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Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01783938
First received: February 1, 2013
Last updated: November 20, 2014
Last verified: April 2014

February 1, 2013
November 20, 2014
April 2013
April 2015   (final data collection date for primary outcome measure)
Incidence of treatment-related grade 3-5 adverse events (AEs) during the induction period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01783938 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: Baseline (Day 1), Week 25 and Week 33 ] [ Designated as safety issue: No ]
    Response rate is defined as the number of subjects who have a complete response (CR) or partial response (PR) at Week 25 (with confirmation at scheduled scan at Week 33) divided by the total number of randomized subjects
  • Progression rates [ Time Frame: Baseline (Day 1), Week 13 and Week 25 ] [ Designated as safety issue: No ]
    Progression rate at a specific timepoint is defined as the number of subjects who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of randomized subjects
Same as current
Not Provided
Not Provided
 
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
An Open-Label, Randomized, Phase 2 Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma

The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced or Metastatic Melanoma
  • Biological: Nivolumab
    Other Name: BMS-936558
  • Biological: Ipilimumab
    Other Name: Yervoy
  • Experimental: Cohort A: Nivolumab followed by Ipilimumab

    Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1

    Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Cohort B: Ipilimumab followed by Nivolumab

    Ipilimumab 3 mg/kg solution intravenously every 3 weeks up to 4 doses in Induction period

    Nivolumab 3 mg/kg solution intravenously every 2 weeks up to 6 doses in Induction period and 3 mg/kg solution intravenously every 2 weeks until disease progression, unacceptable toxicity, or withdrawal of consent in Continuation period for a maximum of 2 years from 1st study treatment in Induction Period 1

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
April 2016
April 2015   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Histologically confirmed unresectable Stage III or IV melanoma
  • Treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease
  • Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Known BRAF V600 mutation status or consent to BRAF V600 mutation testing
  • Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

Exclusion Criteria:

  • Active central nervous system (CNS) metastases
  • Carcinomatous meningitis
  • Active, known or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
  • Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) antibody
  • Prior treatment with other immunotherapies
  • Prior therapy with BRAF inhibitor within 6 weeks of enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01783938
CA209-064
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2014

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