Combining 9MW2821 with toripalimab around surgery for urothelial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, multicenter Phase II trial administering 9MW2821 plus toripalimab to perioperative patients with non-metastatic urothelial carcinoma. Enrollees are placed into arms that include muscle-invasive bladder cancer and high-risk upper tract disease and receive the combination therapy around the time of definitive surgery. Key eligibility includes ECOG 0–1, adequate organ function, available tumor tissue, and no prior systemic therapy for urothelial cancer. The study, led at Sun Yat-sen University Cancer Center, monitors safety and anti-tumor activity such as pathologic response and recurrence outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Sign the informed consent form approved by IEC.
* Male or female subjects aged ≥18 years old.
* ECOG status: 0 or 1.
* Histologically confirmed urothelial cancer.
* Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.
* Adequate tumor tissues submitted for test.
* Life expectancy for more than 12 weeks.
* Adequate organ functions.
* Proper contraception methods.
* Willingness to follow the study procedures.

Exclusion Criteria:

* Prior systemic anti-tumor therapy for urothelial cancer.
* Previously treated with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
* History of another malignancy within 3 years.
* History of autoimmune disease requiring systemic treatment within 2 years.
* History of clinically significant cardiac/cerebrovascular diseases or thrombosis within 1 year.
* Major surgery treated within 28 days; Cystoscopy/ureteroscopy biopsy or intravesical instillation therapy within 7 days.
* Peripheral neuropathy Grade ≥ 2.
* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
* Active HBV/HCV/HIV infection, etc.
* Any other serious chronic or uncontrolled disease.
* Any live vaccines got within 28 days.
* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
* Any potent CYP3A4 inducers/inhibitors taken within 14 days.
* Known allergic sensitivity to any of the ingredients of the study drug.
* History of drug abuse or mental illness.
* Other conditions unsuitable into the study.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhuowei Liu, Professor
• Email: liuzhw@sysucc.org.cn
• Phone: 86-20-87343606

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combination of 9MW2821 and Toripalimab for advanced bladder cancer

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• Combination treatment for advanced urothelial carcinoma

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  Recruiting at 2 sites Phase 3 RemeGen Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT05302284

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

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• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.