[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-carcinoma-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-carcinoma-recurrent":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100540795","phase-1-intraperitoneal-cytokine-induced-memory-like-ciml-natural-killer-nk-cells-in-recurrent-ovarian-cancer-100540795",false,"NCT06321484","Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer","A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.\n* Participants must have measurable cancer defined by RECIST 1.1 criteria.\n* Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant\u002Fintolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.\n* Age ≥18 years and \\\u003C85 years old.\n* ECOG performance status of 0 or 1.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤3 x institutional ULN\n  * Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * Serum creatinine ≤ 2.0 mg\u002FdL OR glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73 m2\n  * Oxygen saturation: ≥ 90% on room air\n  * Left ventricular ejection fraction (cardiac function) ≥ 40%\n  * No laboratory evidence of ongoing hemolysis in opinion of investigator\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Physician assessment indicating the patient would be able to tolerate undergoing a brief procedure for placement of an intraperitoneal port for NK cell infusion.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason and because CIML NK cells and IL-2 may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nExclusion Criteria:\n\n* Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.\n* Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.\n* Participants who are receiving any other investigational agents.\n* Solid organ transplant (allograft) recipients.\n* Participants with known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n* History of severe or anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to CIML NK cells or IL-2 or any of the other agents used in study.\n* For patients with prior exposure to check point inhibitor therapy, those with a prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\n* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., GuillainBarre syndrome and myasthenia gravis). Patients with Hashimoto thyroiditis are eligible.\n* Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by fludarabine\u002Fcyclophosphamide chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high-risk of lethal treatment-related hepatotoxicity in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n* Anaphylactic reactions to murine-based antibody therapy or iron dextran as the CIML NK cell product contains similar reagents at end of manufacturing\u002Finfusion.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.","ALL","18 Years","85 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC).\n\nNames of the study therapies involved in this study are:\n\nCIML NK (cellular therapy) Interleukin-2 (IL-2)",[27,28,29,30,31,32,33],"Platinum-resistant Ovarian Cancer","Recurrent Ovary Cancer","Ovarian Cancer","Ovarian Carcinoma","Ovarian Carcinoma, Recurrent","Endometroid Ovarian Carcinoma","Clear Cell Ovarian Carcinoma",[35,28,29,30,31,32,33],"Platinum-Resistant Ovarian Cancer","RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":40},"2024-10-09",{"date":44,"type":21},"2031-10-31",{"name":46,"class":47},"Dana-Farber Cancer Institute","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100619095","phase-2-trastzumab-deruxtecan-versus-soc-in-recurrent-ovarian-that-progressed-on-prior-parp-inhibitor-therapy-100619095","NCT07340164","Trastzumab Deruxtecan Versus SOC in Recurrent Ovarian That Progressed on Prior PARP Inhibitor Therapy","A Phase 2, Open-label, Multicenter, Randomized Study of Trastuzumab Deruxtecan Versus Investigator's Choice Chemotherapy in Recurrent Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy: TROY (APGOT-OV14)","TROY","Inclusion Criteria:\n\n* 1\\. Adults ≥18 years of age on the day of signing the Informed Consent Form. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n\n  2\\. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.\n\n  3\\. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines by local tests.\n\n  4\\. Availability of tumor tissue for translational research: A formalin-fixed paraffin-embedded (FFPE) tumorblock (preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.\n\n  5\\. Histologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and\u002For fallopian tube cancer that is recurrent.\n\n  6\\. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n\n  7\\. Radiologically confirmed\u002Fdocumented disease progression while on PARP inhibitor therapy in either first or second-line maintenance setting Note: Documentation of disease progression must be within 180 days of last PARPi dose taken. Surgical salvage intervention and\u002For focal ablative therapies are allowed.\n  1. Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed.\n  2. Progression on first-line maintenance PARP inhibitor: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry (note: treatment-free interval on platinum rechallenge must be \\> 6 months, with documented disease progression prior to study entry.\n  3. Progression on second-line maintenance PARP inhibitor: Participants are not allowed any additional systemic anticancer treatment before study entry.\n\n     8\\. Patient with measurable disease according RECIST 1.1 criteria. 9. LVEF ≥50% within 28 days before randomization. 10. Patient has adequate organ function, defined as follows:\n\n  a) Absolute neutrophil count ≥ 1,500 cells\u002FμL b) Platelets ≥ 100,000 cells\u002FμL c) Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL d) Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50mL\u002Fmin using the Cockcroft-Gault equation for patients with creatinine levels \\> 1.5× institutional ULN e) Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN f) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN g) International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN. Patients receiving anticoagulant therapy must have a PT or partial thromboplastin within the therapeutic range of intended use of anticoagulants.\n\n  11\\. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of nonchildbearing potential. Nonchildbearing potential is defined as follows:\n  1. Patient is ≥ 45 years of age and has not had menses for \\> 1 year.\n  2. A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for \\\u003C 2 years without a hysterectomy and oophorectomy.\n  3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:\n* Documented hysterectomy or bilateral oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.\n* Tubal ligation must be confirmed with medical records of the actual procedure.\n* Information must be captured appropriately within the site's source documents. 12. Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 150 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents) 13. Has proteinuria \\\u003C2+. If proteinuria is ≥2+, 24-hour urine must demonstrate \\\u003C1 g of protein in 24 hours.\n\nExclusion Criteria:\n\n\\- 1. Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the last platinum administration in the second-line setting.\n\n2\\. History of additional malignancy within 3 years before the date of enrolment. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence of the Sponsor, is considered cured with minimal risk of recurrence within 3 years. 3. Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \\\u003C 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.\n\nNote: The washout period for radiation therapy is as follows: ≥ 4 weeks for palliative stereotactic radiation to chest and ≥2 weeks palliative stereotactic radiation therapy to other anatomic areas.\n\n4\\. Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.\n\nNote: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging \\[using the identical imaging modality for each assessment, either MRI or CT scan\\] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability. 5. Active and\u002For uncontrolled infection. The following exceptions apply:\n\n1. Participants with HIV infection are eligible if followings are met: a. CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening, b. Virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) at the time of screening and for at least 12 weeks before screening, c. No AIDS-defining opportunistic infections or conditions within the past 12 months, d. On stable ART regimen, without changes in drugs or dose modification, for at least 4 weeks before trial entry (Day 1) and agree to continue ART throughout the trial.\n2. Participants with evidence of chronic HBV infection are eligible if the followings are met: a. the HBV viral load is \\\u003C2000 IU\u002FmL b. start or maintain antiviral treatment, if clinically indicated as per the investigator. c. they have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HBV infection.\n3. Participants with a history of HCV infection are eligible if History of hepatitis C infection eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks and if they Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HCV infection.\n\n   6\\. Patient has not recovered (i.e., to Grade ≤ 1 or to baseline) from cytotoxic therapy-induced adverse events(AEs).\n\nNote: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.\n\n7\\. Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy.\n\n8\\. Patient has a known hypersensitivity to the active substances or to any excipients of the study intervention 9. Evidence of active or ongoing bowel obstruction 10. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required corticosteroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n\n11\\. Uncontrolled or significant cardiovascular disease, including the following:\n\n1. QT interval corrected with Fridericia's formula interval \\>470 ms (average of triplicate determinations).\n2. Diagnosed or suspected long QT syndrome or known family history of long QT syndrome.\n3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.\n4. Myocardial infarction within 6 months prior to screening.\n5. Uncontrolled angina pectoris within 6 months prior to screening.\n6. New York Heart Association Class 2 to 4 congestive heart failure.\n7. Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.\n8. Complete left or right bundle branch block.\n9. Patients with troponin levels above ULN at screening (as defined by the manufaccturer), and wit any MI related symptoms. (For patients with elevated troponin levels but no MI symptoms, a cardiology consultation during the screening period is recommended..\n\n   12\\. Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.\n\n   13\\. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) 14. Patients with current abdominal\u002F pelvic fistula. 15. Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study(including obtaining informed consent).\n\n   16\\. Prior exposure to other HER2-targeted agents or antibody-drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor 17. Patient is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment, or lactating woman.\n\n   18\\. Live vaccines within 30 days of first dose of study intervention and while receiving study intervention. Administration of inactivated vaccines (i.e. inactivated influenza vaccine) is permitted. Inactivated RNA or nonreplicating viral vector-based SARS-CoV-2 vaccines are allowed, as approved by local\u002Fregional Health Authorities. Novel live attenuated SARS-CoV-2 vaccines are not permitted.","FEMALE",{"count":58,"type":21},116,[60],"PHASE2","Ovarian, fallopian tube, and peritoneal cancers are often diagnosed at an advanced stage, requiring chemotherapy. Recently, the standard treatment, platinum-based chemotherapy plus PARP inhibitors, has extended disease-free survival (PFS). However, most patients eventually develop resistance to PARP inhibitors and become unresponsive to conventional treatments. Therefore, an effective standard treatment for patients who relapse after PARP inhibitor resistance has not yet been established. Meanwhile, HER2 protein expression has been identified in some patients, drawing attention as a new therapeutic target.\n\nTrastuzumab deruxtecan (T-DXd), an antibody-drug conjugate (ADC) targeting HER2, has already demonstrated efficacy and safety in other HER2-positive cancers. This study aimed to explore the potential of T-DXd as a new treatment option by evaluating the efficacy and safety of T-DXd in patients with ovarian, fallopian tube, and peritoneal cancer who relapsed after PARP inhibitor treatment and who express HER2.\n\nParticipants will:\n\n* Arm A: T-DXd +\u002F- Bevacizumab, IV, every 3weeks\n* Arm B: Platinum-based chemotherapy +\u002F- Bevacizumab, IV",[29,31,63,64],"Ovarian Cancer Metastatic Recurrent","Ovarian Cancer (OvCa)",[54,66,67],"APGOT-OV14","ENGOT-ov92","2026-04-17",{"date":70,"type":40},"2026-04-20",{"date":72,"type":40},"2026-02-26",{"date":74,"type":21},"2030-12-31",{"name":76,"class":47},"Yonsei University",1]