9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer (NCT07314723) | Clinical Trial Compass
RecruitingPhase 2
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer
China90 participantsStarted 2025-08-01
Plain-language summary
This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.