Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
Key facts
- Where
- Tampa, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Moffitt Cancer CenterTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- H. Lee Moffitt Cancer Center and Research Institute
- Trial code
- NCT07930182
- Record updated
- 10 November 2026
- Original description
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.Read full original descriptionShow less
The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.
Inclusion: Age ≥18 years; Histologically confirmed melanoma (excluding uveal melanoma); Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma; Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma; ECOG Performance Status ≤2; Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN; Baseline imaging obtained within 28 days prior to treatment initiation; Negative pregnancy test for women of childbearing potential; Ability to understand and sign informed consent.
Exclusion: Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment; Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments; Active autoimmune disease requiring systemic immunosuppressive therapy; Unresectable disease; Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation; Contraindication to nivolumab and/or ipilimumab; Uveal melanoma.