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Nivolumab + Ipilimumab for Genitourinary Cancers
Study Summary
This trial is studying a combination of two drugs, Nivolumab and Ipilimumab, as a possible treatment for rare genitourinary cancers. Bladder and upper tract carcinomas with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas, and any genitourinary carcinoma with neuroendocrine differentiation are being studied. Given preliminary results, the study is being tested in additional patients with bladder or upper tract carcinoma with variant histology at this time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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- I agree to use birth control or abstain from sex during and after treatment for 120 days.You have had serious allergic reactions to certain types of medications made from antibodies or proteins.You are allergic to any part of the nivolumab or ipilimumab drug.I can provide a tumor sample and am willing to have a biopsy before treatment, unless it's unsafe.My organs are functioning well.You have a measurable disease as determined by a specific set of guidelines within the 28 days before joining the study.I have tested positive for HIV/AIDS.I haven't had chemotherapy, hormone therapy, or experimental treatments in the last 3 weeks.I have not used immune checkpoint inhibitors for certain cancers.I've taken low-dose steroids for nausea or pain but can start the study within 2 weeks.I haven't had any stomach or throat hole issues or stomach tears in the last 6 months.I need special feeding methods due to GI blockage symptoms.I haven't had radiotherapy in the last 14 days, except for one session to ease symptoms.My cancer has spread to my brain, spinal cord, or leptomeninges.I haven't had certain cancers besides my current one in the last 5 years.I haven't taken high-dose steroids or immunosuppressants for an autoimmune disease in the last 6 months.I have a history of lung scarring or inflammation not caused by infections.I have not had a stroke or mini-stroke in the last 3 months.I have had a stem cell or organ transplant in the past.I have been active and able to care for myself within the last 28 days.My cancer is advanced, cannot be surgically removed, and affects the urinary or reproductive organs.I have serious blood vessel problems.I do not have a bleeding disorder or significant blood clotting issues.I have had symptoms from a deep vein clot or lung clot.I have not had major surgery in the last 4 weeks.I don't have severe side effects from previous cancer treatments.I am currently being treated for an infection.You have air in your belly that can't be explained by a recent medical procedure.I have an ongoing or chronic hepatitis B infection.I have an active hepatitis C infection.Your heart's QTcF interval is too long.My adrenal glands are not working properly and it's not under control.I am 18 years old or older.I have a serious heart condition.I have a serious wound or ulcer that is not healing.I haven't taken any antibiotics by mouth or IV in the last 2 weeks.I have taken a pregnancy test in the last 28 days and it was negative.I haven't taken any immune-weakening medications in the last 2 weeks.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I understand and can follow the study's procedures.My high blood pressure is not well-controlled.
- Group 1: Nivolumab+Ipilimumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are they currently enrolling people in this clinical trial?
"The latest information from clinicaltrials.gov is that this trial is still open for recruitment. The listing was first posted on December 28th, 2017 and has been edited most recently on July 5th, 2022."
How many individuals are included in this research project?
"One hundred patients that meet the pre-stated inclusion criteria are necessary for this clinical trial to move forward. If you are interested, Emory University in Atlanta, Georgia and MD Anderson Cancer Center in Houston, Texas are two of many sites participating in this study."
Does Nivolumab carry a high risk for adverse effects?
"At the moment, there is not enough information to rate Nivolumab's efficacy. However, it has been given a score of 2 in regards to safety because Phase 2 trials have shown that it is safe for human use."
In how many places is this experiment being conducted?
"At the time of writing this, patients are being enrolled at Winship Cancer Institute (Atlanta, GA), Emory University, MD Anderson Cancer Center (Houston, TX), Beth Israel Deaconess Medical Center (Boston, MA), and 6 other locations."
What type of cancer does Nivolumab target?
"Nivolumab is a common treatment for previous anti-angiogenic therapy and other conditions like malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
How does this study compare to others that have used Nivolumab?
"Nivolumab was first studied in 2009 at Texas Children's Hospital. In the years since, there have been a total of 362 completed clinical trials worldwide. Right now, 796 different medical studies are actively recruiting patients; a significant number of these active trials are based out of Atlanta, Georgia."
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