Nivolumab Combined With Ipilimumab for Patients With Advanced Rare Genitourinary Tumors

NCT03333616 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-01-21

No results posted yet for this study

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Bradley A McGregor, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333616 on ClinicalTrials.gov