Phase
Condition
Ovarian Cancer
Allergies & Asthma
Vaginal Cancer
Treatment
COM701
Normal Saline
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer orprimary peritoneal cancer
Has completed at least 2 previous courses (i.e. lines) of platinum-containingtherapy
For the last chemotherapy course prior to being randomized into the study, must havehad a minimum of 4 cycles of a platinum containing regimen and achieved a partial orcomplete tumor response.
Has received prior maintenance therapy with bevacizumab or a PARP inhibitor ifeligible and is not a candidate for, or has declined in writing, bevacizumab or PARPinhibitor therapy.
Have recovered from toxicities of prior chemotherapy or other therapy (to grade 1 orless, except for alopecia and neuropathy recovered to a ≤grade 2).
Exclusion
Exclusion Criteria:
Has had 4 or more lines of cytotoxic chemotherapy in total
Is being treated with immunosuppressive doses of systemic medications, such assteroids within 2 weeks before study drug administration
Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or any other check pointinhibitors
Presence of radiographic or biopsy proven liver metastases at the beginning orcompletion of current line of platinum-based chemotherapy.
Drainage of ascites during last 2 cycles of last chemotherapy or any time aftercompletion of the last chemotherapy regimen.
Bowel obstruction in the 6 weeks prior to randomization.
Have known active central nervous system metastases and/or carcinomatous meningitis / leptomeningeal carcinomatosis.
Has active hepatitis B virus (HBV) or hepatitis C virus (HCV), or subjects withhuman immunodeficiency virus (HIV).
Has active and clinically relevant bacterial, fungal, or viral infection that is notcontrolled or requires systemic antibiotics, antifungals, or antivirals,respectively.
Has received a live viral vaccine within 30 days of planned start of study treatmentor requiring a live vaccine during the study.
Has a history of severe allergic, anaphylactic, or other hypersensitivity reactionsto a human or humanized monoclonal antibody (mAb) or allergy to any excipients inthe investigational products.
Has any serious or unstable concomitant systemic disorder
Has any other condition that may increase the risk associated with studyparticipation or may interfere with the interpretation of study results and, in theopinion of the investigator, would make the subject inappropriate for entry into thestudy.
Is currently participating in or have participated in a clinical study and receivedan investigational agent or used an investigational device within 4 weeks prior tothe first dose of study treatment.
Is pregnant or breastfeeding or planning to become pregnant during the period of thestudy.
Study Design
Study Description
Connect with a study center
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, France 25000
FranceActive - Recruiting
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon 3033123, France 25000
FranceSite Not Available
Oncopole Claudius Regaud
Toulouse, France 31059
FranceActive - Recruiting
Oncopole Claudius Regaud
Toulouse 2972315, France 31059
FranceSite Not Available
Centre Oscar Lambret
Lille, 59000
FranceActive - Recruiting
Centre Oscar Lambret
Lille 2998324, 59000
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 13009
FranceActive - Recruiting
Institut Paoli-Calmettes
Marseille 2995469, 13009
FranceSite Not Available
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
FranceActive - Recruiting
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite 2987314, 69310
FranceSite Not Available
Centre Eugene Marquis
Rennes, 35042
FranceActive - Recruiting
Centre Eugene Marquis
Rennes 2983990, 35042
FranceSite Not Available
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
Saint-Herblain, 44805
FranceActive - Recruiting
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
Saint-Herblain 2979590, 44805
FranceSite Not Available
Gustave Roussy
Villejuif, 94800
FranceActive - Recruiting
Gustave Roussy
Villejuif 2968705, 94800
FranceSite Not Available
Assuta Medical Center
Ashdod, 7747629
IsraelActive - Recruiting
Assuta Medical Center
Ashdod 295629, 7747629
IsraelSite Not Available
Rambam Health Care Campus
Haifa, 3109601
IsraelActive - Recruiting
Rambam Health Care Campus
Haifa 294801, 3109601
IsraelSite Not Available
The Edith Wolfson Medical Center
Holon, 5822012
IsraelActive - Recruiting
The Edith Wolfson Medical Center
Holon 294751, 5822012
IsraelSite Not Available
Hadassah, University Hospital Ein Kerem
Jerusalem, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
IsraelActive - Recruiting
Hadassah, University Hospital Ein Kerem
Jerusalem 281184, 9112001
IsraelActive - Recruiting
Shaare Zedek Medical Center
Jerusalem 281184, 9103102
IsraelSite Not Available
The Chaim Sheba Medical Center
Ramat Gan, 5265601
IsraelActive - Recruiting
The Chaim Sheba Medical Center
Ramat Gan 293788, 5265601
IsraelSite Not Available
Georgia Cancer Center at Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
Georgia Cancer Center at Augusta University
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
The University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
Northwestern Memorial Hospital
Warrenville, Illinois 60555
United StatesActive - Recruiting
The University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Northwestern Memorial Hospital
Warrenville 4915525, Illinois 4896861 60555
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 0221502215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 0221502215
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Corewell Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Corewell Health
Grand Rapids 4994358, Michigan 5001836 49503
United StatesSite Not Available
Corewell Health
Grand Island 5069297, Nebraska 5073708 49503
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center- Main Campus
New York, New York 10065
United StatesActive - Recruiting
University of Rochester Medical Center
Rochester, New York 14642
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center- Main Campus
New York 5128581, New York 5128638 10065
United StatesSite Not Available
University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United StatesActive - Recruiting
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard 5157588, Ohio 5165418 43026
United StatesSite Not Available
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
OU Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
UPMC Magee- Womens Hospital
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
UPMC Magee- Womens Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesSite Not Available
West Cancer Center
Germantown, Tennessee 38138
United StatesSite Not Available
West Cancer Center
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
UVA Comprehensive Cancer Center
Charlottesville, Virginia 22903
United StatesActive - Recruiting
UVA Comprehensive Cancer Center
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available

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