Malignant Melanoma Treatment Protocols

Treatment by Stage

• For patients with stage I and stage IA (≤1 mm thick, no ulceration, mitotic rate < 1/mm2 with no adverse features) melanoma, treatment recommendations include wide-excision surgery
• For patients with stage IA (≤1 mm thick, no ulceration, mitotic rate < 1/mm2 with one or more adverse features), consider wide-excision surgery and discussion of sentinel lymph node biopsy (SLNB)

• Surgery is recommended for stage IIB or IIC; also discuss or offer SLNB
• If SLNB is performed and node positive, then complete dissection of nodal basin should be performed
• Alternatively, observation can be recommended or clinical trial or interferon alfa
• Use of interferon alfa is based on lower level of clinical evidence, and its use should be individualized

Nivolumab (Opdivo) is an adjuvant therapy for patients who have undergone complete resection of melanoma with lymph node involvement or metastatic disease. Recommended dosage is 240 mg IV every two weeks until disease recurrence or unacceptable toxicity for up to one year.

For patients with stage III in-transit disease, primary treatment options include the following:

• Complete resection (preferred, if feasible)
• SLNB for resectable disease
• Hyperthermic perfusion/infusion with melphalan for localized multiple lesions in a single extremity or recurrent lesions in a single limb
• Clinical trial
• Intralesional injection (bacillus Calmette-Guérin [BCG], interferon alfa)
• Local ablation therapy
• Systemic therapy
• Topical imiquimod (Zyclara, Aldara)

• Treatment depends on whether melanoma is limited (resectable) or disseminated (unresectable)
• If limited disease, resection is recommended; alternatively, observation or systemic therapy
• Treatment for limited disease includes clinical trial or systemic therapy with interleukin-2 (IL-2) or temozolomide (Temodar, Temodal, Temcad), dacarbazine, or paclitaxel (Taxol, Onxal) based chemotherapy for two to three cycles, ipilumimab q3 wk four times, and then assessment for response; if stable, continue treatment (see below for drug regimens)
• For patients with unresectable disease without brain metastases, treatment includes systemic therapy; patients with brain metastases require treatment of the central nervous disease
• For stage IV disease in one limb, recommendations include surgery plus lymph perfusion treatment plus options such as observation, clinical trial, or treatment with interferon alfa

Single-Agent Treatment for Advanced or Metastatic Melanoma

See the list below:

• Vemurafenib (Zelboraf) 960 mg PO q12 h (for patients with BRAF V600E mutation); not indicated for wild-type BRAF melanoma
• Dabrafenib (Tafinlar) 150 mg PO BID (for BRAF V600E mutation); not indicated for wild-type BRAF melanoma
• Trametinib (Mekanist) 2 mg PO qd (for BRAF V600E or V600K mutations); not indicated in patients who have received prior BRAF inhibitor therapy

Treatment for Disease Progression Following Ipilimumab and BRAF Inhibitor Treatment

Treatment options for unresectable or metastatic melanoma and disease progression following ipilimumab treatment are as follows:

Oncolytic Immunotherapy

It is administered by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance

Dosage and volume of the injection(s) depend on whether it is the initial dose, second dose, or subsequent doses and by lesion size

Return to the Metastatic Melanoma Guide

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