NCT06592326RecruitingPhase 3
9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer
A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 9 Sept 2024
- Start date
- 22 Aug 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT06592326
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 460
- From 22 Aug 2024 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers/inhibitors taken within 14 days.
- Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.
- Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.
- Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.
Other illness
- 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 6 months.
- Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
- Any other serious chronic or uncontrolled disease.
- Active HBV/HCV/HIV infection, etc.
- 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.
Other
- Peripheral neuropathy Grade ≥ 2.
- Uncontrolled central nervous system metastases or carcinomatous meningitis.
Who the study is looking for
- Sign the informed consent form approved by IEC.
- Male or female subjects aged 18 to 80 years.
- ECOG status: 0 or 1.
- Histologically confirmed local advanced or metastatic urothelial cancer
- Previously untreated with local advanced or metastatic urothelial cancer
- At least one measurable lesion, according to RECIST V1.1.
- Adequate tumor tissues submitted for test
- Suitable for cisplatin/carboplatin-based chemotherapy assessed by investigator
- Life expectancy for more than 12 weeks.
- Adequate organ functions.
- Proper contraception methods.
- Willingness to follow the study procedures.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.