Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of 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
2 other identifiers
interventional
142
2 countries
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2013
Longer than P75 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2013
CompletedFirst Posted
Study publicly available on registry
August 22, 2013
CompletedStudy Start
First participant enrolled
August 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2014
CompletedResults Posted
Study results publicly available
February 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedMarch 18, 2022
February 1, 2022
11 months
August 20, 2013
November 3, 2015
February 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants
Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria. 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.
From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)
Secondary Outcomes (4)
Progression-Free Survival (PFS) - BRAF Wild-type (WT) Participants
From randomization to progression or death (up to approximately 88 months)
Objective Response Rate (ORR) - BRAF Mutant Participants
From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)
Progression-Free Survival (PFS) - BRAF Mutant Participants
From randomization to progression or death (up to approximately 88 months)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score
From Baseline (prior to start of study treatment) to Week 25 after first dose
Study Arms (2)
Nivolumab + Ipilimumab
EXPERIMENTALParticipants 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.
Placebo + Ipilimumab
EXPERIMENTALParticipants 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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
San Francisco Oncology Associates
San Francisco, California, 94115, United States
Orlando Health Inc
Orlando, Florida, 32806, United States
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, 40202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, 89148, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
NYU Clinical Cancer Center
New York, New York, 10016, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
St. Luke's Hospital
Easton, Pennsylvania, 18045, United States
GHS Cancer Institute
Greenville, South Carolina, 29615, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr
Madison, Wisconsin, 53792, United States
Hopital Larrey
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Related Publications (4)
Long GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6.
PMID: 39504507DERIVEDMantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.
PMID: 34855329DERIVEDHodi FS, Chesney J, Pavlick AC, Robert C, Grossmann KF, McDermott DF, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor DR, Salama AK, Taylor MH, Ott PA, Horak C, Gagnier P, Jiang J, Wolchok JD, Postow MA. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1558-1568. doi: 10.1016/S1470-2045(16)30366-7. Epub 2016 Sep 9.
PMID: 27622997DERIVEDPostow 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.
PMID: 25891304DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2013
First Posted
August 22, 2013
Study Start
August 23, 2013
Primary Completion
July 24, 2014
Study Completion
February 26, 2021
Last Updated
March 18, 2022
Results First Posted
February 8, 2016
Record last verified: 2022-02