Study on Nivolumab and Ipilimumab or Chemotherapy for Untreated Inoperable or Metastatic Urothelial Cancer
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03036098
This clinical trial is testing whether the immunotherapy drugs nivolumab and ipilimumab, alone or with standard chemotherapy, are more effective than chemotherapy alone in treating patients with advanced urothelial cancer that cannot be surgically removed.
Patient Parameters
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Program Overview
The aim of this study is to find out if using the immunotherapy drug nivolumab, either with another immunotherapy drug called ipilimumab or with standard chemotherapy, works better than just using chemotherapy alone for treating patients with advanced urothelial cancer that cannot be operated on or has spread to other parts of the body.
Eligibility Criteria
Inclusion Criteria
- Have advanced urothelial cancer that cannot be removed by surgery, affecting areas like the kidney, bladder, or urethra.
- Have not received any chemotherapy for this advanced cancer before.
- Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Agree to use effective contraception methods if applicable.
Exclusion Criteria
- Have cancer that can be treated with local therapy aimed at curing it.
- Have any serious or uncontrolled medical conditions that could increase risks or affect the study results.
- Have previously been treated with certain types of immunotherapy drugs targeting specific immune pathways.
- Other specific criteria as defined by the study protocol.
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