Navigating the Clinical Trial Maze

Clinical trials are key to advancing the ever-evolving field of cancer. However, more than 90% of patients may be missing out on potentially lifesaving new treatments, according to the Cancer Research Institute (CRI).

Currently, 4,000 active clinical trials involve immunotherapy drugs, which are examining T cell targets, cell therapy, vaccines and other immunomodulators. CRI works to help fund and advance this research.

Founded in 1953 by Helen Coley Nauts, the daughter of Dr. William B. Coley — more commonly known as the Father of Cancer Immunotherapy — and her friend Oliver R. Grace Sr., CRI has conducted research in this space for 65 years. Immunotherapy treats cancer by using the body’s immune system to prevent, target, control and eliminate the disease.

“Decades of research have led to breakthrough treatments that mobilize our own immune systems to hunt down and eliminate cancer cells, wherever they are in the body,” Jill O’Donnell-Tormey, who holds a doctorate in philosophy, cell biology and anatomy, and serves as CEO and director of scientific affairs at CRI, said in an interview with CURE®. “It’s a more sophisticated, dynamic and durable approach than other cancer treatments and may prove to be the best way to keep pace with cancers that evolve over time. Immunotherapies have also been proven to synergize with other forms of cancer treatment, increasing response rates while minimizing negative side effects and reducing risk of recurrence in some cancers.”

The Food and Drug Administration has approved seven checkpoint inhibitors, a specific type of immunotherapy, to treat different cancers: Bavencio (avelumab), Imfinzi (durvalumab), Keytruda (pembrolizumab), Libtayo (cemiplimab), Opdivo (nivolumab), Tecentriq (atezoli- zumab) and Yervoy (ipilimumab).

A lot of research must still be done, according to O’Donnell-Tormey. She encourages patients and their caregivers to be open to clinical trials, which give patients an opportunity to receive cutting-edge treatments under the watchful care of an expert team.

“Many patients who participate in clinical trials describe the experience as very positive, often feeling part of the research team while cognizant that they are contributing to science and potentially helping future patients with cancer,” she said. “They can expect to receive lots of information about the study and the rationale supporting it, along with around-the-clock access to a clinical team that can answer any questions patients might have. While the treatments being tested are investigational, it’s important for patients to understand that new drugs or drug combinations undergo extensive laboratory testing before they are given to humans.”

Often, the most challenging part of the process is finding a clinical trial. Not all health care providers discuss these studies with patients, and navigating some websites can be difficult. CRI offers a Clinical Trial Finder to help patients learn about the basics and what to consider before enrolling, as well as connect with navigators who will walk them through the process.

Patients are asked to fill out a disease-specific questionnaire. The navigator needs to know the primary diagnosis, including tumor type; stage or extent of disease, such as if it has spread; and any treatment history. Then the navigator searches a national database of immunotherapy trials to find the best match for the patient.

“Beyond locating trials and connecting to trial sites, our navigation is really customized education that varies by patient,” said Caroline Melendez, director of client services at EmergingMed, the company that runs CRI’s Clinical Trial Finder. “Some people are very familiar with their diagnosis and treatment history, but those who have very little information are offered guidance about what to ask their health care team. Once a patient has identified trial matches, the navigator can help explain the differences between the types of treatment modalities and phases of trials being offered in their match results.”

Enrollment time varies by trial and site, and patients go through an informed consent process, Melendez said. Next, they learn about the specific trial and undergo an examination to determine eligibility. The process can take several days, a few weeks or longer, she said.

“We encourage every patient to ask this question: ‘Is there an interesting clinical trial available to me today?’” Melendez said. “The decision to enroll in a clinical trial is entirely dependent upon whether a compelling new therapy is in development. Everyone’s situation is unique, and patient interest in clinical trials should be informed by discussions with their medical team each time they have to make a treatment decision.”

Several myths surround clinical trials, such as that they are a last resort or that patients are treated like guinea pigs. “Another common misconception is that being on a trial means there’s a chance you’ll receive placebo rather than treatment,” O’Donnell-Tormey said. “This is not true except in cases where there are no existing treatments proven to improve patient outcomes. Generally, patients will receive some form of therapy, whether it’s standard of care, a new drug or a combination of the two.”

Patients should investigate all options, educate them- selves and then make treatment decisions. “Trials open and close all the time, but generally speaking, there are trials for patients at almost every phase of the journey, newly diagnosed to relapsed,” Melendez said. “It’s never too early to get educated and connected to a clinical trial navigator, but it can be too late.”