Combination of 9MW2821 and Toripalimab for advanced bladder 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 phase 3 clinical study aims to evaluate the efficacy, safety, and immunogenicity of the combination of 9MW2821 and Toripalimab compared to standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma. Approximately 460 participants who have not received prior systemic treatment will be enrolled. The study will assess the outcomes based on measurable lesions and adequate organ function, ensuring participants meet specific eligibility criteria.

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 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.

Exclusion Criteria:

* 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.
* 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.
* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.
* Peripheral neuropathy Grade ≥ 2.
* Any other serious chronic or uncontrolled disease.
* Uncontrolled central nervous system metastases or carcinomatous meningitis.
* 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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Dingwei Ye, Professor
• Email: fuscc2012@163.com
• Phone: 13701663571

Similar studies

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

• Combining 9MW2821 with toripalimab around surgery for urothelial cancer

  This trial tests whether giving 9MW2821 together with toripalimab before and after surgery helps adults with non-metastatic urothelial cancer.

  Recruiting Phase 2 Mabwell (Shanghai) Bioscience Co., Ltd. · Guangzhou, Guangdong · NCT07314723

• Comparing two treatments for advanced urothelial carcinoma

  This study is testing if a combination of two treatments can help people with advanced bladder cancer do better than using just one of the treatments alone.

  Recruiting at 2 sites Phase 2 Mabwell (Shanghai) Bioscience Co., Ltd. · Changsha, Hunan and 1 other locations · NCT06823427

• Testing ZM008 alone and with Pembrolizumab in patients with advanced solid tumors

  This study is testing a new treatment called ZM008, alone and with another drug called Pembrolizumab, to see if it can help patients with advanced solid tumors who have run out of other treatment options.

  Recruiting at 3 sites Phase 1 Zumutor Biologics Inc. · Boston, Massachusetts and 2 other locations · NCT06451497

• Combination treatment for advanced urothelial carcinoma

  This study is testing a new combination treatment for advanced bladder cancer to see if it works better than chemotherapy alone for patients who haven't received treatment before.

  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

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

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

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

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.