Study on Nivolumab With and Without Urelumab for Patients Unable to Take Cisplatin or Refusing Chemotherapy with Muscle-Invasive Bladder Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT02845323
This clinical trial is testing the effectiveness of Nivolumab alone versus Nivolumab combined with Urelumab in patients with muscle-invasive bladder cancer who cannot take cisplatin or choose not to undergo chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to compare the effects of two treatments on bladder cancer patients who are either unable to take cisplatin-based chemotherapy or have chosen not to. Participants will be randomly assigned to receive either Nivolumab alone or Nivolumab with Urelumab before undergoing surgery to remove the bladder cancer.
Description
This Phase II clinical trial involves patients with muscle-invasive bladder cancer who cannot or choose not to receive cisplatin-based chemotherapy. Participants will be divided into two groups: one group will receive Nivolumab alone, and the other will receive Nivolumab combined with Urelumab. The study will include adults over 18 years old who are fit for surgery to remove their bladder cancer. Patients with cancer that can be surgically removed and who have positive lymph nodes in the pelvis are eligible.
Eligibility Criteria
Inclusion Criteria
- Unable or unwilling to receive cisplatin-based chemotherapy.
- Meet at least one of the following: low kidney function, poor performance status, significant hearing loss, severe nerve damage, or heart failure.
- Aged 18 years or older.
- Meet specific blood test requirements, including adequate neutrophil, platelet, and hemoglobin levels.
- Provide informed consent to participate in the study.
Exclusion Criteria
- Have advanced bladder cancer that cannot be surgically removed or has spread to other parts of the body.
- Have another active cancer, except for certain skin cancers or prostate cancer.
- Have received recent cancer treatments or have not recovered from their side effects.
- Have had previous treatments with certain immune therapies.
- Have undergone major surgery or radiation therapy recently without full recovery.
- Have a history of severe liver disease or hepatitis.
- Have had an organ or bone marrow transplant.
- Have severe heart conditions or uncontrolled medical issues.
- Are pregnant or breastfeeding, or not using effective birth control if of childbearing potential.
- Are unable or unwilling to follow the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA Institute of Urologic Oncology | 90095 | Los Angeles | California |
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| University of Chicago | 60637 | Chicago | Illinois |
| Johns Hopkins Hospital | 21205 | Baltimore | Maryland |
| Columbia University Medical Center | 10032 | New York | New York |
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