Study Comparing Enfortumab Vedotin and Pembrolizumab with Standard Chemotherapy for Muscle Invasive Bladder Cancer
Sponsor: Merck Sharp & Dohme LLC
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT04700124
This clinical trial is testing a new combination of drugs, Enfortumab Vedotin and Pembrolizumab, to see if they work better than the current standard chemotherapy for patients with muscle invasive bladder cancer who can receive cisplatin.
Patient Parameters
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Program Overview
The study aims to find out if using Enfortumab Vedotin and Pembrolizumab before and after surgery can improve outcomes for patients with muscle invasive bladder cancer compared to the usual chemotherapy treatment. The main goal is to see if this new approach can help patients live longer without the cancer coming back.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with muscle invasive bladder cancer with at least 50% of the cancer being urothelial carcinoma.
- Cancer has not spread beyond the bladder area, as confirmed by scans.
- Eligible for surgery to remove the bladder and nearby lymph nodes.
- In good general health, able to carry out normal activities or light work.
- Have good organ function based on medical tests.
Exclusion Criteria
- Have another cancer that is getting worse or needed treatment in the last 3 years, with some exceptions.
- Have had previous treatments for muscle invasive bladder cancer, except for certain bladder treatments.
- Cancer has spread to more than one lymph node or to other parts of the body.
- Cannot receive cisplatin due to health reasons.
- Have had other cancer treatments or radiation to the bladder in the last 3 years.
- Have had part of the bladder removed.
- Have received a live vaccine in the last 30 days.
- Have immune system problems or infections like HIV or active hepatitis.
- Have mental health or substance abuse issues.
- Have had a tissue or organ transplant.
- Have nerve problems or eye issues.
- Have uncontrolled diabetes with high blood sugar levels.
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