A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01928394
First received: August 21, 2013
Last updated: July 23, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Advanced or Metastatic Solid Tumors
Biological: Nivolumab
Biological: Ipilimumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate (ORR) in all assigned subjects as determined by the investigators [ Time Frame: Up until time of first documented tumor progression or death (approximately up to 17 months) ] [ Designated as safety issue: No ]
    ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of assigned subjects


Secondary Outcome Measures:
  • Rate of treatment-related adverse events (AEs) leading to drug discontinuations during the first 12 weeks of treatment [ Time Frame: Up to Week 12 of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 218
Study Start Date: October 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm N - Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Experimental: Arm N-I: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928394

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Joseph Eder, Site 0015    203-785-5702      
United States, Florida
H. Lee Moffitt Cancer Center & Research Inst, Inc Recruiting
Tampa, Florida, United States, 33612
Contact: Scott Antonia, Site 0021         
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Rathi Pillai, Site 0001    404-712-7485      
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dung Le, Site 0004    443-287-6122      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States
Contact: Patrick Ott, Site 0005    617-582-7545      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Margaret Callahan, Site 0006    646-888-3359      
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Asim Amin, Site 0003    980-442-2305      
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Morse, Site 0008    919-668-6406      
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Matthew Taylor, Site 0007    503-494-1080      
United States, Tennessee
Tennessee Oncology Pllc Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell, Site 0011    615-329-7450      
Vanderbilt-Ingram Cancer Ctr Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Chan, Site 0002    615-343-0798      
United States, Texas
The University Of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Padmanee Sharma, Site 0009    713-563-1602      
Finland
Local Institution Recruiting
Helsinki, Finland, 00029
Contact: Site 0014         
Italy
Local Institution Recruiting
Milano, Italy, 20133
Contact: Site 0019         
Local Institution Recruiting
Napoli, Italy, 80131
Contact: Site 0020         
Spain
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0017         
Local Institution Recruiting
Madrid, Spain, 28050
Contact: Site 0010         
United Kingdom
Local Institution Recruiting
London, Greater London, United Kingdom, SW3 6JJ
Contact: Site 0018         
Local Institution Recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Contact: Site 0012         
Local Institution Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Site 0013         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01928394     History of Changes
Other Study ID Numbers: CA209-032, 2013-002844-10
Study First Received: August 21, 2013
Last Updated: July 23, 2014
Health Authority: Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ministry of Health
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014