[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clear-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clear-cell-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100517924","phase-2-a-three-arm-randomized-phase-ii-study-of-dostarlimab-alone-or-with-bevacizumab-versus-nonplatinum-chemotherapy-in-recurrent-gynecological-clear-cell-carcinoma-dove-apgot-ov7-engot-ov80-study-100517924",false,"NCT06023862","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7\u002F ENGOT-ov80 Study)","A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV07\u002F ENGOT-ov80 Study)","DOVE","Inclusion Criteria:\n\n1. Female patient is at least 18 years of age,\n2. Patient has signed the Informed Consent (ICF) and is able to comply with protocol requirements.\n3. Patient with histologically proven confirmed recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, and vulva\n\n   * Local review by gynecologic pathologist required\n   * ≥50% clear cell histology in case of mixed carcinoma\n   * WT-1 neg (Only in case of ovarian cancer) Note: In the case of including non-ovarian clear cell carcinoma with more than 20 cases, the decision is made through discussion with the SPONSOR.\n4. Patient with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Disease progression within 12 months of completing platinum-based chemotherapy\n6. 1-5 prior lines of therapies\n7. Patient with measurable disease according RECIST 1.1 criteria\n8. Availability of Tumor tissue for translational research . - A formalin-fixed paraffin-embedded (FFPE) tumor block(preferred) or at least 20 slides (unstained, freshly cut, serial sections) must be submitted.\n9. Patients who consent to fresh tumor biopsies\n\n   * Confirmed with at least one lesion with location accessible to safely biopsy per the clinical judgement of the investigator\n   * Note: If mandatory biopsies cannot be performed as per investigator's clinical judgement, discussion and agreement between investigator and Sponsor are required.\n10. Patient has adequate organ function, defined as follows:\n\n    1. Absolute neutrophil count ≥ 1,500 cells\u002FμL\n    2. Platelets ≥ 100,000 cells\u002FμL\n    3. Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n    4. Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault equation for patients with creatinine levels \\> 1.5× institutional ULN\n    5. Total bilirubin ≤ 1.5× ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) or direct bilirubin ≤ 1× ULN\n    6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN\n    7. International normalized ratio or prothrombin time (PT) ≤1.5× ULN and activated partial thromboplastin time ≤1.5× ULN.Participants taking anticoagulants may be included on a stable dose with a therapeutic INR \\\u003C3.5. .\n11. Patient must have a negative serum pregnancy test within 72 hours of the first dose of study medication, unless they are of non-childbearing potential. If a negative result cannot be confirmed by a urine test, a serum pregnancy test is required. Non-childbearing potential is defined as follows:\n\n    1. Patient is ≥ 45 years of age and has not had menses for \\> 1 year.\n    2. A follicle-stimulating hormone value in the postmenopausal range upon screening evaluation if amenorrhoeic for \\\u003C 2 years without a hysterectomy and oophorectomy.\n    3. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation:\n\n       * Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound, MRI, or CT scan.\n       * Tubal ligation must be confirmed with medical records of the actual procedure.\n       * Information must be captured appropriately within the site's source documents.\n12. Patient of childbearing potential must agree to use a highly effective method of contraception with their partners starting from time of consent through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient (Information must be captured appropriately within the site's source documents).\n\nExclusion Criteria:\n\n1. Patient has had ≥ 6 prior lines of chemotherapy. Surgery of the recurrence is allowed.\n2. Patient has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.\n3. Patient has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy) within 21 days or \\\u003C 5 times the half-life of the most recent therapy prior to Study Day 1, whichever is shorter.\n\n   Note: Palliative radiation therapy to a small field ≥ 1 week prior to Day 1 of study treatment may be allowed after discussion with the SPONSOR.\n4. Patient with contraindication to chemotherapy or immune checkpoint inhibitor treatments or anti-angiogenic inhibitor\n5. Patients with uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) based on an average of ≥ 3 BP readings on ≥ 2 sessions.\n6. Patients with evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)\n7. Patients with current abdominal\u002Fpelvic fistula\n8. Patient has a concomitant malignancy, or patient has a prior non-gynecological malignancy who has been disease-free for \\\u003C 3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.\n9. Patient has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of disease progression by imaging \\[using the identical imaging modality for each assessment, either MRI or CT scan\\] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability.\n10. Patient has a known history of human immunodeficiency virus (HIV; HIV ½ antibodies). Participants with known human immunodeficiency virus(HIV) are allowed if they meet all of the following criteria:\n\n    * Cluster of differentiation 4(CD4) ≥350\u002FμL and viral load \\\u003C50 copies\u002FmL.\n    * No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months before enrollment.\n    * No history of HIV-associated malignancy for the past 5 years.\n    * Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV started \\>4 weeks before study enrollment.\n11. Patient with presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months before first dose of dostarlimab treatment.\n\n    * Participants who are hepatitis B surface antigen positive may be enrolled if their HBV-DNA level is below the institutional lower limit.\n    * Participants with chronic hepatitis B virus (HBV) infection who meet the criteria for anti-HBV therapy may be eligible if the participant is on a suppressive antiviral therapy before initiation of cancer therapy.\n    * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA polymerase chain reaction is obtained. Hepatitis C participants may be eligible if they both have completed curative therapy and have a hepatitis C viral load \\\u003C!-- Not Allowed Tag Filtered --\\>\\\u003Cquantifiable limit.\n12. Patient has an active autoimmune disease that required systemic treatment in the past 2 years. Replacement therapy is not considered a form of (eg, thyroid hormone or insulin).\n13. diagnosis immunodeficiency receiving steroid any other immunosuppressive within 7 days prior to first dose study treatment. Patients who have received acute and\\>\u002For low-dose systemic immunosuppressive medications (e.g,, a one-time dose of dexamethasone for nausea or chronic use of ≤ 10 mg\u002Fday of prednisone or dose equivalent corticosteroid) may be enrolled in the study after discussion with and approval by the Sponsor. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed.\n14. Patient has not recovered (to Grade ≤ 1) from previous anti-cancer therapy-induced adverse events (AEs).\n\n    Note: Patients with Grade ≤ 2 neuropathy, Grade ≤ 2 alopecia, or Grade ≤ 2 fatigue are an exception to this criterion and may qualify for the study.\n15. Patient has not recovered adequately from AEs or complications from any major surgery prior to starting therapy. Major surgical procedures, other than for diagnosis, within 4 weeks prior to initiation of study treatment\n16. Patient has a known hypersensitivity to bevacizumab or dostarlimab components or excipients.\n17. Patient is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment.\n18. Patient is considered a poor medical condition due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n19. Patients with known history of non-infectious pneumonitis that required steroids or has current pneumonitis.\n20. Use of any of the following immunomodulatory agents within 28 days prior to the first dose of study drug:\n\n    * Interferons\n    * Interleukins\n    * Live vaccine Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. mRNA and adenoviral-based COVID-19 vaccines are considered non-live and are not exclusionary. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed as other killed vaccines, if done at least 2 weeks prior the first dose of study drug; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n21. Patient who are pregnant or lactating, or plan to become pregnant or lactate during the expected duration of the study, from screening through 180 days after the last dose of study drug.","FEMALE","18 Years",{"count":20,"type":21},198,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Multicenter, randomized, open-label, phase II clinical study comparing Dostarlimab +\u002F- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma.\n\n198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio.\n\n1. Group A: Dostarlimab monotherapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n2. Group B: Dostarlimab + Bevacizumab combination therapy\n\n   * First 3 cycles: Dostalimab 500mg every 3 weeks, IV\n   * 4 cycles \\~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV\n   * Bevacizumab administered IV at 15 mg\u002Fkg every 3 weeks until disease progression or unacceptable toxicity\n3. Group C: General chemotherapy (one of Pegylated liposomal doxorubicin, Doxorubicin, Paclitaxel, and Gemcitabine)",[27,28,29,30,31,32],"Ovarian Neoplasms","Endometrial Neoplasms","Uterine Cervical Neoplasms","Vulvar Cancer","Vagina Neoplasm","Clear Cell Carcinoma","RECRUITING","2026-04-30",{"date":36,"type":37},"2026-05-06","ACTUAL",{"date":39,"type":37},"2024-01-22",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"Yonsei University","OTHER",27,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100598495","phase-1-phase-i-study-of-allogeneic-transforming-growth-factor-beta-receptor-type-2-knockout-cd70-car-nk-cells-in-treatment-refractory-clear-cell-renal-cell-carcinoma-100598495","NCT07072234","Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refractory Clear Cell Renal Cell Carcinoma","Eligibility Criteria\n\n* Participants must have histologically confirmed ccRCC that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.\n* Confirmation of CD70 expression ≥ 10% by immunohistochemistry staining of the participants primary renal tumor or a metastatic lesion biopsy specimen will be required for enrollment in the study.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.\n* Participants must have previously received treatment with at least one ICI and one TKI. Participants must have had unequivocal disease progression on ICI treatment.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CD70 TGFβR-2 knockout CAR NK cells in Participants \\\u003C18 years of age, children are excluded from this study.\n* Participants must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinas inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy.\n* Participants must be at least 3 months from any cell therapy for malignancy.\n* Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, provided that there are additional measurable non-irradiated disease sites.\n* Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for Participants \\> 16 years of age.\n* Adequate organ function at screening, as defined by the following:\n\n  * Renal: Serum creatinine ≤ 1.5 mg\u002FdL or estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥30 ml\u002Fmin\u002F1.73 m2o Hepatic: alanine transaminase (ALT)\u002Faspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg\u002FdL or ≤ 3.0 mg\u002FdL for Participants with Gilbert's Syndrome. No history of liver cirrhosis.\n  * Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)\n  * Pulmonary: No clinically significant pleural effusion (per principal investigator \\[PI\\] judgement), and baseline oxygen saturation ≥ 92% on room air. Subjects with active interstitial lung disease (ILD)\u002Fpneumonitis requiring treatment with systemic steroids will be excluded.\n* Hematological: absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, platelet count ≥ 75,000\u002Fmm3, and hemoglobin ≥ 8 g\u002FdL.\n\n  o Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Participants on therapeutic doses of anticoagulation medication must have INR and\u002For aPTT ≤ the upper limit of the therapeutic range for intended use.\n* Able to provide written informed consent.\n* Aged ≥18 years.\n* Weight ≥40 kg.\n* All male and female Participants who are able to have children must practice effective birth control while on study therapy and for up to 3 months post completion of study therapy. Acceptable forms of birth control for female Participants include: hormonal contraception (implant, injectable contraceptive, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, diaphragm with spermicide, condom with spermicide, or abstinence. Female Participants who become pregnant or suspect pregnancy must immediately notify their doctor. Female Participants who become pregnant will be taken off study. Men who are able to have children must use effective birth control while on the study therapy. Acceptable forms of birth control for male Participants include: vasectomy, condom with spermicide or abstinence. If the male Participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n* Negative serum or urine beta human chorionic gonadotropin pregnancy test for females of childbearing potential (defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females) at screening.\n* Signed consent to long-term follow-up on protocol PA17-0483 and lab protocols PA17-0577 and LAB02-152.\n\nExclusion Criteria\n\n* Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated withthe previous anticancer treatment, as determined by the PI. Toxicities related to priorsurgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.\n* Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Participants with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n* Known active hepatitis B or C.\n* Known human immunodeficiency virus (HIV).\n* Presence of active neurological disorder(s).\n* Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).\n* Amyloidosis or POEMS syndrome.\n* Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days.\n* Participants must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or active non-life-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the Participant's ability to participate and\u002For complete this trial. Examples include but are not limited to urothelial cancer Grade Ta or T1 and adenocarcinoma of the prostate treated by active surveillance.\n* Presence of any other serious medical condition that may endanger the Participant at investigator's discretion, including but not limited to:\n* New York Heart Association Class III or IV heart failure\n* Myocardial infarction or stroke ≤ 26 weeks prior to CAR NK cell infusion\n* Unstable angina within ≤ 13 weeks prior to CAR NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)\n* Severe aortic stenosis\n* Uncontrolled arrhythmia. PI approval is required for Participants with arrhythmia who may be included as an exception.\n* Congenital long QT syndrome. PI approval is required.\n* Documentation, during the screening process, of a QTc \\> 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of each other. The patient should be reclining for 5 minutes prior to ECGs. Local readings may be used for this exclusion criterion.\n* Major surgery \\\u003C 4 weeks prior to first dose of lymphodepleting chemotherapy.\n* Concomitant use of other investigational agents.\n* Concomitant use of other anticancer agents.\n* Participants receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone daily (physiological substitutive doses are allowed).\n* Received antithymocyte globulin within 14 days or alemtuzumab within 28 days of enrollment.\n* Participants receiving immunosuppressive therapy.\n* Pregnant or breastfeeding.\n* Has received a live vaccine within 6 weeks prior to CAR NK cell infusion. Examples of live vaccines include but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virusvaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.","ALL",{"count":54,"type":21},30,[56],"PHASE1","Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.",[32,59,60],"Phase 1","Growth Factor","2026-04-28",{"date":63,"type":37},"2026-04-29",{"date":65,"type":37},"2025-09-25",{"date":67,"type":21},"2030-02-01",{"name":69,"class":44},"M.D. Anderson Cancer Center",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100474599","phase-2-a-phase-ii-randomized-open-label-non-inferiority-study-of-niraparib-maintenance-after-3-vs-6-cycles-of-platinum-based-chemotherapy-in-completely-debulked-advanced-hrdpositive-high-grade-ovarian-cancer-patients-in-first-line-therapy-100474599","NCT05460000","A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy","A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy (N-Plus)","N-Plus","Inclusion Criteria:\n\n1. Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.\n2. Female patient, age ≥ 18 years.\n3. FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)\n4. Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.\n5. Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score \\>83 independent of BRCA status, based on these results.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Patients must be able to take oral medications.\n8. Synchronous and secondary malignancies are allowed if the prognosis of the ovarian cancer is not affected. The investigator must contact the medical monitoring team before enrolling the patient in the clinical trial.\n9. Patients must have normal organ and bone marrow function:\n\n   1. Hemoglobin ≥ 10.0 g\u002FdL independent of transfusion ≤ 14 days prior to screening hemoglobin assessment\n   2. Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\n   3. Platelet count ≥ 100 x 109\u002FL\n   4. Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); \\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome\n   5. Aspartate aminotransferase \u002FSerum Glutamic Oxaloacetic Transaminase (ASAT\u002FSGOT)) and Alanine aminotransferase \u002FSerum Glutamic Pyruvate Transaminase (ALAT\u002FSGPT)) ≤ 2,5 x ULN\n   6. Serum creatinine ≤ 1.5 x institutional ULN and creatinine clearance \\> 30 mL\u002Fmin.\n10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. Female patients of childbearing potential must have a negative serum pregnancy test result ≤3 days prior to administration of the first dose of study treatment.\n\nPatients are considered to be of childbearing potential unless 1 of the following applies:\n\n1. Considered to be permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and\u002For bilateral oophorectomy; or\n2. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level consistently in the postmenopausal range (30 mIU\u002FmL or higher) may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to confirm a postmenopausal state.\n\nFemale patients of reproductive potential must practice highly effective methods (failure rate \\\u003C 1% per year) of contraception with their partners, if of reproductive potential, during treatment and for 6 months following the last dose of chemotherapy or the last dose of niraparib, whichever occurs later, or longer if requested by local authorities. Highly effective contraception includes: Ongoing use of progesterone only injectable or implantable contraceptives; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Bilateral tubal occlusion; Sexual abstinence as defined as complete or true abstinence, acceptable only when it is the usual and preferred lifestyle of the patient; periodic abstinence (e.g., calendar, symptothermal, post-ovulation methods) is not acceptable; or Sterilization of the male partner, with appropriate post-vasectomy documentation of absence of sperm in ejaculate.\n\nExclusion Criteria:\n\n1. Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary.\n2. Low-grade ovarian, fallopian tube or peritoneal cancer.\n3. Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.\n4. Has known hypersensitivity to platin-containing compounds other than carboplatin.\n5. Patients posttransplant, including previous allogeneic bone marrow transplant.\n6. Has undergone interval debulking of the tumor.\n7. Has received any anti-cancer therapy for ovarian cancer other than primary surgery.\n8. Administration of other simultaneous chemotherapy drugs, any other anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted as are steroidal antiemetics).\n9. Has received prior treatment with a PARP inhibitor or has participated in a trial where any treatment arm included the administration of a PARP inhibitor.\n10. Bevacizumab is planned to be given together with first line chemotherapy or as maintenance.\n11. Clinically significant cardiovascular disease:\n\n    1. Cerebrovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment\n    2. Severe cardiac arrhythmia (recent event or active or uncontrolled)\n    3. New York Heart Association grade ≥2 congestive heart failure\n    4. Uncontrolled hypertension (defined as systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy or posterior reversible encephalopathy syndrome\n    5. History of stroke or transient ischemic attack ≤6 months before start of study treatment\n    6. Coronary\u002Fperipheral artery bypass graft ≤6 months before start of study treatment\n    7. Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment\n12. History or evidence of brain metastases or spinal cord compression.\n13. Known history of MDS or a pre-treatment cytogenetic testing result at risk for a diagnosis of MDS\u002FAML.\n14. Current, clinically relevant bowel obstruction at the time of randomization.\n15. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n16. Pregnant or lactating women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (see inclusion criteria) starting with the screening visit through at least 6 months after the last dose of chemotherapy treatment or through at least 1 month after the last dose of niraparib, whichever occurs later.\n17. Participation in another clinical study with an investigational product immediately prior to randomization. Earliest time point for randomization is after the time required for the investigational product to undergo 5 half-lives has passed.\n18. Has a known history of Human Immunodeficiency Virus (HIV) infection (known HIV1\u002FHIV2 antibodies positive) or acquired immunodeficiency syndrome (AIDS) related illness.\n19. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] has been detected) infection.\n20. Has active infection with SARS-CoV-2 (antigen test).\n21. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of chemotherapy treatment and while and 28 days after the last dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccine. Administration of inactivated vaccines is allowed.\n22. Patient has contraindications listed in the most recent SmPC.\n23. Patient who might be dependent on the sponsor, CRO, site or the investigator.\n\n22\\. In Germany: Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40a S. 1 Nr. 2 AMG.",{"count":80,"type":21},640,[24],"Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.",[84,85,86,32],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[88,89,90,91,92,93,94,95,96,97],"maintenance therapy","niraparib","HRDpositive","R0","primary tumor debulking","chemotherapy","LOH","carboplatin","paclitaxel","first line","2026-02-11",{"date":100,"type":37},"2026-02-12",{"date":102,"type":37},"2024-10-11",{"date":104,"type":21},"2032-10-01",{"name":106,"class":44},"North Eastern German Society of Gynaecological Oncology",47,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":70},"100410361","an-investigation-of-kidney-and-urothelial-tumor-metabolism-in-patients-undergoing-surgical-resection-andor-biopsy-100410361","NCT04623502","An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and\u002For Biopsy","Inclusion Criteria:\n\n* Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.\n* Age ≥ 18 years\n* Subjects of all races and ethnic origins\n* The willingness to sign and ability to understand a written informed consent.\n* Patients participating in other clinical trials are eligible, and will be evaluated on a case by case basis by the Principal Investigator, Dr. Vitaly Margulis, MD.\n\nExclusion Criteria:\n\n* Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion\n* Pregnant or breastfeeding\n* Not a surgical candidate",true,{"count":116,"type":21},600,[118],"NA","The purpose of this study is to understand the metabolism of cancers involving the kidney, including renal cell carcinomas and urothelial cell carcinomas, and how kidney cancers use different types of fuel to support tumor growth. This study uses specially labeled nutrient tracers of compounds normally found circulating in the blood. The nutrients (glucose, fructose, glutamine, acetate, and lactate) are also found in common foods. A nutrient tracer will be given to the participants through an intravenous (IV) catheter during surgery or biopsy, and blood will be collected every 30 minutes during the infusion to monitor safety parameters and the nutrient tracers. The investigators will collect a tissue sample after the completion of surgery. Participants not having an infusion will have their tissue collected after surgery or biopsy.\n\nParticipation in this study will not change patient care. All patients will receive standard of care treatment as determined by their doctors.",[121,122,32,123,124,125,126,127,128,129,130,131],"Kidney Cancer","Renal Cell Carcinoma","Urothelial Carcinoma","Metastatic Kidney Cancer","Metastatic Urothelial Carcinoma","Papillary Renal Cell Carcinoma","Chromophobe Renal Cell Carcinoma","Fumarate Hydratase Deficiency","Succinate Dehydrogenase-Deficient Renal Cell Carcinoma","HLRCC","Hereditary Leiomyomatosis and Renal Cell Cancer","2026-01-27",{"date":134,"type":37},"2026-01-28",{"date":136,"type":37},"2019-09-30",{"date":138,"type":21},"2027-09-30",{"name":140,"class":44},"University of Texas Southwestern Medical Center"]