FirstHealth Makes History Enrolling the First Patient in Immunotherapy Clinical Trial Addressing Cervical Cancer

Sep 8, 2019 | Cancer, Cervical Cancer, FirstHealth of the Carolinas, Leading Sites, North Carolina, Site Success, Site Watch

Doctor or psychiatrist consulting and diagnostic examining stressful woman patient on obstetric - gynecological female illness, or mental health in medical clinic or hospital healthcare service center

FirstHealth of the Carolinas enrolled the first patient in a worldwide clinical trial testing the efficacy and safety of immune therapies designed to battle cervical cancer. Selected by sponsors’ GOG Foundation, Inc. and Agenus Inc. for the multi-national clinical trial to test 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.

The Study

AGEN2034 is a randomized, blinded, non-comparative, two-arm Phase II clinical trial assessing the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1-monotherapy) or with AGEN1884 (Treatment Arm 2—combined therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study, not intended to compare the efficacy of the two experimental arms, but rather the efficacy of each arm will be evaluated against its relevant historical controls as appropriate. Patients are receiving AGEN2034 with placebo as a monotherapy or with AGEN1884 as combination therapy for a maximum of 24 months or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study or withdrawal from the trial occurs.

Placebo administration in Treatment Arm 1 (AGEN2034 monotherapy) of the study is intended to preserve the integrity of the investigators’ interpretation of the efficacy and safety data by eliminating biases in disease assessment monitoring, declaration of disease progression and assessment of toxicities. Hence the investigators, patients, and research personnel won’t know whether patients have received AGEN2024/placebo (Treatment Arm 1) or AGEN2034/AGEN1884 (Treatment Arm 2).

The study sponsors recruited 70 clinical investigator sites and is targeting up to 200 participants.

FirstHealth Investigator Comment

Michael Sundborg, MD reports “we have crossed the frontier into treating patients with cancer-specific therapies designed to unleash an immune attack on malignant cells.” The gynecologic oncologist continued “This is a pivotal time in cancer research and a seminal time for patients with cervical cancer.” Sundborg noted in the study “One of the key benefits from the combination of the anti-CTLA and anti-PD-1 is the anticipated improvement in response rates and duration of response for patients.”

Cervical Cancer in the United States

The American Cancer Society estimates in 2019 that approximately 13,170 new cervical cancer cases will be diagnosed and up to 4,250 women will die this year from the disease. In North Carolina, the home of FirstHealth, 410 women will be diagnosed with cancer and 210 women will die this year.

FirstHealth Clinical Trials Program

FirstHealth started its clinical trials program In the early 1990s with one doctor and one coordinator. Today numerous doctors (investigators) oversee the program with four coordinators that manage 25 to 30 active clinical trials and hundreds of patients ongoing.

The FirstHealth Outpatient Cancer Clinic in Pinehurst hosts much of the clinical research as many of the clinical studies FirstHealth conducts are oncology related. The Anson Record notes that FirstHealth is routinely approached by biopharmaceutical companies and research organizations to participate in clinical research.

Charles S. Kuzma, MD, institutional principal investigator of clinical trials at FirstHealth of the Carolinas notes “FirstHealth offers a wide array of clinical trials that far exceeds the average for regional community medical centers.” Dr. Kuzma continued “patients in 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.” Hence FirstHealth has accelerated the “clinical research as a care option” in more rural parts of North Carolina for example.

Lead Contacts

Charles S. Kuzma, MD 

Michael Sundborg, MD 

Call to Action: Do you or a loved one know of someone with cervical cancer that lives near the Carolinas? It might be wise to connect with FirstHealth (we include contacts above). Are you a sponsor or CRO and looking for high-quality health providers with community clinical research divisions—FirstHealth may represent the right kind of partnership.