A Potential Option Beyond Standard of Care Treatment
Offering the highest standard of care, the potential promise of investigational immunotherapy, and physicians dedicated to patient care and ovarian cancer research
OVATION-2 is a phase 1/2 study, evaluating the safety and potential efficacy of an investigational immunotherapy (GEN-1), when used in combination with standard chemotherapy treatment and surgery in treating ovarian cancer.
Study Overview
130
Number of Participants
21
Locations: 21 cancer centers in the
United States and Canada
Investigational Drug
GEN-1, an immunotherapy. Administered through a catheter directly into the abdomen over 1-2 hours.
Participants in OVATION-2 will be randomly selected (by chance) to receive one of two treatments:
Standard of care chemotherapy and surgery* plus GEN-1
Standard of care chemotherapy and surgery*
Study Schedule
PRE-SURGERY
Chemotherapy
(9 Weeks)
Chemotherapy every 3 weeks.
GEN-1 once a week for 8 weeks.
SURGERY
Surgery
(7-8 Weeks)
Surgery 3-4 weeks after last dose of chemotherapy.
One month recovery post-surgery.
POST-SURGERY
Chemotherapy
(9 Weeks)
Chemotherapy every 3 weeks.
GEN-1 once a week for 9 weeks.
MAINTENANCE
Maintenance
(Ongoing)
Follow-up appointment for tests and assessments 3-6 weeks after last dose of chemotherapy.
Follow-up tests every 3 months.
PRE-SURGERY
Chemotherapy
(9 Weeks)
Chemotherapy every 3 weeks.
SURGERY
Surgery
(7-8 Weeks)
Surgery 3-4 weeks after last dose of chemotherapy.
One month recovery post-surgery.
POST-SURGERY
Chemotherapy
(9 Weeks)
Chemotherapy every 3 weeks.
MAINTENANCE
Maintenance
(Ongoing)
Follow-up appointment for tests and assessments 3-6 weeks after last dose of chemotherapy.
Follow-up tests every 3 months.
All participants will receive at no cost:
Care and monitoring from physicians specializing in ovarian cancer and dedicated to ovarian cancer research
Close monitoring by a clinical team using study-related tests and assessments
Potential access to the investigational immunotherapy
Reimbursement for study-related travel and expenses may also be available.
Choosing to take part in a clinical research study is a big decision.
Clinical research studies are monitored by an independent Institutional Review Board (IRB) or Ethics Committee (EC), composed of physicians and experts who are not participating in the study, and who are responsible for protecting the safety and rights of participants.
The study team wants to make sure that you’re comfortable with all aspects of participating in a clinical research study. The team will speak with you and go over a document called an Informed Consent Form, which will help you understand what the study is about, the potential risks and benefits, and what will be involved before you agree to participate. You are free to share this form with your family and personal physician when deciding if participation is right for you. If you are eligible and choose to participate in the study, you will sign the Informed Consent Form. Once you are a participant, you can decide to stop participating at any time and for any reason.
Participating in clinical research can help advance potential ovarian cancer therapies for women now and in the future.
All study drugs must be tested in clinical research studies before they are approved and available to be prescribed by doctors. Clinical research studies are necessary to get medical treatments approved for use. These studies are designed to carefully test the safety and effectiveness of a drug or a treatment in a group of volunteers who are usually patients.