Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01844505
First received: April 29, 2013
Last updated: April 1, 2014
Last verified: March 2014

April 29, 2013
April 1, 2014
June 2013
October 2016   (final data collection date for primary outcome measure)
Endpoint of Overall Survival (OS) in all randomized subjects [ Time Frame: Approximately up to 44.1 months ] [ Designated as safety issue: No ]
OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive. OS data will be collected continuously while subjects are on study medication and every 3 months via in-person or phone contact after discontinuation of study medication
Same as current
Complete list of historical versions of study NCT01844505 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
    PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first
  • Objective Response Rate (ORR) [ Time Frame: Baseline (Day 1), Week 12 every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (expected to be no more than 5 years) ] [ 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 randomized subjects for each treatment group. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first
  • Differences in OS, PFS, and ORR between the two experimental arms [ Time Frame: OS: Approximately up to 44.1 months; PFS and OOR: Baseline (Day 1), Week 12, every 6 weeks thereafter up to week 49, and then every 12 weeks until disease progression is documented (Approximately around 5 years) ] [ Designated as safety issue: No ]
  • OS based on PD-L1 expression [ Time Frame: Baseline (Day 1) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in EORTC-QLQ-C30 [ Time Frame: Day 1 of Week 1, Day 1 of Week 5 and Follow up visits 1 and 2 ] [ Designated as safety issue: No ]
    European Organisation for Research and Treatment of Care Quality of Life Questionnaire (EORTC QLQ) C-30 global health status/QoL composite scale data and the remaining EORTC QLQ C-30 scale data will be summarized by timepoint using descriptive statistics for each treatment group
Same as current
Not Provided
Not Provided
 
Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend survival compared to Ipilimumab alone

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Unresectable or Metastatic Melanoma
  • Biological: Nivolumab
    Other Names:
    • BMS-936558
    • MDX-1106
  • Biological: Ipilimumab
    Other Names:
    • Yervoy
    • BMS-734016
    • MDX-010
  • Biological: Placebo for Nivolumab
  • Biological: Placebo for Ipilimumab
  • Experimental: Arm A: Nivolumab+Placebo for Ipilimumab+Placebo for Nivolumab
    Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Ipilimumab 0 mg/kg solution intravenously on weeks 1, 4 and Placebo matching with Nivolumab on weeks 4 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Nivolumab
    • Biological: Placebo for Nivolumab
    • Biological: Placebo for Ipilimumab
  • Experimental: Arm B: Nivolumab+Ipilimumab+Placebo for Nivolumab
    Nivolumab 1 mg/kg solution intravenously combined with Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solution intravenously every 2 weeks plus Placebo matching with Nivolumab on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
    • Biological: Placebo for Nivolumab
  • Experimental: Arm C: Ipilimumab+Placebo for Nivolumab
    Ipilimumab 3 mg/kg solution intravenously every 3 weeks for a total of 4 doses plus Placebo matching with Nivolumab 0 mg/kg solution intravenously on weeks 3 and 5 for cycles 1 and 2, until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    Interventions:
    • Biological: Ipilimumab
    • Biological: Placebo for Nivolumab
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
915
October 2017
October 2016   (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 stage III (unresectable) or stage IV melanoma
  • Treatment naïve patients
  • Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria
  • Tumor tissue from an unresectable or metastatic site of disease for biomarker analyses
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases
  • Ocular melanoma
  • 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 treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Ireland,   Italy,   Netherlands,   New Zealand,   Norway,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01844505
CA209-067, 2012-005371-13
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2014

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