Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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, because this study involves an investigational agent
whose genotoxic, mutagenic and teratogenic effects on the developing fetus and
newborn are unknown; 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 skull base to midthigh) positron
emission tomography (PET)/CT