For Patients
A Phase I/II Study Evaluating the Dosing, Safety, Efficacy and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PPC Lipopolymer)
Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
✓ Recruiting
Trial Purpose
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The OVATION 2 Study is a clinical research study to evaluate an investigational drug for the treatment of patients newly diagnosed advanced Ovarian Cancer. |
(NCT 03393884)When speaking with your doctor, have this trial reference number available |
| visit www.clinicaltrials.gov or call your doctor to discuss |
About the Trial
All eligible patients enrolled in the study will receive the standard treatment for their cancer.
50% will receive standard treatment (chemotherapy and surgery)
50% will receive a combination of standard treatment and an investigational drug, GEN-1
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Phase I-II This Phase I-II study evaluates the safety, efficacy, and biological activity of the medicine in approximately 110 volunteers. Volunteers have the disease or condition the medicine is designed to treat. Phase I-II trials take place in hospitals, clinics or physician offices. |
Dates Actual Study Start Date Phase I September 5, 2018 Phase II August 1, 2020 Estimated Completion Dates Phase I May 27, 2020 Phase II December 31, 2021 Estimated Study Completion Date April 2023(PFS) Dec 2024 (OS) |
Now enrolling newly diagnosed patients who meet eligibility.
Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in
starting a conversation with your doctor
| Condition(s) | Age Range | Gender(s) |
| Ovarian Cancer | 18 or older | Female |
Trial Locations US and Canada
Locations provided may not reflect the most current site information. Click to access ClinicalTrials.gov site to view study locations or call 609-482-2472 to confirm.
| OVATION 2 Clinical Trial Sites | City & State |
| University of Alabama Birmingham | Birmingham, Alabama |
| University of South Alabama | Mobile, Alabama |
| University of California San Diego | La Jolla, California |
| Hoag Hospital | Newport Beach, California |
| Advent Health | Orlando, Florida |
| Women’s Care Florida | Saint Petersburg, Florida |
| Massachusetts General Hospital | Boston, Massachusetts |
| Washington University | St. Louis, Missouri |
| MD Anderson at Cooper | Camden, New Jersey |
| Hackensack UMC | Hackensack, New Jersey |
| Northwell Health | Lake Success, New York |
| NYU Langone | New York, New York |
| University of Oklahoma | Oklahoma City, Oklahoma |
| Providence Cancer Institute | Portland, Oregon |
| Sanford Health | Sioux Falls, South Dakota |
| Chattanooga’s Program in Women’s Oncology | Chattanooga, Tennessee |
| The West Clinic | Germantown, Tennessee |
| Providence Health Care | Spokane, Washington |
| Medical College of Wisconsin | Milwaukee, Wisconsin |
| CHUM | Montreal, Canada |
What Can You Do Next?
If you think this trial might be a fit and are interested in participating, take the next step to see if you are eligible
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Contact Our Clinical Trial Information Center 609-482-2472 to learn more |
Discuss With Your Doctor Print this page or email it to your doctor to discuss at your next visit. |
(NCT 03393884)When speaking with your doctor, have this clinical trial reference number available |
Participating in a clinical trial is an important decision.
Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.