Ovarian cancer can be difficult to recognize and diagnose at first, explains Herzog, because the symptoms are vague and mild, making it difficult to treat. Treatments include surgery and platinum-based chemotherapy, which contains the chemical element platinum as part of its molecular makeup and forms structures that prevent cancer cells from growing or cause them to die. .
Ovarian cancer trial design
The trial will test the effectiveness of a combination of two immunotherapy drugs called nemvaluekin alfa and pembrolizumab compared with standard non-platinum-based chemotherapy. Immunotherapy helps strengthen and train the body’s own immune system to identify and destroy diseased cells.
“There is a high unmet clinical need to treat patients with platinum-resistant ovarian cancer, and the ARTISTRY-7 trial provides an avenue to meet those unmet needs by combining combines cutting-edge scientific advances in targeted cancer therapy into a single treatment protocol in Herzog, Associate Director of the University of Cincinnati Cancer Center, clinical director, and Paul and Carolyn Flory, Professors in Gynecological Oncology at the UC School of Medicine and a gynecological oncologist for UC Health.
Pembrolizumab, sold under the brand name Keytruda, is an immunotherapy drug that has been used to treat many types of cancer. Nemvaleukin alfa is a new drug created by the pharmaceutical company Alkermes that received a fast-track designation from the Food and Drug Administration last fall to expedite safety and efficacy reviews. of drugs.
“Nemvaluekin alfa is a drug that works with your body’s immune system to expand cancer-fighting immune cells,” says Herzog. “It is based on an established immune pathway that has shown promise in several types of cancer.”
Herzog said the trial will enroll and randomly assign 376 patients to one of four study groups. One group of patients will receive both immunotherapy drugs, one will receive only nemvaluekin alfa, another will receive only pembrolizumab, and the final group will receive standard chemotherapy.
Single immunotherapy groups will be monitored for effectiveness early in the trial, with the option to close these groups prior to full enrollment if they prove ineffective. Herzog says single immunotherapy treatments for platinum-resistant ovarian cancer have not shown to be effective in the past, and he is excited to see if the combined immunotherapy could provide a new treatment options for the patient.
ARTISTRY-7 is a phase 3 trial. It is designed to confirm preliminary evidence from previous trials that the treatment option is safe, beneficial and effective for patients, and Herzog said by Preliminary evidence has been promising. Alkermes was the trial sponsor, and Herzog helped design the study for the specific group of patients it would target.
Trial sites have opened in Florida and New York, and Herzog said UC will soon begin accepting patients and serving as a trial site.
“If this trial is successful, patients will have a new treatment option where limited options exist and it will allow for a pause in repeated chemotherapy, thus potentially achieving efficacy,” he said. better efficiency and safety,” he said.