Recruiting
Phase 2

ctDNA

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT07930182

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nivolumab

Ipilimumab

Haystack MRD ctDNA Assay

Study Details

Brief summary:

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.

Conditions

Melanoma

Study ID

NCT07930182

Start date

Oct 21, 2026

Status verified date

Nov, 2026

Completion date

Oct 21, 2030

Anticipated

Primary completion date

Oct 21, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

Nivolumab

Administered intravenously as neoadjuvant and/or adjuvant therapy for melanoma according to protocol-defined dosing schedules.

Ipilimumab

Administered intravenously in combination with nivolumab in participants meeting ctDNA-defined criteria for treatment escalation.

Haystack MRD ctDNA Assay

Tumor-informed circulating tumor DNA assay performed on serial plasma samples to evaluate molecular residual disease and guide treatment adaptation.

Primary outcome measure

  • Event-Free Survival (EFS) in the Neoadjuvant Cohort [ Time Frame: Up to 5 Years ]
  • Relapse-Free Survival (RFS) in the Adjuvant Cohort [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Anjana Menon

813-745-5537Anjana.Menon@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Zeynep Eroglu, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.