Holy Name's groundbreaking clinical trials for therapeutics to fight COVID-19 garnered national attention this spring, marking the latest addition to an already robust research portfolio at the medical center that safely affords patients access to leading-edge treatments.
There are now a dozen investigational studies - and six more in the pipeline - at Holy Name's Institute for Clinical Research involving treatments for gynecological cancers.
Collaborating with Major Partners
The trials have major industry partners, such as the pharmaceutical giants Merck, Genentech and AstraZeneca. Access to some of the trials are available through non-profit groups funded by NRG Oncology, the GOG (Gynecologic Oncology Group), and the National Cancer Institute. Participating in the multi-site trials from those groups puts Holy Name in a league with some of the most respected research and medical centers in the country.
“We are able to provide our patients with access to promising new drugs that may improve quality of life and, in some cases, potentially prevent or delay recurrence of the cancer,” said Sharyn N. Lewin, MD, medical director of gynecologic oncology at Holy Name. Dr. Lewin is a member of the prestigious Investigator Council of GOG.
Dr. Lewin and her colleague, Holy Name gynecologic oncologist Maria Schiavone, MD, are the principal investigators in the trials and have helped build a “very significant portfolio of gynecological studies,” at Holy Name, said Ravit Barkama, MD, MPH, assistant vice president for clinical development, who manages the research unit. “Our portfolio competes and even surpasses those of some big academic medical centers.”
In some of the studies, patients receive the prevailing standard of care in addition to the treatments under investigation. Holy Name enrolls patients who meet the necessary criteria and would benefit from access to promising new targeted treatments, such as the use of PARP inhibitors and immunotherapies, which harness the body’s own immune system to fight disease.
Stopping the Progression of the Disease
An ongoing study that uses the drug pembrolizumab (Keytruda) in the treatment of endometrial cancer has produced positive results for the seven patients who are enrolled, Dr. Barkama noted. Likewise, Dr. Lewin said the results of a trial using the drug mirvetuximab soravtansine (in clinical trials Soraya and Mirasol) to treat recurrent ovarian and fallopian tube cancers has generated “incredible responses” for women in the studies.
“We’ve had positive responses regarding quality of life and progression-free survival,” Dr. Barkama said.
All studies are carefully controlled and closely monitored to ensure the safety of participants. In addition to Drs. Lewin and Schiavone, the team includes nurse practitioners and nurses who track patients throughout the process. Patients come from New Jersey and adjacent states, said Dr. Barkama. “We have really good teamwork and collaboration here, that’s what brings us to that level of success,” she said. “We try to enroll every patient we can so we can give hope to patients and their families.”
The Institute for Clinical Research at Holy Name Medical Center provides investigators, facilities and services for sponsoring agencies to advance patient care through clinical research. High quality clinical trials are conducted to test new medications, devices, diagnostic modalities and treatment protocols. The Institute conducts both inpatient and outpatient Phase I – IV studies in multiple therapeutic areas in a state–of–the–art facility. For more information call 201-541-6312 or email firstname.lastname@example.org. Details of all studies may be found at the U.S. government's website, clinicaltrials.gov.