A clinical trial was a cancer patient’s best hope. Here’s what happened next.

When two rounds of antibiotics failed to quell Linda Morton's persistent cough, a chest scan revealed the reason why.

The uterine cancer she hoped she had beaten was back — and this time it was growing in her lung.

The prognosis the 73-year-old Edgemoor, South Carolina, matriarch faced when she got that news in the fall of 2019 was grim. If she did chemotherapy alone, a standard treatment for a recurrence of her cancer, it might buy her a year or so. Her gynecologic oncologist, Dr. Matt McDonald, offered an alternative.

He suggested Morton consider a clinical trial evaluating the effectiveness of treating recurrent uterine cancers like hers with an immunotherapy drug as well as chemo.

The Novant Health Agnes B. and Edward I. Weisiger Cancer Institute in Charlotte was participating in the trial. By enrolling, Morton could make her mark on medical science and possibly benefit from a leading-edge treatment she couldn't otherwise get, McDonald said.

Morton was on board. "I told my husband and my boys, 'I really don't have anything to lose and I have a lot to gain.'"

Trial was her best hope

But there was a catch: Neither patient nor doctor would know if the regular infusions Morton would receive through the Phase 3 trial would actually contain the medication to supercharge her immune system to fight her cancer.

In a randomized trial, some participants get the study medicine along with the standard therapy, and others get the standard therapy alone. Neither patient nor doctor knows who gets which. The idea is to remove any bias by preventing them from figuring out which group the patient is in.

In other words, Morton had a good chance of getting the investigational drug on top of the standard treatment and beyond that, unknown odds for benefiting from it, even if she did.

She just had one question.

"When Dr. McDonald suggests I do something, I always tell him, 'If I was your mother, what would you advise me to do?’” she said. “And whatever he says he’d tell his mother, that’s what I do.”

The trial stood as her best hope. So that’s what she did.

‘No evidence of disease’

For women with recurrent uterine cancer, chemo may work for a few months but then these tumors become resistant, forcing doctors to switch from drug to drug, McDonald said. Most patients don't survive. Among women with uterine cancer that has spread, the five-year survival rate is 18%, according to the American Society of Clinical Oncology.

Morton had actually done well after her first bout with cancer. In 2016, doctors found an aggressive cancer in the lining of her uterus (endometrium). After a complete hysterectomy, chemotherapy and radiation, she was in remission for almost three years when a persistent cough sent her to the doctor. Tests revealed that the same cancer had now spread to one of her lungs.

The ongoing investigation is comparing how these recurrent cancers respond to standard care (chemo) versus various treatment combos that include an immunotherapy drug. These drugs help the immune system recognize and attack cancer cells.

For Morton, the trial has been a life-altering — and lifesaving — experience.

Since completing chemo in 2020, she has made the 40-mile trip to Charlotte every six weeks for a 30-minute intravenous infusion. She gets blood tests and computed tomography (CT) scans regularly. And while neither doctor nor patient knows for sure whether Morton is receiving the study medication, her response to the regimen seems telling.

Except for a little itching at the start, she has had no unwelcome side effects — and four years in, McDonald said, Morgan's status is "NED," meaning she has "no evidence of disease."

In fact, when her time in the trial officially ended, she was doing so well that McDonald asked for — and was granted — permission for her to continue the infusion regimen. At this point, no one knows what might happen if she stops — or if she doesn't.

"She wants to take it and I want to support her," McDonald said. "So the (pharmaceutical) company said, 'yes, she can continue.'" As a condition of their participation in a trial, he and other Novant Health team members are not yet allowed to identify the drug or its manufacturer.

But McDonald was able to say that the medication is approved by the U.S. Food and Drug Administration (FDA) and is already a standard treatment for some cancers. Researchers are trying to learn which other cancers may also respond well to it.

While a doctor can prescribe an approved drug for an "off-label" use, that is, to treat conditions for which it is not specifically approved, insurance companies often refuse to pay when they do. And, McDonald said, for most patients, the price tag — often $10,000 a month or more — is prohibitive. “The upside with a clinical trial is you have a chance of obtaining these medications through an alternative means,” he said.