100 Participants Needed

Nivolumab + Ipilimumab for Genitourinary Cancers

Recruiting at 5 trial locations
Bradley McGregor, MD - Dana-Farber ...
Overseen ByBradley A McGregor, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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 McGregor, MD - Dana-Farber ...

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

I agree to use birth control or abstain from sex during and after treatment for 120 days.
I can provide a tumor sample and am willing to have a biopsy before treatment, unless it's unsafe.
My organs are functioning well.
See 6 more

Exclusion Criteria

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 have tested positive for HIV/AIDS.
See 29 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab and Ipilimumab intravenously every 3 weeks for a total of 4 doses, followed by Nivolumab monotherapy every 4 weeks

12 weeks
4 visits (in-person) for combination therapy, followed by monthly visits for monotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, with radiologic disease assessments every 6-12 weeks

up to 24 months
Regular imaging every 6-12 weeks

Treatment Details

Interventions

  • Ipilimumab
  • Nivolumab
Trial OverviewThe trial is testing a combination of Nivolumab and Ipilimumab as treatment options for patients with specific genitourinary cancers that are either unresectable or metastatic. The study focuses on those whose conditions haven't improved with standard treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Nivolumab+IpilimumabExperimental Treatment2 Interventions
* Nivolumab and Ipilimumab are administered intravenously every 3 weeks for a total of 4 maximum doses. After combination therapy, nivolumab will be administered as monotherapy every 4 weeks. * Doses are determined per protocol.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Yervoy for:
  • Advanced melanoma
  • Stage III unresectable melanoma
  • Stage IV metastatic melanoma
🇪🇺
Approved in European Union as Yervoy for:
  • 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

Trials
1,128
Recruited
382,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Findings from Research

Nivolumab combined with ipilimumab significantly improves overall survival in adult patients with intermediate/poor-risk advanced renal cell carcinoma compared to sunitinib, with a hazard ratio of 0.63, indicating a 37% reduction in the risk of death.
In the study involving 1096 patients, the median overall survival was not reached for the nivolumab + ipilimumab group, while it was 25.95 months for the sunitinib group, highlighting the potential of this combination therapy for better long-term outcomes.
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma.Ali, S., Camarero, J., Hennik, P., et al.[2021]
Immune checkpoint inhibitors (ICIs) like nivolumab, pembrolizumab, and atezolizumab have been approved for treating metastatic urothelial carcinoma and renal cell carcinoma, significantly improving systemic therapy outcomes.
Future strategies aim to combine ICIs with targeted therapies to boost immune responses against tumors, while there is a critical need for biomarkers to predict patient responses and resistance to ICI therapy.
[Mode of action, new targets and potential biomarkers in modern immunotherapy].Bedke, J., Stühler, V., Todenhöfer, T., et al.[2019]
Cabozantinib combined with nivolumab (CaboNivo) and with ipilimumab (CaboNivoIpi) showed manageable safety profiles, with 75% and 87% of patients experiencing grade 3 or 4 treatment-related adverse events, respectively, including fatigue and hypertension.
The treatment demonstrated promising efficacy, with an overall response rate of 30.6% and a median overall survival of 12.6 months for all patients, while patients with metastatic urothelial carcinoma had even better outcomes, with a median overall survival of 25.4 months.
Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors.Apolo, AB., Nadal, R., Girardi, DM., et al.[2023]

References

Results of a multicenter, phase 2 study of nivolumab and ipilimumab for patients with advanced rare genitourinary malignancies. [2021]
European Medicines Agency extension of indication to include the combination immunotherapy cancer drug treatment with nivolumab (Opdivo) and ipilimumab (Yervoy) for adults with intermediate/poor-risk advanced renal cell carcinoma. [2021]
[Mode of action, new targets and potential biomarkers in modern immunotherapy]. [2019]
Characterization of outcomes in patients with advanced genitourinary malignancies treated with immune checkpoint inhibitors. [2022]
Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors. [2023]
Conditional immune toxicity rate in patients with metastatic renal and urothelial cancer treated with immune checkpoint inhibitors. [2021]
Incidence of Immune-Related Adverse Events with Program Death Receptor-1- and Program Death Receptor-1 Ligand-Directed Therapies in Genitourinary Cancers. [2020]
[Treatment with PD-1/PD-L1 and CTLA-4 immune checkpoint inhibitors : Immune-mediated side effects]. [2022]
Mechanism and Management of Checkpoint Inhibitor-Related Toxicities in Genitourinary Cancers. [2022]
[Immunotherapy in the treatment of genitourinary cancers]. [2018]