Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma (CheckMate 069)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01927419
First received: August 20, 2013
Last updated: September 10, 2014
Last verified: September 2014

August 20, 2013
September 10, 2014
August 2013
July 2014   (final data collection date for primary outcome measure)
Objective response rate (ORR) as assessed by the investigator [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
The ORR is defined as the # of subjects with a best overall response (BOR) of complete response (CR) or Partial Response (PR) divided by the number of randomized BRAF wild type (WT) subjects
Same as current
Complete list of historical versions of study NCT01927419 on ClinicalTrials.gov Archive Site
  • Investigator assessed progression free survival (PFS) in BRAF WT subjects [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
    The PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first
  • ORR and PFS in BRAF mutant subjects [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in the EORTC-QLQ-C30 global health status/QoL composite scale [ Time Frame: Every 6 weeks for the first 6 months ] [ Designated as safety issue: No ]

    EORTC-QLQ-C30 = European Organisation for Research and Treatment of Care

    QoL = Quality of life

Same as current
Not Provided
Not Provided
 
Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma (CheckMate 069)
Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma

Not Provided
Interventional
Phase 2
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 Name: BMS-936558
  • Biological: Ipilimumab
  • Biological: Placebo matching with Nivolumab
  • Experimental: Arm A: Nivolumab + Ipilimumab and Nivolumab

    Part I:

    Nivolumab 1 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles)

    Part II:

    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends

    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Arm B: Nivolumab-placebo + Ipilimumab and Nivolumab-placebo

    Part I:

    Placebo matching with Nivolumab 0 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles)

    Part II:

    Placebo matching with Nivolumab 0 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends

    After documented disease progression, subjects in Arm B will have the option to either start Nivolumab monotherapy on-study (3 mg/kg solution intravenously every 2 weeks) or proceed to follow-up phase of the protocol

    Interventions:
    • Biological: Ipilimumab
    • Biological: Placebo matching with 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
142
April 2015
July 2014   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system
  • No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized
  • Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses. In order to be randomized, tumor tissue should be received by the central laboratory. Biopsy should be excisional, incisional punch or core needle. Fine needle aspirates or other cytology samples are insufficient
  • Known BRAF V600 mutation status as determined by an FDA approval test. Subjects with either V600 wild-type or V600 mutation-positive melanoma are eligible

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01927419
CA209-069, 2013-002018-11
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

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