RecruitingPhase 2NCT05583708

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

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)

Sponsor

Weill Medical College of Cornell University

Enrollment

18 participants

Start Date

Aug 3, 2023

Study Type

INTERVENTIONAL

Conditions

Merkel Cell Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer treatments — lutetium-177 dotatate (a radioactive therapy that targets tumors) and immunotherapy — in people with Merkel cell cancer, a rare and aggressive form of skin cancer. The combination aims to work together to attack cancer cells that express somatostatin receptors. **You may be eligible if...** - You are 18 or older - You have confirmed Merkel cell cancer - Your tumor shows somatostatin receptors on a Ga-68 dotatate scan - Your cancer has gotten worse on or after treatment with anti-PD-1/L1 immunotherapy - Your cancer can be measured on scans - You are in good overall health **You may NOT be eligible if...** - Your tumor does not show somatostatin receptors on the required scan - You have not previously been treated with immunotherapy - You have serious other medical conditions that make the treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.