JPRN-jRCT2080225217
Completed
Phase 2
Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer - OLAPem
ational Cancer Center Hospital East0 sites30 target enrollmentJune 3, 2020
ConditionsOvarian Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- ational Cancer Center Hospital East
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Has given signed informed consent to participate in the clinical trial of her own will.
- •2\. Is aged 20 years or older on the day of signing the informed consent.
- •3\. Has been diagnosed with histologically confirmed, Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by the International Federation of Gynecology and Obstetrics (FIGO) staging system (2014\), with a histological type of high\-grade serous or Grade 3 endometrioid carcinoma.
- •4\. Have measurable disease based on RECIST 1\.1\.
- •5\. Is a candidate for debulking surgery.
- •6\. Has an HRD\-positive tumor.
- •7\. Has an ECOG Performance Status of 0 or 1\.
- •8\. Laboratory test results within 21 days prior to enrollment have met the following organ function criteria. However, measurements within 14 days of blood transfusion or administration of granulocyte\-colony stimulating factor (G\-CSF) are excluded.
- •Neutrophil count \>\= 1,500/mm3
- •Platelet count \>\= 100,000/mm3
Exclusion Criteria
- •1\. Has received previous allogeneic bone\-marrow transplantation.
- •2\. Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids. Interstitial lung disease/pneumonitis includes radiation pneumonitis.
- •3\. Has received prior antitumor therapy (e.g., chemotherapy, molecular\-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy).
- •4\. Has received surgery under general anesthesia within 28 days prior to enrollment. However, surgery to diagnose ovarian/fallopian tube/peritoneal cancer performed under general anesthesia is allowed.
- •5\. Has received radiation or radioactive isotope therapy within 28 days prior to enrollment.
- •6\. Has uncontrolled pericardial effusion, pleural effusion, or peritoneal effusion.
- •7\. Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment.
- •8\. Has a history of deep vein thrombosis or pulmonary embolism.
- •9\. Is receiving systemic glucocorticoid therapy or systemic immunosuppressive therapy.
- •10\. Has a history of autoimmune disease.
Outcomes
Primary Outcomes
Not specified
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