Nivolumab + Ipilimumab for Genitourinary Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, Nivolumab (Opdivo) and Ipilimumab (Yervoy), to treat certain rare genitourinary cancers, including specific types of bladder cancer. The researchers aim to determine if these drugs can stop or slow down these cancers. Suitable candidates for this trial include those with advanced bladder cancer that cannot be surgically removed and who have not previously used similar treatments. Participants will receive the drugs through an IV (intravenous) in a medical setting. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before starting. You must stop taking systemic immunosuppressive medications and certain treatments like chemotherapy or hormone therapy within specific timeframes before the study begins. However, some medications like low-dose steroids or specific hormone therapies may be allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of nivolumab and ipilimumab has been tested in various cancers, such as kidney and liver cancer. These studies found the treatment to be generally safe. Specifically, patients with advanced kidney cancer experienced a lower risk of death with this combination. Although safety was a primary concern, some serious side effects occurred but were usually manageable.
The studies also found that patients lived longer after receiving this treatment compared to those who did not, which is encouraging. This suggests that many people can tolerate the treatment well. It is important to remember that side effects can vary among individuals, but these findings offer a hopeful perspective on the treatment's safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about nivolumab and ipilimumab for genitourinary cancers because they offer a novel approach by harnessing the power of the immune system to fight cancer. Unlike traditional chemotherapy that directly targets cancer cells, these drugs are immune checkpoint inhibitors. They work by blocking proteins that often prevent the immune system from attacking cancer cells effectively. This can potentially lead to a more durable response and may improve survival rates compared to existing therapies. Additionally, the combination of these two drugs may enhance their effectiveness, offering new hope for patients with these challenging cancers.
What evidence suggests that this combination of drugs could be an effective treatment for genitourinary cancers?
Research has shown that using nivolumab and ipilimumab together yields promising results for treating certain cancers. In patients with advanced kidney cancer, this combination reduced the risk of death by 28% compared to another treatment. Studies also indicate that this combo can enhance patient response to treatment across various cancers. Specifically, for a group of patients with bladder cancer, the results were positive, suggesting potential benefits for other urinary system cancers as well. In this trial, participants will receive the combination of nivolumab and ipilimumab, supporting the idea that these drugs could effectively treat rare urinary cancers.12356
Who Is on the Research Team?
Bradley A McGregor, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Adults (18+) with advanced rare genitourinary tumors, including certain types of bladder, prostate, penile cancer, and others. Participants must have good organ function, no recent serious illnesses or surgeries, and not be on immunosuppressive drugs. Women who can bear children must test negative for pregnancy and agree to contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab and Ipilimumab intravenously every 3 weeks for a total of 4 doses, followed by Nivolumab monotherapy every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with radiologic disease assessments every 6-12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Ipilimumab
- Nivolumab
Ipilimumab is already approved in United States, European Union for the following indications:
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
- Advanced melanoma
- Stage III unresectable melanoma
- Stage IV metastatic melanoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania