[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-ovarian-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,85,108,133,154,181,207],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100592715","phase-1-a-phase-1-study-of-bms-986500-as-monotherapy-or-combination-therapy-in-advanced-solid-tumors-100592715",false,"NCT06997029","A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4\u002F6 Inhibitor Pre-treated Advanced Breast Cancer","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},234,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4\u002F6 inhibitor pre-treated advanced breast cancer.",[26,27,28],"Advanced Solid Tumor","Advanced Breast Cancer","Advanced Ovarian Cancer",[30,31,32],"cancer","oncology","solid tumor","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-08-01",{"date":41,"type":20},"2028-12-14",{"name":43,"class":44},"Bristol-Myers Squibb","INDUSTRY",21,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100558186","phase-1-a-study-of-mov18-ige-in-patients-with-solid-tumours-that-express-folate-receptor-alpha-100558186","NCT06547840","A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha","A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha","Inclusion criteria:\n\nPatients must meet all of the following criteria:\n\n1. Female ≥18 years of age.\n2. Written (signed and dated) informed consent.\n3. Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous\u002Fendometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:\n\n   * HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+\n   * ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines\n4. Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).\n\n   Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.\n\n   Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.\n5. Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.\n\n   Note: this test will be performed at a reference laboratory.\n6. Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).\n7. Prior therapies:\n\n   Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.\n\n   Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n8. Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.\n\n   ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.\n9. No evidence of bowel obstruction.\n10. ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.\n11. Estimated life expectancy of \\>3 months, in the opinion of the Investigator.\n12. Adequate haematological function, including all of the following:\n\n    i. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (\\>1,500\u002Fmm3). G-CSF or GM-CSF may not be used to achieve this level.\n\n    ii. Platelets ≥100 × 109\u002FL (\\>100,000 per mm3) iii. Haemoglobin level \\>9 g\u002FdL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g\u002FdL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.\n\n    iv. Adequate coagulation function at screening as determined by prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) or international normalised ratio (INR) \\\u003C1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Does not apply to patients on an anti coagulant with a stable dose within 28 days prior to first dose.\n\n    v. Lymphocyte count ≥1000 cells\u002Fmm3, (1.0x10\\*9\u002FL)\n13. Intact immune system as demonstrated by CD4 count ≥500 cells\u002Fmm3 and CD8 count ≥150 cells\u002Fmm3.\n14. Adequate renal function as demonstrated by either estimated glomerular filtration rate \\[eGFR\\] or calculated creatinine clearance \\>45 mL\u002Fmin (Cockcroft Gault equation: creatinine clearance: (140-age \\[years\\]) × weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) × 0.85 ≤1.5 × ULN, or ≥60 mL\u002Fmin for a patient with creatinine levels \\>1.5 × institutional ULN.\n15. Adequate hepatic function:\n\n    i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \\>1.5 × ULN.\n\n    ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n\n    iii. Albumin ≥3.0 g\u002FdL.\n16. Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).\n17. No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.\n18. No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and\u002For no history of autoimmune disease that required treatment with steroids or immunosuppressive medication within 6 months of the first administration of MOv18 IgE.\n19. Negative serum or urine pregnancy test.\n20. Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy.\n21. Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months, (182 days), following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.\n22. Willing and able to comply with all protocol-specified assessments and the trial visit schedule.\n23. Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18 IgE.\n\nExclusion criteria:\n\nPatients must not meet any of the following criteria:\n\n1. Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).\n2. Presence of ascites\u002Fpleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.\n3. Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants\u002FMAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.\n\n   i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion\n4. History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.\n5. History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.\n6. Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng\u002FmL.\n7. Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.\n8. Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).\n9. Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.\n10. Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (\\>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.\n11. Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.\n12. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n13. Historical positive serology test for human immunodeficiency virus (HIV).\n14. History of interstitial lung disease or active pneumonitis.\n15. Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).\n16. Positive serology for hepatitis B or C.\n17. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.\n18. Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.\n19. Concomitant use of drugs known to prolong QT\u002FQTc interval (Appendix 1).\n20. Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.\n21. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.\n22. Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.\n23. Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.\n24. Currently breastfeeding.\n25. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the trial\n26. Patient is under legal custodianship.\n27. First-degree relatives of the Investigator, trial staff or Sponsor employees.","FEMALE",{"count":55,"type":20},45,[23],"EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer\n\nThe dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).\n\nPart 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.",[28,59,60,61,62,63],"Platinum-resistant Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Triple -Negative Breast Cancer","Endometrial Cancer","Advanced Endometrial Cancer",[65,66,67,68,69,70,71,72,73,74],"Ovarian","Cancer","Resistant","IgE","Advanced","Platinum","Folate Receptor alpha","Antibody","Endometrial","Triple Negative Breast","2026-03-31",{"date":77,"type":37},"2026-04-06",{"date":79,"type":37},"2024-09-03",{"date":81,"type":20},"2027-03",{"name":83,"class":44},"Epsilogen Ltd",7,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100353205","phase-2-investigation-of-the-anti-tumor-effect-of-2x-121-in-patients-with-recurrent-advanced-ovarian-cancer-100353205","NCT03878849","Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer","Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK\u002FPD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age 18 years or older.\n3. Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous\u002Fendometrioid histology (independent of BRCA1 and HRD status).\n4. Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.\n5. Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy.\n6. Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1\n7. Performance status of ECOG ≤ 1.\n8. Patients must have a life expectancy of \\>16 weeks.\n9. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy, or treatment with cytotoxic, hormonal, or biologic agents.\n10. Adequate conditions as evidenced by the following clinical laboratory values:\n\n    1. Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL\n    2. Hemoglobin \\> 9.0 g\u002FdL\n    3. Platelets ≥ 100 x 103 μL\n    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which case they must be ≤5 x ULN\n    5. Serum bilirubin ≤ 1.5 ULN\n    6. Creatinine ≤ 1.5 ULN\n    7. Blood urea nitrogen (BUN) ≤2X ULN.\n11. FFPE tumor tissue should be available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue. Note: Patients treated with a PARP inhibitor must have a new biopsy unless there is an archival biopsy that was done after the PARP inhibitor treatment was discontinued.\n12. Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP is defined as premenopausal women or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization or hysterectomy or bilateral salpingo-oophorectomy.\n13. Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.\n\nExclusion Criteria:\n\n1. Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.\n2. Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.\n3. Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.\n4. Any active infection requiring parenteral or oral antibiotic treatment.\n5. Known HIV positivity.\n6. Known active hepatitis B or C.\n7. Clinically significant cardiovascular disease:\n\n   1. Stroke within ≤ 12 months prior to day 1\n   2. Transient ischemic attach (TIA) within ≤ 12 months prior to day 1\n   3. Myocardial infarction within ≤ 12 months prior to day 1\n   4. Unstable angina\n   5. New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)\n   6. Uncontrolled cardiac arrhythmia requiring medication\n8. Other medications or conditions that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results.\n9. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.\n10. Requiring immediate palliative treatment of any kind including surgery and\u002For radiotherapy.\n11. Patients unable to be regularly followed for any reason (geographic, familiar, social, psychological, housed in an institution e.g., prison because of a court agreement or administrative order).\n12. Patients, who are close colleagues, associates, or family members of, or in any way dependent on the sponsor or the investigator.\n13. Ascites requiring drainage \\>500cc in the 2 weeks prior to enrolment.",{"count":93,"type":20},40,[95],"PHASE2","The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK\u002FPD, safety, and efficacy data.",[28],"2025-08-22",{"date":100,"type":37},"2025-08-28",{"date":102,"type":37},"2019-04-15",{"date":104,"type":20},"2027-09",{"name":106,"class":44},"Allarity Therapeutics",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":132},"100602203","phase-2-combination-therapy-of-senaparib-and-bevacizumab-for-first-line-maintenance-therapy-in-newly-diagnosed-advanced-homologous-recombination-proficient-ovarian-cancer-based-on-exosome-protein-marker-100602203","NCT07120451","Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker","Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker: a Single Arm, Prospective Clinical Study","Inclusion Criteria:\n\n1. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;\n2. Age range of 18 to 75 years old (calculated from the day of signing informed consent);\n3. Patients with newly diagnosed epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathology;\n4. FIGO stage III-IV, stage III subjects must have undergone one optimal tumor reduction surgery (first cell reduction surgery or intermittent cell reduction surgery). Participants in Phase IV studies must have undergone biopsy and\u002For first-time cytoreductive surgery or intermittent cytoreductive surgery; Can provide 10 pathological white films for subsequent research;\n5. Tested as HRP\n6. Achieving CR or PR after receiving platinum based treatment; CR refers to measurable and\u002For unmeasurable lesions without RECIST v1.1 criteria in imaging evaluation, and within the normal range of CA125. PR refers to the achievement of PR according to the RECIST v1.1 standard in imaging evaluation after chemotherapy, or the absence of measurable and\u002For unmeasurable lesions according to the RECIST v1.1 standard in imaging evaluation, with CA125 higher than the normal range and no sustained increase;\n7. Before treatment, the CA125 test results must meet the following specific criteria:\n\nIf the first detection value is ≤ the upper limit of normal (ULN), the subjects can be randomly divided into groups without the need for a second sampling; If the first detection value is greater than ULN, a second evaluation must be conducted at least 7 days after the first detection. If the second evaluation value of the subject is higher than the first evaluation value by ≥ 15%, the subject is not eligible for selection; 8. Within 8-12 weeks of the last chemotherapy administration, participants must be enrolled and the trial medication must be started; 9. ECOG score: 0 to 1; 10. The main organ functions are normal and meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):\n\n1. Blood routine examination: ① Hemoglobin (HB) ≥ 100g\u002FL; ② Absolute neutrophil count (ANC) ≥ 1.5 × 10 \\^ 9\u002FL; ③ Platelet count (PLT) ≥ 1 × 10 \\^ 11\u002FL;\n2. Blood biochemistry test: ① alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (liver metastasis ≤ 5 × ULN); ② Serum total bilirubin (TBIL) ≤ 1.5 × ULN or direct bilirubin ≤ 1.0 × ULN; ③ Serum creatinine Cr ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 ml\u002Fmin;\n3. Coagulation function test: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; 11. Subjects with fertility are required to use at least one medically approved contraceptive measure (such as intrauterine device or condom) during the study treatment period and within 6 months after the last administration of the trial medication; And the serum HCG test result must be negative within 72 hours before the first administration; And it must be non lactating.\n\nExclusion Criteria:\n\n1. Previous (within 5 years) or concurrent incurable malignant tumors, except for cured skin basal cell carcinoma, thyroid carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence more than 3 years after the completion of radical surgery;\n2. Have not previously used PARP inhibitors;\n3. Those who are unable to swallow pills normally or have gastrointestinal dysfunction that may affect drug absorption, as determined by researchers;\n4. Patients with a history of gastrointestinal perforation or major surgery within 4 weeks prior to the first use of medication; Patients with bleeding or bleeding events ≥ CTCAE grade 3, or with unhealed wounds, ulcers, or fractures;\n5. Imaging (CT or MRI) shows tumor invasion of large blood vessels or unclear boundary with blood vessels;\n6. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg);\n7. Urine routine shows that urine protein is ≥ 2+, and it is confirmed that the 24-hour urine protein content is ≥ 1.0 g;\n8. Individuals who have experienced intestinal obstruction within the past 3 months;\n9. Cancer ascites and pleural effusion with clinical symptoms that require puncture or drainage, or those who have received ascites or pleural effusion drainage within 2 months before the first trial medication;\n10. Patients with abnormal coagulation function (INR\\>1.5 or prothrombin time (PT)\\>ULN+4 seconds), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy are allowed to receive low-dose low-molecular-weight heparin or oral aspirin for anticoagulation prevention during the trial period;\n11. Those who have used other drugs in clinical trials within the previous 4 weeks;\n12. Prior to the first dose of the study drug, individuals who have received CYP3A4 potent inhibitors or CYP3A4 potent inducers (those with a half-life of ≥ 5 after elution from the first dose of the study drug can be enrolled) are not allowed to use CYP3A4 potent inhibitors or CYP3A4 potent inducers during the study period, as outlined in Appendix IV.\n13. Participants may receive other systemic anti-tumor treatments during the study period;\n14. Individuals known to be allergic to the excipients of Senaparib and Bevacizumab;\n15. According to the researchers' assessment, there may be other factors that could lead to the forced termination of this study, such as other serious illnesses (including mental illnesses) requiring concurrent treatment, serious laboratory abnormalities, and family or social factors that could affect the safety of the subjects or the collection of data and samples.","75 Years",{"count":117,"type":20},37,[95],"This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and explore relevant biomarkers for evaluating the efficacy of maintenance therapy through exosome. Researchers will look at the Progression-Free Survival, Overall Survival, safety, and any side effects.",[28],"NOT_YET_RECRUITING","2025-08-06",{"date":124,"type":37},"2025-08-13",{"date":126,"type":20},"2025-10-10",{"date":128,"type":20},"2028-10-31",{"name":130,"class":131},"Fudan University","OTHER",1,{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100597529","design-and-validation-of-plasma-proteins-and-cytokine-panels-to-identify-markers-associated-with-response-to-niraparib-as-maintenance-treatment-after-first-line-platinum-based-regimen-in-patients-with-advanced-ovarian-cancer-100597529","NCT07059676","Design and Validation of Plasma Proteins and Cytokine Panels to Identify Markers Associated With Response to Niraparib as Maintenance Treatment After First-line Platinum-based Regimen in Patients With Advanced Ovarian Cancer","LIBINI-1","Inclusion Criteria\n\n1. Signed informed consent and ability to comply with treatment and follow up.\n2. Patients ≥ 18 years old.\n3. ECOG 0-1\n4. Histologically confirmed diagnosis of FIGO stage III-IV high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.\n5. BRCA status according to local practice is known. It is encouraged to have BRCA testing in tumor.\n6. Homologous recombination status according to local practice is encouraged.\n7. Patients must meet the following front-line therapy requirements:\n\n   1. Patients must have received at least 4 cycles of platinum-based therapy\n   2. Patients must have non-evidence of disease or achieved a complete or partial response to platinum-based regimen Patient must meet all the required criteria for niraparib maintenance as single agent after first line platinum-based chemotherapy and receive niraparib therapy according to local prescribing information (see ANNEX 3).\n\nExclusion Criteria\n\n1. According to niraparib's local prescribing information (see ANNEX 3): Patients must not be pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 6 months after the last dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to initiation of study treatment and have to use an effective contraceptive method along the participation in the study.\n2. Patients must not have a known hypersensitivity to the components of niraparib or the excipients.\n3. Patients must not have received prior treatment with a known PARP inhibitor.\n4. Patients must not have had any known, persistent (\\>4 weeks), ≥Grade 3 hematological toxicity or fatigue from prior cancer therapy.\n5. Patients must not have any known history of myelodysplastic syndrome (MDS) or a pretreatment cytogenetic testing result at risk for a diagnosis of MDS\u002Facute myeloid leukemia (AML).\n6. Patients must not have symptomatic uncontrolled brain or leptomeningeal metastases.",{"count":141,"type":20},120,"OBSERVATIONAL","PARPi inhibitors have been incorporated into managing first-line advanced ovarian cancer with different approvals depending on homologous recombination (HR) status. Niraparib has received approval independent from HR status. Although the benefit is more remarkable in HR-deficient patients, there is no biomarker to predict sustained response to niraparib at the start of treatment helping the clinician to make decisions among the different treatment options.\n\nThe aim of the LIBINI-1 (Liquid biopsy for predicting niraparib benefit if 1st line) study is to identify predictive biomarkers of sustained response to niraparib using liquid biopsy with two different technologies:\n\n1. Proteomic and secretome analysis tools. The first part of the LIBINI-1 project is to create a platform for rapid screening and analysis by multiple detections of niraparib response-associated proteins in patients with advanced ovarian cancer.\n2. ctDNA analysis. The second part of the LIBINI-1 project is to correlate the baseline level of ctDNA and change in ctDNA at 4 and 12 weeks with the benefit to niraparib.",[28],"2025-07-01",{"date":147,"type":37},"2025-07-11",{"date":149,"type":20},"2025-07-25",{"date":151,"type":20},"2028-03-31",{"name":153,"class":131},"Clinica Universidad de Navarra, Universidad de Navarra",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":115,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100557779","phase-3-efficacy-and-safety-of-ak104-pd-1ctla-4-bispecial-antibody-combined-with-chemotherapy-for-neoadjuvant-treatment-of-advanced-ovarian-cancer-100557779","NCT06542549","Efficacy and Safety of AK104 (PD-1\u002FCTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer","Efficacy and Safety of AK104 (PD-1\u002FCTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study","Inclusion Criteria:\n\n1. Agree to sign the informed consent form.\n2. 18 years ≤ age \\\u003C75 years, female.\n3. Patients with epithelial ovarian cancer (high-grade serous adenocarcinoma, ovarian endometrial carcinoid adenocarcinoma), peritoneal or fallopian tube carcinoma, or clear cell carcinoma confirmed by histopathology, FIGO 2018 stage III-IV.\n4. Evidence of compliance with neoadjuvant chemotherapy for ovarian cancer: (a) Preoperative evaluation by gynecologic oncologists (multidisciplinary if necessary) indicates that R0 resection is less likely to be achieved after primary tumor reduction; (b) Patients whose physical state cannot tolerate PDS and are not suitable for immediate surgery (such as perioperative high risk, old age, medical complications, etc.); (c) Without any systematic anti-tumor therapy for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy); Note: Histopathology is obtained by puncture biopsy, laparoscopic exploration, etc. Lymph node resection or biopsy for clinical staging purposes is permitted.\n5. Those with at least one measurable lesion (RECIST version 1.1).\n6. ECOG Physical status score 0-2.\n7. Estimated survival time \\> 12 weeks.\n8. Good organ function.\n9. Participants of reproductive age must agree to use effective contraception during the trial; Serum or urine pregnancy tests for women of childbearing age must be negative.\n10. Non-lactating patients.\n\nExclusion Criteria:\n\n1. Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g., borderline tumors).\n2. Patients with other malignant tumors in the past (within 5 years) or at the same time, with the exception of cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer with no recurrence \\>3 years after radical surgery.\n3. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBV surface antigen \\[HBsAg\\] positive) with HBV DNA \\> 1000 IU\u002FmL, and subjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU\u002FmL were admitted. Subjects with cured viral hepatitis C, HCVAb positive and HCV RNA negative were admitted.\n4. A history of testing positive for known human immunodeficiency virus or known acquired immunodeficiency syndrome.\n5. Have an active or possibly recurring autoimmune disease; The following are excluded: vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes.\n6. A history of severe allergic reactions to any monoclonal antibody and\u002For investigational drug ingredient.\n7. Subjects with known active TB and suspected active TB should undergo clinical examination to rule out known active syphilis infection.\n8. There is a history or current presence of noninfectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid therapy.\n9. Severe infections occurring within 4 weeks prior to first dosing, including but not limited to active infections with comorbidification requiring hospitalization, sepsis, or severe pneumonia that received systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).\n10. Serious medical conditions or concomitant non-oncological conditions, such as neurological disorders, psychosis, infectious diseases, or laboratory abnormalities, may increase the risk of participating in the study or taking the investigational drug, which the investigator believes would make the patient unfit for entry into the study.\n11. Patients with clinically significant cardiovascular disease.\n12. Patients who were judged by the investigator to be unsuitable for this study.",{"count":162,"type":20},100,[164],"PHASE3","This is a randomized, controlled, single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and\u002For unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.",[28,167,168,169,170],"AK104(PD-1\u002FCTLA-4 Bispecial Antibody)","Chemotherapy","Efficacy","Safety","2024-08-03",{"date":173,"type":37},"2024-08-07",{"date":175,"type":20},"2024-10-01",{"date":177,"type":20},"2030-10-31",{"name":179,"class":180},"Anhui Provincial Hospital","OTHER_GOV",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":53,"minAge":17,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":132},"100510310","phase-2-plasmodium-immunotherapy-for-advanced-ovarian-cancer-100510310","NCT05924776","Plasmodium Immunotherapy for Advanced Ovarian Cancer","Clinical Study of Plasmodium Immunotherapy for Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Subjects must meet all the following inclusion criteria:\n\n  1. 18-80 years old(including the threshold), female;\n  2. The patients with ovarian cancer, who has been diagnosed by histopathological examination, can provide pathological reports, and is classified as stage III or stage IV according to the American Joint Committee on Cancer (AJCC) ovarian cancer staging version 8 (2017);\n  3. Platinum-resistant patient who has received at least the first line of platinum-containing standard chemotherapy (refer to China's Guidelines for the Diagnosis and Treatment of Ovarian Cancer (2022)) in the past, and have been evaluated as disease progression by objective imaging;\n  4. According to the evaluation standard of solid tumor efficacy RECIST 1.1, the therapeutic effect can be evaluated if there is ≥ 1 measurable lesion or continuous positive tumor marker;\n  5. There are no plans and requirements for receiving other anti-tumor treatment during the treatment of Plasmodium immunotherapy;\n  6. The score of Eastern Cooperative Oncology Group(ECOG) is 0-1;\n  7. Expected survival time ≥ 3 months;\n  8. If no platelets or red blood cells are transfused within 14 days before screening, and no thrombopoietin (TPO), granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), interleukin 11 (IL-11) or other drugs are used to correct abnormal blood picture: neutrophil (NEUM) ≥ 1.5 × 10\\^9\u002FL, platelet (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (HGB) ≥ 90g\u002FL, no obvious abnormality of erythrocyte morphology; Albumin (ALB) ≥ 35g\u002FL;\n  9. For female subjects with the possibility of pregnancy: from the time of signing the informed consent form (ICF) to the end of Plasmodium immunotherapy treatment at least 24 weeks, consent to abstinence or use of effective contraceptive methods, including intrauterine devices, etc. (Note: women of childbearing age have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy), or have menopause for more than 24 menstrual cycles, That is, there is no possibility of pregnancy);\n  10. Subjects are fully capable of understanding and signing the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who have any of the following conditions cannot be included in the study:\n\n  1. Have received any investigational drug within 4 weeks before the first inoculation of Plasmodium parasite, or have participated in another clinical study at the same time (except that the subjects have participated in the observational and non-interventive clinical study, or are in the follow-up period of the intervention clinical study);\n  2. Immunodeficiency diseases, including HIV infection, other acquired and congenital immunodeficiency diseases;\n  3. Coagulation dysfunction, or acute or chronic hemorrhagic disease;\n  4. Have received other anti-tumor treatment in the past, and the period from the termination of treatment to the screening is less than 14 days or 5 half-lives (whichever occurs first);\n  5. The time interval between radiotherapy and treatment in this study for patients who have previously received external or internal radiotherapy is less than 28 days;\n  6. Patients with severe hemoglobinopathy or severe Glucose-6-Phosphate Dehydrogenase(G6PD) deficiency;\n  7. After splenectomy or splenomegaly;\n  8. Drug addicts or alcohol addicts;\n  9. Plenty of pleural effusion, pericardial effusion or ascites;\n  10. Patients with active hepatitis B or hepatitis C;\n  11. Patients with obvious defects in immunocyte classification test (CD4+T cell absolute count\\\u003C200\u002F μ l）； Or receive any form of immunosuppressive treatment within 28 days before the trial treatment;\n  12. Have serious or uncontrolled systemic diseases (including but not limited to active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, grade III or IV heart disease, serious arrhythmia, liver and kidney insufficiency, myocardial infarction, etc.);\n  13. Currently has mental disorder or a history of mental illness;\n  14. Having undergone major surgery within three months from the screening period;\n  15. Have received bone marrow transplantation or organ transplantation in the past;\n  16. Moderate or severe pulmonary ventilation dysfunction;\n  17. Those who are currently receiving regular anti-tumor treatment, and the treatment is effective or there is no obvious progress in the disease;\n  18. The investigator evaluated the patients who could not tolerate Plasmodium immunotherapy;\n  19. Pregnancy, lactation or pregnancy within 6 months after treatment;\n  20. According to the judgment of the researcher, the other conditions of the subject are not suitable for participating in the test.","80 Years",{"count":190,"type":20},30,[95,164],"The main purpose of this study is to evaluate the safety and effectiveness of Plasmodium immunotherapy in the treatment of advanced ovarian cancer. This study plans to enroll 30 patients with advanced ovarian cancer. Each patient is inoculated with Plasmodium vivax 1-5 × 10\\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after the inoculation of Plasmodium, the change of the parasite density in the peripheral blood of the whole treatment cycle and the control effect of the drug on the parasite density, the main clinical symptoms and signs, laboratory test indicators, immunological test indicators and changes in the quality of life. To evaluate the safety and tolerance of the subjects to Plasmodium immunotherapy, as well as the changes of tumor related indicators and immunological indicators.",[28],[195,196,197],"Advanced ovarian cancer","Plasmodium immunotherapy","Plasmodium vivax","2024-07-18",{"date":200,"type":37},"2024-07-22",{"date":202,"type":20},"2024-07-20",{"date":204,"type":20},"2029-03-30",{"name":206,"class":44},"CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":132},"100500315","phase-2-adjuvant-therapeutic-cancer-vaccine-ast-201-pumvc3-higfbp-2-in-patients-with-advanced-ovarian-cancer-100500315","NCT05794659","Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer","A Randomized Phase 2 Study to Evaluate the Efficacy and Safety for Adjuvant Therapeutic Cancer Vaccine (AST-201, pUMVC3-hIGFBP-2) in Patients With Advanced Ovarian Cancer (Cornerstone-004)","Cornerstone4","Inclusion Criteria:\n\n* Newly diagnosed stage III (FIGO classification) epithelial ovarian cancer including primary peritoneal cancer, fallopian-tube cancer\n* Has received upfront surgery and optimally debulked(a residual tumor less than 1 cm)\n* Can start adjuvant therapy within 6 weeks of debulking surgery\n* Has Homologous Recombination Proficiency (HRP) tumor defined by FDA-approved testing\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhuGM-CSF\n* Has a history of active malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease\n* Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs\n* Has active or prior autoimmune disease or inflammatory disease\n* Has active infectious disease including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study",{"count":216,"type":20},98,[95],"The purpose of this phase 2 study is to assess the efficacy and safety for adjuvant therapeutic cancer vaccine AST-201 (pUMVC3-hIGFBP-2) in patients with newly diagnosed homologous-recombination proficient(HRP) advanced ovarian cancer (Stage III) after debulking surgery. Patients will receive AST-201 with rhuGM-CSF(Colony Stimulating Factor) or placebo with rhuGM-CSF in combination with standard adjuvant chemotherapy(Paclitaxel\u002FCarboplatin).",[28],[221,222,195,223],"cancer vaccine","phase 2 study","homologous-recombination proficient (HRP)","2023-07-18",{"date":226,"type":37},"2023-07-20",{"date":228,"type":20},"2023-11-15",{"date":230,"type":20},"2027-11-15",{"name":232,"class":44},"Aston Sci. Inc."]