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.
Verified March 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: March 31, 2014
Last verified: March 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)


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: 160
Study Start Date: October 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01928394

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

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/ Partners Cancer Care, Inc. 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
Vanderbilt-Ingram Cancer Ctr Recruiting
Nashville, Tennessee, United States, 37232
Contact: Emily Chan, Site 0002    615-343-0798      
Tennessee Oncology PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell, Site 0011    615-329-7450      
United States, Texas
The University Of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
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, 28050
Contact: Site 0010         
Local Institution Recruiting
Madrid, Spain, 28041
Contact: Site 0017         
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: March 31, 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 April 17, 2014