Surgically Treated Adjuvant Merkel Cell Carcinoma with Pembrolizumab (STAMP) Trial
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What is the STAMP/EA6174 study?
This study is seeking to find out whether treatment with an 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. agent (pembrolizumab) after surgery to remove your Merkel cell Merkel cell Merkel cells are found in the lower part of the epidermis. Although the exact function of Merkel cells is unknown, they are thought to be touch receptors. Also known as neuroendocrine cells, they have machinery similar to nerve cells and to hormone-secreting (endocrine) cells. 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. (MCC) may reduce the likelihood of the cancer coming back. Immunotherapy drugs such as pembrolizumab stimulate the body’s immune system to help the body fight cancer. These drugs have been shown to be effective and approved to treat many other cancers, including melanoma melanoma A form of skin cancer that begins in melanocytes (the skin cells that produce the pigment melanin). Melanoma affects about 42,000 Americans per year and has about a 15% mortality. skin cancer. Approximately 500 people will take part in this study.
Why is this study important to me and patients like me?
Merkel cell cancer is a rare disease, and there currently is no FDA-approved drug for MCC patients after their surgery. The usual approach to manage patients after surgery is observation (“watchful waiting”) and to sometimes add radiation therapy radiation therapy The use of radiation to kill cancer cells and shrink tumors. Merkel cell carcinoma is a highly radiation sensitive cancer in most cases. . It is not yet known whether adding an immunotherapy drug after surgery will be more effective than the usual approach. The STAMP study will help researchers answer that important question and has the potential to offer a new treatment option to patients with Merkel cell cancer.
What will happen if I choose to participate in this study?
If you are receiving this information, it means your doctor thinks you may be eligible for the STAMP study. If you decide to participate, a computer will randomly assign you to one of two groups:
• Arm A: If you are in this group, you will receive IV (intravenous through the vein) pembrolizumab over approximately 30 minutes, once every 21 days (17 cycles) for up to 1 year after your surgery.
• Arm B: If you are in this group, you will be followed with close observation for 1 year after surgery.
Patients in both groups also may receive radiation therapy, and you should discuss this with your study doctor.
Are there risks to being in the study?
Even if you are not on a study, there are risks associated with cancer treatment. All the possible risks are clearly stated in the study consent form. If you are selected, your oncologist oncologist A doctor who specializes in treating cancer. Three main types of oncologists exist: radiation oncologist, medical oncologist, and surgical oncologist. and nurse will carefully monitor for any side effects that you may experience during this study, and they will provide supportive therapy to help manage them.
What happens when my treatment is over?
For all study participants, regardless of which group you are assigned to, your doctor will continue to follow your condition for 4 years after you finish the study and watch you for side effects and any sign that your cancer has come back. You will have clinic visits every 6 months during this follow-up period. This means you will keep seeing your doctor for a total of 5 years.
What are the costs of taking part in this study?
The routine costs of the care required in clinical studies are usually covered by health insurance; however, coverage may not be the same from plan to plan, so please discuss these issues with your healthcare provider and your insurer. If you are assigned to receive pembrolizumab (Arm A), it will be provided at no cost to you during the course of the study.
What should I do if I’m interested?
For more information about the STAMP/EA6174 study, talk with your doctor, or:
• Click here for educational material. If you are seeking information about medical facilities where this study is available, click here.
• Call the NCI Cancer Information Service: 1-800-CANCER (1-800-422-6237)