Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03333616
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    is an immunotherapy medication that stimulates the immune system to fight cancer cells throughout the body.
  • Nivolumab — DRUG
    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

Study Details

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

Key Dates

Start date
Dec 28, 2017
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab+Ipilimumab
    * 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.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Imaging will occur every 6-12 weeks study entry up until disease progression (up to 24 months) ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By research site
University of California, San Diego Moores Cancer Center· La Jolla, CAWinship Cancer Institute, Emory University· Atlanta, GABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAOhio State University Comprehensive Cancer Center· Columbus, OHMD Anderson Cancer Center· Houston, TX

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