The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified dose on specified days
Specified dose on specified days
Event-free survival (EFS)
Time frame: Up to 4 years
Recurrence-free survival (RFS) Time from Surgery
Time frame: Up to 5 years
RFS Time from Adjuvant Therapy
Time frame: Up to 5 years
Pathologic response rate (pRR) by immune-related pathologic response (irPR)
Time frame: Up to 5 years
Concordance major pathologic response (MPR) by local and central pathology Review
MPR is defined as participants achieving either pathologic complete response (pCR) or near pCR
Time frame: Up to 5 years
RFS by MPR
Time frame: Up to 5 years
Incidence of Adverse Events (AEs)
Time frame: Up to 5 years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Incidence of deaths
Time frame: Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 5 years
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 5 years
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Local Institution
Gilbert, Arizona, United States
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Tucson, Arizona, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
...and 108 more locations
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 5 years
Change from baseline in Health-related quality of life (HRQoL) by the Trial Outcome Index (TOI) and Melanoma Subscale (MS)
Time frame: Up to 5 years