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

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ClinicalTrials.gov Identifier: NCT01928394
Recruitment Status : Active, not recruiting
First Posted : August 23, 2013
Results First Posted : March 24, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 21, 2013
First Posted Date  ICMJE August 23, 2013
Results First Submitted Date  ICMJE February 5, 2020
Results First Posted Date  ICMJE March 24, 2020
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE October 7, 2013
Actual Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
Objective Response Rate ( ORR ) [ Time Frame: 60 months ]
The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
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) ]
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Brief Summary 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.
Detailed Description

All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Metastatic Solid Tumors
Intervention  ICMJE
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • MDX-1106
  • Biological: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
    • MDX-010
  • Drug: Cobimetinib
    Other Name: Cotellic
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 12, 2020)
1131
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2013)
160
Estimated Study Completion Date  ICMJE October 24, 2022
Actual Primary Completion Date February 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Subjects with histologically or cytologically 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Finland,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT01928394
Other Study ID Numbers  ICMJE CA209-032
2013-002844-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

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