Lehigh Valley Topper Cancer Institute Is Now Offering a Pioneering Rectal Cancer Trial

In June 2022, hematologist oncologist Maged Khalil, MD, with Lehigh Valley Topper Cancer Institute, started receiving calls about a groundbreaking clinical trial for rectal cancer.

The results of the 14-person Memorial Sloan Kettering Cancer Center (MSK) study, which was evaluating the effectiveness of an immunotherapy drug that boosts the body’s immune system to recognize and fight cancer, were remarkable. All the participating individuals, who had stage 2 or stage 3 rectal adenocarcinoma tumors that were positive for a certain biomarker, completely responded to the treatment.

“By the end of the trial, all of the patients’ tumors were no longer visible on MRI imaging,” Khalil says. “These results were revolutionary, and they could have a significant impact on how we treat rectal cancer in the future.”

At the time, Khalil and his colleagues could not offer access to the trial. But now, Lehigh Valley Topper Cancer Institute (the only cancer center in the region that is a member of the Memorial Sloan Kettering Cancer Alliance) is the first and only site in Pennsylvania offering the study.

Although rectal cancer is curable, its standard treatment regimen (which includes chemotherapy, radiation and surgery) can cause life-altering side effects, like gastrointestinal problems, infertility, sexual dysfunction and more.

“Being able to treat rectal cancer with immunotherapy alone could have an incredible impact on patient quality of life,” Khalil says. “In the MSK trial, no significant side effects were reported. That’s a world of difference from the standard of care treatments we offer currently.”

According to Alexandra Bauman, RN, Supervisor of Oncology Clinical Research with the Network Office of Research and Innovation, the Cancer Institute hopes to recruit five individuals with stage 2 or stage 3 rectal cancer that has not been previously treated and is positive for the deficient DNA mismatch repair (dMMR) biomarker.

“If your cancer is positive for the dMMR biomarker, it means the genes that would normally repair problems inside your cells aren’t working, causing certain cells to become cancerous,” Bauman says. “Lehigh Valley Topper Cancer Institute’s hematologist oncologists regularly test patients with rectal cancer for this and other biomarkers, which will help us identify who may benefit from this trial.”

Once enrolled in the trial, participants will receive doses of dostarlimab, an immunotherapy drug, every three weeks for up to six months. They also will be closely monitored to make sure their cancer is responding and not progressing. If a participant’s tumor shows growth at any time during the trial, they will be switched to the standard of care treatment (chemotherapy, radiation and surgery). 

“Patients may be concerned about their cancer spreading while they undergo this experimental therapy,” Khalil says. “We want them to know that we will be monitoring them very closely to make sure their tumor does not grow throughout the trial. Our main focus is their health.”

This clinical trial is one of many offered by Lehigh Valley Topper Cancer Institute.

“We provide access to more than 200 clinical trials,” Khalil says. “Our cancer experts work closely with the clinical trials program to identify specific studies for our patients. We are always looking for new avenues of care for our current patients, and with clinical trials, we are also striving to expand or improve the treatments available to future patients.”