Study on Nivolumab and Ipilimumab for Treating Advanced Rare Genitourinary Tumors
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT03333616
This clinical trial is exploring a combination of two drugs, Nivolumab and Ipilimumab, to treat rare types of advanced genitourinary cancers, including certain bladder cancers and other rare forms. The study aims to see if these drugs can effectively treat these cancers and is currently focusing on bladder cancer with specific characteristics.
Patient Parameters
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Program Overview
This research is testing a combination of two drugs, Nivolumab and Ipilimumab, to see if they can help treat rare types of advanced genitourinary cancers. These include certain bladder cancers, adrenocortical carcinoma, and other rare types of genitourinary cancers. The study is currently focusing on bladder cancer with specific characteristics. The drugs are being tested to see if they can shrink tumors and are safe for patients to use.
Description
This study is a Phase II clinical trial, which means it is testing how safe and effective the combination of Nivolumab and Ipilimumab is for treating certain rare genitourinary cancers. Although these drugs are approved for treating melanoma, they are still being studied for these specific cancers. The researchers want to see how well the cancer responds to the treatment, check the safety of the drugs, and look for markers in the tumor and blood that might predict how well the treatment works.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a performance status that allows for daily activities with some restrictions.
- Have advanced or metastatic rare genitourinary cancers, such as certain bladder cancers or neuroendocrine tumors.
- Only certain groups, like those with bladder cancer, are currently open for new participants.
- Must provide a tumor sample for testing, if available, and be willing to have a biopsy if needed.
- Have measurable disease based on specific criteria.
- Have adequate organ function as shown by blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Must be able to understand and agree to follow the study procedures.
Exclusion Criteria
- Have previously used similar immune checkpoint inhibitors for these cancers.
- Are taking certain immunosuppressive medications.
- Have had recent chemotherapy, hormone therapy, or other investigational treatments.
- Have untreated or active brain metastases.
- Have other cancers within the last 5 years, except for certain low-risk types.
- Have severe allergies to the study drugs.
- Have active autoimmune diseases requiring treatment.
- Have uncontrolled adrenal insufficiency.
- Have certain lung diseases or active infections like HIV or hepatitis.
- Have significant heart disease or uncontrolled high blood pressure.
- Have had recent major surgery or other serious medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Winship Cancer Institute, Emory University | 30322 | Atlanta | Georgia |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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