[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-cancer-stage-iv":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,48,90,124,146,198,224,246,276,298],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100416360","phase-1-microdevice-in-ovarian-fallopian-tube-and-peritoneal-cancer-100416360",false,"NCT04701645","Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer","Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer","Inclusion Criteria:\n\n* Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.\n* Participants must meet one of the following clinical categories:\n\n  * Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n  * Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.\n  * Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and\u002For remove oligometastatic lesions.\n  * Cohort 4: Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.\n* Participants must be 18 years of age or older.\n* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.\n* Participants will undergo laboratory testing within 14 days\\* prior to the microdevice placement.\n\n  * Patients must have absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 75,000\u002FmcL\n  * PT (INR) \\\u003C 1.5\n  * PTT \\\u003C 1.5x control\n  * Women of childbearing potential must have negative pregnancy test (urine or serum) \\*\\*Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement\n* Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and\u002For medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.\n* The following criteria must be met:\n\n  * Participants must have undergone an abdominal\u002Fpelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.\n\nCT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.\n\n* Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.\n* Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.\n* A lesion can be selected where the microdevice is to be implanted that is\n\n  * Amenable to percutaneous placement\n  * Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.\n\n    * Patients must have the ability to understand and the willingness to sign a written informed consent document.\n    * Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n\nExclusion Criteria:\n\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 the safety of a biopsy and\u002For surgery.\n* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy\u002Fdevice placement in an abdominal lesion.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.\n* Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)","FEMALE","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.\n\nThe name of the study intervention involved in this study is:\n\n-implantable microdevice",[26,27,28,29,30,31,32],"Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancer Stage III",[26,27,28,34,29,30,31,32],"Implantable Microdevice","RECRUITING","2026-05-14",{"date":38,"type":39},"2026-05-18","ACTUAL",{"date":41,"type":39},"2022-11-01",{"date":43,"type":20},"2027-06-30",{"name":45,"class":46},"Brigham and Women's Hospital","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100538389","phase-2-study-of-acute-normovolemic-hemodilution-anh-in-people-with-ovarian-cancer-who-are-having-cytoreductive-surgery-100538389","NCT06290193","Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Cytoreductive Surgery","A Prospective Randomized Trial of Acute Normovolemic Hemodilution (ANH) in Patients Undergoing Cytoreductive Surgery for Ovarian Cancer","Inclusion Criteria:\n\n* Adults (≥18 years)\n* BLOODS score ≥2 as calculated by surgeon\n* High preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen\u002Fpelvis\n* Planned for exploratory laparotomy and primary or interval cytoreductive surgery\n* Preoperative hemoglobin concentration ≥10 mg\u002Fdl within 45 days of surgery\n* Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for only diagnostic laparoscopy should not be included\n\nExclusion Criteria:\n\n* A history of active coronary artery disease\n\n  o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 45 days of surgery.\n* A history of cerebrovascular disease\n* A history of congestive heart failure\n* A history of uncontrolled hypertension\n* A history of restrictive or obstructive pulmonary disease\n* A history of renal dysfunction (Cr \\>1.6 mg\u002Fdl)\n* Abnormal coagulation parameters (INR \\>1.5 not on coumadin, or platelet count \\\u003C100,000 mcL)\n* Presence of active infection\n* Evidence of hepatic metabolic disorder (bilirubin \\>2 mg\u002Fdl, ALT \\>75 U\u002FL in the absence of biliary tract obstruction)\n* Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery\n* Refusal to accept allogenic or autologous blood transfusion\n* Patients scheduled for cytoreductive surgery with planned Hyperthermic Intraperitoneal Chemotherapy (HIPEC)","ALL",{"count":57,"type":20},86,[59],"PHASE2","Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution\u002FANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution\u002FANH may decrease the need for allogenic blood transfusion\u002FABT in people having primary cytoreductive surgery.",[26,62,63,64,65,66,30,31,27,28],"Fallopian Tube Carcinoma","Ovarian Carcinoma","Peritoneal Carcinoma","Ovarian Cancer Stage IIIC","Fallopian Tube Cancer Stage IIIC",[68,69,70,71,72,73,74,75,76,77,78,79,80],"ovarian cancer","ovarian carcinoma","ovarian cancer stage IIIC","ovarian cancer stage IV","fallopian tube cancer","fallopian tube carcinoma","fallopian tube cancer stage IIIC","fallopian tube cancer stage IV","peritoneal cancer","peritoneal carcinoma","Acute Normovolemic Hemodilution","Memorial Sloan Kettering Cancer Center","23-392","2026-03-31",{"date":83,"type":39},"2026-04-01",{"date":85,"type":39},"2024-02-23",{"date":87,"type":20},"2029-02-23",{"name":79,"class":46},7,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100423118","phase-3-prehabilitation-in-gynaecological-cancer-patients-100423118","NCT04789694","Prehabilitation in Gynaecological Cancer Patients","Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.","PHOCUS","Inclusion criteria\n\nTwo groups of patients will be eligible for the trial:\n\ni) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery\n\nii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.\n\nExclusion criteria\n\n1. Second malignant tumour (under the treatment)\n2. Patient is not suitable for any surgery delay\n3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk","85 Years",{"count":100,"type":20},64,[102],"PHASE3","Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients.\n\nPHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.",[26,29,30,105,106],"Endometrial Cancer","Frailty",[108,109,110,111,112,106,113],"Prehabilitation","Epitelial ovarian cancer","Functional capacity","Quality of life","Multimodal prehabilitation","Endometrial cancer","2026-03-18",{"date":116,"type":39},"2026-03-19",{"date":118,"type":39},"2021-01-25",{"date":120,"type":20},"2026-06-30",{"name":122,"class":46},"Charles University, Czech Republic",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":47},"100476062","phase-2-a-combination-therapy-strategy-to-prevent-anti-pd-1-therapy-resistance-in-metastatic-ovarian-cancer-patients-100476062","NCT05479045","A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients","Inclusion Criteria:\n\n1. Be able and willing to provide written and signed informed consent prior to performing any protocol-related procedures, including screening evaluations.\n2. Women, 18 years or older, with stage III \u002F IV platinum-refractory Ovarian Cancer (OC) (progressed on a platinum containing regimen within 6 months of therapy and adenocarcinoma histology) that can be evaluable by RECISTv1.1 criteria who progressed on standard treatment. Participants will be recruited irrespective of if they earlier received available FDA-approved therapies (including for participants with targetable mutations, such as BRCA mutations)\n3. Subjects will be eligible for study entry based on the following diagnostic workup:\n\n   1. History\u002Fphysical examination within 28 days prior to registration.\n   2. Imaging of target lesion(s) within 28 days prior to registration.\n   3. Study-specific assessments:\n   4. Recovery from effects of recent surgery, radiotherapy or chemotherapy.\n   5. Free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection).\n   6. Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration.\n   7. Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C).\n   8. Any prior radiation therapy must be completed at least 4 weeks prior to registration.\n   9. At least 4 weeks must have elapsed since major surgery.\n4. Subjects must have received and have progressed, are refractory, or are intolerant to standard platinum therapy. Subjects should not have received more than 2 prior lines of systemic therapy for recurrent or metastatic disease (including both standard of care and investigational therapies).\n5. Subjects must have at least 1 lesion that is measurable using RECIST Version 1.1 guidelines.\n\n   1. A previously irradiated lesion can be considered a target lesion if the lesion is well defined, measurable per RECIST Version 1.1, and has clearly progressed.\n   2. Subjects undergoing fresh tumor biopsies must have additional non-target lesions that can be biopsied at acceptable risk as judged by the investigator (optional).\n6. Subjects must consent to provide archived tumor specimens for correlative biomarker studies. Tumor tissue must be identified and availability confirmed prior to initiation of study therapy. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.\n7. All subjects are encouraged to consent to and provide both pretreatment and on-treatment (optional) tumor biopsies.\n8. Eastern Cooperative Oncology Group (ECOG) Performance score of 2 or less.\n9. In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.\n10. Adequate organ function as determined by:\n\n    a) Hematological: i) Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL (1,000\u002Fmm3) ii) Absolute lymphocyte count (ALC) ≥ 0.5 × 109\u002FL (500\u002Fmm3) iii) Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3) without transfusion support within first 2 weeks prior to first dose iv) Hemoglobin ≥ 9.0 g\u002FdL without transfusion support within first 2 weeks prior to first dose b) Renal: i) Calculated creatinine clearance\\* (CrCl) or 24-hour urine CrCl \\> 50 mL\u002Fminute c) Hepatic: i) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); for subjects with documented\u002Fsuspected Gilbert's syndrome, bilirubin ≤ 3 × ULN ii) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (AST and\u002For ALT can be up to 5 × ULN in the presence of liver metastasis, but cannot be associated with concurrent elevated bilirubin)\n11. Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product. The male partner of the female subject must use male condom plus, if locally available, spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Not engaging in sexual activity for the duration of the study is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.\n\n    1. Females of childbearing potential are defined as those who are not surgically sterile (i.e., have not undergone bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or who are not postmenopausal (defined as 12 months with no menses without an alternative medical cause).\n    2. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n    3. Subjects must refrain from breastfeeding while on study and for 180 days after the final dose of investigational product.\n\nExclusion Criteria:\n\n1. Subjects who have received prior therapy with regimens containing nivolumab or CTLA-4, PD-L1, PD-L2 or PD-1 antagonists or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.\n2. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n3. History of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the subject did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the study drug formulations.\n4. Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener's granulomatosis) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Graves disease, Hashimoto disease, autoimmune diseases that will be consider stable by hormones \u002Fsteroid replacement or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n5. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.\n6. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose of the combination treatment; in the case of monoclonal antibodies, 28 days or 5 half-lives, whichever is shorter, prior to the first dose of the combination treatment.\n7. Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.\n8. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE V5.0, Grade 0 or 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss)\n9. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of any treatment regimen. The following are exceptions to this criterion:\n\n   1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)\n   2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent\n   3. Steroids as premedication for hypersensitivity reactions (e.g., computerized tomography (CT) scan premedication)\n10. History of primary immunodeficiency, solid organ transplantation, or tuberculosis.\n11. Test results indicating active infection with hepatitis B or C defined by positive Hepatitis B DNA, Hepatitis C RNA or known HIV infection.\n12. Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational products (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of investigational products).\n13. Pregnant or breastfeeding women.\n14. Major surgery (as defined by the investigator) within 4 weeks prior to first dose of treatment regimen, or still recovering from prior surgery. Local surgery of isolated lesions for palliative intent is acceptable.\n15. Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast or non invasive bladder carcinoma that has\u002Fhave been surgically removed.\n16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, history of myocarditis, myocardial infarction ≤6 months, or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the subject to give written informed consent. In addition, participants with a left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiogram will be excluded.",{"count":131,"type":20},24,[59],"This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III\u002FIV ovarian cancer (OC).",[30,29,135],"Ovarian Cancer Stage 3","NOT_YET_RECRUITING","2026-03-12",{"date":139,"type":39},"2026-03-16",{"date":141,"type":20},"2026-09",{"date":143,"type":20},"2028-11",{"name":145,"class":46},"Georgetown University",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":123},"100536733","phase-2-tart-cherry-juice-as-a-dietary-supplement-for-the-prevention-of-paclitaxel-induced-neuropathy-100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":57,"type":20},[59],"This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[157,158,159,160,161,162,26,163,164,29,30,165,166,167,168,135,169,65,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188],"Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Breast Cancer Stage IV","Invasive Breast Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage IIIb","Breast Cancer Stage IIIA","Breast Cancer Invasive","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Cancer","Mammary Carcinoma","Breast Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","2026-03-02",{"date":191,"type":39},"2026-03-04",{"date":193,"type":39},"2024-08-15",{"date":195,"type":20},"2027-12",{"name":197,"class":46},"University of California, Davis",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":123},"100439038","exercise-as-a-preventive-agent-to-combat-immobility-in-patients-with-ovarian-or-endometrial-cancers-receiving-chemotherapy-100439038","NCT04997096","Exercise as a Preventive Agent to Combat Immobility in Patients With Ovarian or Endometrial Cancers Receiving Chemotherapy","Inclusion Criteria:\n\n* Newly diagnosed patients with stages III-IV ovarian or endometrial cancer\n* Receiving first-line carboplatin and paclitaxel chemotherapy after surgery\n* ≥18 years, children under the age of 18 will be excluded due to rarity of disease\n* Physician's clearance to participate in moderate-vigorous intensity exercise\n* Able to read, write, and understand English\n* Ability to understand and the willingness to sign an informed consent document\n* Willing to undergo two venous blood draws for the study\n\nExclusion Criteria:\n\n* Pre-existing musculoskeletal, neurological, or cardiorespiratory conditions, as determined by the treating oncologist\n* Participants with uncontrolled intercurrent illness, as determined by the treating oncologist\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, as determined by the treating oncologist\n* Participants who have received prior chemotherapy for cancer treatment (e.g. taxanes for breast cancer)",{"count":205,"type":20},30,[207],"NA","The purpose of this research is to determine whether a 16-week virtually supervised aerobic and resistance exercise program is feasible in patients receiving first-line chemotherapy after surgery for ovarian or endometrial cancer and if it will improve lower extremity function (function of the legs), lessen chemotherapy-induced peripheral neuropathy (CIPN; numbness or tingling in the hands or feet), and if there is any effect on inflammatory blood markers (the level of a certain marker in the blood that is associated with inflammation; redness and swelling).",[26,63,30,29,135,105,210],"Endometrial Cancer Stage",[26,63,30,29,135,105,212,213,214],"Aerobic Exercise","Strength Training","Cardiovascular training","2026-02-17",{"date":217,"type":39},"2026-02-19",{"date":219,"type":39},"2022-04-02",{"date":221,"type":20},"2029-04-30",{"name":223,"class":46},"Dana-Farber Cancer Institute",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":123},"100517439","predicting-outcome-of-cytoreduction-in-advanced-ovarian-cancer-100517439","NCT06017557","Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer","Predicting Outcome of Cytoreduction in Advanced Ovarian Cancer, Using a Machine Learning Algorithm and Patterns of Disease Distribution at Laparoscopy (PREDAtOOR)","PREDAtOOR","Inclusion Criteria:\n\n* Patients treated at Fondazione Policlinico Gemelli Hospital, Rome Italy, Trillium -Credit Valley Hospital, Mississauga, Ontario and Princess Margaret Cancer Centre, Toronto, Canada\n* Patients fit for cytoreductive surgery\n* Patients with a primary diagnosis of suspect Stage III-IV ovarian cancer\n* Patients selected for interval cytoreductive surgery after NACT\n\nExclusion Criteria:\n\n* Patients with pre-operative Stage I-II disease confined to the pelvis\n* Patients unfit for surgery\n* Lack of information about patients' surgical outcomes and clinicopathological characteristics\n* LGSOC, Clear cell and mucinous, non-epithelial histologic subtypes (if available)",{"count":233,"type":20},151,[207],"PREDAtOOR is a pilot study and this study aims at improving the selection of the best treatment strategy for patients with advanced ovarian cancer by using Camera Vision (CV) to predict outcomes of cyto reduction at the time of Diagnostic laparoscopy.",[29,30],"2025-12-15",{"date":239,"type":39},"2025-12-19",{"date":241,"type":39},"2023-01-02",{"date":243,"type":20},"2026-09-01",{"name":245,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":55,"minAge":254,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":123},"100598112","phase-1-sequential-cd146-and-gpc3-car-t-cell-therapy-in-advanced-ovarian-cancer-100598112","NCT07067255","Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer","Phase 1\u002F2 Study of Sequential CD146 and GPC3 CAR-T Cell Therapy in Advanced Ovarian Cancer","BAH2573-104","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed epithelial ovarian carcinoma (including fallopian tube or primary peritoneal carcinoma considered as ovarian cancer) that is relapsed or refractory to standard therapies. Patients must have received and progressed on or after at least one line of platinum-based chemotherapy (or be platinum-resistant) and have no curative standard treatment options.\n* Target Antigen Expression: Tumor must demonstrate positive expression of CD146 and GPC3 by immunohistochemistry (IHC) on a recent tumor tissue sample. Expression of both targets is required for eligibility (to ensure the presence of the CAR-T targets in the patient's cancer).\n* Disease Status: Measurable disease as defined by RECIST 1.1 criteria (at least one measurable lesion on imaging).\n* Age: Adults aged ≥18 years. (Patients must be legally adult and able to provide informed consent. Upper age limit may not be specified, but patients must meet other health criteria.)\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (indicative of fully active or restricted in physically strenuous activity only).\n* Organ Function: Adequate organ and bone marrow function, including: absolute neutrophil count (ANC) above a minimum threshold, platelet count above threshold, hemoglobin above threshold (transfusion allowed), serum AST\u002FALT and bilirubin ≤2× upper limit of normal (unless due to liver involvement by tumor), and adequate renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or per protocol criteria).\n* Consent: Ability to understand and sign informed consent, and willing to comply with trial procedures and follow-up. Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for a defined period after CAR-T cell infusion (due to unknown risks to a fetus).\n\nExclusion Criteria:\n\n* Prior Therapy: Previous treatment with any CAR-T cell therapy or other gene-engineered T-cell therapy targeting CD146 or GPC3. (Patients who received prior immunotherapies such as checkpoint inhibitors are allowed if a washout period is met, but prior CAR-T could confound results or pose increased risk.)\n* CNS Involvement: Active central nervous system (CNS) metastases or carcinomatous meningitis. (Patients with a history of CNS metastases that have been effectively treated and are radiographically stable off steroids may be eligible, per protocol specifics.)\n* Comorbid Illness: Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, clinically significant heart failure (e.g. NYHA Class III-IV), unstable angina or arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. (Patients with controlled chronic conditions may be eligible at the investigator's discretion.)\n* Immunosuppression: Active hepatitis B or C infection with viremia, or known HIV infection with uncontrolled viral load. Patients requiring chronic systemic immunosuppressive therapy (e.g. for an autoimmune condition or organ transplant) are excluded, except for physiologic dose steroids.\n* Pregnancy or Breastfeeding: Pregnant or breastfeeding women are excluded due to potential risks to the fetus or infant from the study treatment. Women of child-bearing potential who are unwilling or unable to use adequate contraception are not eligible.\n* Other Malignancy: Presence of another active malignancy requiring treatment (with the exception of certain early-stage cancers or those in remission for a specified period, per protocol). This is to avoid confounding outcomes and ensure patient safety.\n* Hypersensitivity: Known severe hypersensitivity to any component of the investigational CAR-T cell products or to the lymphodepletion chemotherapy drugs (cyclophosphamide, fludarabine).\n* Other Exclusions: Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study (such as life expectancy limited by comorbid illness, or significant laboratory abnormalities not covered above).","21 Years","90 Years",{"count":257,"type":20},80,[23,59],"This is a multicenter, open-label Phase 1\u002F2 clinical trial evaluating the safety and preliminary efficacy of sequentially administered CD146-targeted and GPC3-targeted CAR-T cell therapy in patients with advanced relapsed or refractory ovarian cancer. Eligible patients will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an infusion of autologous CD146-directed CAR-T cells (Arm A) and a subsequent infusion of autologous GPC3-directed CAR-T cells (Arm B). The Phase 1 portion will assess safety, tolerability, and dose-limiting toxicities (DLTs) to determine a recommended Phase 2 dose, while the Phase 2 portion will evaluate efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Patients will be followed for up to 36 months after CAR-T infusion to monitor long-term outcomes and adverse events.",[26,63,261,30],"Ovarian Sarcoma",[263,264,265,266,26],"GPC3","CD146","CRISPR-Cas9","CAR-T","2025-07-05",{"date":269,"type":39},"2025-07-16",{"date":271,"type":39},"2025-04-29",{"date":273,"type":20},"2029-12-28",{"name":275,"class":46},"Essen Biotech",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":21,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":4},"100566094","phase-2-neoadjuvant-olaparib-combination-ovarian-cancer-targeted-study-100566094","NCT06650709","NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study","A Phase 2, Proof of Concept Trial Investigating the Safety and Efficacy of the Neoadjuvant Triplet Olaparib, Durvalumab and Bevacizumab in Advanced FIGO Stage IV High Grade Serous Ovarian Cancer","NEOCATS","Inclusion Criteria:\n\n1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n2. Histologically proven high grade serous ovarian\u002F fallopian tube or primary peritoneal cancer.\n3. Chemotherapy naïve for high grade serous ovarian\u002F fallopian tube or primary peritoneal cancer.\n4. FIGO Stage IVA\u002FB disease not suitable for primary debulking surgery but must have the intention of proceeding to interval surgical debulking if treatment response is demonstrated\n5. Patients must have disease amenable to pre-operative screening biopsies for additional translational endpoints or availability of sufficient archival tissue for additional translational endpoints including HRR pathway testing.\n6. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (or magnetic resonance imaging \\[MRI\\] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. The baseline scan must be obtained within 28 days prior to the first dose of study treatment.\n7. Age ≥18 years.\n8. Body weight \\>30 kg\n9. ECOG performance status 0-1 within 7 days of study registration.\n10. Life expectancy of \\> 4 months.\n11. Normal organ and bone marrow function within 14 days prior to first dose, including:\n\n    1. Platelets ≥100x109\u002FL\n    2. Hemoglobin ≥10 g\u002FdL with no blood transfusion in the past 28 days\n    3. ANC ≥ 1.5 X 109\u002FL\n    4. Total bilirubin ≤1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome\n    5. AST (SGOT) \\& ALT (SGPT) ≤2.5×ULN, unless liver metastases are present, in which case they must be ≤5×ULN\n    6. Estimated creatinine clearance ≥51 mL\u002Fmin using the Cockroft-Gault equation or based on a 24 hour urine test\n12. Females of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least 1 acceptable method of contraception from the time of signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of olaparib, for at least 6 months after last dose of Bevacizumab, and at least 90 days from the last dose of durvalumab, or they must totally\u002Ftruly abstain from any form of sexual intercourse during these time periods.\n\n    Non-sterilized male partners of a female patient must use male condom plus spermicide throughout this period.\n\n    Cessation of birth control after this point should be discussed with a responsible physician. Not engaging in sexual activity for the total duration of the drug treatment and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.\n13. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as:\n\n    1. Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\n    2. Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50\n    3. radiation-induced oophorectomy with last menses \\>1 year ago\n    4. chemotherapy-induced menopause with \\>1 year interval since last menses\n    5. surgical sterilisation (bilateral oophorectomy or hysterectomy)\n14. Ability to understand and the willingness to sign a written informed consent document.\n15. Subject's willingness and ability to comply with scheduled visits, treatment plans, on study biopsies, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Known germline BRCA1\u002F2 mutation carriers or known somatic BRCA1\u002F2 mutation associated HGSOC (prior to screening)\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the Triplet Combination (olaparib, durvalumab, bevacizumab).\n3. Use of any other anti-cancer therapy including systemic, targeted, immunotherapy, hormonal, biological, chemotherapy, other novel agents or investigational agents within 4 weeks of registration.\n4. Participation in another clinical trial with an investigational product within 4 weeks of registration\n5. Previous treatment with an immune checkpoint inhibitor, including durvalumab study regardless of treatment arm assignment\n6. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n7. Previously received a PARP\u002FVEGF\u002FPD\u002FL-1\u002FCTLA4 targeted therapy for this cancer diagnosis or any other cancer diagnosis in the last 5 years.\n8. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n   1. Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n   2. All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n   3. Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n   4. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n9. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal breast carcinoma in situ, Stage 1, grade 1 endometrial carcinoma, or other solid tumors (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.\n10. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n11. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n12. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>470 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n13. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n14. Any unresolved toxicity (NCI CTCAE grade ≥2) from previous anticancer therapy, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n    1. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor.\n    2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the sponsor.\n15. Patients with myelodysplastic syndrome\u002Facute myeloid leukaemia or with features suggestive of MDS\u002FAML.\n16. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n17. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n18. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent\n19. History of leptomeningeal carcinomatosis\n20. Patients with a contraindication to the use of Bevacizumab including perceived risk of perforation and uncontrolled bleeding or clotting disorder, patients with current signs and\u002For symptoms of bowel obstruction or signs and\u002For symptoms of bowel obstruction within 28 days before study enrollment.\n21. Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. Concomitant use of known strong (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg, bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital land 3 weeks for other agents. Please refer to Table 3 for full details\n22. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n23. History of active primary immunodeficiency. Human immunodeficiency virus (HIV) positive (positive HIV 1\u002F2 antibodies) patients must have undetectable virology. Active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) is not allowed.\n24. Patients with known active hepatitis (i.e., hepatitis B or C). Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n25. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n26. Receipt of live attenuated vaccine within 30 days prior to enrolment\n27. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n    1. Patients with vitiligo or alopecia\n    2. Patients with hypothyroidism (e.g. following Hashimoto syndrome) and stable on hormone replacement therapy\n    3. Any chronic skin condition that does not require systemic treatment\n    4. Patients without active disease in the last 5 years may be included but only after consultation with the study sponsor\n    5. Patients with celiac disease controlled by diet alone\n28. Current or prior use of immunosuppressive medication within 14 days before the first dose of enrolment. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication).\n29. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.\n30. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":285,"type":20},40,[59],"The goal of this phase 2 clinical trial is to learn if the three treatments olaparib, durvalumab and bevacizumab can treat participants with a diagnosis of stage 4 high grade serous ovarian cancer that is too advanced to undergo upfront surgery.\n\nThe main questions it aims to answer are:\n\nIs the treatment able to shrink the cancer sufficiently for participants to undergo surgery? Is the combination of treatments safe in this neoadjuvant (before surgery) setting? This is a single arm study with no comparator arm.\n\nParticipants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle:\n\nOlaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 (Day 15 omitted in C3)\n\nParticipants will be assessed throughout the study for safety and efficacy endpoints",[30],"2024-10-21",{"date":291,"type":39},"2024-10-23",{"date":293,"type":20},"2024-11-01",{"date":295,"type":20},"2028-11-01",{"name":297,"class":46},"British Columbia Cancer Agency",{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":306,"enrollmentInfo":307,"targetDuration":309,"studyType":310,"phases":4,"briefSummary":311,"conditions":312,"keywords":313,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":123},"100537008","tumor-microenvironment-in-ovarian-cancer-100537008","NCT06272240","Tumor Microenvironment in Ovarian Cancer","Study of the Role of the Tumor Microenvironment in Ovarian Cancer","MICO","Inclusion Criteria:\n\n* Age \\> 18 years\n* Age \\\u003C 80 years\n* Serous ovarian carcinoma\n* FIGO Stage III-IV\n\nExclusion Criteria:\n\n* Ongoing or suspended immunosuppressive therapy within the last 6 months\n* Congenital or acquired immunodeficiency\n* Immunosuppressive state\n* Administration of chemotherapy for another neoplasm in the past 12 months\n* Non-epithelial ovarian tumors\n* Patients not undergoing surgical intervention\n* BMI \\> 30\n* Absence of Informed Consent","80 Years",{"count":308,"type":20},50,"36 Months","OBSERVATIONAL","A detailed understanding of molecular mechanism of cancer genesis is fundamental to develop innovative and personalized therapies. The new frontier in biomedical research is represented by organoids, a three-dimensional cell culture system obtained from a tissue fragment that accurately reproduces the essential properties of the original tissue in vitro, which could provide a valuable model for explanation of ovarian cancers pathogenesis and will allow to predict the response to a specific therapy. With this research project, we expect to generate ovarian cancer organoids to characterize in vitro interactions and molecular pathway among tumor cells, immune cells, and resident microbiota (intratumoral bacteria and\u002For microbial-derived molecules).",[29,30],[314],"organoids,tumor microenviroment,ovarian cancer","2024-02-14",{"date":317,"type":39},"2024-02-22",{"date":319,"type":39},"2024-01-02",{"date":321,"type":20},"2027-01",{"name":323,"class":46},"University of Udine"]