Trial record 1 of 1 for:    NCT01927419
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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)

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: January 8, 2016
Last verified: November 2015
  Purpose
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

Condition Intervention Phase
Unresectable Melanoma
Metastatic Melanoma
Drug: Nivolumab
Drug: Ipilimumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 179
Study Start Date: August 2013
Estimated Study Completion Date: May 2016
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Nivolumab
Other Name: Opdivo, BMS-936558
Drug: Ipilimumab
Other Name: Yervoy
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.
Drug: Ipilimumab
Other Name: Yervoy
Drug: Placebo
Matching nivolumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927419

  Show 19 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01927419     History of Changes
Other Study ID Numbers: CA209-069  2013-002018-11 
Study First Received: August 20, 2013
Results First Received: November 3, 2015
Last Updated: January 8, 2016
Health Authority: United States: Food and Drug Administration
France: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 05, 2016