Narrow Excision Versus Wide Excision for the Treatment of Adults With Invasive Cutaneous Melanoma, ICEMAN Trial

Inclusion Criteria:

• Participants or legally authorized representatives (LAR) must provide writteninformed consent before any study-specific procedures or interventions are performed

• Age ≥ 18 years; all biological gender identities and racial/ethnic groups will beincluded

• Participants must have histologically confirmed primary cutaneous melanoma. Acralmelanomas are eligible.

• Participants must have one of the following:

• American Joint Committee on Cancer (AJCC) 8th Ed clinical stage IA disease withBreslow thickness > 0.5 mm AND at least one high-risk feature (Mitotic rate ≥ 2/mm2, age ≤ 42, lymphovascular invasion, head/neck location)

• AJCC 8th Ed Clinical Stage IB melanoma

• If a melanoma is widely transected and the true Breslow depth isuncertain, then to be eligible for this trial, the melanoma must bere-biopsied to ascertain an accurate Breslow depth.

• The index melanoma must be classified as low risk on the Merlin Assay (SkylineDx)

• Study intervention (surgery) must be completed within 120 days of the originaldiagnostic biopsy

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)

• Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial

• Participants with a history of HIV infection are eligible

• Participants can speak, read and write in English or Spanish

Exclusion Criteria:

• Uncertain diagnosis of melanoma (i.e. severely dysplastic nevi, melanocytic lesionof unknown malignant potential, atypical intraepidermal melanocytic proliferations)

• The patient has already undergone wide local excision at the site of the primaryindex lesion

• The patient has a pure desmoplastic melanoma. A pure desmoplastic melanoma isdefined as being > 90% desmoplastic type. Melanomas with < 90% desmoplastic type maybe included in this trial

• Mucosal and ocular melanomas are also excluded, as these are approached differentlyfor surgical excision

• Physical, clinical, radiographic, or pathologic evidence of satellite, in-transit,regional, or distant metastatic melanoma

• Participants with known or suspected cancer with regional or distant metastasis areexcluded from this clinical trial because this trial is aimed at evaluating thecontrol of localized disease

• The patient has undergone surgery on a separate occasion to clear the lymph nodes ofthe probable draining lymphatic field, including a sentinel lymph node biopsy, ofthe index melanoma

• Planned adjuvant radiotherapy to the primary melanoma site after excision

• Participant is unwilling or unable to comply with study procedures