First Health Contributes in Immunotherapy Clinical Trial Bringing Advanced Therapies to the Carolinas

First Health Contributes in Immunotherapy Clinical Trial Bringing Advanced Therapies to the Carolinas

FirstHealth of the Carolinas is driving innovation with its clinical trials program as one of its clinical investigator sites enrolled the first patient into a worldwide clinical trial testing the efficacy and safety of immune therapies designed to take on cervical cancer.

The Background

FirstHealth was selected by the GOG Foundation, Inc. (GOG) and Agenus, Inc. to participate as a center in a multi-national clinical trial. FirstHealth has conducted many clinical trials with GOG, a foundation existing to promote excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva.

Cervical Cancer: A Dangerous Situation

The American Cancer Society estimates that in 2019 approximately 13, 170 new cases of invasive cervical cancer will be diagnosed and 4,250 women will die from the disease nationwide. In North Carolina, that equals about 410 new diagnoses and 210 deaths.

The Study

A randomized, multi-national study—blinded and non-comparative, two-arm Phase II clinical trial to assess the efficacy and safety of Agenus’ AGEN2034 (PD-1) administered alone or in combination with Agenus’ AGEN1884 (CTLA) for the treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line, platinum-based chemotherapy.

77 sites are expected to participate globally with 50 of those in America, representing a total of approximately 200 participants.

Throughout the two-year cancer treatment period, the patient will be monitored for potential side effects and response to therapy, using blood markers and imaging, such as CT scans. Those results will be shared with the clinical trial sponsors and aggregated with those of other trial participants as one step in many to help determine which treatment protocol is more effective.

What is Anti-PD-1 and Anti-CTLA-4

These are immune therapies designed to enable the immune system to seek out and destroy cancer. Michael Sundborg, MD reports that “one of the key benefits expected from the combination of anti-CTLA-4 and anti-PD-1 is the anticipated improvement in response rates and duration of response for patients.  For more information see the link to Agenus Inc.’s pipeline.

FirstHealth Clinical Trials Program

The clinical trials program at FirstHealth started in the early 1990s with one doctor and one coordinator. Now numerous doctors oversee, and four coordinators manage, 25 to 30 active studies involving hundreds of patients. As many of the clinical trials at FirstHealth are related to cancer, the program is housed in the FirstHealth Outpatient Cancer Clinic in Pinehurst. However, FirstHealth is routinely approached by drug companies or research organizations to participate in studies involving medical conditions beyond cancer.

FirstHealth of the Carolinas

FirstHealth of the Carolinas, a private, not-for-profit health care network, is headquartered in Pinehurst, NC. Its nearly 5,000 employees serve 15 counties in the mid-Carolinas. Licensed for four hospitals and 610 beds, FirstHealth demonstrates a commitment to treating the whole patient and to providing quality health care for the entire community—especially those in need. It represents a fantastic organization to consider clinical research as care options for underserved communities.

Lead Research/Investigator

Charles S. Kuzma, MD, Institutional Principal Investigator

Michael Sundborg, MD, Gynecologic Oncologist

Call to Action: Do you or a loved one have a cervical cancer diagnosis? Do you live in the Carolinas? Consider talking with FirstHealth-visit here.