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Melanoma

MELANOMA TREATMENT WITH KEYTRUDA

For stage 3 melanoma

KEYTRUDA may help prevent melanoma from returning after surgery to remove it and the lymph nodes that contain cancer

KEYTRUDA is an FDA-approved immunotherapy that may be used to prevent melanoma from coming back after stage 3 melanoma and the lymph nodes that contain cancer have been removed by surgery. Learn more about the risk of melanoma returning and why treatment after surgery may be right for you.

Understanding options after surgery for stage 3 melanoma

You’ll learn:

  • About options after surgery
  • That melanoma may return after surgery
  • Questions to ask your care team

Options after surgery

If you’ve had surgery to remove stage 3 melanoma, your doctor will likely refer you to an oncologist.

The oncologist may recommend:

  • Treatment after surgery, called adjuvant (a-joo-vunt) treatment, which may help lower the chance of melanoma coming back
  • Observation, when you have regular check-ups to see if the melanoma has returned. This is also known as “watch and wait”

What is recurrence?

Even if you’ve had surgery to remove melanoma and the lymph nodes that contained cancer, there’s a chance it can return. When melanoma returns, it’s called recurrence. Your doctor may recommend treatment that may help prevent cancer from coming back.

What is the risk of recurrence?

When learning about next steps in treatment, it’s important to understand the risk of melanoma coming back after surgery. Your doctor may recommend treatment after surgery, or opt to “watch and wait.”

A study reviewing medical charts of patients with stage 3 melanoma who were recommended to “watch and wait” found that:

  • 50% of people (125 out of 251) who underwent watch and wait after surgery for stage 3 melanoma had their cancer return.
  • 33% of people (43 out of 129) who had treatment after surgery for stage 3 melanoma had their cancer return.

It’s important to talk with the doctors on your care team and understand their treatment recommendations. Learn more about the different roles of doctors on your team on the next card.

Know who may be on your care team

Your care team may be made up of several health care providers. Learn more about 3 doctors you may see and their roles:

A dermatologist specializes in the skin and may be the doctor who diagnoses your stage 3 melanoma. They may also monitor you after surgery to check that cancer has not returned.

Surgeons are doctors who perform operations. Stage 3 melanoma may be removed by a surgeon. They may refer you to an oncologist after surgery.

An oncologist specializes in cancer and cancer treatments and will help develop a treatment plan for you. It’s important to speak with an oncologist about options after surgery for stage 3 melanoma.

Questions to ask your care team

If you have had surgery to remove stage 3 melanoma, talk to your oncologist to see if adjuvant treatment with KEYTRUDA, an immunotherapy, is right for you.

  • What are the chances the melanoma will come back?
  • What are my options after surgery?
  • How does KEYTRUDA work?
  • What is the treatment schedule for KEYTRUDA?
  • What are the risks and benefits of KEYTRUDA?
  • Is KEYTRUDA right for me?

Talk to your doctor about KEYTRUDA

Now that you’ve learned about options after surgery for stage 3 melanoma, you may be ready to explore a possible treatment option like KEYTRUDA.

For help starting that conversation, find helpful tools and information below:

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Patient support throughout your treatment

Patients who have been prescribed KEYTRUDA for an approved indication can access additional support from KEY+YOU, the patient support program for KEYTRUDA. KEY+YOU helps eligible patients by offering educational resources and support information throughout treatment.

FDA-Approved Indications

KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma. KEYTRUDA may be used:

  • when your melanoma has spread or cannot be removed by surgery (advanced melanoma), or
  • in adults and children 12 years of age and older with stage IIB, stage IIC, or stage III melanoma, to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery.
Important Safety Information

KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen any time during treatment or even after your treatment has ended.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse. These are not all of the signs and symptoms of immune system problems that can happen with KEYTRUDA:

Lung problems: cough, shortness of breath, or chest pain.

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

Kidney problems: decrease in the amount of your urine; blood in your urine; swelling of your ankles; loss of appetite.

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.

Problems can also happen in other organs and tissues. Signs and symptoms of these problems may include: chest pain; irregular heartbeat; shortness of breath; swelling of ankles; confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs; double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight; persistent or severe muscle pain or weakness; muscle cramps; low red blood cells; bruising.

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feeling like passing out, fever, and back pain.

Rejection of a transplanted organ or tissue. Your health care provider should tell you what signs and symptoms you should report and they will monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your health care provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your health care provider will check you for these problems during treatment with KEYTRUDA. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Before you receive KEYTRUDA, tell your health care provider if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ or tissue transplant, including corneal transplant, or have had or plan to have a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic); have had radiation treatment in your chest area; have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

If you are pregnant or plan to become pregnant, tell your health care provider. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, you will be given a pregnancy test before you start treatment. Use effective birth control during treatment with KEYTRUDA and for 4 months after your last dose of KEYTRUDA. Tell them right away if you think you may be pregnant or you become pregnant during treatment with KEYTRUDA.

Tell your health care provider if you are breastfeeding or plan to breastfeed. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your last dose of KEYTRUDA.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Common side effects of KEYTRUDA when used alone include feeling tired; pain, including pain in muscles; rash; diarrhea; fever; cough; decreased appetite; itching; shortness of breath; constipation; bones or joints and stomach-area (abdominal) pain; nausea; and low levels of thyroid hormone.

In children, when KEYTRUDA is used alone, fever, vomiting, headache, stomach area (abdominal) pain, and low levels of white blood cells and red blood cells (anemia) are more common than in adults.

Common side effects of KEYTRUDA when given with certain chemotherapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with chemotherapy with radiation therapy medicines include feeling tired or weak; nausea; constipation; diarrhea; decreased appetite; rash; vomiting; cough; trouble breathing; fever; hair loss; inflammation of the nerves that may cause pain, weakness, and paralysis in the arms and legs; swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; mouth sores; headache; weight loss; stomach-area (abdominal) pain; joint and muscle pain; trouble sleeping; bleeding, blisters, or rash on the palms of your hands and soles of your feet; urinary tract infection; and low levels of thyroid hormone.

Common side effects of KEYTRUDA when given with enfortumab vedotin include rash; tingling or numbness of the arms or legs; feeling tired; itching; diarrhea; hair loss; weight loss; decreased appetite; dry eye; nausea; constipation; changes in sense of taste; and urinary tract infection.

Common side effects of KEYTRUDA when given with chemotherapy and bevacizumab include tingling or numbness of the arms or legs; hair loss; low red blood cell count; feeling tired or weak; nausea; low white blood cell count; diarrhea; high blood pressure; decreased platelet count; constipation; joint aches; vomiting; urinary tract infection; rash; low levels of thyroid hormone; and decreased appetite.

Common side effects of KEYTRUDA when given with axitinib include diarrhea; feeling tired or weak; high blood pressure; liver problems; low levels of thyroid hormone; decreased appetite; blisters or rash on the palms of your hands and soles of your feet; nausea; mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina; hoarseness; rash; cough; and constipation.

These are not all the possible side effects of KEYTRUDA. Talk to your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Medication Guide for KEYTRUDA and discuss it with your doctor. The physician Prescribing Information also is available.