Melanoma treatment with immunotherapy guided by serial ctDNA testing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional study in adults with melanoma, examining the use of serial ctDNA monitoring to guide adjuvant or neoadjuvant immunotherapy with nivolumab and ipilimumab. Participants are divided into neoadjuvant (resectable Stage III/IV) or adjuvant (completely resected Stage IIB–IV) cohorts and must have adequate organ function and performance status. Blood-based ctDNA measurements are used alongside standard care to inform treatment decisions during and after the initial drug exposure. The trial is led by Moffitt Cancer Center and uses the Haystack MRD ctDNA assay as part of the management strategy.

Why it matters

Who can join: the full rules

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

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Zeynep Eroglu, MD — Moffitt Cancer Center
• Study coordinator: Anjana Menon
• Email: Anjana.Menon@moffitt.org
• Phone: 813-745-5537

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.