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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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Participants: 56 · Started: Oct 21, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07930182

Locations in the U.S.

FloridaMoffitt 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.