As a participating health care site in a cooperative national research group, scientists and clinicians at The Ohio State University are actively investigating the potential of immunotherapy to reduce recurrence of endometrial cancer. The phase III study compares the effectiveness of radiation alone versus radiation in conjunction with pembrolizumab.
Ohio State is one of 125 participating sites for this National Cancer Institute phase III study, with research led by primary investigator Floor Backes, MD, associate professor in the Division of Gynecologic Oncology at The Ohio State University and vice chair of the Cancer Institutional Review Board at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).
“Some newly diagnosed stage I/II endometrial cancer patients have a deficiency in mismatch repair, which puts them at higher risk of recurrence,” Dr. Backes explains. “Tumors in this patient group usually don’t respond to chemotherapy, but we believe the addition of immunotherapy to radiation can positively impact outcomes.”
The research will evaluate the three-year recurrence-free survival rate of women with high intermediate risk (HIR) stage I/II mismatch repair deficient (dMMR) endometrioid endometrial cancer treated with radiation and pembrolizumab (MK-3475) versus radiation alone.
Patients will be randomized (2:1) into one of the two groups. Both groups will undergo vaginal brachytherapy, and two-thirds of the patients will also receive immunotherapy for one year. For the group receiving additional immunotherapy, pembrolizumab will be administered via IV within seven days before the start of radiation therapy. This treatment with pembrolizumab then repeats every six weeks for up to a year for a total of nine cycles, as long as there’s absence of disease progression or unacceptable toxicity.
Following treatment completion, patients in both groups will be evaluated every three months for two years, then every six months for three years.
“In addition to recurrence rates, we will also evaluate the safety and tolerability of this concurrent therapy versus just radiation, including the effect on GI symptoms and fatigue,” Dr. Backes says. “We will then extend evaluation to consider recurrence-free survival at five years in each group and estimate long-term survival as well. Ultimately, we want patients to enjoy longer lives, but also more years with a better quality of life.”
This study, “A Phase III Randomized Trial of Radiation +/- Pembrolizumab (MK-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer,” is currently recruiting patients at the OSUCCC – James, with a goal of 106 participants. For more information about eligibility, please contact Kelly.Dodd@osumc.edu.