A Single Arm Study With Safety Run-in of Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Immunotherapy for Patients With Merkel Cell Cancer (HCRN MCC20-443; iPRRT Study)
Weill Medical College of Cornell University
Summary
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.
Description
The study design will be a single arm phase 2 study in patients who have progressed on immunotherapy and who are candidates to continue pembrolizumab. Prior to enrollment in the Phase II portion, a run-in study will be performed to ensure safety and tolerability of the combination of pembrolizumab and lutetium Lu 177 dotatate. Peptide receptor radionuclide therapy (PRRT) will be given every 2 months for 4 doses. Pembrolizumab will be given every 6 weeks at 400mg fixed dosing for up to 2 years, until disease progression, or unacceptable toxicity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 2. Male and female, age ≥ 18 years at the time of consent. 3. ECOG Performance Status of 0-1 within 28 days prior to registration. 4. Histological or cytological evidence of Merkel cell cancer per AJCC, 8th edition. 5. Presence of somatostatin receptors by Ga-68 dotatate (or equivalent) imaging, which is a requirement for PRRT (lutetium Lu 177 dotatate \[Lutathera®\]).…
Interventions
- DrugPembrolizumab
Pembrolizumab 400mg IV
- DrugLutetium Lu 177 dotatate
7.4GBq (200 mCi) IV
Locations (3)
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Weill Cornell Medicine/NewYork-Presbyterian HospitalNew York, New York
- University of Wisconsin Carbone Cancer CenterMadison, Wisconsin