Ensayos clínicos

Inclusion Criteria:

• Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review
• Have measurable disease based on RECIST 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol
• Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging
  • Patients with locoregionally confined disease are not eligible
• No prior immunotherapy for advanced/metastatic MCC
• Patients with known or suspected central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms
• Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria
  • No prior radiation therapy (> 5 Gy) to the metastasis intended to be treated with SBRT
• No history of the following:
  • Autoimmunity requiring systemic immunosuppression within 2 years
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following:
    • CD4 counts >= 350 mm^3
    • Serum HIV viral load of < 25,000 IU/ml
• No other active malignancy that the investigator determines would interfere with the treatment and safety analysis
• Not pregnant and not nursing; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =< 28 days prior to registration is required
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9.0 g/dl
• Total bilirubin =< 2.0 mg/dl
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN)
• Systolic blood pressure (BP) =< 150 mg HG
• Diastolic BP =< 90 mg HG
• Albumin > 3 mg/dl
• Blood urea nitrogen (BUN) =< 30 mg/dl
• Creatinine =< 1.7 mg/dl
• The following imaging workup to document metastases within 45 days prior to study registration are required: CT scans of the chest, abdomen and pelvis with radionuclide bone scan OR whole body (at least skullbase to midthigh) positron emission tomography (PET)/CT