Author: Christopher Darus, M.D., MS, medical director, Providence Gynecologic Oncology Program
Providence Cancer Institute’s scientists want to determine if some types of gynecologic cancers – advanced epithelial ovarian, fallopian tube or primary peritoneal cancers – would have increased survival rates using a combination of neoadjuvant chemotherapy (NACT) and immunotherapy.
Clinical trial eligibility
This phase II clinical trial is estimated to enroll 130 patients across several sites in the U.S. and Canada. Patients will be assessed for overall survival after three years. Patients with newly diagnosed stage III/IV cancers are eligible, including those with:
- High-grade serous adenocarcinoma
- Endometrioid adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Adenocarcinoma not otherwise specified (N.O.S.)
Details about the OVATION 2 study
Study of GEN-1 With NACT for Treatment of Ovarian 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 uses 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 2021, following promising preliminary data and a manageable safety profile. 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.
Additional gynecologic cancer studies
The Providence Gynecologic Oncology Program’s 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.
Our team of gynecologic cancer specialists
The Providence Gynecologic Oncology Program provides specialized care for patients 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.
- See all gynecologic cancer studies and multi-indication trials.
- Visit our website to view studies for all types of cancer.
- View Dr. Darus’s provider profile.
- Visit Providence Gynecologic Cancer Program.
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