Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of 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: June 20, 2016
Last verified: November 2015

August 20, 2013
June 20, 2016
August 2013
July 2014   (final data collection date for primary outcome measure)
Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population [ Time Frame: Randomization to a minimum of 6 months ] [ Designated as safety issue: No ]
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.
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
Complete list of historical versions of study NCT01927419 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population [ Time Frame: Randomization to a minimum of 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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

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 ] [ Designated as safety issue: Yes ]
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.
Not Provided
 
Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
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, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, 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 Melanoma
  • Metastatic Melanoma
  • Drug: Nivolumab
    Other Name: Opdivo, BMS-936558
  • Drug: Ipilimumab
    Other Name: Yervoy
  • Drug: Placebo
    Matching nivolumab
  • 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
Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor D, Salama AK, Taylor M, Ott PA, Rollin LM, Horak C, Gagnier P, Wolchok JD, Hodi FS. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006-17. doi: 10.1056/NEJMoa1414428. Epub 2015 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
179
December 2016
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT01927419
CA209-069, 2013-002018-11
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2015

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