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Trial record 1 of 1 for:    checkmate 069
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Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma (CheckMate 069)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01927419
Recruitment Status : Active, not recruiting
First Posted : August 22, 2013
Results First Posted : February 8, 2016
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 20, 2013
First Posted Date  ICMJE August 22, 2013
Results First Submitted Date  ICMJE November 3, 2015
Results First Posted Date  ICMJE February 8, 2016
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE August 21, 2013
Actual Primary Completion Date July 24, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population [ Time Frame: Randomization to a minimum of 6 months ]
Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
Objective response rate (ORR) as assessed by the investigator [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population [ Time Frame: Randomization to a minimum of 6 months ]
    Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
  • Investigator-assessed Progression-free Survival (PFS) in All Populations [ Time Frame: Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months ]
    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. WT=wild type
  • Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response [ Time Frame: Randomization to a minimum of 6 months ]
    Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
  • Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score [ Time Frame: From Baseline to Week 25 ]
    Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2013)
  • 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) ]
    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) ]
  • 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 ]
    EORTC-QLQ-C30 = European Organisation for Research and Treatment of Care QoL = Quality of life
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2016)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs [ Time Frame: Day 1 of treatment to within 30 days past last dose ]
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
Official Title  ICMJE 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
Brief Summary The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Unresectable Melanoma
  • Metastatic Melanoma
Intervention  ICMJE
  • Drug: Nivolumab
    Other Name: Opdivo, BMS-936558
  • Drug: Ipilimumab
    Other Name: Yervoy
  • Drug: Placebo
    Matching nivolumab
Study Arms  ICMJE
  • Experimental: Nivolumab + Ipilimumab
    Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Experimental: Placebo + Ipilimumab
    Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
    Interventions:
    • Drug: Ipilimumab
    • Drug: Placebo
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: January 8, 2016)
179
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2013)
150
Estimated Study Completion Date  ICMJE December 15, 2020
Actual Primary Completion Date July 24, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Histologically confirmed unresectable Stage III or Stage IV melanoma
  • 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 and sent to 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-approved test. Patients with either V600 wild-type or V600 mutation-positive melanoma are eligible.

Key Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases. Patients with treated brain metastases are eligible if there is no evidence of progression on magnetic resonance imaging scan for at least 8 weeks after completion of treatment 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
  • Patients with active, known, or suspected autoimmune disease. Those 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.
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 France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01927419
Other Study ID Numbers  ICMJE CA209-069
2013-002018-11 ( 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 May 2020

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