Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
RecruitingPhase 2Healthy volunteers welcome
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment * Contraindication to nivolumab and/or ipilimumab * Active autoimmune disease requiring systemic immunosuppressive therapy * Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments * Unresectable disease * Uveal melanoma * Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation
About the study
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.
What is being tested
- Nivolumab (drug)
- Ipilimumab (drug)
- Haystack MRD ctDNA Assay (diagnostic test)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Participants: 56 · Started: Oct 21, 2026
Contact the study team
- Anjana Menon · Phone: 813-745-5537
Official record on ClinicalTrials.gov — NCT07930182
Locations in the U.S.
| Florida | Moffitt Cancer Center, Tampa |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.