The clinical trials program at FirstHealth of the Carolinas is again making history, as the site enrolled the first patient into a worldwide trial testing the efficacy and safety of immune therapies designed to battle cervical cancer.
“We have crossed the frontier into treating patients with cancer with specific therapies designed to unleash an immune attack on malignant cells,” said FirstHealth gynecologic oncologist Michael Sundborg, M.D. “This is a pivotal time in cancer research and a seminal time for patients with cervical cancer.”
FirstHealth was chosen by The GOG Foundation, Inc. (GOG) and Agenus Inc. to participate as a center in a multi-national clinical trial. This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of Agenus’ AGEN2034 (PD-1) administered alone or in combination with Agenus’ AGEN1884 (CTLA-4) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line, platinum-based chemotherapy. Anti-PD-1 and Anti-CTLA-4 are immune therapies designed to enable the immune system to seek out and destroy cancer.
“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,” Sundborg added.
Seventy sites are expected to participate globally with 50 of those in the United States, representing a total of approximately 200 participants. This is one of many clinical trials FirstHealth has participated in with GOG.
“When we see clinical trials with promise, we immediately determine which of our patients could be a match,” Sundborg said. “Our primary goal is the best possible outcome, and clinical trials offer a way to gain access to new, state-of-the-art treatments before they are widely available to the public.”
He added that because it is a randomized, blinded study, they do not know which test group the patient is in. Doctors do know the patient is receiving the proven standard for care, but do not know if the patient is receiving the additional drug.
The press release stated that 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.
The American Cancer Society estimates in 2019 that 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 translates into 410 new diagnoses and 210 deaths.
“While our immediate goal is to find a cure for our own local patients, the collective results of this and all clinical trials will advance our knowledge and practice of medicine around the world. Women with cancer are the bravest soldiers I know,” Sundborg said, also a veteran.
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 offers a wide array of clinical trials that far exceeds the average for regional community medical centers,” said Charles S. Kuzma, M.D., institutional principal investigator of clinical trials at FirstHealth of the Carolinas. “Patients in the Sandhills oftentimes do not need to travel to larger institutions to participate in trials that could potentially help themselves and others with the same condition.”
The Anson Record