QUILT-3.009: Patients With Stage III (IIIB) or Stage (IV) Merkel Cell Carcinoma (MCC)

Exclusion Criteria

• •1. Major surgery within 30 days before study entry.
• •2. Any of the following clinical laboratory values at the time of enrollment:
• •1. Absolute neutrophil count (ANC) \< 1,000 cells/mm\^3.
• •2. Platelets \< 50,000 x 10\^9/L.
• •3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g. AST, ALT, GGT) \> 2 x the ULN. Elevation related to direct tumor infiltration is allowed.
• •4. Renal insufficiency as indicated by a creatinine level \> 2 x the ULN.
• •5. Myocardial infarction within 6 months prior to enrollment or New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the Investigator. Prior to study entry any known abnormality on an electrocardiogram (ECG) must be determined and documented by the Investigator to be not clinically significant to the patient participation in this study.
• •6. Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
• •7. Female patients who are pregnant or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
• •1. Patients who have been continuously disease-free for any solid tumor malignancy \>3 years prior to the time of enrollment.
• •2. Patients with basal cell carcinoma or squamous cell carcinoma.
• •3. Patients with prior history of in situ cancer (e.g., breast, melanoma, squamous cells carcinoma of the skin, cervical).
• •4. Patients with prior history of prostate cancer that is not under active systemic treatment (except hormonal therapy), but with undetectable PSA (\<0.2 ng/mL).