Study of the Drug Olvi-Vec in Women with Ovarian Cancer
https://www.facingourrisk.org/research-clinical-trials/study/334/study-of-the-drug-olvi-vec-in-women-with-ovarian-cancer
Clinicaltrials.gov identifier:
NCT05281471 (https://clinicaltrials.gov/show/NCT05281471)
Treatment
Treatment for women diagnosed with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer or whose cancer did not respond to prior chemotherapy
About the Study
This study will test how safe and effective the immunotherapy drug Olvi-Vec is, when it is followed by further chemotherapy and the drug bevacizumab in women diagnosed with platinum-resistant or platinum-refractory (didn't respond to previous treatment) ovarian, fallopian tube or primary peritoneal cancer. People receiving the drug Olvi-Vec will have it administered through an intraperitoneal catheter (a method of injecting drugs directly into the abdomen.) A previous phase of this study showed this method of delivery was efficient in stimulating the death of tumor cells and immune response.
Another group of people in this study will be given their doctor’s choice of chemotherapy and the drug bevacizumab.
What the Study Involves
People are assigned at random to one of the following two study groups:
Group A:
- People will receive two infusions (on two days in a row) of Olvi-Vec through an intraperitoneal catheter.
- People then receive a combination of chemotherapy (carboplatin or cisplatin) known as "platinum-doublet" chemotherapy along with bevacizumab by IV (into the veins) beginning in Week 4.
Group B:
- People will receive their doctor's choice of chemotherapy (which can be platinum or non-platinum) and bevacizumab.
The study team will monitor participants for up to 36 months.
This Study is Open To:
People 18 years and older who have:
- Ovarian, fallopian tube or primary peritoneal cancer that cannot be removed with surgery
- Received a minimum of 3 prior lines of chemotherapy
- Cancer that has progressed after the last line of chemotherapy
- Time since the last doses of Platinum-based chemotherapy has been less than or equal to 24 months
- Received prior bevacizumab treatment
This Study is Not Open To:
People with the following are not eligible to participate:
- Have an HIV infection, a recent hepatitis B or hepatitis C virus, or other systemic infection
- Have had a recent (circulating) blood clot or have significant heart disease
- Have had a recent bowel obstruction or active gastrointestinal bleeding
- Has had a stroke or blood clot in the previous 6 months
- Received chemotherapy, radiation, or certain other anti-cancer therapies within 4 weeks prior to study treatment
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.