST v1.1. * Participant must not ha...