[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ovarian-clear-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ovarian-clear-cell-carcinoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,70,103,155,175,203,226],{"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":25,"conditions":26,"keywords":35,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548",false,"NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[27,28,29,30,31,32,33,34],"Advanced Solid Tumor","Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Endometrial Cancer","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,32,33,53,54,55,56],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)","RECRUITING","2026-08-18",{"date":60,"type":61},"2026-08-19","ACTUAL",{"date":63,"type":61},"2019-09-18",{"date":65,"type":20},"2030-02-27",{"name":67,"class":68},"Novartis Pharmaceuticals","INDUSTRY",80,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100648384","phase-2-sacituzumab-tirumotecan---pembrolizumab-in-io-exposed-metastatic-or-recurrent-ovarian-clear-cell-cancer-100648384","NCT07718854","Sacituzumab Tirumotecan +\u002F- Pembrolizumab in I\u002FO Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer","A Phase 2 Randomized Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to Immunotherapy","Inclusion Criteria:\n\nType of Participant and Disease Characteristics\n\n1. Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial.\n2. Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002F radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n3. Patients must have received at least one prior platinum and taxane based chemotherapy regimen. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen.\n4. Patients must have also received one prior line containing an immune checkpoint inhibitor (ICI) More than one prior line of ICI treatment will be exclusionary.\n5. Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n6. ECOG performance status 0-1\n7. Is an individual of assigned female sex at birth and is at least 18 years of age at the time of providing the informed consent.\n8. Participant is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   * Is not a Person of Child-Bearing Potential (POCBP) OR\n   * Is a POCBP and:\n\n     \\- Agrees to use of a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction. The length of time required to continue contraception for Sacituzumab tirumotecan is 210 days.\n\n     ◦ sacituzumab tirumotecan: 210 days\n\n     \\- The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n     * Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5.\n     * Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n     * Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\nInformed Consent 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study.\n\nAdditional Categories 9. Has provided an archival tumor tissue sample (slides or block) for pathologic confirmation of diagnosis at Tufts Medical Center.\n\n10\\. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n\n11\\. Adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days before the start of study intervention.\n\n12\\. Any other medical condition that will prevent the safe administration of study drugs in the opinion of the treating physician.\n\n13\\. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n\n14\\. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n1. Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n2. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening.\n3. Absence of any AIDS-defining opportunistic infections within the past 12 months\n4. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates. Refer to https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor\u002Fsubstrate of CYP3A4.\n\nHIV testing at screening is not otherwise required. 15. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\nHepatitis B testing at screening is not required unless:\n\n* There is a known history of HBV infection\n* Mandated by local guidelines 16. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.\n\nHepatitis C testing at screening is not required unless:\n\n* There is a known history of HCV infection\n* Mandated by local guidelines\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n3. Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n4. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n5. History of stem cell\u002Fsolid organ transplant. Prior\u002FConcomitant Therapy\n6. Received prior treatment with a TROP2-targeted ADC.\n7. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n8. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n9. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has radiation pneumonitis.\n\n   Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n10. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n    Refer to Section 6.2 for information on COVID-19 vaccines.\n11. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n    Note: A list of strong inducers\u002Finhibitors of CYP3A4 can be found at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer\u002Finhibitor of CYP3A4.\n\n    Prior\u002FConcurrent Clinical Study Experience\n12. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n13. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n\n    Diagnostic Assessments\n14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n    Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of any organ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n    Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n15. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously-treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n16. Has an active infection requiring systemic therapy.\n17. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n\n    Other Exclusions\n18. Severe hypersensitivity (Grades ≥3) to study interventions, any of their excipients, and\u002For to another biologic therapy.\n19. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\n    Note: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.\n20. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.","FEMALE",{"count":79,"type":20},50,[24],"This is a phase II randomized study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy.",[33,83,84],"Metastatic Ovarian Cancer","Recurrent Ovarian Clear Cell Adenocarcinoma",[86,87,88,89,90],"clear cell carcinoma","ovarian","Sacituzumab","MK2870","pembrolizumab","NOT_YET_RECRUITING","2026-07-17",{"date":94,"type":61},"2026-07-22",{"date":96,"type":20},"2026-06",{"date":98,"type":20},"2032-03",{"name":100,"class":101},"Tufts Medical Center","OTHER",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":122,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100460887","phase-3-efficacy--safety-of-olvi-vec-and-platinum-doublet--bevacizumab-compared-to-physicians-choice-of-chemotherapy-and-bevacizumab-in-platinum-resistantrefractory-ovarian-cancer-prroc-onprime-gog-3076-100460887","NCT05281471","Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant\u002FRefractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)","Inclusion Criteria:\n\n* Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.\n* High-grade serous \\[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \\& 3 allowed\\], endometrioid, or clear-cell ovarian cancer.\n* Performance status ECOG of 0 or 1.\n* Life expectancy of at least 6 months.\n* Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.\n* Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of \\\u003C 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.\n* Received prior bevacizumab (or biosimilar) treatment.\n* No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).\n* Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.\n* At least 1 measurable target lesion per RECIST 1.1 based on abdominal\u002Fpelvis imaging scan at screening.\n* Evidence by CT and\u002For PET scans or physical exam of abdominal\u002Fpelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).\n* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.\n\nExclusion Criteria:\n\n* Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).\n* Bowel obstruction within last 3 months prior to screening.\n* Active urinary tract infection, pneumonia, other systemic infections.\n* Active gastrointestinal bleeding.\n* Known current central nervous system (CNS) metastasis.\n* Inflammatory diseases of the bowel.\n* History of HIV infection.\n* Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.\n* History of thromboembolic event within the prior 3 months.\n* Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.\n* Clinically significant cardiac disease at screening (New York Heart Association Class III\u002FIV).\n* Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.\n* Oxygen saturation \\\u003C90%.\n* Received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Receiving concurrent antiviral agent.\n* Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal\u002Fsquamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I\u002FII local malignancies.\n* Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.\n* Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.\n* Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.\n* Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \\> once every 14 days.\n* Known hypersensitivity to gentamicin.",{"count":111,"type":20},186,[113],"PHASE3","The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant\u002Frefractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant\u002Frefractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.",[116,117,118,119,120,121,33],"Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","High-grade Serous Ovarian Cancer","Endometrioid Ovarian Cancer",[123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144],"olvimulogene nanivacirepvec","GL-ONC1","GLV-1h68","oncolytic virus","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","ovarian cancer","fallopian tube cancer","primary peritoneal cancer","platinum resistant","platinum refractory","recurrent ovarian cancer","platinum resensitization","chemoresistance","heavily pre-treated","immune activation","reversal of platinum resistance or refractoriness","resensitize","2026-07-08",{"date":147,"type":61},"2026-07-10",{"date":149,"type":61},"2022-08-31",{"date":151,"type":20},"2027-12",{"name":153,"class":68},"Genelux Corporation",32,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":102},"100521120","phase-1-safety-and-efficacy-of-targeting-pp2a-in-ovarian-clear-cell-carcinoma-using-dostarlimab-and-lb-100-100521120","NCT06065462","Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100","Inclusion Criteria:\n\nInclusion criteria will be assessed within 28 days of starting study treatment:\n\n1. Ability to provide signed informed consent\n2. Age 18-75 years at time of study entry\n3. Willingness and ability to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n4. Histology showing recurrent clear cell ovarian, peritoneal, or fallopian tube cancer (mixed histology with predominant clear cell component is acceptable).\n5. Receipt of at least one prior line of therapy for recurrent disease or development of platinum resistant or refractory disease, defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment\n6. Available somatic mutation testing results (CLIA source) that reveal no PPP2R1A mutations\n7. Measurable disease based on modified RECIST v1.1. For the purposes of this study measurable disease is defined at least one \"target lesion\" that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be \\>20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \\>10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Second lesion selected for pre-treatment biopsy must be biopsy accessible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Section 14.\n9. Life expectantly of ≥12 weeks\n10. Adequate normal organ and bone marrow function as defined below.\n\n    1. Hemoglobin ≥8.0 g\u002F dL\n    2. Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n    3. Platelet count ≥100 x 109\u002FL (\\>100,000\u002Fmm3)\n    4. Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n    5. AST (SGOT)\u002FALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5 x ULN\n    6. Measured creatinine clearance (CL) ≥ 50 mL\u002Fmin or Calculated creatinine CL ≥ 50 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n    Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n11. Evidence of post-menopausal status or negative serum pregnancy test for female pre-menopausal patients. The effects of dostarlimab and LB-100 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (See Section 5.6.2).\n12. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    1. Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n    2. Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy)\n\nExclusion Criteria:\n\nExclusion criteria will be assessed within 28 days of starting study treatment:\n\n1. Participation in another clinical study with an investigational product (IP) during the last 28 days.\n2. Prior treatment with anti-CTLA-4 or anti-PDL-1\u002FPD-1 antibodies.\n3. Patients with mismatch repair deficient (dMMR) by IHC or microsatellite instability-high tumors\n4. Concurrent treatment on another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n5. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤21 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of the agent, a longer wash-out period will be required, as agreed by study sponsors and the investigators.\n6. 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. Subjects with Grade 2 neuropathy will be evaluated on a case-by-case basis after consultation with the principal investigator.\n   2. Subjects with irreversible toxicity not reasonably expected to be exacerbated by the treatment with investigational therapy may be included only after consultation with the primary investigator.\n7. Any concurrent chemotherapy, immunotherapy, or hormonal therapy for cancer treatment.\n8. Major surgical procedure (defined by the investigator) within 28 days prior to the first dose of treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n9. History of allogenic or hematologic organ transplantation.\n10. Active or prior documented autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis in the last 6 months (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome.\n\n    a. The following exceptions to this criterion are listed below. i. Subjects with vitiligo or alopecia. ii. Subjects with hypothyroidism stable on hormone replacement. iii. Any chronic skin condition that does not require systemic therapy. iv. Subjects without active disease in the last 5 years may be included but only after consultation with the primary investigator.\n\n    v. Subjects with celiac disease controlled by diet alone\n11. Uncontrolled intercurrent illness, including but not limited to: ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrythmia; interstitial lung disease; chronic obstructive pulmonary disease requiring systemic steroid therapy, oxygen, or hospitalization; 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.\n12. Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of participant safety or study results.\n13. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen, or HBsAg, result), hepatitis C, or human immunodeficiency virus (positive HIV 1\u002F2 antibodies).\n\n    1. Subjects with a past or resolved HBV infection (defined as presence of hepatitis B core antibody, or anti-HBc, and absence of HBsAg) are eligible.\n    2. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n    3. Patients with positive results of HIV that meet all of the following eligibility criteria may be enrolled:\n\n    i. Have a T-cell (CD4+) count ≥350 cells\u002FµL ii. No history of opportunistic infections or other malignancies iii. Have an HIV viral load less than 400 copies\u002FmL prior to enrollment iv. In the opinion of the investigator, their antiretroviral therapy (ART) or other HIV treatments will not interfere with the activity of the investigational product or cause any confusion with the assessment of the investigational drug toxicities\n14. History of another primary malignancy except for the following histories:\n\n    1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of treatment and of low potential risk of recurrence.\n    2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    3. Adequately treated carcinoma in situ without evidence of disease.\n15. History of leptomeningeal carcinomatosis.\n16. Untreated brain metastases or spinal cord compression. Subjects with suspected brain metastases at screening should have an MRI (preferred) or CT preferably with IV contrast of the brain prior to study entry.\n\n    a. Subjects with treated brain metastasis as evidenced by stable findings on brain MRI performed 4-6 weeks after completion of treatment would be eligible.\n17. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms\n18. Current or prior use of immunosuppressive medication within 14 days before the first dose of trial therapies. Listed below are the exceptions to this criterion.\n\n    1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular infection)\n    2. Systemic corticosteroids at physiologic doses not to exceed 10mg\u002Fday of prednisone or its equivalent\n    3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n19. Receipt of live attenuated vaccine within 30 days prior to the first dose of treatment. Note: subjects, if enrolled, should not receive live vaccines whilst receiving treatment and up to 90 days after the last dose of treatment\n20. Female subjects who are pregnant or breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 180 days after the last dose of treatment\n\n    a. Pregnant women are excluded from this study because the investigational agents have unknown teratogenic or abortifacient effects. Because there is also an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued.\n21. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients\n22. Unresolved partial or complete small or large bowel obstruction\n23. Judgment by the investigator that the patient is unsuitable to participate in the study or that the patient is unlikely to comply with study procedures, restrictions, and requirements",{"count":162,"type":20},21,[23,24],"To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma",[33],"2026-06-22",{"date":168,"type":61},"2026-06-23",{"date":170,"type":61},"2023-11-10",{"date":172,"type":20},"2027-10-01",{"name":174,"class":101},"M.D. Anderson Cancer Center",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":102},"100593123","phase-3-invigorate-a-study-of-ql1706-and-bevacizumab-in-advanced-first-line-ovarian-clear-cell-carcinoma-100593123","NCT07002346","INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma","A Randomized, Open-label, Active-controlled, Multicenter Phase 3 Trial Evaluating QL1706 With Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-line Treatment for Advanced Ovarian Clear Cell Carcinoma","INVIGORATE","Inclusion Criteria:\n\n* Voluntary participation in the study and signed informed consent form.\n* Age ≥ 18 years and \\\u003C 75 years, female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Expected survival ≥ 3 months.\n* Histologically or cytologically newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma.\n* Patients are planned to undergo primary debulking surgery (PDS), regardless of whether satisfactory debulking is achieved, and have complete surgical records and residual disease assessment results (R0 vs R1\u002FR2).\n* No prior first-line postoperative systemic antitumor therapy for the current ovarian clear cell carcinoma, including chemotherapy, targeted therapy, immunotherapy, etc.\n* Adequate organ function confirmed by the following requirements:\n\nHematological (no use of any blood components or cell growth factors within 7 days prior to initiation of study treatment):\n\ni. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (1,500\u002Fmm\\^3). ii. Platelet count ≥ 100 × 10\\^9\u002FL (100,000\u002Fmm\\^3). iii. Hemoglobin ≥ 90 g\u002FL.\n\nRenal:\n\ni. Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin. CrCl will be calculated using the Cockcroft-Gault formula: CrCl (mL\u002Fmin) = \\[(140 - age) × weight (kg) × F\\] \u002F \\[SCr (mg\u002FdL) × 72\\], where F = 0.85 for females and SCr = serum creatinine.\n\nii. Urine protein \\\u003C 2+ or 24-hour quantitative urine protein \\\u003C 1.0 g.\n\nHepatic:\n\ni. Total serum bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN.\n\nCoagulation:\n\ni. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n\\- For women of childbearing potential, a negative serum or urine pregnancy test within one week prior to enrollment, and effective contraceptive measures must be used after enrollment, for example, use of physical barrier contraception (condoms) or complete abstinence. Oral, injectable, or implantable hormonal contraceptives are not permitted. Or, women of non-childbearing potential, defined as: i. Naturally postmenopausal for at least 1 year. ii. Surgically sterile, including bilateral oophorectomy, bilateral salpingectomy, or hysterectomy.\n\niii. Serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the postmenopausal range for the study center's laboratory.\n\n* Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.\n* Patient is willing to cooperate in completing quality of life questionnaires during the trial treatment and follow-up period, and agrees that these questionnaire results can be used for clinical research.\n\nExclusion Criteria:\n\n* Histologically confirmed ovarian cancer of other epithelial origin or non-epithelial origin, other than ovarian clear cell carcinoma; ovarian tumors of low malignant potential, such as borderline tumors.\n* Prior systemic preoperative antitumor therapy for the current ovarian clear cell carcinoma, including but not limited to neoadjuvant chemotherapy (NACT) or other types of neoadjuvant therapy, or planned neoadjuvant therapy followed by interval debulking surgery (IDS) during screening.\n* Prior treatment with immune checkpoint inhibitors, such as PD-1\u002FPD-L1 antibodies, or drugs targeting other T-cell receptors, such as CTLA-4, as well as immune checkpoint agonist antibodies, such as anti-ICOS, CD40, CD137, GITR, or OX40 antibodies, and immune cell therapy.\n* Systemic use of corticosteroids or other immunosuppressive drugs, such as cyclophosphamide, azathioprine, methotrexate, thalidomide, or TNFα inhibitors, within 2 weeks before the first dose. Note: Inhaled or topical steroids, steroids as premedication for hypersensitivity reactions, such as CT scan contrast agent premedication or cytotoxic chemotherapy premedication, or adrenal replacement steroids, daily ≤10 mg prednisone or equivalent, are permitted in the absence of active autoimmune disease.\n* Prior, within 5 years, or concurrent malignancies, 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.\n* Patients with contraindications to bevacizumab, including but not limited to prior gastrointestinal perforation, surgery within 28 days before medication or incompletely healed wounds, severe bleeding or recent hemoptysis, or other situations where the investigator deems bevacizumab unsuitable.\n* Receipt of live vaccine within 30 days before the first dose of study treatment, persisting until 90 days after the last dose of study treatment. Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza virus vaccines not containing live virus, inactivated COVID-19 vaccines, etc., are permitted.\n* Active autoimmune disease requiring systemic treatment, such as use of disease-modifying drugs, corticosteroids, or immunosuppressants, within 2 years before the first dose. Replacement therapies, such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, are not considered systemic treatment. Note: Patients with cataracts, Graves' disease, or psoriasis not requiring systemic treatment within the past 2 years are not excluded.\n* Systemic infection requiring systemic antibiotic treatment or other severe infections within 2 weeks before randomization, or unexplained fever \\>38.0°C during the screening period or before enrollment, and inability to discontinue aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for more than 5 days.\n* Severe illness or concomitant non-tumor diseases, such as neurological disorders, psychiatric disorders, infectious diseases, or laboratory abnormalities, that may increase the risk of participating in the study or taking study drugs, and which the investigator deems would make the patient unsuitable for the study.\n* Pregnant or lactating women.\n* Clinically significant cardiovascular diseases, including but not limited to:\n\n  1. Myocardial infarction or unstable angina within 6 months before the first dose.\n  2. Stroke or transient ischemic attack within 6 months before the first dose.\n  3. Hypertension not controlled by optimal antihypertensive therapy, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n  4. Poorly controlled arrhythmias. Patients who have stabilized before the first dose and have been stable for ≥14 days may be enrolled.\n  5. Congestive heart failure, New York Heart Association (NYHA) functional class II-IV.\n  6. Myocarditis.\n* Expectation of needing any other form of anti-tumor therapy during the study period.\n* Receipt of traditional Chinese medicines with anti-tumor indications or immunomodulatory drugs, including but not limited to thymosin, interferon, interleukin-2, etc., within 2 weeks before the first dose.\n* HIV-positive patients.\n* Known history of anti-tuberculosis treatment within one year before the first administration of study treatment.\n* Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) ≥2000 IU\u002FmL or 10\\^4 copies\u002FmL; HCV antibody positive and HCV RNA positive.\n* Pre-existing peripheral neuropathy of grade ≥2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.\n* Current or recent, within 10 days before the first dose of study drug, continuous use of full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 days. Note: Prophylactic use of low-dose anticoagulants is permitted, including low-dose warfarin (≤1 mg\u002Fday), low-dose heparin (≤12,000 U\u002Fday), or low-dose aspirin (≤100 mg\u002Fday), provided the prothrombin time international normalized ratio (INR) is ≤1.5.\n* Hereditary bleeding tendency or coagulation dysfunction, or history of thrombosis, or imaging showing tumor invasion\u002Finfiltration of major blood vessels, or investigator or radiologist assessment of bleeding tendency.\n* Known history of severe allergy to macromolecular protein preparations, or to any component of QL1706 or other investigational drugs, or severe allergic history to chemotherapeutic drugs such as carboplatin, paclitaxel, nab-paclitaxel, or their premedications.\n* Currently participating in interventional clinical research treatment, or receiving any other investigational drug or research device treatment within 4 weeks before the first dose. Patients who failed screening for other clinical trials may be included in this study.\n* Patients deemed unsuitable for participation in this study by the investigator.","75 Years",{"count":185,"type":20},226,[113],"The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to \\\u003C75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are:\n\n1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)?\n2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience?\n\nResearchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma.\n\nParticipants will:\n\n1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria.\n2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments.\n3. Complete quality of life questionnaires as required.",[33],[33,190,191,192,193],"QL1706","Bevacizumab","First-line treatment","Immunotherapy","2026-05-13",{"date":196,"type":61},"2026-05-18",{"date":198,"type":61},"2025-11-15",{"date":200,"type":20},"2029-06-01",{"name":202,"class":101},"Tongji Hospital",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":183,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100611364","phase-2-liposomal-irinotecan-combined-with-sintilimab-and-anlotinib-in-the-treatment-of-recurrent-or-persistent-ovarian-clear-cell-carcinoma-100611364","NCT07239622","Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma","Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Voluntarily agrees to participate in the clinical study and signs a written informed consent form.\n* Age between 18 and 75 years, with histologically confirmed recurrent or persistent ovarian clear cell carcinoma.\n* Has received at least one prior line of platinum-based chemotherapy.\n* ECOG performance status of 0-2.\n* Expected survival greater than 12 weeks.\n* Has measurable disease as defined by RECIST version 1.1:\n* Each lesion must measure ≥10 mm in its longest diameter by CT, MRI, or clinical examination;\n* Lesions measured by chest X-ray must be ≥20 mm;\n* Lymph nodes must have a short axis ≥15 mm when measured by CT or MRI.\n* At least 4 weeks have elapsed since the last systemic anticancer therapy.\n* Hematologic, hepatic, renal, thyroid, and cardiac enzyme tests are within normal limits.\n\nExclusion Criteria:\n\n* Non-clear cell histologic subtype of ovarian carcinoma.\n* Prior treatment with immune checkpoint inhibitors, including PD-1, PD-L1, or CTLA-4 inhibitors.\n* Contraindications to anlotinib, including but not limited to: history of gastrointestinal perforation; surgery within 28 days before combination therapy or unhealed wounds; severe bleeding or recent hemoptysis; or any other condition deemed unsuitable for anlotinib use by the investigator.\n* Known allergy to irinotecan, anlotinib, or sintilimab.\n* Brain metastases requiring surgical intervention.\n* History of other malignancies within the past 5 years.\n* Active autoimmune disease within the past 2 years.\n* Vaccination within 1 month prior to study enrollment.\n* Blood transfusion or platelet transfusion within 4 weeks before first dosing.\n* Systemic corticosteroid therapy (excluding topical, inhaled, or intranasal corticosteroids) or any other form of immunosuppressive therapy (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 7 days prior to first dosing.\n* Use of systemic antitumor traditional Chinese medicine or immunomodulatory agents (e.g., thymosin, interferon, interleukin) within 2 weeks before first dosing, except for local use to control pleural effusion.\n* Continuous use of aspirin (\\>325 mg\u002Fday) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days within 10 days before first dosing.\n* Continuous full-dose oral or parenteral anticoagulant or thrombolytic therapy for 10 consecutive days within 10 days before first dosing.\n* Hereditary bleeding tendency or coagulation disorder; history of hypertension with thrombosis; tumor invasion of major vessels, or radiologic evidence suggesting risk of bleeding, as determined by the investigator or radiologist.\n* Presence of serious unhealed wounds, ulcers, or fractures.\n* History of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation.\n* Known history of human immunodeficiency virus (HIV) infection (positive HIV-1\u002F2 antibodies).\n* Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA copies).\n* Unresolved toxicities from prior therapy (≥Grade 2), except for alopecia, neuropathy, lymphopenia, or skin depigmentation.\n* Presence of severe or uncontrolled systemic diseases",{"count":211,"type":20},36,[24],"\\*\\*Primary Objective:\\*\\* The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC).\n\n\\*\\*Treatment Regimen:\\*\\*\n\nParticipants will receive the following treatment:\n\n* \\*\\*Liposomal irinotecan:\\*\\* Initial dose of 50 mg\u002Fm²; if well tolerated, the dose will be increased to 70 mg\u002Fm² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle.\n* \\*\\*Sintilimab:\\*\\* 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle.\n* \\*\\*Anlotinib:\\*\\* 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.\n\n\\*\\*Follow-up Schedule:\\*\\* Patients will be followed every 3 months during treatment and within the first year after completion of therapy, every 6 months from Year 2 to Year 5, and annually thereafter. Follow-up assessments will include physical examination, laboratory testing, and imaging studies.",[215,33],"Ovarian Cancer",[133],"2025-11-18",{"date":219,"type":61},"2025-11-20",{"date":221,"type":20},"2026-01-01",{"date":223,"type":20},"2029-12-31",{"name":225,"class":101},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":183,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":102},"100537536","a-comparative-study-of-the-treatment-of-real-world-patients-with-clear-cell-carcinoma-of-the-ovary-100537536","NCT06279104","A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary","Inclusion Criteria:\n\n1. Female patients with age ≥ 18 years old and ≤ 75 years old.\n2. There must be a histological diagnosis of ovarian clear cell carcinoma.\n3. Patients with recurrent or persistent ovarian clear cell carcinoma must have at least one-line pretreated platinum-containing chemotherapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.\n5. Expected survival time ≥ 12 weeks.\n\nExclusion Criteria:\n\n1.Histological evidence of non-ovarian clear cell carcinoma.",{"count":233,"type":20},150,"OBSERVATIONAL","The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed\u002Frefractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:\n\n* What is the efficacy of physician's choice of chemotherapy in relapsed\u002Frefractory OCCC patients in the real world?\n* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed\u002Frefractory OCCC patients?\n* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent\u002FPersistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?\n\nParticipants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.",[33],[238,239,240],"Ovarian clear cell carcinoma","real world study","immune checkpoint inhibitor","2024-08-11",{"date":243,"type":61},"2024-08-13",{"date":245,"type":61},"2023-03-01",{"date":247,"type":20},"2025-05-01",{"name":202,"class":101}]