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Cutaneous Melanoma

Treatment

How is Melanoma of the Skin Treated?

People diagnosed with melanoma have more (and better) treatment options than ever before.

The melanoma treatment landscape is changing every day as researchers learn more about this disease in the lab and as more clinical trials enroll patients. Understanding all of the melanoma treatment options will help you play an active role in your treatment and care. 

Up-to-date recordings on a variety of melanoma treatments can be found on our Educational Recordings page.

Surgery

Surgery is the mainstay of therapy for early-stage cutaneous (skin) melanoma. Skin biopsies of various types are used in diagnosing the primary melanoma tumor on the skin; once diagnosed, many other types of surgery are employed when appropriate. Melanomas have a tendency to spread to lymph nodes (see below), and so assessment of the lymph nodes is an important part of the evaluation of every melanoma patient, and sometimes this involves surgery for diagnosis and/or treatment of lymph node metastases of melanoma.

Types of Surgery

The initial biopsy may be performed by a dermatologist or dermatologic surgeon. Once diagnosed, in virtually every case, the primary melanoma should be removed with a margin of surrounding normal skin. Surgery to remove the melanoma may be performed by a surgical oncologist, a plastic surgeon, a head-and-neck surgeon or by a combination of these specialists. Even if an excisional biopsy was performed that removed the entire visible melanoma, along with a small amount of non-cancerous skin at the edges, wider removal, or excision, of a measured margin of normal skin is almost always indicated. Sentinel lymph node biopsies are used in some, but not all, cases of melanoma in which the lymph nodes feel normal to the surgeon on physical examination.

  • Wide Excision, often called Wide Local Excision or Radical Wide Excision, is done to decrease the chance of local recurrence. A wide excision, usually 1-2 cm, is made around the original melanoma site, and the tissue is sent to the pathologist for evaluation under a microscope. A skin graft or other type of reconstruction may be required in areas where skin is under tension, such as on the scalp or over the shin bone (tibia) on the lower leg. If sentinel node biopsy is indicated, it would be done at the same time as the wide excision. General anesthesia is often used.
  • Mohs Surgery is occasionally performed for early stage melanomas on the face, neck or scalp or other areas where conservation of tissue is a primary consideration. Most Mohs surgery is performed by specially trained dermatologists, who remove a relatively small section of apparently normal skin beyond the visible melanoma under local anesthesia, and look at it themselves under a microscope while the patient waits. If tumor cells are identified at the edges, another small section is removed. This process continues until the edges of what has been removed no longer show evidence of melanoma. If a skin graft or other reconstruction is required, it may be done on a different day from the Mohs surgery itself.
  • Sentinel Lymph Node Biopsy involves a radioactive tracer and blue dye injected into the site of the primary melanoma, and these travel to and identify the lymph node or nodes directly connected to the primary melanoma. Sentinel nodes are any nodes connected to the primary site, but the tracer and dye do not identify melanoma cells or indicate if the lymph nodes are normal or abnormal. The sentinel nodes are removed at the same time as the wide excision, and are examined by a pathologist under a microscope to determine if there are any melanoma cells detected. General anesthesia is typically used.
  • Complete Lymph Node Dissection: If lymph nodes are known to have melanoma in them, either because of a sentinel node biopsy or because they are enlarged or abnormal on ultrasounds or CT scans, removal of all the lymph nodes in that region may be recommended. General anesthesia is almost always used, and overnight hospitalization may be required.

Lymph Node Status

Lymph nodes are small glands that work as filters throughout the body. They contain immune cells that help fight infection and destroy germs carried in lymph fluid. There are hundreds of lymph nodes throughout your body and they are located primarily in the neck, armpits and groin, as well as internally within the chest and abdomen.

If the primary melanoma on the skin has certain high-risk characteristics, your doctor may want to have a pathologist examine your lymph nodes. This will help your doctor determine whether melanoma cells have traveled beyond the original site of the lesion. To check this, a surgeon will perform a sentinel lymph node biopsy (SLNB). The sentinel node is the first lymph node to which cancer is most likely to spread. If melanoma is found, the surgeon may remove additional lymph nodes to check for melanoma, but this is not always necessary.

The extent of lymph node involvement, as well as other factors, will help your doctor determine your stage of diagnosis. It is very important to find out your stage as this information will help drive your treatment plan as well as determine the frequency and nature of any follow-up testing.

Neoadjuvant Therapy

You may be hearing more about neoadjuvant therapy lately. This has become a hot topic that researchers are very interested in to determine if neoadjuvant therapy can be better than adjuvant therapy for the treatment of melanoma. 

 

View the Neoadjuvant Treatment Webinar!

 

Let’s start with discussing adjuvant therapy. Adjuvant therapy is therapy given after surgery, and several drugs have been approved by the FDA for the adjuvant treatment of patients with completely resected Stage III and for some patients with completely resected Stage IV melanoma at high risk of recurrence.

Both adjuvant immunotherapy and targeted therapy have shown the ability to decrease the risk of a recurrence. Now, a very active area of international research is exploring whether there is a benefit from giving therapy in the neo-adjuvant setting, which is giving treatment before surgery. This has shown benefit in some patients with other types of cancer, like breast and lung cancer.

What is neoadjuvant therapy?

Neoadjuvant therapy is treatment given before surgery that is intended to completely remove melanoma, while adjuvant therapy is given after surgery. Neoadjuvant therapy was initially studied in breast cancer in order to shrink the tumor and allow women the options of a smaller surgery, a lumpectomy or a partial mastectomy, in addition to the option of a complete mastectomy.

Both adjuvant and neoadjuvant treatment have the goal of decreasing the risk of the melanoma returning (recurrence) by attacking microscopic disease that cannot be seen by the eye, either in the area of the surgery or anywhere in the body.

Neoadjuvant therapy has additional goals, which include:

  • shrinking the tumor before surgery to minimize the area of surgery and maximize success
  • examining the tumor under the microscope before and after surgery to see if the tumor responded completely, partially or was resistant to the type of systemic neoadjuvant treatment given. This information could influence the use of adjuvant therapy or type of adjuvant therapy.
  • possible elimination or shortening of systemic treatment
  • allowing investigators to identify additional markers that predict success of treatment so that patients can be better matched to treatment
  • to determine if, as in breast cancer, the tumor completely resolves (called a pathologic complete response, i.e., no tumor visible under the microscope when examined by a pathologist). This can be a way that the FDA could identify and approve new drugs more quickly than following patients for years to see if the tumor recurs clinically.

Who should consider neoadjuvant therapy?

Stage III melanoma patients with clinically detectable disease and whom are eligible for surgery are ideal candidates for neoadjuvant therapy. This is because these patients represent a high-risk population, who often experience poor outcomes when treated with surgery as a first-line treatment.

Ask your doctor if you are a good candidate for the trials listed on www.clinicaltrials.gov and the new ones researchers are currently developing.

What is happening in neoadjuvant therapy clinical trials?

Several clinical trials exploring neoadjuvant melanoma therapy are currently underway and more trials are being developed. Some are exploring FDA-approved treatments, and some are exploring new drugs, not yet approved by the FDA, as single agents and in combinations. Treatments are being given to clinical trial participants before surgery, and sometimes after surgery, so researchers can compare and better understand how best to treat patients. These trials will also have questions that ask if there are better biomarkers to use to select treatment for each patient and if a pathologic complete response can be used to find and more quickly approve new drugs for patients in need.

Adjuvant Therapy

Adjuvant therapy in melanoma is a treatment or treatments that are given after primary treatment in order to lower the risk of recurrence (that the cancer may return). Most often in melanoma, the primary treatment is surgery. Surgery aims to remove all visible tumor on physical examination and scans, such as Xrays and CT scans. It is possible that small numbers of cancer cells may be undetectable and therefore not removed by surgery. Adjuvant therapy aims to assist primary treatment by eliminating any microscopic cells that may have escaped surgical removal.

In addition to surgery, radiation is sometimes recommended as an adjuvant treatment if there is a high risk for local occurrence where the tumor or lymph nodes were surgically removed.

Newer, recently approved systemic (traveling through the bloodstream) adjuvant therapies mean that medicines can target cells or enhance the immune system anywhere in the body.

FDA-Approved Adjuvant Treatments for Melanoma

Four immunotherapies and one targeted therapy combination are currently FDA approved for adjuvant therapy of melanoma:

Pembrolizumab (Keytruda®)

In February 2019, Keytruda was FDA-approved for the adjuvant treatment of patients with melanoma with lymph node(s) involvement, following complete resection. Approval was based on EORTC1325/KEYNOTE-054, a randomized, double-blind, placebo-controlled trial in 1,019 patients with completely resected Stage IIIa, IIIb or IIIc melanoma. The primary efficacy outcome measure was recurrence-free survival (RFS).

Dabrafenib (Tafinlar®) + Trametinib (Mekinist®)

In April 2018, Tafinlar and Mekinist were approved in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Approval was based on COMBI-AD (NCT01682083), an international, multi-center, randomized, double-blind, placebo-controlled trial in 870 patients with Stage III melanoma with BRAF V600E or V600K mutations. The major efficacy outcome was relapse-free survival (RFS). Patients who received the combination treatment had a statistically significant improvement in RFS compared with those receiving placebo.

Nivolumab (Opdivo®)

In December 2017, Opdivo was approved as an adjuvant treatment for completely resected Stage III or IV melanoma based on a clinical trial comparing Opdivo to Yervoy. Opdivo is the first PD-1 inhibitor to be approved as an adjuvant therapy in patients with lymph node involvement or metastatic disease who have undergone complete resection. Patients treated with Opdivo had fewer side effects, with 9% of patients discontinuing treatment due to adverse reactions and showed a longer time before a recurrence compared to Yervoy. More time is needed to follow patients and to learn the effect on overall survival.

Ipilimumab (Yervoy®)

In December 2019, findings from a study (E1609) published in the Journal of Clinical Oncology reported that ipilimumab given at a dosage of 3 mg/kg (ipi3) showed significant overall survival when compared to high dose interferon (HDI). Researchers also compared ipilimumab given at a dosage of 10 mg/kg (ipi10) compared to HDI and those trends favored ipi10 over HDI as well. Researchers concluded that the currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacy to HDI.

In October 2015, Yervoy, an anti-CTLA-4 antibody, was approved as an adjuvant therapy in patients with Stage III melanoma based on findings that survival was prolonged when compared to patients treated with placebo. Side effects can be significant, leading to discontinuation of therapy in half of the patients.

Peginterferon alpha 2-b (Sylatron®)

In December 2019, a study in the Journal of Clinical Oncology showed results indicating ipilimumab at a dosage of 3 mg/kg is superior to high dose interferon, leading many melanoma experts to believe that interferon no longer has a place in the adjuvant melanoma treatment setting.

Peginterferon was approved in 2011 for treatment of high-risk melanoma after surgery. Its use has been controversial due to its harsh side effects and low impact on recurrence and survival. Interferon has not shown a beneficial effect in advanced melanoma.

So, what does this mean for patients?

With new drug approvals, patients have more and better treatment options than ever before. These advances have changed the way patients are treated. Patients with early stage disease completely removed by surgery should discuss adjuvant therapies with their treatment team. Some questions to ask include:

  • Will adjuvant therapy decrease my chance of recurrence?
  • Which adjuvant therapy do you recommend and why?
  • What are the side effects?
  • How long would I be treated?
  • Is there a clinical trial that would be right for me?

Risk of Recurrence

Adjuvant therapies are recommended for those at moderate or high risk of recurrence. Risk is associated with characteristics of the tumor such as thickness, ulceration, high mitotic (growth) rate and involvement of local lymph nodes. This information is used to determine the stage of melanoma.

Clinical trials are exploring which patients may be at moderate or high risk for recurrence. Trials are also working to determine if there are other factors that can identify which patients would benefit from adjuvant therapy. A medical oncologist will work with a surgeon to determine whether adjuvant treatment may be helpful in lowering the risk of recurrence.

What’s next?

Great progress has been made but questions remain. Clinical trials are testing additional treatments, including vaccines, combination immunotherapies and targeted therapies. Clinical trials are examining the best dose, the duration of treatment, drug combinations vs single drugs, and biomarkers that may help doctors choose the best drug for each patient.

Building on the improvement seen in patients with advanced disease, clinical trials have assessed whether patients with early stage melanoma at moderate to high-risk of recurrence would also benefit. Three immunotherapies already approved for metastatic disease (pembrolizumab, ipilimumab and nivolumab) are now approved for adjuvant therapy with benefit seen in both BRAF mutant and BRAF wild-type patients. Single agent BRAF inhibitor, vemurafenib, did not show overall benefit as adjuvant therapy. However, results of the combination of a BRAF plus MEK inhibitor trial (dabrafenib plus trametinib) compared to placebo is showing a lot of promise and is being reviewed by the FDA.

The bottom line? Both FDA approved therapies and clinical trials can be a good option for patients. All options should be thoroughly discussed with your treatment team.

Immunotherapy

Immunotherapy is a type of systemic (whole body) therapy used for treating metastatic melanoma or melanoma that has a high risk for recurrence (returning). Immunotherapy treats the whole body by attempting to activate a person’s immune system so that it will destroy any melanoma cells within the body.

Immunotherapy is prescribed and administered by a medical oncologist in a variety of ways, most commonly by using biologic agents that stimulate the immune system. Other mechanisms are currently under investigation in clinical trials and include vaccine therapy, intra-lesional therapy, stem cell manipulation and others.

FDA-Approved Immunotherapy Treatments for Melanoma

Commonly prescribed immune stimulants include biologic agents such as antibodies, interferons and interleukins, which are administered in much higher doses than are usually present in the body.

Lifileucel (Amtagvi®)

In February 2024, the FDA-approved lifileucel (Amtagvi®) for the treatment of adult patients with cutaneous melanoma that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (specifically, a PD1 inhibitor and if relevant, a BRAF inhibitor with or without a MEK inhibitor). This is the first treatment for cancer that uses immune cells called tumor-infiltrating lymphocytes, or TILs, collected from the patient’s tumor.

Relatlimab + Nivolumab (Opdualag®)

In March 2022, the FDA approved nivolumab and relatlimab-rmbw (Opdualag) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.

Atezolizumab (Tecentriq®)

FDA-approved in July 2020 in combination with cobimetinib and vemurafenib (read more about these approvals in the Targeted Treatment section) for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This is the first time a triplet therapy has been approved for melanoma. Atezolizumab, a PD-L1 blocking antibody, when paired with the combined targeted therapy, was shown to be superior in the endpoint of progression-free survival when compared to the combined targeted therapy alone.

T-VEC (Imlygic®)

FDA-approved in October 2015. Imlygic is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients whose melanoma has recurred after initial surgery. Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors, causing tumors to rupture (cell death).

Ipi + Nivo (Yervoy® + Opdivo®)

Combination was FDA-approved in September 2015 based on improved response rates and progression-free survival in previously treated patients.

Nivolumab (Opdivo®)

FDA-approved in November 2015 as a first line therapy in previously untreated patients who do not have a positive BRAF V600 mutation. It was previously approved in 2014 for patients whose melanoma had progressed following ipilimumab and, if BRAF V600 mutation positive, also a BRAF inhibitor. It is the second anti-PD-1 drug approved for the treatment of unresectable (cannot be removed by surgery) or advanced (metastatic) melanoma, but the only anti-PD-1 therapy approved as a single agent for first-line use in patients with advanced BRAF V600 wild-type (not mutated) melanoma. In December 2017, Opdivo was approved (the first PD-1 inhibitor) as an adjuvant therapy in patients with lymph node involvement or metastatic disease who have undergone complete resection. This includes both BRAF mutant and BRAF wild-type patients. Opdivo is the first and only agent approved for the adjuvant treatment of melanoma based on head-to-head trial against an active comparator (Yervoy) with a proven overall survival benefit.

Pembrolizumab (Keytruda®)

FDA-approved in 2014 for demonstrating durable responses in patients whose disease has progressed following ipilimumab and, if BRAF V600 mutation positive, also a BRAF inhibitor. Randomized trials are in progress to assess the ability of pembrolizumab to improve time to progression and overall survival. Keytruda is the first anti-PD-1 drug to be approved by the FDA for melanoma.

Ipilimumab (Yervoy®)

FDA-approved 2011; the first drug in 13 years to be approved for the treatment of metastatic melanoma. In October 2015, Yervoy was approved as adjuvant therapy in patients with Stage III melanoma.

Peginterferon alpha 2-b (Sylatron®)

Peginterferon was approved in 2011 for treatment of high-risk melanoma after surgery. Its use has been controversial due to its harsh side effects and low impact on recurrence and survival. Interferon has not shown a beneficial effect in advanced melanoma.

Interleukin-2 (IL-2; Proleukin®)

FDA-approved in 1998; the first drug to be approved for metastatic melanoma; was approved on the basis of long-lasting complete response. Randomized trials of IL-2 have not been conducted, so precise information on long-term overall survival is not available.

Side Effects of Immunotherapy Treatments

Take a look at our Immunotherapy: Managing Side Effects webinar, hosted by Mike Postow, MD of Memorial Sloan Kettering Cancer Center.

Webinar: Immunotherapy Side Effects

Side effects of immunotherapy treatments are not the same as side effects of traditional cancer treatments, like chemotherapy. Side effects are not an indicator that the drug is working or not working. It is very important to report all side effects to your treatment team as soon as you notice them. Most side effects can be managed if they are treated early, and this may allow you to stay on the treatment longer. Because immunotherapies are still relatively new, little is known about the long-term side effects of these treatments. The most common side effects of immunotherapies include:

  • Fatigue
  • Muscle or joint pain
  • Itching or rashes
  • Colitis or other GI problems
Targeted Therapy

Targeted therapy is a form of treatment in which drugs (or other substances) are developed with the goal of destroying cancer cells while leaving normal cells intact. These drugs are designed to interfere with the specific molecules that are driving the growth and spread of the tumor. Because they are “targeted” to the tumor, these therapies may be more effective and associated with fewer side effects compared to chemotherapy and radiation therapy. A targeted therapy approach allows the classification of melanoma into different “subtypes” based on the genetic profile of the tumor. This facilitates personalized treatment as patients receive drugs based on the unique genetic profile, or subtype, of their tumor. Targeted therapies are usually taken in pills or capsules.

FDA-Approved Targeted Therapies for Melanoma

Know Now Patient Booklet

Encorafenib (Braftovi™) + Binimetinib (Mektovi®)

FDA-approved in June 2018 for the treatment of unresectable or metastatic melanoma with a BRAF V600E or BRAF V600K mutation. The approval followed a phase 3 trial which showed the combination doubled median progression-free survival (mPFS) compared to vemurafenib as a single therapy. It is not indicated for the treatment of patients with wild-type BRAF melanoma.

Vemurafenib (Zelboraf®) + Cobimetinib (Cotellic®)

FDA-approved in November 2015 for the treatment of BRAF V600 mutant melanoma. Vemurafenib was previously approved in 2011 but in research studies, this combination showed improved progression-free and overall survival compared to vemurafenib alone.

Dabrafenib (Tafinlar®) + Trametinib (Mekinist®)

FDA-approved in 2014 for demonstrating durable responses in patients with unresectable or metastatic melanomas that carry the BRAF V600E or V600K mutation. Randomized trials are in progress to assess the ability of the combination to improve time to progression and overall survival compared with dabrafenib alone. Most recently, in April 2018, Tafinlar and Mekinist were approved in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Approval was based on an international, multi-center, randomized, double-blind, placebo-controlled trial in 870 patients with Stage III melanoma with BRAF V600E or V600K mutations. The major efficacy outcome was relapse-free survival (RFS). Patients who received the combination treatment had a statistically significant improvement in RFS compared with those receiving placebo.

Dabrafenib (Tafinlar®)

FDA-approved in 2013 for the treatment of BRAF V600 mutant melanoma that cannot be removed by surgery. This drug is only approved for those patients who have tested positive for the BRAF mutation. It is not indicated for the treatment of patients with wild-type BRAF mutation.

Trametinib (Mekinist®)

FDA-approved in 2013 for the treatment of BRAF V600E or V600K mutations. It is a first-in-class MEK inhibitor approved for the treatment of unresectable or metastatic melanoma. It is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.

Vemurafenib (Zelboraf®)

FDA-approved in 2011 for the treatment of BRAF V600E mutant melanoma that cannot be removed by surgery. This drug is only approved for those patients who have tested positive for the BRAF mutation.

Genomics and Biomarkers

What is Personalized Medicine?

As research has become more advanced, scientists have discovered that not all types of melanoma are identical. Each cancer is as unique as the patient in which it is found. According to the NCI, personalized medicine, also known as precision medicine, is a “form of medicine that uses information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease. In cancer, personalized medicine uses specific information about a person’s tumor to help diagnose, plan treatment, find out how well treatment is working, or make a prognosis”.

The MRF’s webinar, Precision Medicine in Melanoma, may help you better understand the importance of genomic testing, biomarkers and what it means for the treatment of melanoma.

Webinar: Precision Medicine in Melanoma

Side Effects of Targeted Therapies

Side effects of targeted therapies are not the same as side effects of traditional cancer treatments, like chemotherapy. Side effects are not an indicator that the drug is working or not working. It is very important to report all side effects to your treatment team as soon as you notice them. Most side effects can be managed if they are treated early, and this may allow you to stay on the treatment longer. Because targeted therapies are still relatively new, little is known about the long-term side effects of these treatments. The most common side effects of targeted therapies include:

  • Fever
  • Rash
  • Itching
  • Sensitivity to sun
  • Development of squamous cell skin cancers
  • Joint pain
Radiation

Radiation therapy uses high energy rays, like x-rays, to kill cancer cells. Although radiation is not an overly common melanoma treatment option, it is most often used as a symptom-relieving therapy in patients whose melanoma has spread to the brain or bones. In these situations, the radiation would not be expected to cure the melanoma, but it may help to make the patient more comfortable. Radiation may also be given to high risk Stage III patients after surgery, as a form of adjuvant, or preventative, treatment to reduce the risk of the melanoma spreading or returning.

Radiation treatments only last a few minutes and are much like getting an x-ray, only the radiation is much stronger. Because of the strong energy that is used, radiation therapy requires careful planning to reduce the impact on surrounding, healthy tissues. Be sure to talk to your melanoma treatment team, especially your radiation oncologist, about the pros and cons of radiation for the treatment of melanoma.

Webinar: Radiology Basics

 

Possible side effects of radiation may include:

  • Issues to the skin at the site of the radiation
  • Fatigue
  • Nausea
  • Loss of appetite
  • Weight loss
  • Hair loss
Chemotherapy

Chemotherapy is a medication-based, systemic therapy to treat many types of cancer, including melanoma, by destroying melanoma cells throughout the body. The success of chemotherapy in the treatment of melanoma has been shown to be limited. Chemotherapy is prescribed and administered by a medical oncologist, a physician specially trained in oncology. The medical oncology team usually consists of physicians and specially trained nurses.

Chemotherapy Agents

  • Dacarbazine (DTIC) is the only FDA-approved chemotherapy agent for the treatment of Stage IV melanoma. It is administered as an intravenous infusion.
  • Temozolomide is an oral form of dacarbazine. This medication is not FDA-approved for the treatment of melanoma, but is often used in that setting with similar efficacy to its DTIC.
  • Other chemotherapy agents are sometimes used for the treatment of metastatic melanoma, including the taxanes (i.e. docetaxel, paclitaxel) and platinum agents (i.e. cisplatin, carboplatin), all with limited success.

Isolated limb perfusion (ILP)

Isolated limb perfusion (ILP) is a technique to deliver chemotherapy to arms or legs without causing overwhelming systemic damage. Roughly half of all melanomas occur in the extremities, and about 10 percent of patients with those lesions develop a recurrence.

Clinical Trials

All treatments that are available today have been discovered through clinical trials. Clinical trials are often viewed as the best treatment option for Stage II, III and IV melanoma patients, so it is important to learn about trials so you make an informed treatment decision. All treatment options, including clinical trials, should be thoroughly discussed with your melanoma team. 

What is a Clinical Trial?

Clinical research studies help find new ways to treat, prevent and diagnose diseases. A clinical trial is carefully designed to closely monitor people’s progress as they go through treatment with an investigational drug, product, device or method of treatment that has not been approved by the FDA. Today, all medications prescribed by a doctor must first be tested in clinical trials. Study participants receive close medical supervision and provide valuable feedback on their experiences.

All treatments must go through three phases of research before becoming available to the public:

  • Phase I  focuses primarily on safety in a small number of human volunteers
  • Phase II  tests the effectiveness of the new drug on a small number of human volunteers
  • Phase III  usually tests the new drug in comparison with the standard therapy currently being used on a larger number of human volunteers

Participating in a clinical trial is voluntary and participants may choose to discontinue participation at any time.

Finding Melanoma Clinical Trials

There are many ways you can learn more about available clinical trials, which centers of excellence are participating in clinical trials, and how to enroll in a trials; however, two of the easiest are noted below:

1. The MRF’s Clinical Trial Finder, hosted through our partner, EmergingMed, can provide you with a free, confidential, personalized service that helps you understand which trials may be an option for you. For best results, we recommend that you register and complete the profile information. This helps ensure you learn of the best possible trials for you.

Find a Melanoma Trial

2. The NIH hosts a world-wide clinical trial database provided by the U.S. National Library of Medicine. Be specific in your search terms to find the most helpful results.

 

Learn more about clinical trials, patient safety and questions to ask your doctor HERE!

Content reviewed by:

Content last updated: May 14, 2020

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This Interactive Decision Support Tool may help you better understand your diagnosis and available treatment options. The tool allows you to enter specific information about your diagnosis and become a partner in your care. Once all your information is entered, the tool will provide treatment options chosen by 5 melanoma experts based on your information, which you can print and share with your oncologist.