OVATION 2 Study:

a clinical trial for newly diagnosed ovarian cancer patients

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

The OVATION 2 Study is a clinical research study to evaluate an investigational drug for the treatment of patients newly diagnosed advanced Ovarian Cancer.

View Trial on ClinicalTrials.gov 

(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

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

 

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.