Defining moments – Why clinical trials matter

Kerry Hardy and his wife Beth
Kerry Hardy and his wife Beth, photo provided

The wedding day in Charleston dawned cold and windy. It didn’t matter to the best man, Kerry Hardy, though. He wasn’t supposed to be alive to see the day anyway. The day was a gift, and as fate would have it, just 15 minutes before the ceremony, the clouds parted and the strong winds settled.

The sky dissolved into the colors of a beautiful sunset as the bride and groom exchanged vows. It’s a moment Hardy will never forget, especially since many doctors expected the 54 year-old to have succumbed to non-small cell lung cancer long before February 18, the day of his oldest son’s wedding.

Diagnosed with stage 4 lung cancer in 2015, Hardy knew the weather and his presence were both miracles. The father of four boys lives with his wife Beth in Augusta, Georgia, and is close to all his children.

“I know the trend is going away from Dad being the best man. But Rhodes asked me and pointed out to me that I was the only person that had been there for every important thing he’d ever done. After crying, I accepted with honor. I was so happy to be with him on the biggest day of his life.”

Not only was Hardy there, he was able to deliver a speech with his usual quick wit and down-home style of humor that had his wife rolling her eyes and, by the end, everyone tearing up. Hardy’s quick to explain he’s a man of faith and not afraid of dying. He believes in fighting to be there for his kids, though, so he can experience as many special moments as he can.

“You have no idea how many times after the diagnosis I wondered if I’d see the boys get married, graduate college, have grandchildren,” he says. “All those things mean more than you could imagine.”

As immunotherapy clinical trials continue to transform the cancer landscape, more of these miracles are happening. Hardy, who enrolled in an immunotherapy clinical trial at Hollings Cancer Center in 2016, knows he’s lucky, because while immunotherapy treatment works for some, it doesn’t for others. There are many factors that come into play, including the type of cancer and the genetic mutations a person has.

A specialist in lung cancer, John Wrangle, M.D., knows the statistics. It is diagnosed far more often than other cancers in the state, and it takes more lives. The rate of deaths from lung cancer is more than three times the level of the next most-common cancer, colorectal.

Dr. John Wrangle and Kerry Hardy
Dr. John Wrangle in the clinic with Kerry Hardy.

“It’s exhausting to give bad news all the time,” Wrangle says. He and colleague Mark Rubinstein, Ph.D., teamed up to develop this trial in the hopes they could give lung cancer patients, often diagnosed at later stages of cancer, more options. Wrangle didn’t sleep the night before the trial’s first patient received the drugs. They had never administered this combination of a checkpoint drug, nivolumab, with a new and powerful immune stimulation drug, ALT-803. The side effects were unknown.

Hardy had a tumor the size of a lemon in his lungs. “When you have someone who has a tumor with molecular characteristics like his, you have close to zero expectation that immunotherapy is going to work for it,” he says, adding that he admired how Hardy was in for the fight.

“He is one of the most positive guys I have ever met. He’s an ebullient character. He always makes it his mission to make everyone around him smile. What a wonderful response to being in a predicament that no one wants.”

The wedding day in Charleston dawned cold and windy. It didn’t matter to the best man, Kerry Hardy, though. He wasn’t supposed to be alive to see the day anyway. The day was a gift, and as fate would have it, just 15 minutes before the ceremony, the clouds parted and the strong winds settled.

 

“You have no idea how many times after the diagnosis I wondered if I’d see the boys get married, graduate college, have grandchildren.”
- Kerry Hardy

The sky dissolved into the colors of a beautiful sunset as the bride and groom exchanged vows. It’s a moment Hardy will never forget, especially since many doctors expected the 54 year-old to have succumbed to non-small cell lung cancer long before February 18, the day of his oldest son’s wedding.

Diagnosed with stage 4 lung cancer in 2015, Hardy knew the weather and his presence were both miracles. The father of four boys lives with his wife Beth in Augusta, Georgia, and is close to all his children.

“I know the trend is going away from Dad being the best man. But Rhodes asked me and pointed out to me that I was the only person that had been there for every important thing he’d ever done. After crying, I accepted with honor. I was so happy to be with him on the biggest day of his life.”

Not only was Hardy there, he was able to deliver a speech with his usual quick wit and down-home style of humor that had his wife rolling her eyes and, by the end, everyone tearing up. Hardy’s quick to explain he’s a man of faith and not afraid of dying. He believes in fighting to be there for his kids, though, so he can experience as many special moments as he can.

“You have no idea how many times after the diagnosis I wondered if I’d see the boys get married, graduate college, have grandchildren,” he says. “All those things mean more than you could imagine.”

“He is one of the most positive guys I have ever met. He’s an ebullient character.”
- Dr. John Wrangle

As immunotherapy clinical trials continue to transform the cancer landscape, more of these miracles are happening. Hardy, who enrolled in an immunotherapy clinical trial at Hollings Cancer Center in 2016, knows he’s lucky, because while immunotherapy treatment works for some, it doesn’t for others. There are many factors that come into play, including the type of cancer and the genetic mutations a person has.

A specialist in lung cancer, John Wrangle, M.D., knows the statistics. It is diagnosed far more often than other cancers in the state, and it takes more lives. The rate of deaths from lung cancer is more than three times the level of the next most-common cancer, colorectal.

“It’s exhausting to give bad news all the time,” Wrangle says. He and colleague Mark Rubinstein, Ph.D., teamed up to develop this trial in the hopes they could give lung cancer patients, often diagnosed at later stages of cancer, more options. Wrangle didn’t sleep the night before the trial’s first patient received the drugs. They had never administered this combination of a checkpoint drug, nivolumab, with a new and powerful immune stimulation drug, ALT-803. The side effects were unknown.

Hardy had a tumor the size of a lemon in his lungs. “When you have someone who has a tumor with molecular characteristics like his, you have close to zero expectation that immunotherapy is going to work for it,” he says, adding that he admired how Hardy was in for the fight.

“He is one of the most positive guys I have ever met. He’s an ebullient character. He always makes it his mission to make everyone around him smile. What a wonderful response to being in a predicament that no one wants.”

Kerry Hardy and family at his son’s wedding
Hardy and family at his son’s wedding. Photo provided.

Buying Time

Wrangle wishes he could see those results with all his patients and is thankful for the ones who do respond as well as Hardy. The results of the trial were recently published in The Lancet Oncology.

In the early phase 1b trial, there were nine patients of 21 treated who had positive responses with their conditions stabilizing and some experiencing a decrease in tumor size.  Of the 21 patients, 11 had previously received immunotherapy that had stopped working.  Several of these patients’ tumors shrank again with the addition of ALT-803 to a failing immune-checkpoint therapy. Wrangle says it’s these cases that keep him and his colleague, Mark Rubinstein, Ph.D., pushing forward.

“Observing people who are meeting all kinds of milestones and seeing incredible kinds of things happen in their life that they otherwise wouldn’t have gotten to enjoy and participate in, that’s 100 percent what it’s all about,” Wrangle says. The trial was designed to be delivered in an outpatient setting, and he’s encouraged to see that the treatment seems to be well-tolerated. “We design these therapies so these people can get on with living their lives, not so they can be cancer patients forever and ever.”

To say I’m ecstatic is an understatement... If you could see me now, you’d never know that I have been sick.
- Kerry Hardy

Only time will tell if this therapy will bear out in more advanced trials, he said. It’s important to get funding so researchers can keep exploring immunotherapy advances that show great promise. The next phase for him and Rubinstein will be to explore different dosing schedules and further define the mechanisms behind the differences in patients’ responses.

“There’s a lot of work to do with the science to find out who does respond and who doesn’t. To identify the mechanisms of non-responders is just as important as those who do,” he says.

“Will we cure all cancers? Probably not in my lifetime. Will we cure some solid tumor cancers that were previously considered incurable? Yes, there are some people for whom that is going to happen.”

Wrangle cautions patients to not lump all cancers together as one entity, and that not even all lung cancers can be seen as one group, given genetic variations among the tumors. Each case needs a tailored approach. “Our therapy won’t work for everyone, but we desperately want to find out for whom it will work. Will it be a cure? It’s possible, but for a select few. Some won’t be cured but will be alive for years and years just because we’re able to stabilize the disease or reach equilibrium between the immune system and the tumor.”

When that miracle happens though, Wrangle says there’s no better feeling than to deliver good news based on a therapy he and Rubinstein have developed.

What are Clinical Trials?

Clinical trials explore promising new approaches for cancer prevention, diagnosis and treatment, often providing access to new drugs and interventions before they become widely available. Ask your doctor if a clinical trial is right for you.

Find out more about Hollings’ clinical trials at musc.co/hcc-clinical-trials.