OncoMatch/Clinical Trials/NCT07647289
EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC
Is NCT07647289 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including enfortumab vedotin (EV) and Toripalimab for muscle-invasive bladder cancer (mibc).
Treatment: enfortumab vedotin (EV) · Toripalimab · Gemcitabine (Chemotherapy) · Cisplatin
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy for urothelial carcinoma
Exception: intravesical instillation therapy permitted
Prior systemic anti-tumor therapy for urothelial carcinoma, including radiotherapy, chemotherapy, targeted therapy, or biological therapy (except for intravesical instillation therapy)
Cannot have received: PD-1/PD-L1 inhibitor
Prior treatment with PD-1/PD-L1 inhibitors
Cannot have received: antibody-drug conjugate
Prior treatment with ...antibody-drug conjugates (ADCs)
Cannot have received: allogeneic hematopoietic stem cell transplantation
Prior allogeneic hematopoietic stem cell transplantation
Cannot have received: solid organ transplantation
Prior ...solid organ transplantation
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤ 3 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF interval ≤ 480 ms
Adequate organ function, defined by the following laboratory values (obtained without blood transfusion within 14 days or growth factor support within 7 days prior to testing): Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF interval ≤ 480 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07647289 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages