NCT05583708

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 400mg IV
DRUG	Lutetium Lu 177 dotatate	7.4GBq (200 mCi) IV

Timeline

• Start date: 2023-08-03
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-10-18
• Last updated: 2025-05-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study