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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: November 20, 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: 410
Study Start Date: October 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: August 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 #.

  Show 21 Study Locations
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: November 20, 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 November 24, 2014