A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Conditions
Advanced or Metastatic Solid Tumors
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nivolumab Type: Biological
Name: Ipilimumab Type: Biological
Overall Status
Recruiting
Summary
To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 4 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), and small cell lung cancer (SCLC) and Bladder Cancer (BC).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Subjects with histologically confirmed locally advanced or metastatic disease of the following tumor types:

- Triple Negative Breast Cancer

- Gastric Cancer

- Pancreatic Cancer

- Small Cell Lung Cancer

- Bladder Cancer

- Subjects must have measurable disease

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment

- Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited
Locations
Yale University
New Haven, Connecticut, United States
Status: Recruiting
Contact: Joseph Eder, Site 0015 - 203-737-1889
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, United States
Status: Recruiting
Contact: Scott Antonia, Site 0021 - 813-745-3883
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Rathi Pillai, Site 0001 - 404-712-7485
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Contact: Dung Le, Site 0004 - 410-955-4429
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Patrick Ott, Site 0005 - 617-632-5115
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Neil Segal, Site 0006 - 646-888-3359
Levine Cancer Institute
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Asim Amin, Site 0003 - 980-442-2305
Duke Cancer Institute
Durham, North Carolina, United States
Status: Recruiting
Contact: Michael Morse, Site 0008 - 919-684-6342
Oregon Health & Science University
Portland, Oregon, United States
Status: Recruiting
Contact: Matthew Taylor, Site 0007 - 503-494-1080
Tennessee Oncology Pllc
Nashville, Tennessee, United States
Status: Recruiting
Contact: Johanna Bendell, Site 0011 - 615-329-7450
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States
Status: Recruiting
Contact: Emily Chan, Site 0002 - 800-811-8480
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Padmanee Sharma, Site 0009 - 713-563-1602
Local Institution
Helsinki, CT, Finland
Status: Recruiting
Contact: Site 0014
Local Institution
Saint Herblain, TN, France
Status: Not yet recruiting
Contact: Site 0027
Krankenhaus Nordwest Gmbh, Frankfurt
Frankfurt, Lanarkshire, Germany
Status: Recruiting
Contact: Akin Atmaca, Site 0026 - +496979014518
Nationales Centrum Fuer Tumorerkrakungen (Nct) Heidelberg
Heidelberg, TN, Germany
Status: Recruiting
Contact: Dirk Jaeger, Site 0016 - +4962215637372
Local Institution
Mainz, TN, Germany
Status: Not yet recruiting
Contact: Site 0025
Local Institution
Napoli, CT, Italy
Status: Recruiting
Contact: Site 0020
Local Institution
Padova, Greater London, Italy
Status: Not yet recruiting
Contact: Site 0032
Local Institution
Milano, Lanarkshire, Italy
Status: Recruiting
Contact: Site 0019
Local Institution
Bologna, TN, Italy
Status: Not yet recruiting
Contact: Site 0024
Local Institution
Barcelona, CT, Spain
Status: Not yet recruiting
Contact: Site 0022
Local Institution
Madrid, CT, Spain
Status: Recruiting
Contact: Site 0010
Local Institution
Madrid, Lanarkshire, Spain
Status: Not yet recruiting
Contact: Site 0023
Local Institution
Madrid, Lanarkshire, Spain
Status: Recruiting
Contact: Site 0017
Local Institution
London, Greater London, United Kingdom
Status: Recruiting
Contact: Site 0018
Local Institution
Glasgow, Lanarkshire, United Kingdom
Status: Recruiting
Contact: Site 0012
Local Institution
Sutton, Surrey, United Kingdom
Status: Recruiting
Contact: Site 0013
Start Date
October 2013
Completion Date
August 2017
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page