Phase
Condition
Vaginal Cancer
Allergies & Asthma
Ovarian Cysts
Treatment
Normal Saline
COM701
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
West Cancer Center
Germantown, Tennessee 38138
United StatesActive - Recruiting
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