Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
NCT ID: NCT01927419
Last Updated: 2022-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
142 participants
INTERVENTIONAL
2013-08-23
2021-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Nivolumab
Ipilimumab
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.
Ipilimumab
Placebo
Matching nivolumab
Interventions
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Nivolumab
Ipilimumab
Placebo
Matching nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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San Francisco Oncology Associates
San Francisco, California, United States
Orlando Health Inc
Orlando, Florida, United States
University Of Louisville Medical Center, Inc., Dba
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers Of Nevada
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
University Of New Mexico Cancer Center
Albuquerque, New Mexico, United States
NYU Clinical Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's Hospital
Easton, Pennsylvania, United States
GHS Cancer Institute
Greenville, South Carolina, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr
Madison, Wisconsin, United States
Hopital Larrey
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Mantia 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.
Hodi 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.
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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2013-002018-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-069
Identifier Type: -
Identifier Source: org_study_id
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