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    Sharing Mayo Clinic: Successful Clinical Trial Means Celebration

BridgetBillBirthday805Bridget Clausen refers to her seven grandchildren and three great-grandchildren as "the love of my life." She treasures each of them and is proud to have a great-granddaughter named after her. The joy of a namesake is especially sweet, because when Bridget learned her granddaughter was pregnant, she wasn't sure she would be here to meet the baby.

At that time, Bridget was being treated for melanoma that had spread to several places in her body. Her treatment choices were dwindling. She decided to go to Mayo Clinic in Rochester, Minnesota, to see if doctors could offer any other options. As a result of that visit, Bridget enrolled in a clinical trial of a new drug. It turned out to be the answer she needed.

The drug, now available under the brand name Keytruda, was approved by the Food and Drug Administration  in December 2015 as a first-line treatment for advanced melanoma. Interestingly, the foundation of the drug's development began in a Mayo Clinic lab more than 15 years ago. In Bridget's case, it successfully shrunk her tumors and stopped the spread of cancer. It also gave her the opportunity to meet her new great-granddaughter. 

"I've been there for her first birthday, her second birthday, her third birthday," Bridget says. "These are things I never thought I'd see. This treatment has given me life."

Confronting a difficult diagnosis

Bridget's journey to Mayo Clinic and the clinical trial that would be so important to her began in 2008 with a small, bothersome mole on one of her legs. The mole was raised and itchy, and  her doctor recommended it be removed and examined. The result was an unwelcome surprise: a diagnosis of melanoma. Surgery quickly followed to take out additional tissue and check Bridget's lymph nodes. The lymph nodes were clear. The cancer had been removed. Knowing how dangerous melanoma can be, though, Bridget began regular appointments with an oncologist and a dermatologist.

"At that point, we thought everything was good. They thought they had it all," she says. "However, through the course of my visits with my oncologist, I had PET scans. After several years, one showed that the melanoma did come back in the same area."

Bridget had another surgery, followed by radiation. Although no evidence of melanoma was left after the surgery, there was a small area on her right kidney that concerned her doctors. It didn't appear to be related to the melanoma, and they were able to get rid of it with an ablation procedure.

"After that, I went on with my life, and everything was under control, I thought," says Bridget. "Then, in December of 2011, I had a follow-up appointment to check on my kidneys. My right kidney was fine. But a CT scan revealed a tumor on my left kidney and in one of my lungs.

So then I was very concerned that both kidneys might be damaged. And what should I do about my lung? Things were getting complicated."

Choosing a novel alternative

After reviewing and rejecting several treatment possibilities — and engaging in much discussion and thought — Bridget and her oncologist in Fargo, North Dakota, agreed she would seek care at Mayo Clinic. She made the five-hour trip from her home in Nevis, Minnesota, to Rochester, where she met medical oncologist Roxana Dronca, M.D.

"It just clicked with Dr. Dronca. Sometimes you meet people in your life that you click with, and we did," says Bridget. "We talked a lot. We went over all the options. I met with two surgeons. There were also two clinical trials I could do. In the end, I decided to go with the clinical trial that was testing a brand new drug."

"You can almost compare it to releasing the immune system's brakes. It's as if the immune system is inhibited ... and this drug releases it and allows it to go full force against the cancer." — Roxana Dronca, M.D.

The drug was then known only as MK-3475. It showed promise in treating melanoma that had spread. A novel type of treatment, the drug uses a person's own immune system to fight cancer.

"You can almost compare it to releasing the immune system's brakes," says Dr. Dronca. "It's as if the immune system is inhibited or unable to fight the cancer, and this drug releases it and allows it to go full force against the cancer."

Although the clinical trial Bridget enrolled in was one of the first research studies to offer MK-3475, and she was among the first people to receive it, its roots stretched back more than a decade at Mayo Clinic. In 1999, Haidong Dong, M.D, Ph.D., a Mayo Clinic cancer researcher, discovered a molecule that became critical to MK-3475. The work his research lab did to identify that molecule laid the foundation for the drug's eventual development.

Meeting success

Bridget began the clinical trial in February 2012. For four years, she drove to Mayo Clinic every three weeks to receive an infusion of MK-3475. The results went far beyond her expectations. The tumor on her lung went away. The tumor on her left kidney shriveled up. No new cancer appeared anywhere else in her body.

"Being part of this clinical trial meant there was hope for me," says Bridget. "I totally believe that these results are a combination of my strong faith, the best doctors I could possibly find, a drug company that came up with the right drug, and the molecule that started it all with Dr. Dong at Mayo Clinic."

In December 2015, during one of her trips to Mayo Clinic, Bridget was pleased to have the opportunity to meet and spend time with Dr. Dong, and thank him for the impact his research has had on her life.

"It was so special. Honestly, it felt like I was meeting a celebrity," she says. "He is a very important person in my life. And it was a treat to find he is so delightful and funny. He was not someone you'd picture being in a lab all day long. His sense of humor is marvelous. And he seemed as happy to meet me as I was to meet him."

Looking ahead with optimism

With the success of her treatment in mind — along with the knowledge that experimental drug MK-3475 has become FDA-approved Keytruda — in January 2016, Bridget decided to hold off on additional treatments. After receiving 67 infusions and driving more than 37,000 miles in four years between Nevis and Rochester, she was ready for a break.

"My condition hasn't changed in quite a while, and I don't have evidence of disease," she says. "But melanoma is tricky. It can hide and then a tumor can start very quickly. So they'll watch me closely moving forward. I'll get scans at Mayo Clinic every three months. For melanoma, I understand there is no cure. But I'm very comfortable knowing Dr. Dronca is my oncologist."

Bridget also is optimistic others may benefit from the progress made in melanoma treatment as a result of the clinical trial in which she participated.

"When cancer treatment doesn't work, it can be so frightening. I am very grateful and happy that this worked for me. Although it's not a cure, I think this drug might be able to help many other people, too," she says. "My hope is that this is just the first step, and it's the beginning of the end of this type of cancer."