Flora-5

About FLORA-5 Program

Sponsored by OncoQuest Pharmaceuticals, the experimental drug used in this study is oregovomab. Oregovomab is being investigated in the Phase 3 FLORA-5 (NCT04498117, 2020-002270-26) study in patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal cancer. The study will assess whether oregovomab when combined with paclitaxel and carboplatin will slow down the progress of the cancer, prolong life and has an acceptable preliminary safety profile as compared to the combination of paclitaxel and carboplatin which is the current standard treatment in patients with this type of cancer. About 602 subjects will be enrolled in this study. The study will be conducted in approximately 120 medical centers in North America, Europe, Asia, and South America.

Results of Previous Clinical Trials

Who can participate in FLORA-5?

Adults 18 years old or older

Women with newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin

Surgical removal of as much cancer as possible either a diagnosis or after certain amount of treatment with chemotherapy

Negative result for genetic mutation

Adequate bone marrow, liver, and renal functions

Negative for active autoimmune disease

No anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study

What exams, tests, and procedures are involved in FLORA-5?

Participating in research is different from getting standard medical care. The primary purpose of research is to create new knowledge for the benefit of future patients and society in general, although it might benefit the patients participating in the trials as well. Research studies may or may not benefit the people who participate in them. The description below will help you further understand the expectation of the research process for FLORA-5 (NCT04498117, 2020-002270-26).

Screening Period

Before you begin the study, your Study Doctor will review the results of your exams, tests, and procedures. This helps your Study Doctor decide if it is safe for you to take part in the study. If you join the study, you will have more study procedures done to monitor your safety and health as approved by the study ethics committees. Most of these are included in the usual care even if you were not in a study.

Treatment Period

If you meet study requirements, you will be at random selected to receive one of the two treatments. This means that you, your Study Doctor or the study staff will not know whether you are taking oregovomab or placebo until the end of the study. If at any point in the study your safety is considered to be at risk, your study doctor can either alter the dose of the drug(s) or terminate the treatment.

End of Treatment (EOT) and
Safety Follow-up

Whenever you discontinue the study drug, a visit to assess the status of your cancer and any side-effects will be conducted within about two weeks, of the decision to stop the study drug. During this visit, your Study Doctor will perform EOT study procedures. About one month after your last dose of the study drug, your study doctor will follow up on your well-being. This is done for your safety.

Post-Treatment Follow-Up Period

If you complete the treatment period, your Study Doctor will still follow up with you to see how you are approximately every three months for the first two years, and then every six months starting in the 3rd year and beyond. These follow-ups may be through a doctor's office visit or could be a phone call. Your doctor will let you know if you need to come back to the clinic.

Current Study Countries

Currently approved countires are listed below.

Study listings: clinicatrials.gov

Argentina

Belgium

Brazil

Canada

Chile

China

Czech Republic

Hungary

Italy

Mexico

Poland

Romania

South Korea

Spain

Taiwan

USA