OncoMatch/Clinical Trials/NCT06592326
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
Is NCT06592326 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including 9MW2821 and Toripalimab for urothelial carcinoma.
Treatment: 9MW2821 · Toripalimab · Gemcitabine · Cisplatin/Carboplatin — This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or CTLA-4 inhibitor
Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors
Cannot have received: antibody-drug conjugate
Exception: ADCs which target Nectin-4 or are conjugated with payload MMAE
Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE
Cannot have received: radiation therapy
Exception: within 21 days
Radiotherapy or Intravesical therapy treated within 21 days
Cannot have received: major surgery
Exception: within 28 days
Major surgery treated within 28 days
Cannot have received: live vaccine
Exception: within 28 days
Any live vaccines got within 28 days
Cannot have received: traditional Chinese medicine
Exception: within 14 days
Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ functions.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06592326 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