Actively Recruiting
Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
Led by Weill Medical College of Cornell University · Updated on 2026-04-22
18
Participants Needed
3
Research Sites
278 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
H
Hoosier Cancer Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization
- Male or female aged 18 years or older
- ECOG Performance Status of 0-1 within 28 days prior to registration
- Histological or cytological confirmation of Merkel cell carcinoma
- Presence of somatostatin receptors by Ga-68 dotatate imaging with at least one measurable lesion
- Progression after treatment with at least 2 doses of anti-PD-1/L1 monoclonal antibody documented within 12 weeks
- Prior cancer treatments completed with recovery from acute toxic effects to Grade 1 or baseline
- Adequate organ function based on blood counts, kidney, liver, and coagulation tests within 28 days prior to registration
- Negative serum pregnancy test for sexually active females of childbearing potential within 7 days prior to registration
- Willingness to use effective contraception or abstain from heterosexual activity during and after the study as specified
- If HBsAg positive, must be on antiviral therapy with undetectable viral load prior to registration
- If history of HCV infection, must have undetectable viral load and completed curative therapy at least 4 weeks prior
- HIV-infected participants must have well-controlled HIV with stable ART and no recent AIDS-defining infections
- Ability to understand and comply with study procedures for the entire study duration
You will not qualify if you...
- Additional active malignancy requiring treatment within past 3 years (some exceptions apply)
- Known active central nervous system metastases or carcinomatous meningitis
- Receipt of live or live-attenuated vaccine within 30 days prior to first study dose
- Diagnosis of immunodeficiency or recent use of high-dose systemic steroids or immunosuppressive therapy
- History of allogeneic tissue or solid organ transplant
- Severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment within past 2 years
- History of pneumonitis requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- Active tuberculosis infection
- Any medical or psychiatric condition that could interfere with study participation or safety
- Pregnancy, breastfeeding, or plans to conceive or father children during study and specified post-treatment periods
- Significant cardiovascular disease or cardiac insufficiency including recent myocardial infarction or unstable angina
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
3
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
A
Anna C Pavlick, BSN, MSc, DO, MBA
CONTACT
A
Allison Lipps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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