Research & Trial Information
Protocol#: SWOG – S1801
Cancer Type: Melanoma
- Patients must have resectable melanoma in order to be eligible for this study. Patients must have clinically detectable Stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or Stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with melanoma of uveal origin are not eligible. Patients with a history of brain metastases are not eligible. Clinically detectable is defined as disease that is apparent and measurable via physical examination or radiographic imaging.
- Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by H & E stained slides.
- Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
- Patients must not have received previous neoadjuvant treatment for their melanoma. Patients may have received prior non-immunotherapy adjuvant therapy. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, PEG-IFN, anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies.
- Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on protocol therapy.
- Patients may have received prior radiation therapy, including after prior surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to ≤ Grade 1 prior to randomization.
- Patients must be ≥ 18 years of age.
- All patients must have disease status documented by a complete physical examination and imaging studies within 42 days prior to randomization.
- Patients must have Zubrod Performance Status ≤ 2.
- Prior malignancy is allowed providing it does not require concurrent therapy.