Study on Pembrolizumab Plus V940 for Bladder Cancer After Surgery
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06305767
This clinical trial is testing whether adding the drug V940 to pembrolizumab can improve outcomes for patients with high-risk bladder cancer after surgery. The study aims to see if this combination helps patients live longer without the cancer returning compared to using pembrolizumab alone.
Patient Parameters
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Program Overview
The goal of this study is to find out if combining the drug V940 with pembrolizumab is more effective than using pembrolizumab alone in preventing the return of bladder cancer after surgery. This study focuses on patients with high-risk muscle-invasive urothelial carcinoma (MIUC) who have had their cancer surgically removed. Researchers hope that the combination treatment will lead to better disease-free survival, meaning patients live longer without the cancer coming back.
Description
Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately April of 2025.
Eligibility Criteria
Inclusion Criteria
- Have muscle-invasive urothelial carcinoma (MIUC), a type of bladder cancer.
- The main type of cancer cells must be urothelial carcinoma (UC).
- Have high-risk cancer features after surgery to remove the tumor.
- Must provide a tumor tissue sample for genetic testing.
- Must provide blood samples for V940 production and testing for cancer DNA in the blood.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities, assessed within 7 days before starting the study.
Exclusion Criteria
- Have received any previous systemic cancer treatment.
- Have received a live vaccine within 30 days before starting the study treatment.
- Have another cancer that is progressing or needed treatment within the last 3 years.
- Have severe allergies to V940, pembrolizumab, or their ingredients.
- Have current lung inflammation or lung disease.
- Have an active infection that requires treatment.
- Have active hepatitis B or C infections.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro | 90095 | Los Angeles | California |
| AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102) | 32804 | Orlando | Florida |
| University of Chicago Medical Center ( Site 0109) | 60637 | Chicago | Illinois |
| University of Iowa ( Site 0110) | 52242 | Iowa City | Iowa |
| Icahn School of Medicine at Mount Sinai ( Site 0101) | 10029 | New York | New York |
| Duke Cancer Institute ( Site 0107) | 27710 | Durham | North Carolina |
| Cleveland Clinic Main ( Site 0100) | 44195 | Cleveland | Ohio |
| Fox Chase Cancer Center ( Site 0106) | 19111 | Philadelphia | Pennsylvania |
| UT Southwestern Medical Center ( Site 0103) | 75390 | Dallas | Texas |
| Houston Methodist Hospital-Department of Urology ( Site 0111) | 77030 | Houston | Texas |
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