It Starts with One Trial

At first glance, Robert Rose’s visits to Memorial Sloan Kettering’s Rockefeller Outpatient Pavilion may appear deceptively routine.

Robert, 67, has kidney cancer. Once a month, he sees MSK nurses Kristen Clemens and Stephanie Hicklin. Working as part of a team, they ask him about such symptoms as fatigue or feeling unusually cold, take his vital signs, and draw his blood, all while bantering about “what’s going on with each other’s families and who’s expecting a baby,” says Robert.

But on closer examination, these procedures are part of an intricate effort at the furthest frontier of cancer research, and Ms. Clemens and Ms. Hicklin are playing a vital role. They are clinical trials nurses, with specialized skills for testing potential new therapies. Robert is participating in a phase I clinical trial — a first-in-human investigation that is the high-stakes moment when medicine that has shown great promise in a lab is given to people for the very first time.

First in Human

For eight years, Ms. Clemens worked at MSK as an inpatient nurse, caring for people in the hospital as they recovered from surgery and other cancer treatments. However, she felt drawn to research to advance the understanding and treatment of cancer. In 2017, she joined a specialized nursing team at MSK that cares for people who enroll in first-in-human clinical trials.

“First-in-human trials are done to establish a standard therapeutic dose of a new cancer drug and to make sure it’s safe and effective in people,” says Ms. Clemens. “That means that my patient could be one of a handful of humans — or maybe even the very first human — to receive what could become the next blockbuster cancer treatment. For me as a nurse, it adds an entirely different dimension to the time we spend together.”

Her feelings are echoed by her colleague Ms. Hicklin. “I wanted to specialize as a clinical trials nurse because we are at the forefront of cancer research while still providing direct patient care,” Ms. Hicklin says. Providing that care in a first-in-human clinical trial requires a substantial team. This includes principal investigators, who oversee the trial and evaluate patients while continuously analyzing the trial’s results.

“Without [clinical trials] nurses, I wouldn’t be able to do my job,” explains Eytan Stein, Director of the Center for Drug Development in Leukemia. “Nurses assess and help manage toxicities, and coordinate the tests that are crucial to understanding how these new drugs affect patients. They make sure that patients understand their treatment and receive the support they need to successfully participate in the clinical trial.”

A Special Bond with Patients

Of course, caring for people who are part of a first-in-human investigation requires not just superb medical skills but also compassion and a warm bedside manner. MSK’s clinical trials nurses make sure every patient knows they are being cared for according to their individual needs. Ms. Hicklin explains that being part of a clinical trial that investigates a new therapy “can sometimes be scary for patients and their families because they don’t know how they’re going to react or if it is even going to work. But I remind them that the whole team will be here every step of the way supporting them through it, and that every cancer treatment available today started with a trial just like theirs.”

While caring for Robert over the past two and a half years, both nurses have developed a strong bond with him. Ms. Hicklin says, “He asks a lot of questions about our lives. He is the kind of person who cares about his nurses.”

Ms. Clemens adds, “I love to see him when I’m training clinical trials nurses because he really knows the drill. He will run down the list of questions he knows I’m going to ask.”

Robert’s health has improved considerably on the trial, which combines the immunotherapy treatment nivolumab (Opdivo®) with an investigational drug called IL-10, which he injects into his belly every day. “His tumors have shrunk or disappeared, after years of being sick,” says Ms. Clemens. “He is back to gardening and growing tomatoes. He was able to see his daughter get married.”

In short, Ms. Clemens says, “He is living life to the fullest.”

Creating the Future of Cancer Care

Still, successes with first-in-human trials are few and far between, which makes it challenging to find funding. “Philanthropy plays a crucial role in getting first-in-human trials off the ground, especially for rare diseases for which large pharmaceutical companies may not be focusing their efforts,” Dr. Stein says.

MSK works to ensure that philanthropy has the maximum impact on vital research. For instance, at the recently opened David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, which was generously supported by a $150 million gift — the largest in MSK’s history — an entire floor is devoted to clinical trials, especially those in the earliest phases. With this greater capacity, MSK, which already has one of the largest clinical trial programs in the country, will further strengthen its efforts to develop new therapies.

“There are never any guarantees that a treatment will work for everyone,” Ms. Clemens says, “but the hope that it might help someone really bonds me to my patients. Without these patients, discovering medications wouldn’t be possible. They are very brave.”

Ms. Hicklin is just as impressed by her patients, as well as the doctors, nurses, and other care team members she works with. “Clinical trials are providing more treatment options for patients, helping people live longer, and ultimately bringing us closer to a cure. The work that we are doing is changing the future of cancer care,” she says. “And that is a really cool thing to be a part of.”