TRICK-MCC (Triple Immune Checkpoint Inhibition in MCC)

What is the purpose of the TRICK-MCC Trial?

The TRICK-MCC (Triple Immune Checkpoint Inhibition in Merkel) trial is for patients with Merkel cell carcinoma Merkel cell carcinoma A skin cancer composed of cells that look microscopically similar to normal Merkel cells present in the skin. MCC was first described in 1972 and only in the 1990s was the CK20 antibody developed to make it easily identifiable by pathologists. Many doctors and patients are not aware of this cancer because of its recent description and relative rarity (~2,000 cases/year in the US--roughly 30 times less common than melanoma). About 40% of patients treated for MCC will experience a recurrence, making it far more aggressive than most other types of skin cancer, including melanoma. (MCC) that has spread and is growing after standard immunotherapy immunotherapy A therapy that improves the function of the cells that recognize and destroy foreign objects in your body, such as a virus, bacteria or cancer. . This trial will study the benefits of three different immunotherapy drugs when given together. These 3 drugs are designed to kill cancer cancer A term used to describe diseases in which abnormal cells continually divide without normal regulation. Cancerous cells may invade surrounding tissues and may spread to other regions of the body via blood and the lymphatic system. cells by helping the immune cells work better.

Are there FDA approved therapies for MCC that has stopped responding to Anti-PD-1 agents?

There are currently no FDA approved therapies for MCC that has stopped responding to standard immunotherapy. Chemotherapy Chemotherapy Treatment with drugs to kill cancer cells or to render them less active. May be given intravenously or orally depending on the drug and situation. is sometimes used for treating MCC, but generally doesn’t lead to long-term benefit and has considerable side-effects.

Are the 3 drugs used in the TRICK-MCC trial approved by the FDA?

Only one (Retifanlimab or Anti-PD-1) of the 3 drugs being used in this trial has been approved by the FDA for use in MCC patients. The other two drugs (Anti-LAG-3 and Anti-TIM-3) in this trial are considered experimental and will be given to patients with MCC for the first time.  All three drugs have been given, either alone or in combination, to patients with other advanced cancers.

How do I know if I am eligible?

Eligible patients have MCC that has spread and is growing after standard immunotherapy (such as Keytruda, Bavencio and other similar agents). Your study doctor will provide you more detailed information about your final eligibility.

Where is the closest treatment center for me?

The trial is being conducted at the University of Washington and Fred Hutchinson Cancer Center in Seattle, WA (USA).

What are the potential risks of participating in this trial?

We do not yet know if this drug combination will be effective at treating MCC. We also still need to learn more about the risks of this 3-drug combination. These drugs may cause immune damage to body organs, such as liver, lung, kidney et cetera. In some cases, these side effects may be severe and life-threatening. Your study doctor will provide you more detailed information about the potential risks. Your study team will also monitor your well-being during your participation in the trial and ensure that you receive the appropriate care.

Are there costs associated with this trial?

If you decide to join this study, the study drugs will be provided to you at no cost. You may incur costs associated with your medical care, such as doctor’s visits, laboratory tests, scans and any other medical care needed, including treatment of side effects. You or your insurance company will be responsible for these costs. Your study team will help you find out whether your insurance company will cover these costs.

There may be limited reimbursement of eligible travel expenses while participating on the trial. However, this is not guaranteed.  Please ask the study team for more information.

Can I stop the clinical trial at any time?

Participating in the TRICK-MCC trial is completely voluntary. You can change your mind and stop at any time. You will need to inform the study team so that you end the study in the safest way.

What will happen if I stop the trial?

Your doctor will discuss other treatment options as they apply to your situation. They may also talk to you about follow-up care, if needed.

What will happen after the study ends?

The study team will find out how well the treatment worked for the MCC patients and the side-effects of the treatment. If the therapy is effective, we would open another trial for more MCC patients across the country. Information collected during the trial may be used for future MCC research.

Who can I contact to find out more information about this trial?

Please contact [email protected] for more information about this trial. Your oncologist oncologist A doctor who specializes in treating cancer. Three main types of oncologists exist: radiation oncologist, medical oncologist, and surgical oncologist. should also be able to help connect you with the study team members.