Phase II study of neoadjuvant combination therapy for ovarian cancer
While recent medical and surgical advancements have improved outcomes for some cancers, ovarian cancer remains the leading cause of gynecologic cancer death among women in the United States. Investigators at Providence Cancer Institute hope a new phase II clinical trial of neoadjuvant chemotherapy (NACT) plus immunotherapy will improve survival for patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancers.
Providence is the only center in Oregon to offer the trial. Find the details here:
A Phase II Study Evaluating Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OVATION 2)
In this randomized, open-label study known as OVATION 2, investigators will evaluate the safety and effectiveness of GEN-1, an experimental DNA-mediated interleukin-12 (IL-12) immunotherapy, given with standard-of-care NACT (paclitaxel and carboplatin) compared to NACT and surgery alone.
IL-12 is a cytokine involved in the anticancer immune response of T-lymphocytes and natural killer cells. GEN-1 utilizes a nanoparticle delivery system designed for local administration of the IL-12 plasma vector to avoid the toxicities associated with recombinant IL-12.
The U.S. Food and Drug Administration granted GEN-1 Fast Track designation in February following promising preliminary data and a manageable safety profile.1 In the dose-escalation portion of the study, all patients in the high-dose experimental cohorts achieved a complete or partial response, while 67 percent of patients in the low-dose experimental cohorts reported a complete or partial response.
Patients with newly diagnosed stage III/IV cancers are eligible, including:
- high-grade serous adenocarcinoma
- endometrioid adenocarcinoma
- undifferentiated carcinoma
- clear cell adenocarcinoma
- mixed epithelial carcinoma
- adenocarcinoma not otherwise specified (N.O.S.)
The study is led by Christopher Darus, M.D., MS, gynecologic oncologist and medical director of the Providence Gynecologic Oncology Program. Dr. Darus is an experienced investigator and active member of the Society of Gynecologic Oncology and other leading medical associations dedicated to advancing research, treatment, and prevention of gynecologic cancers.
For more information or to enroll a patient, call our Clinical Research office at 503-215-2614 or submit a referral form.
See more gynecologic cancer studies
Our research portfolio includes more than 15 clinical trials for gynecologic cancers. From early-stage disease to metastatic cancer, our studies include phase I, first-in-human studies and NCI-supported cooperative group trials of surgical procedures, immunotherapies and other investigational agents in the adjuvant and neoadjuvant settings.
New studies are added frequently. Please visit our website to view studies for all types of cancer.
A team of gynecologic cancer specialists
The Providence Gynecologic Oncology Program provides specialized care for women with suspected or known gynecologic malignancies and complex precancerous conditions. Through the program, patients have access to advanced treatments, such as robotic surgery, immunotherapy, and the latest research and clinical trials. Patients also have the convenience of receiving all their care under one roof.
In addition to our providers, members of the team include oncology nurses, radiation oncologists, gynecologic pathologists, genetic risk experts, oncology social workers, integrative medicine providers, nutrition specialists, clinical trials nurses, medical assistants, and others.
To learn more, visit Providence Gynecologic Cancer Program.
Rosa, K. FDA Grants Fast Track Status to Immunotherapy GEN-1 in Advanced Ovarian Cancer. OncLive. 2021 Feb 22. Accessed May 14, 2021. https://www.onclive.com/view/fda-grants-fast-track-status-to-immunotherapy-gen-1-in-advanced-ovarian-cancer