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8110 Gatehouse Road, Falls Church, VA 22042

Surgically Treated Adjuvant Merkel cell Carcinoma with Pembrolizumab, a Phase III Trial (STAMP)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03712605

Background Information

This study is being done to determine if the chance of cancer growing back is lessened by adding a study drug after surgery.

This study may help discover if this approach is better or worse than the usual approach for Merkel Cell Carcinoma. The usual approach is defined as care most people get after surgery to remove cancer. The usual approach for patients who are not in a study is treatment with surgery, followed by close observation and sometimes radiation. A doctor can explain which treatment may be best. These treatments can reduce symptoms and may stop the tumor from growing for a few months or longer.

This study has public funding from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United States Department of Health and Human Services.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A department of Inova Fairfax Hospital

Eligibility Information

  • Adults over the ages of 18
  • Participants must have an ECOG performance Status: 0, 1, or 2. (However, those patients with a performance state of 3 because they are wheel chair bound due to congenital or traumatic events more than one year before the diagnosis of Merkel cell carcinoma are eligible)
  • A histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb
    • Stage I patients with negative sentinel lymph node biopsy are ineligible. Patients who have a positive biopsy or for whom no biopsy was done are eligible
  • Operative notes from participant’s surgical resection must be accessible
  • Additional eligibility in protocol

Ineligibility Information

  • Pregnancy/breastfeeding
  • Distant metastatic disease (stage IV)
  • Previous systemic therapy or radiation therapy prior to surgery for Merkel cell carcinoma and cannot have completed adjuvant radiation therapy for Merkel Cell Carcinoma more than 6 weeks prior to registration. Patients actively undergoing radiation therapy or having completed adjuvant radiation therapy within 6 weeks of registration are eligible, as long as resection date is within 16 weeks of registration
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03712605