Nivolumab + Ipilimumab for Genitourinary Cancers
Trial Summary
What is the purpose of this trial?
This research study is studying a combination of drugs as a possible treatment for rare genitourinary malignancies among four cohorts, bladder or upper tract carcinoma with variant histology, adrenocortical carcinoma, other rare genitourinary carcinomas and any genitourinary carcinoma with neuroendocrine differentiation. Given preliminary results, the study is being tested in additional patients with bladder or upper tract carcinoma with variant histology at this time while the adrenocortical carcinoma, other rare genitourinary malignancies arms have closed to accrual -The names of the study drugs involved in this study are: * Nivolumab * Ipilimumab
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.
What data supports the effectiveness of the drug combination Nivolumab and Ipilimumab for genitourinary cancers?
The combination of Nivolumab and Ipilimumab has shown effectiveness in treating advanced renal cell carcinoma, as demonstrated in a large study where it improved overall survival compared to another drug, sunitinib. Additionally, immune checkpoint inhibitors like Nivolumab have been approved for use in genitourinary cancers, indicating their potential benefit in these types of cancers.12345
Is the combination of Nivolumab and Ipilimumab safe for treating genitourinary cancers?
The combination of Nivolumab and Ipilimumab can cause immune-related side effects, such as skin rash, diarrhea, liver inflammation, and lung issues. These side effects are generally manageable with medications like corticosteroids, but they can be serious, so it's important to monitor and treat them early.56789
How is the drug combination of Nivolumab and Ipilimumab unique for treating genitourinary cancers?
The combination of Nivolumab and Ipilimumab is unique because it uses two immunotherapy drugs that work together to boost the body's immune system to fight cancer cells, which is different from traditional chemotherapy that directly targets and kills cancer cells. This combination is particularly novel for treating advanced rare genitourinary cancers, where standard treatments may not be available.124510
Research Team
Bradley A McGregor, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
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
Treatment Details
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