Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
Melanoma
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 56 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not randomized
- Masking
- No masking
Neoadjuvant cohort
Patients with resectable stage III/IV melanoma eligible for neoadjuvant treatment will be enrolled. Patient cases will be reviewed with the surgery team to confirm surgical resectability prior to enrollment and CT imaging will be obtained at baseline, as per standard of care.
Drug: Nivolumab · Drug: Ipilimumab · Diagnostic Test: Haystack MRD ctDNA Assay
Adjuvant cohort
Patients who already underwent complete surgical resection of stage IIB/IIC/III/IV melanoma (and did not receive prior neoadjuvant treatment.) All patients in this cohort must be within 10 weeks of surgery and have CT scans post-surgery prior to study enrollment to confirm they are radiographically disease-free. Following study enrollment, all patients will have the first ctDNA analyses done within 12 weeks of date of surgery.
Drug: Nivolumab · Drug: Ipilimumab · Diagnostic Test: Haystack MRD ctDNA Assay
Nivolumab DRUG
Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules.
Ipilimumab DRUG
Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation.
Haystack MRD ctDNA Assay DIAGNOSTIC_TEST
Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Event-Free Survival (EFS) in the Neoadjuvant Cohort
Time frame: Up to 5 Years
Defined as the time from initiation of study treatment to disease progression precluding surgery, melanoma recurrence, progression, or death from any cause.
Relapse-Free Survival (RFS) in the Adjuvant Cohort
Time frame: Up to 5 years
Defined as the time from initiation of adjuvant treatment to melanoma recurrence or death from any cause.
Secondary measures
Pathologic Response Rate (Neoadjuvant Cohort)
Time frame: Up to 12 weeks
Proportion of participants achieving pathologic response in the surgical specimen following neoadjuvant treatment, including pathologic complete response (pCR) and major pathologic response (MPR).
Objective Response Rate (ORR) by RECIST v1.1 (Neoadjuvant Cohort)
Time frame: Up to 12 weeks
Proportion of participants achieving a complete response or partial response according to RECIST version 1.1 based on radiographic assessments performed during neoadjuvant treatment.
Relapse With Undetectable ctDNA
Time frame: Up to 5 years
Frequency of participants who maintain undetectable circulating tumor DNA (ctDNA) during serial monitoring and subsequently experience clinical and/or radiographic melanoma relapse.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Study team and timeline
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study start
- Oct 21, 2026 Actual
- Primary completion
- Oct 21, 2030 Estimated
- Study completion
- Oct 21, 2030 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026