Not recruiting

Study Comparing High Dose Interferon, Ipilimumab, and Pembrolizumab for Patients with High Risk Resected Melanoma

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for high-risk resected melanoma, a type of skin cancer that has been surgically removed but has a high chance of returning. The study is comparing the effectiveness of different treatments, including a medication called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a type of drug that helps the immune system fight cancer. The trial also involves other treatment options, such as high-dose interferon and ipilimumab, which are also used to treat melanoma.

The purpose of the study is to compare how well these treatments work in helping patients live longer and stay free from cancer recurrence. Participants in the study will receive one of these treatments, and their progress will be monitored over time. Some patients may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatments being studied.

The study will take place over a period of time, with regular check-ups and assessments to track the health and progress of the participants. The goal is to determine which treatment option provides the best outcomes for patients with high-risk resected melanoma, ultimately helping to improve future treatment strategies for this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Registration and initial assessments
Upon joining the study, the first step involves registration and initial assessments. This includes a complete physical examination and imaging studies to confirm a disease-free status. A CT or MRI of the brain is required to ensure no brain metastases are present.
Blood tests will be conducted to check bone marrow, liver, and kidney functions. A baseline ECG will be performed to assess heart health. If applicable, a pregnancy test will be conducted for women of childbearing potential.
Step 2
Specimen submission
Participants must provide a minimum of 5 unstained slides from the primary, lymph node, or metastatic site to determine PD-L1 expression. Blood samples may also be required for further analysis.
Step 3
Randomization
Participants will be randomly assigned to one of the treatment groups. This could involve receiving either high dose interferon, ipilimumab, or pembrolizumab (also known as MK-3475).
Step 4
Treatment administration
If assigned to the pembrolizumab group, the medication will be administered as an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.
Participants in the other groups will receive either high dose interferon or ipilimumab according to the study guidelines.
Step 5
Ongoing assessments
Throughout the trial, regular assessments will be conducted to monitor health status and treatment effects. This includes physical exams, imaging studies, and laboratory tests.
Participants will be required to complete quality of life questionnaires if they are able to do so in English, Spanish, or French.
Step 6
Follow-up
After completing the treatment phase, follow-up visits will be scheduled to continue monitoring health and any long-term effects of the treatment. This phase is crucial for assessing overall survival and relapse-free survival.

Who can join the trial?

19 criteria

Patients must have had their melanoma completely removed through surgery.
The melanoma must be of skin origin or unknown origin, but not from the eye.
Patients must be classified as Stage IIIA (N2a), IIIB, IIIC, or Stage IV melanoma.
Patients must not have a history of cancer spreading to the brain.
Patients must be free of disease as shown by a physical exam and imaging tests within 42 days before joining the study.
Patients must have a CT or MRI scan of the brain within 90 days before joining the study.
Patients must have adequate bone marrow function, which means having enough blood cells: ANC (a type of white blood cell) ≥ 1,500 per microliter, platelets ≥ 100,000 per microliter, and hemoglobin ≥ 10 grams per deciliter.
Patients must have adequate liver function, shown by specific blood tests being within normal limits.
Patients must have adequate kidney function, shown by specific blood tests being within normal limits.
Patients must have a LDH (lactate dehydrogenase) test done within 42 days before joining the study.
Patients must have a Zubrod Performance Status of 0 or 1, which means they are fully active or restricted in physically strenuous activity but can carry out light work.
Patients must have a normal ECG (electrocardiogram) or one that is not considered significant within 42 days before joining the study.
Patients who are HIV positive can join if they have stable and adequate CD4 counts (≥ 350 per cubic millimeter) and a low HIV viral load.
Women who can have children must have a negative pregnancy test within 28 days before joining the study and agree to use effective birth control during the study and for 120 days after the last dose of study medication.
Patients must be able to complete questionnaires in English, Spanish, or French.
Patients must be willing to provide tissue samples for testing.
Patients must be willing to have blood samples taken for specific tests if they are in the MK-3475 group.
Patients may have had previous radiation therapy, but any side effects must have resolved to a mild level before joining the study.
Patients must be 18 years of age or older.

Who cannot join the trial?

13 criteria

Patients with a history of other types of cancer, except for certain skin cancers that have been treated and are not active.
Patients who have had an organ transplant.
Patients with an active infection that requires treatment.
Patients who are pregnant or breastfeeding.
Patients with a known allergy to any of the study drugs.
Patients who have received another investigational drug within the last 4 weeks.
Patients with a history of autoimmune disease, which is when the body's immune system attacks its own tissues.
Patients with a history of certain heart conditions.
Patients with a history of certain lung conditions.
Patients with a history of certain liver conditions.
Patients with a history of certain kidney conditions.
Patients with a history of certain neurological conditions, which affect the brain and nerves.
Patients who are unable to comply with the study procedures.

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Investigated drugs

Interferon alfa-2b
is a medication used to help the body's immune system fight cancer. It is often used in treating melanoma, a type of skin cancer. In this trial, it is one of the options for patients who have had their melanoma surgically removed. The goal is to see if it can help improve survival rates by preventing the cancer from coming back.
Ipilimumab
is another medication used in this trial. It works by helping the immune system attack cancer cells more effectively. Ipilimumab is used for patients with melanoma that has been surgically removed, and the trial aims to determine if it can help patients live longer without the cancer returning.
MK-3475 (Pembrolizumab)
is a medication that also boosts the immune system's ability to fight cancer. It is being tested in this trial to see if it can improve survival rates for patients with melanoma that has been removed by surgery. Pembrolizumab is known for its role in treating various types of cancer by targeting specific proteins that help cancer cells evade the immune system.

Pembrolizumab

What is already known about the treatment

High Dose Interferon Alfa-2b
This medication is administered through an injection, typically given under the skin or into a vein. It is currently used in medicine to treat high-risk resected melanoma, a type of skin cancer. The main purpose of this medication is to help prevent the cancer from coming back after surgery. It works by boosting the body's immune system to fight cancer cells more effectively. Interferon Alfa-2b is classified as an immunotherapy drug, which means it helps the immune system to attack cancer cells.
Ipilimumab
Ipilimumab is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. It is used in the treatment of high-risk resected melanoma to help prevent the cancer from returning. The drug works by blocking a specific protein on immune cells, which enhances the body's immune response against cancer cells. Ipilimumab is part of a class of medications known as immune checkpoint inhibitors, which help the immune system recognize and destroy cancer cells.
Pembrolizumab (MK-3475)
Pembrolizumab is administered as an intravenous infusion, allowing it to enter the bloodstream directly. It is used to treat high-risk resected melanoma, aiming to reduce the chance of cancer recurrence. The medication functions by targeting a protein on immune cells, thereby boosting the immune system's ability to detect and attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer more effectively.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new mole or a change in an existing mole, and it can be identified by its irregular shape, multiple colors, and larger size. As melanoma progresses, it can grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. In its early stages, melanoma is typically confined to the outer layer of skin, but as it advances, it can penetrate deeper layers and become more difficult to treat. The disease is more likely to spread if it reaches the lymphatic system or bloodstream. Early detection and monitoring of changes in the skin are crucial for managing melanoma effectively.