New treatments for muscle-invasive bladder cancer
Understanding Tumor and Immune Dynamics and Predicting Response to Various Perioperative Therapies in Patients With Muscle-invasive Bladder Cancer
This study is testing new treatments for muscle-invasive bladder cancer in patients who can't take standard chemotherapy to see if a combination of two drugs can help improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | pembrolizumab, Sacituzumab, chemotherapy, immunotherapy |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT06341478 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates various neoadjuvant therapies for patients with muscle-invasive bladder cancer (MIBC) who cannot receive or refuse cisplatin-based chemotherapy. It aims to evaluate the effectiveness of antibody-drug conjugates, specifically Sacituzumab govitecan, alone and in combination with pembrolizumab, to improve patient outcomes. The study also focuses on developing a biomarker program to better understand the biology of MIBC and identify which patients may benefit from these therapies. Participants will be those enrolled in related clinical trials or candidates for radical cystectomy.
Who should consider this trial
Good fit: Ideal candidates include patients with histopathologically-confirmed urothelial carcinoma and clinical stage T2-T4N0M0 MIBC.
Not a fit: Patients who refuse to participate in the related studies or lack available baseline tumor and blood samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new effective treatment options for patients with MIBC who currently have limited choices.
How similar studies have performed: Previous studies have shown promising results with single-agent immunotherapy in similar patient populations, indicating potential for success with these new approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion in NureCombo (NCT04876313), SURE-01 (NCT05226117), and SURE-02 (NCT05535218) clinical trials or candidates to radical cystectomy as per routine clinical practice. 2\. Histopathologically-confirmed urothelial carcinoma (UC). 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4. Clinical stage T2-T4N0M0, muscle-invasive bladder cancer (MIBC) Exclusion Criteria: 1. Refusal to partecipate to the above studies 2. Unavailability of baseline tumor and blood samples
Where this trial is running
Milan, Mi
- IRCCS Ospedale San Raffaele — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Necchi, MD
- Email: necchi.andrea@hsr.it
- Phone: +390226435789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.