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1 Study Matches

Site for A Phase III Randomized Trial Comparing Adjuvant MK3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.

We are asking you to take part in a research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.

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Joseph Drabick
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712605
SITE00000461
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Inclusion Criteria:
Patients must have an ECOG performance Status: 0, 1, or 2
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years

Exclusion Criteria:
Women who are pregnant
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Cancer
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Location Contacts
Hershey, PA ,