A new clinical study at Roswell Park Cancer Institute is the first to test the combination of an immunotherapy drug with two other drugs as treatment for recurrent epithelial ovarian cancer, and the first ovarian study to analyze a patient’s microbiome – the bacteria present in the human gut and other organs.
Dr. Emese Zsiros, assistant professor of oncology in Roswell Park’s Department of Gynecologic Oncology and Center for Immunotherapy, is principal investigator for the phase II clinical trial. It will enroll about 40 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. The study looks to evaluate the impact of using a combination of the immunotherapy drug pembrolizumab (Keytruda) with IV Avastin and oral Cytoxan.
Pembrolizumab has been approved by the U.S. Food and Drug Administration for treatment of advanced melanoma, some non-small cell lung cancers and recurrent squamous cell head and neck carcinoma, but has only been tested in a small number of ovarian cancer patients, Roswell officials said.
“Our biggest hope is that by trying these three drugs in combination, we can significantly extend the lives of patients with recurrent ovarian cancer,” Zsiros said in a news release. “We also hope to minimize the side effects associated with chemotherapy drugs, and to markedly improve the quality of our patients’ lives. We will be looking at potential biomarkers that will tell us who can most benefit from this therapy combination and to better understand how cancer cells and immune cells communicate with one another so that we can design better medications to kill cancer efficiently.”
As part of this study, the clinical team will analyze microbiome samples to try to identify possible associations with clinical outcomes and tumor response. The study, supported by a grant from Merck & Co. Inc., maker of pembrolizumab, will be one of the first to analyze these bacteria to determine possible associations with cancer-fighting treatments.
To learn more, call 877-275-7724, email to firstname.lastname@example.org or visit clinicaltrials.gov.