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A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 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 30, 2016
Last verified: November 2016

August 21, 2013
November 30, 2016
October 2013
August 2017   (final data collection date for primary outcome measure)
Objective response rate (ORR) [ Time Frame: 60 months ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01928394 on ClinicalTrials.gov Archive Site
  • Number of treatment-related adverse events (AEs) leading to drug discontinuations [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • Progression Free Survival (PFS) [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 60 months ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
To investigate the safety and efficacy of Nivolumab as a single agent or in combination with Ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of Nivolumab with Ipilimumab and Cobimetinib is also investigated in PC.

The following Tumor Types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Ovarian Cancer

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced or Metastatic Solid Tumors
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • MDX-1106
  • Biological: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
    • MDX-010
  • Drug: Cobimetinib
    Other Name: Cotellic
  • 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
    Intervention: Biological: Nivolumab
  • Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab
    Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 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
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab
    Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg 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
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab
    Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg 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
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab
    Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
    Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
    • Drug: Cobimetinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1150
December 2018
August 2017   (final data collection date for primary outcome measure)

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
  • Ovarian Cancer
  • Subjects must have measurable disease
  • Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  • Adequate hematological and organ function as confirmed by laboratory values

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
Both
18 Years and older   (Adult, Senior)
No
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 #.
United States,   Canada,   Denmark,   Finland,   Germany,   Italy,   Spain,   United Kingdom
France
 
NCT01928394
CA209-032, 2013-002844-10
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP