Phase II Study of Combining Radioactive and Immunotherapy Drugs for Merkel Cell Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT05583708

This clinical trial is exploring the effects of combining an immunotherapy drug, pembrolizumab, with a radioactive drug, Lutathera, to treat Merkel cell cancer. While pembrolizumab is already approved for this cancer, Lutathera is not, making this combination an experimental approach.

Patient Parameters

Parameter	Options

Program Overview

The study aims to see how well a combination of pembrolizumab, an immunotherapy drug, and Lutathera, a radioactive drug, works in treating Merkel cell cancer. Pembrolizumab helps the immune system fight cancer, while Lutathera targets and kills cancer cells. Although pembrolizumab is approved for Merkel cell cancer, Lutathera is not, so this combination is considered investigational.

Description

This study involves patients whose Merkel cell cancer has worsened despite previous immunotherapy. Before the main study begins, a preliminary phase will ensure the safety of combining pembrolizumab and Lutathera. Participants will receive Lutathera every two months for a total of four doses. Pembrolizumab will be administered every six weeks at a fixed dose for up to two years, or until the cancer progresses or side effects become unacceptable.

Eligibility Criteria

Inclusion Criteria

Must provide written consent and authorization for the release of health information.
Must be 18 years or older.
Must have a good performance status, meaning they are fully active or only slightly restricted in physical activity.
Must have confirmed Merkel cell cancer.
Must have specific receptors on their cancer cells that allow Lutathera to work.
Must have cancer that has worsened after at least two doses of previous immunotherapy.
Must have recovered from any previous cancer treatments.
Must have adequate organ function based on blood tests.
Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
Men must agree to use contraception.
Participants with hepatitis B or C must have controlled infections.
HIV-positive participants must have well-controlled HIV.
Must be able to understand and comply with study procedures.

Exclusion Criteria

Have another active cancer that requires treatment.
Have active cancer spread to the brain or spinal cord.
Have received a live vaccine recently.
Have an immune deficiency or are on high-dose steroids.
Have had an organ transplant.
Have severe allergies to pembrolizumab.
Have an active autoimmune disease requiring treatment.
Have a history of lung inflammation requiring steroids.
Have an active infection or tuberculosis.
Have any condition that could interfere with the study.
Have psychiatric or substance abuse issues affecting participation.
Are pregnant or breastfeeding.
Have significant heart disease.

Locations

FACILITY	ZIP	CITY	STATE
University of Iowa Hospitals and Clinics	52242	Iowa City	Iowa
Weill Cornell Medicine/NewYork-Presbyterian Hospital	10065	New York	New York
University of Wisconsin Carbone Cancer Center	53792	Madison	Wisconsin

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