Phase
Condition
Ovarian Cysts
Pelvic Cancer
Fallopian Tube Cancer
Treatment
olvimulogene nanivacirepvec
Platinum chemotherapy: carboplatin (preferred) or cisplatin
Bevacizumab (or biosimilar)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed (from prior treatment) non-resectable ovarian, fallopiantube or primary peritoneal cancer.
High-grade serous [including malignant mixed Mullerian tumor (MMMT) with metastasisthat contains high-grade epithelial carcinoma, FIGO grades 2 & 3 allowed],endometrioid, or clear-cell ovarian cancer.
Performance status ECOG of 0 or 1.
Life expectancy of at least 6 months.
Received a minimum of 3 prior lines (including the 1st line) of systemic therapywith no maximal limit.
Platinum-resistant or -refractory disease based on platinum-free interval (PFI) fromthe last dose of the most recent. platinum-based line of therapy (must have receiveda minimum of 2 doses of platinum in that line) to subsequent disease progressionbased on radiological assessment. Platinum-refractory: PFI of < 1 month (includingdisease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6months.
Received prior bevacizumab (or biosimilar) treatment.
No contraindication to receive carboplatin, cisplatin or bevacizumab (orbiosimilar).
Have disease progression after last prior line of therapy based on radiologicalassessment prior to randomization.
At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imagingscan at screening.
Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likelyhaving disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequateimmune function by lymphocyte count.
Exclusion
Exclusion Criteria:
Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrinesubtypes, MMMT tumors absent an epithelial component on recent biopsy, ornon-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).
Bowel obstruction within last 3 months prior to screening.
Active urinary tract infection, pneumonia, other systemic infections.
Active gastrointestinal bleeding.
Known current central nervous system (CNS) metastasis.
Inflammatory diseases of the bowel.
History of HIV infection.
Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.
History of thromboembolic event within the prior 3 months.
Contraindications for intraperitoneal (IP) catheter placement: Bowel obstructionwith distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis,abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
Clinically significant cardiac disease at screening (New York Heart AssociationClass III/IV).
Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transientischemic attack (TIA) in previous 6 months.
Oxygen saturation <90%.
Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
Receiving concurrent antiviral agent.
Prior malignancy of other histology active within previous 3 years except forlocally curable cancers apparently cured such as basal/squamous cell skin cancer,superficial bladder cancer, carcinoma in situ of cervix or breast, any other stageI/II local malignancies.
Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4weeks prior to planned treatment.
Underwent surgery within 4 weeks, or have insufficient recovery fromsurgical-related trauma or wound healing, prior to first study treatment in eitherArm.
Receiving immunosuppressive therapy or steroids (except acute concurrentcorticosteroid of no more than 20 mg per day for medical management withprednisolone equivalent.
Symptomatic malignant ascites or pleural effusions defined as rapidly progressiveascites with abdominal distension and gastrointestinal dysfunction, pleuraleffusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.
Known hypersensitivity to gentamicin.
Study Design
Study Description
Connect with a study center
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama 36604
United StatesActive - Recruiting
The University of South Alabama, Mitchell Cancer Institute
Mobile 4076598, Alabama 4829764 36604
United StatesSite Not Available
University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesActive - Recruiting
University of Arizona Cancer Center
Tucson 5318313, Arizona 5551752 85719
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesActive - Recruiting
UC San Diego Health - Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
Hoag Gynecologic Oncology
Newport Beach, California 92663
United StatesActive - Recruiting
UCI Health Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesActive - Recruiting
City of Hope
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
UC San Diego Health - Moores Cancer Center
La Jolla 5363943, California 5332921 92093
United StatesSite Not Available
Hoag Gynecologic Oncology
Newport Beach 5376890, California 5332921 92663
United StatesSite Not Available
UCI Health Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
United StatesSite Not Available
AdventHealth Cancer Institute
Orlando, Florida 32804
United StatesActive - Recruiting
Women's Cancer Associates with Women's Care Florida
Saint Petersburg, Florida 33713
United StatesSite Not Available
Sarasota Memorial Research Institute
Sarasota, Florida 34239
United StatesActive - Recruiting
Tampa General Hospital/University of South Florida
Tampa, Florida 33606
United StatesSite Not Available
Women's Cancer Associates with Women's Care Florida
Tampa, Florida 33713
United StatesActive - Recruiting
AdventHealth Cancer Institute
Orlando 4167147, Florida 4155751 32804
United StatesSite Not Available
Sarasota Memorial Research Institute
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
Women's Cancer Associates with Women's Care Florida
St. Petersburg 4171563, Florida 4155751 33713
United StatesSite Not Available
Tampa General Hospital/University of South Florida
Tampa 4174757, Florida 4155751 33606
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Indiana University Simon Comprehensive Cancer Center
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
Holy Cross Hospital
Silver Spring, Maryland 20910
United StatesActive - Recruiting
Holy Cross Hospital
Silver Spring 4369596, Maryland 4361885 20910
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesSite Not Available
Mercy Hospital St. Louis
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Mercy Hospital St. Louis
St Louis, Missouri 63141
United StatesActive - Recruiting
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Mercy Hospital St. Louis
St. Louis, Missouri 63141
United StatesSite Not Available
Washington University School of Medicine
St. Louis, Missouri 63110
United StatesActive - Recruiting
Mercy Hospital St. Louis
St Louis 4407066, Missouri 4398678 63141
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United StatesActive - Recruiting
Center of Hope
Reno, Nevada 89511
United StatesActive - Recruiting
Women's Cancer Center of Nevada
Las Vegas 5506956, Nevada 5509151 89106
United StatesSite Not Available
Center of Hope
Reno 5511077, Nevada 5509151 89511
United StatesSite Not Available
Southwest Women's Oncology Inc./Optimum Clinical Research Group
Albuquerque, New Mexico 87109
United StatesSite Not Available
Stony Brook Cancer Center
Stony Brook, New York 11794
United StatesActive - Recruiting
Stony Brook Cancer Center
Stony Brook 5139865, New York 5128638 11794
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
East Carolina University
Greenville, North Carolina 27834
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
East Carolina University
Greenville 4469160, North Carolina 4482348 27834
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
OhioHealth Research Institute
Columbus, Ohio 43214
United StatesActive - Recruiting
Kettering Health
Kettering, Ohio 45429
United StatesActive - Recruiting
ProMedica Flower Hospital
Sylvania, Ohio 43560
United StatesActive - Recruiting
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
Kettering Health
Kettering 4515843, Ohio 5165418 45429
United StatesSite Not Available
ProMedica Flower Hospital
Sylvania 5173572, Ohio 5165418 43560
United StatesSite Not Available
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Oklahoma University Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
AHN West Penn Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15224
United StatesSite Not Available
Hollings Cancer Center
Charleston, South Carolina 29425
United StatesActive - Recruiting
Hollings Cancer Center
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee 37403
United StatesSite Not Available
Erlanger Health, Inc.
Chattanooga, Tennessee 37403
United StatesActive - Recruiting
Erlanger Health, Inc.
Chattanooga 4612862, Tennessee 4662168 37403
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas 77030
United StatesActive - Recruiting
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
University of Texas Science Center at Houston, McGovern Medical School
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
United StatesActive - Recruiting
Providence Sacred Heart Medical Center & Children's Hospital
Spokane 5811696, Washington 5815135 99204
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.