Finding Strength in the Face of Advanced Melanoma

Dave Janicki recounts how constants, like hard work and friendship, helped him face an unexpected diagnosis.

May 01, 2019

  This is intended for U.S. residents 18 years of age and older.
D

ave Janicki takes care of others. As a restaurant owner for more than 17 years, he invited everyone to dine at his communal kitchen table. The restaurant was a constant in his life. The staff, the patrons, the dinner rush – all reliable and familiar. When Dave was confronted with a daunting cancer diagnosis, his restaurant offered comfort and community in the face of the unknown. 

Dave with his daughter, Alisha.

Dave with his daughter, Alisha.

It started when Dave noticed an abnormal growth on his face. He attempted to see a dermatologist, but the doctor’s next availability was more than six months away. Dave, committed to his restaurant, continued running his business. 

Dave’s doctor ultimately recommended a biopsy of the growth. Dave, still without symptoms, had the growth removed. Then came his diagnosis – melanoma.  

“I was shocked,” said Dave. “I didn’t understand how this could happen without any warning signs.” 

Melanoma is one of the most common forms of cancer in the United States, and the incidence of the disease has increased over the past 25 years. In approximately four percent of patients, melanoma will metastasize, or spread, to other parts of the body, potentially becoming fatal.

I had to stay positive. I had a family to think about, and I knew my restaurant staff was counting on me for their livelihood.
Dave found that working in his restaurant offered him comfort and support.

Dave found that working in his restaurant offered him comfort and support.

Dave felt blindsided but forged ahead. “I had to stay positive. I had a family to think about, and I knew my restaurant staff was counting on me for their livelihood.”

Dave immersed himself in learning about melanoma, its implications and treatment options, quickly becoming his own advocate. He worked with multiple doctors — sometimes traveling across states — to chart, what he believed to be, the best path forward.  

Eventually, Dave underwent surgery to remove his tumor. Several months afterward, he received a devastating update: his melanoma had not only returned, but metastasized. He and his physician agreed Dave’s next step would be treatment with a combination of immunotherapies – treatments that work with the body’s own immune system to fight cancer. This combination, Bristol-Myers Squibb’s OPDIVO® (nivolumab) + YERVOY® (ipilimumab), represents the first ever immunotherapy combination approved for people diagnosed with melanoma that has spread or cannot be removed by surgery (advanced melanoma). Because immunotherapies may help the body’s immune system find and fight cancer cells, they might also cause the immune system to harm healthy cells. In addition, a Boxed WARNING is associated with YERVOY regarding immune-mediated side effects.

INDICATION

OPDIVO® (nivolumab) is a prescription medicine and may be used alone or in combination with YERVOY® (ipilimumab) to treat melanoma, a type of skin cancer, that has spread or cannot be removed by surgery (advanced melanoma).

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous use.

Serious Side Effects

OPDIVO and YERVOY are associated with a number of serious risks that may impact a patient’s ability to work, function, and participate in activities of daily living. Some of these risks include problems that can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions. Additional serious side effects observed during a separate study of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.

Study Design and Results

OPDIVO, used in combination with YERVOY or as a single agent, was approved by the FDA for this use based on a clinical trial of 945 patients with previously untreated, unresectable or metastatic melanoma, in which 314 patients received treatment with the OPDIVO + YERVOY combination, 316 patients received OPDIVO alone and 315 patients received YERVOY alone.

In the primary analysis of the trial, OPDIVO + YERVOY and OPDIVO reduced the risk of the cancer spreading, growing, or getting worse by 58% and 43%, respectively, compared to YERVOY at 9 months.

Half of the patients on OPDIVO + YERVOY went 11.5 months and half of the patients on OPDIVO went 6.9 months without the cancer spreading, growing, or getting worse versus 2.9 months with YERVOY. OPDIVO + YERVOY and OPDIVO reduced the risk of dying by 45% and 37% compared to YERVOY at 28 months. In a follow-up analysis of this trial, half the patients treated with YERVOY were alive at 19.9 months while half the patients treated with OPDIVO were alive at 36.9 months and more than half of patients treated with OPDIVO + YERVOY were alive.

OPDIVO + YERVOY and OPDIVO have also been shown to reduce or shrink tumors. Among patients treated with OPDIVO + YERVOY or OPDIVO, respectively, 50% and 40% of all tumors shrank or disappeared completely (41% of tumors shrank while 9% disappeared completely with OPDIVO + YERVOY; 31% of tumors shrank while 9% disappeared completely with OPDIVO) at 9 months compared to 14% for patients treated with YERVOY (12% of tumors shrank while 2% disappeared completely).

The efficacy of OPDIVO + YERVOY cannot be compared to OPDIVO.

Common Side Effects

The most common side effects of OPDIVO + YERVOY include: feeling tired; rash; diarrhea; nausea; fever; pain in muscle, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of OPDIVO include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; abdominal pain. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

Please see additional safety information below.

While receiving this immunotherapy combination, Dave’s tumors started to shrink until they completely disappeared. These results are not typical of every patient and results may vary. Patients are encouraged to speak with their doctor about the treatment plan that may be right for them. Today, Dave receives treatment every other week for a half hour – and soon he may switch his treatment to once a month.

“When I was diagnosed, the doctor prepared me for the fact that I might not have much time left. But, I wasn't willing to accept that and kept researching my options. I talked to multiple doctors, got multiple opinions. It’s not always easy to talk about because it’s emotional, but there’s so much information out there,” said Dave. “Going from that initial prognosis to responding well to treatment; that’s been incredible.”

Throughout this experience, Dave enjoyed spending time with family and friends, and his restaurant community provided a steadfast support system. His co-workers and restaurant patrons provided positive reinforcement. His steakhouse became more than space for a good meal; it became a gathering place for meaningful conversation.  

You can’t change the past, but you can impact the future. Your body will tell you what’s wrong. Listen to it and don’t let a little thing become a bigger thing. Take care of yourself and live life to the fullest.

For people facing a similar diagnosis, Dave encourages open dialogue with their health care providers. By becoming his own advocate and working closely with his doctor, Dave found the appropriate treatment option for him – one that is helping him stay positive and enjoy time with the people he loves.

“It’s eye-opening,” said Dave. “You can’t change the past, but you can impact the future. Your body will tell you what’s wrong. Listen to it and don’t let a little thing become a bigger thing. Take care of yourself and live life to the fullest.”

*Dave is a Bristol-Myers Squibb Patient Ambassador.

INDICATION

OPDIVO® (nivolumab) is a prescription medicine and may be used alone or in combination with YERVOY® (ipilimumab) to treat melanoma, a type of skin cancer, that has spread or cannot be removed by surgery (advanced melanoma).

It is not known if OPDIVO is safe and effective in children less than 18 years of age.

Important Safety Information for OPDIVO® (nivolumab) and the OPDIVO+YERVOY® (ipilimumab) Regimen

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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 serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY. 
 
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment. 

Serious side effects may include:

  • Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness.
  • Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; and feeling less hungry than usual; and decreased energy.
  • Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine.
  • Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
  • Skin Problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes.
  • Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
  • Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; and severe muscle weakness; and chest pain.

Additional serious side effects observed during a separate study of YERVOY alone include:

  • Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet. 
  • Eye Problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness. 

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.

OPDIVO can cause serious side effects, including:

  • Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out. 

Pregnancy and Nursing: 

  • Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy. 
  •  Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869. 
  •  Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of YERVOY.   

Tell your healthcare provider about:

  • Your health problems or concerns if you: have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO when used alone include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; and abdominal pain.

The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscle, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor 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 see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY including Boxed WARNING regarding immune-mediated side effects for YERVOY.

© 2019 Bristol-Myers Squibb Company.
OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company
7356US1900961-01 5/19