Phase
Condition
Fallopian Tube Cancer
Ovarian Cysts
Pelvic Cancer
Treatment
Platinum chemotherapy: carboplatin (preferred) or cisplatin
Bevacizumab (or biosimilar)
olvimulogene nanivacirepvec
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
University of Arizona Cancer Center
Tucson, Arizona 85719
United StatesActive - Recruiting
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
AdventHealth Cancer Institute
Orlando, Florida 32804
United StatesActive - Recruiting
Women's Cancer Associates with Women's Care Florida
Saint Petersburg, Florida 33713
United StatesActive - Recruiting
Sarasota Memorial Research Institute
Sarasota, Florida 34239
United StatesActive - Recruiting
Tampa General Hospital/University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
Women's Cancer Associates with Women's Care Florida
Tampa, Florida 33713
United StatesActive - Recruiting
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Holy Cross Hospital
Silver Spring, Maryland 20910
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Mercy Hospital St. Louis
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Washington University School of Medicine
Saint 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
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United StatesActive - Recruiting
Center of Hope
Reno, Nevada 89511
United StatesActive - Recruiting
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
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
East Carolina University
Greenville, North Carolina 27834
United StatesActive - Recruiting
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
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Hollings Cancer Center
Charleston, South Carolina 29425
United StatesActive - Recruiting
Chattanooga's Program in Women's Oncology
Chattanooga, Tennessee 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
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
United StatesActive - Recruiting
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