Clinical Trial Information
Protocol: SWOG – S1801
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- 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 have histologically proven Stage IIIB or higher. This would entail pathologic confirmation beyond the primary or initial diagnosis of melanoma involving fine needle aspiration cytology or biopsy confirmation of any N-category or M-category resectable site.
- 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 any of the prohibited therapies listed in Section 7.2 during treatment phases on the study.
- Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on
- 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. Imaging studies must include a total body PET-CT scan that is of diagnostic quality with iodine contrast-enhanced images (with or without brain) or a CT of the chest, abdomen and pelvis with intravenous contrast. For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with intravenous contrast or iodine contrastenhanced PET-CT through the region) is required. If the patient has unknown primary with disease in the axilla, neck imaging is required CT
imaging should be done with intravenous contrast if there are no contraindications for it.
- All patients must have a CT or MRI of the brain within 42 days prior to randomization. The brain CT or MRI should be performed with
intravenous contrast (unless contraindicated).
- Patients must have Zubrod Performance Status ≤ 2.