NCT03333616

Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors

A Phase II Study of Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the combination of drugs works in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved nivolumab in combination with ipilimumab for this specific disease but the combination is approved for use in melanoma patients. In this research study, the investigators are... * Investigating the response of the participant's cancer to treatment with nivolumab plus ipilimumab, * Assessing the safety of treatment with nivolumab and ipilimumab and * Evaluating response and resistance to treatment by looking at the participant's tumor tissue and blood for markers to predict response and resistance to therapy.

Conditions

• Genitourinary Cancer
• Adrenocortical Carcinoma
• Non-urothelial Bladder
• Non-urothelial Upper Tract
• Penile Cancer
• Non-adenocarcinoma Prostate Cancer
• Refractory Germ-cell
• High Grade Neuroendocrine Carcinoma/Small Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Ipilimumab	is an immunotherapy medication that stimulates the immune system to fight cancer cells throughout the body.
DRUG	Nivolumab	Nivolumab binds to and blocks the activation of PD-1. This results in the activation of T-cells and cell-mediated immune responses against tumor cells

Timeline

• Start date: 2017-12-28
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2017-11-07
• Last updated: 2026-01-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study