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Merkel Cell Carcinoma Treatment Study

Clinical Trial Title: 
A randomized phase Ii study of anti-pd1 antibody [mk-3475 (pembrolizumab)] alone versus anti-pd1 antibody plus stereotactic body radiation therapy in advanced merkel cell carcinoma.
Clinical Trial Protocol ID: 
18020604
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

Study for anti-pd1 antibody [mk-3475 (pembrolizumab)] alone versus anti-pd1 antibody plus stereotactic body radiation therapy for subjects with merkel cell carcinoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have pathologically (histologically or cytologically) proven diagnosis of merkel cell carcinoma (MCC) by local pathology review.
  • Have measurable disease based on RECIST 1.1 with at least two cancerous deposits. At least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT.
  • Have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging.
  • Have no prior immunotherapy for advanced/metastatic MCC (prior palliative RT is allowed as long as there are two unirradiated measureable cancerous deposits).

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of the following:
    • Have autoimmunity requiring systemic immunosuppression within 2 years.
    • Are HIV positive, unless you meet the following conditions:
      • CD4 counts ≥ 350 mm3
      • Serum HIV viral load of <25,000 IU/ml
  • Have other active malignancy that the investigator determines would interfere with the treatment and safety analysis.
  • Are pregnant and/or nursing.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Dermatology
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC