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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07412171 | NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC | PHASE2 | NOT YET_RECRUITING | 40 | — | — | Feb 1, 2026 | Dec 1, 2028 | Feb 17, 2026 | 1 | China |
Pathologic complete response (pCR) is defined as the absence of residual viable urothelial carcinoma in the resected primary tumor and sampled lymph nodes (e.g., ypT0N0) based on final surgical pathology following radical nephroureterectomy with or without lymph node dissection.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Toripalimab + 9MW2821 | EXPERIMENTAL | Participants receive neoadjuvant toripalimab plus 9MW2821 followed by radical nephroureterectomy with or without lymph node dissection. |
| Upfront Surgery (SOC) | ACTIVE_COMPARATOR | Participants undergo upfront radical nephroureterectomy with or without lymph node dissection according to standard of care. |
| Name | Type | Description |
|---|---|---|
| Toripalimab | DRUG | Toripalimab is administered intravenously at a dose of 240 mg every 3 weeks for 3 cycles as neoadjuvant therapy prior to surgery. |
| 9MW2821 | DRUG | 9MW2821 is administered intravenously at a dose of 1.25 mg/kg on Day 1 and Day 8 every 3 weeks for 3 cycles as neoadjuvant therapy. |
| Radical Nephroureterectomy with or without Lymph Node Dissection | PROCEDURE | Participants undergo radical nephroureterectomy with or without lymph node dissection according to institutional standard of care. |
Inclusion Criteria: * Adults aged 18 to 80 years, male or female. * Histologically confirmed upper tract urothelial carcinoma (UTUC) involving the renal pelvis and/or ureter, with predominant (≥50%) urothelial histology. * Treatment-naïve, non-metastatic disease (M0) with clinical stage T1-T3, as d...