Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Patients With Untreated Inoperable or Metastatic Urothelial Cancer

Status: Active

Description

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating patients with previously untreated inoperable or metastatic urothelial cancer.

Eligibility Criteria

Inclusion Criteria

  • Metastatic or inoperable urothelial cancer
  • Must have at least 1 lesion with measurable disease
  • Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
  • No prior systemic chemotherapy treatment in the metastatic setting

Exclusion Criteria

  • Patients with disease that is suitable for local therapy administered with curative intent
  • Patients with active brain metastases or leptomeningeal metastases
  • Patients with active, known or suspected autoimmune disease
  • Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Locations & Contacts

California

Fresno
VA Central California Fresno Medical Center
Status: Active
Contact: Margaret Lynne Chase
Phone: 559-225-6100ext4154
Email: Margaret.Chase2@va.gov

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Milford
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Status: Active
Name Not Available
South Weymouth
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New Mexico

Albuquerque
Presbyterian Kaseman Hospital
Status: Active
Name Not Available
University of New Mexico Cancer Center
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-901
Secondary IDs NCI-2017-02285, 2016-003881-14
Clinicaltrials.gov ID NCT03036098