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Study of the Drug Olvi-Vec in Women with Ovarian Cancer

Clinicaltrials.gov identifier:
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

Study of the Drug Olvi-Vec in Women with Ovarian Cancer

About the Study

This study will test how safe and effective the 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, 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.

Alabama

City: Mobile RECRUITING
Facility: The University of South Alabama, Mitchell Cancer Institute
Contact Info:
swhite@southalabama.edu 251-445-9834
Jennifer Pierce, MD

Arizona

City: Tucson RECRUITING
Facility: University of Arizona Cancer Center
Contact Info:
calkhairi@arizona.edu 520-626-0975
Setsuko K. Chambers, MD

California

City: Duarte RECRUITING
Facility: City of Hope
Contact Info:
edwang@coh.org 877-467-3411
Edward Wang, MD, PhD

City: La Jolla RECRUITING
Facility: UC San Diego Health - Moores Cancer Center
Contact Info:
aocronin@health.ucsd.edu 858-822-3975
Michael McHale, MD
Ramez Eskander, MD

City: Newport Beach RECRUITING
Facility: Hoag Gynecologic Oncology
Contact Info:
Esmeralda.Martinez@hoag.org 949-764-5827
Alberto Mendivil, MD

City: Orange RECRUITING
Facility: UCI Health Chao Family Comprehensive Cancer Center
Contact Info:
ktewari@hs.uci.edu 714-456-7971
Krishnansu S. Tewari, MD

Florida

City: Orlando RECRUITING
Facility: AdventHealth Cancer Institute
Contact Info:
Karla.Hernandezcruz@AdventHealth.com 407-609-4437
Robert W Holloway, MD

City: Sarasota RECRUITING
Facility: Sarasota Memorial Research Institute
Contact Info:
Angele-price@smh.com 941-917-3614
Kristen-McKenzie@smh.com 941-917-1830
Beverly Long, MD

City: Tampa RECRUITING
Facility: Tampa General Hospital/University of South Florida
Contact Info:
mrengifopardo@tgh.org 813-844-5842
Matthew L. Anderson, MD, PhD

City: Tampa RECRUITING
Facility: Women's Cancer Associates with Women's Care Florida
Contact Info:
mindermaur@womenscarefl.com 727-826-0795
rlittle@womenscarefl.com 727-826-0795
Megan Indermaur, MD

Indiana

City: Indianapolis RECRUITING
Facility: Indiana University Simon Comprehensive Cancer Center
Contact Info:
chawest@iupui.edu 317-278-3021
Jessica E. Parker, MD

Maryland

City: Silver Spring RECRUITING
Facility: Holy Cross Hospital
Contact Info:
kalnitsl@holycrosshealth.org 301-754-7552
Frederick D Min, MD

Michigan

City: Ann Arbor RECRUITING
Facility: University of Michigan
Contact Info:
jeanmarie@med.umich.edu 734-936-6686
Jean Siedel, MD

City: Detroit RECRUITING
Facility: Karmanos Cancer Institute
Contact Info:
rmorris@med.wayne.edu 313-576-9442
Robert Morris, MD

Missouri

City: Saint Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
odibol@wustl.edu 314-362-1705
Premal Thaker, MD

City: Saint Louis RECRUITING
Facility: Mercy Hospital St. Louis
Contact Info:
Crystal.tindall@mercy.net 314-251-7058
Jessica.Black@mercy.net
Madhavi Manyam, MD

North Carolina

City: Charlotte RECRUITING
Facility: Levine Cancer Institute
Contact Info:
Leah.J.Wilson@atriumhealth.org 980-442-4866
Erin K Crane, MD

City: Greenville RECRUITING
Facility: East Carolina University
Contact Info:
Grainger.Lanneau@ecuhealth.org 252-816-2273
Grainger Lanneau, MD

Nevada

City: Las Vegas RECRUITING
Facility: Women's Cancer Center of Nevada
Contact Info:
tescamilla@wccenter.com 702-851-4672
Jamador@wccenter.com 702-851-4672
Nicola M. Spirtos, MD

City: Reno RECRUITING
Facility: Center of Hope
Contact Info:
Plim@cohreno.com 775-327-4611
Peter Lim, MD

New York

City: Stony Brook RECRUITING
Facility: Stony Brook Cancer Center
Contact Info:
Sumbul.Yousafi@stonybrookmedicine.edu 631-638-0829
Anu.John@stonybrookmedicine.edu 631-972-0147
Gabrielle Gossner, MD

Ohio

City: Cleveland RECRUITING
Facility: Cleveland Clinic
Contact Info:
ludwigj@ccf.org 216-390-2492
Peter Rose, MD

City: Columbus RECRUITING
Facility: OhioHealth Research Institute
Contact Info:
Meagan.Hebert@ohiohealth.com 614-566-1264
Aine Clements, MD

City: Kettering RECRUITING
Facility: Kettering Health
Contact Info:
daniel.geyer@ketteringhealth.org 937-395-6017
tammy.schleich@ketteringhealth.org 937-395-8483
Thomas J. Reid, MD

Oklahoma

City: Oklahoma City RECRUITING
Facility: Oklahoma University Health Stephenson Cancer Center
Contact Info:
Debra-Richardson@ouhsc.edu 405-271-1112
Ashma-Acharya@ouhsc.edu 405-271-8001
Debra Richardson, MD

Pennsylvania

City: Pittsburgh RECRUITING
Facility: AHN West Penn Hospital
Contact Info:
clinicaltrials@ahn.org 412-578-1116
Sarah Crafton, MD

South Carolina

City: Charleston RECRUITING
Facility: Hollings Cancer Center
Contact Info:
knoxc@musc.edu 843-792-2803
Brian Orr, MD

Texas

City: Houston RECRUITING
Facility: Baylor College of Medicine
Contact Info:
jan.sunde@bcm.edu 832-957-6500
Jan Sunde, MD

City: Houston RECRUITING
Facility: University of Texas Science Center at Houston, McGovern Medical School
Contact Info:
Edgar.M.RiveraHernandez@uth.tmc.edu 713-500-6382
Joseph Lucci, III, MD

Washington

City: Spokane RECRUITING
Facility: Providence Sacred Heart Medical Center & Children's Hospital
Contact Info:
Jodie.mactagone@providence.org 509-474-3821
Melanie Bergman, MD

This Study is Open To:

People 18 years and older who have:

Ovarian, 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