The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and/or resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Male and female, age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histological or cytological evidence of Merkel cell cancer per AJCC, 8th edition.
Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Patients with controlled CLL must be off all therapy for at least 6 months.
Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.
Single group
Pembrolizumab
DrugPembrolizumab 400mg IV
Lutetium Lu 177 dotatate
Drug7.4GBq (200 mCi) IV
Objective Response Rate (ORR)
The objective response rate is the proportion of all subjects with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1.
Progression free survival (PFS)
Progression-free survival is defined as the time from the start of study treatment until the criteria for disease progression is met as defined by RECIST 1.1 or death due to any cause occurs. Subjects who are alive and have not progressed by the analysis cutoff will be censored at the date of the last disease evaluation.
Overall survival (OS)
Overall survival is defined as the time from the start of study treatment to death due to any cause. Subjects still alive by the analysis cutoff will be censored at their last date known to be alive.
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Weill Medical College of Cornell University
Lead sponsor
Hoosier Cancer Research Network
Collaborator
