[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-grade-serous-ovarian-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-grade-serous-ovarian-cancer":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,76],{"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":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100329062","phase-1-study-of-regn4018-ubamatamab-administered-alone-or-in-combination-with-cemiplimab-in-adult-patients-with-recurrent-ovarian-cancer-or-other-recurrent-mucin-16-expressing-muc16-cancers-100329062",false,"NCT03564340","Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers","A Phase 1\u002F2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:\n\n   1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)\n   2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)\n   3. documented relapse or progression on or after the most recent line of therapy\n   4. no standard therapy options likely to convey clinical benefit\n2. Adequate organ and bone marrow function as defined in the protocol\n3. Life expectancy of at least 3 months\n4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.\n5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:\n\n   1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol\n   2. 1-4 prior lines of systemic therapy, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Prior treatment with anti-Programmed Cell Death (PD-1)\u002FPD-L1 therapy, as described in the protocol\n2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)\n3. Prior treatment with a MUC16 - targeted therapy\n4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol\n5. History and\u002For current cardiovascular disease, as defined in the protocol\n6. Severe and\u002For uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen\n\nNote: Other protocol-defined Inclusion\u002FExclusion Criteria apply","FEMALE","18 Years",{"count":19,"type":20},890,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The main purpose of this study is to:\n\n* Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus\n* The study will also look at the levels of ubamatamab and\u002For cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics\n* The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus\n* To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)",[27,28,29,30,31,32],"Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Recurrent Primary Peritoneal Cancer","Recurrent Endometrial Cancer","Endometrial Cancer","Low-grade Serous Ovarian Cancer","RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":37},"2018-05-21",{"date":41,"type":20},"2027-05-10",{"name":43,"class":44},"Regeneron Pharmaceuticals","INDUSTRY",52,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100546428","phase-2-a-study-of-avutometinib-defactinib-and-letrozole-in-people-with-low-grade-serous-ovarian-cancer-100546428","NCT06394804","A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer","Combination Targeted and Hormonal treAtMEnt of Low-gradE Serous Ovarian Cancer in the upfroNt Setting","CHAMELEON","Inclusion Criteria:\n\n* Female patients ≥ 18 years of age\n* Histologically-confirmed LGSOC (ovarian, peritoneal) by tissue biopsy read by pathology at study institution. NOTE: Patients with a prior history of serous borderline tumors without prior systemic (cytotoxic or hormonal) treatment but a new diagnosis of low-grade serous ovarian cancer are eligible.\n* Determination that the patient is not a primary surgical candidate by a gynecologic oncologist surgeon; or has undergone an attempted primary debulking with residual RECIST measurable disease.\n* Measurable disease according to RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be ≥10mm when measured by CT or MRI. Lymph nodes must be ≥15mm by short axis when measured by CT or MRI.\n* An Eastern Cooperative Group (ECOG) performance status of ≤1. Patients with an ECOG performance status of 2 are permitted on trial if this is deemed to be secondary to cancer but not to other comorbidities.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic brain metastases that do not require intervention are also eligible.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on anti-HCV treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Female patients with reproductive potential agree to use highly effective method of contraceptive during the trial and for 1 month following the last dose of study intervention, unless surgical menopause is conferred. Women of child-bearing potential must have a negative pregnancy test within 14 days prior to commencement of study treatment. Non-hormonal methods of highly effective contraception include:\n\n  * intrauterine device (IUD)\n  * bilateral tubal occlusion\n  * vasectomized partner\n  * sexual abstinence\n* Patients must have adequate cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n* Baseline QTc interval \\\u003C 460 ms (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 1) using Fredericia's QT correction formula. NOTE: This criterion does not apply to patients with a right or left bundle branch block.\n* Adequate organ function, defined by the following parameters:\n\n  °Adequate hematologic function\n* Hemoglobin \\[Hb\\] ≥ 9.0 g\u002FdL. If a red blood cell transfusion has been administered the Hb must remain stable and ≥ 9.0 g\u002FdL for at least 1 week prior to first dose of study intervention.\n* Platelets ≥ 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\[ANC\\] ≥ 1000\u002Fmm\\^3\n\n  °Adequate hepatic function:\n* Total bilirubin ≤1.5 × upper limit of normal \\[ULN\\] for the institution; patients with Gilbert syndrome may enroll if total bilirubin is \\\u003C3.0mg\u002FdL (51 μmole\u002FL) upon discussion with MSK PI.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or \\\u003C5 xULN in patients with liver metastases).\n\n  * Adequate renal function with creatinine clearance rate of ≥50 mL\u002Fmin as calculated by the Cockcroft-Gault formula or serum creatinine of ≤ 1.5 x ULN.\n  * Creatine phosphokinase (CPK) ≤2.5 x ULN.\n\nExclusion Criteria:\n\n* Patients who are deemed in the opinion of their treating physician to be appropriate candidates for a primary debulking surgery are not eligible for this trial, unless measurable disease remains after a primary cytoreductive surgery.\n* Prior systemic anti-cancer therapy for LGSOC or serous borderline disease.\n* Major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week of the first dose of study intervention. Open and close laparotomy and\u002For laparoscopy will be considered minor surgery.\n* Treatment with warfarin. Patients on warfarin for deep vein thrombosis\u002Fpulmonary embolism can be converted to low-molecular-weight heparin or direct oral anticoagulants (DOACs).\n* Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage PEG tube. Patients with diagnosis of bowel obstruction \\\u003C3 months from study enrollment will be excluded unless surgically cured or approved by study PI.\n* Symptomatic brain metastases requiring steroids or other interventions. Patients with new asymptomatic CNS metastases detected during the screening period must receive radiation therapy and\u002For surgery for CNS metastases. Following treatment, these patients may then be eligible if all other criteria are met.\n* Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n* Patients with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions.\n* History of rhabdomyolysis.\n* Patients with a history of hypersensitivity to any of the active (Avutometinib, defactinib) or inactive (hydroxypropylmethylcellulose, mannitol, magnesium stearate) ingredients of the investigational product.\n* Female patients who are breastfeeding.\n* Any other medical condition (e.g., cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the Investigator would places the patient at unacceptably high risk for toxicity.\n* Exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with study interventions within 14 days prior to the first dose of study intervention and during the course of therapy (Appendix 1), including:\n\n  * strong CYP3A4 inhibitors or inducers, due to potential drug-drug interactions with both Avutometinib and defactinib.\n  * strong CYP2C9 inhibitors or inducers, due to potential drug-drug interactions with defactinib.\n  * P-glycoprotein (P-gp) inhibitors or inducers, due to potential drug-drug interactions with defactinib.",{"count":55,"type":20},20,[24],"The researchers are doing this study to find out whether the combination of avutometinib, defactinib, and letrozole is an effective treatment for people with low-grade serous ovarian cancer (LGSOC). The researchers will also look at the safety of this combination.",[59],"Low-Grade Serous Ovarian Cancer",[61,62,63,64],"Avutometinib","Defactinib","Letrozole","24-014","2026-04-22",{"date":67,"type":37},"2026-04-23",{"date":69,"type":37},"2024-04-29",{"date":71,"type":20},"2027-04",{"name":73,"class":74},"Memorial Sloan Kettering Cancer Center","OTHER",8,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100521683","phase-3-a-study-of-avutometinib-vs-6766--defactinib-vs-6063-in-recurrent-low-grade-serous-ovarian-cancer-100521683","NCT06072781","A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer","A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)","RAMP 301","Inclusion Criteria:\n\nPatients may be eligible for inclusion in the study if they meet the following criteria:\n\n1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)\n2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.\n3. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.\n4. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.\n5. Measurable disease according to RECIST v1.1.\n6. An Eastern Cooperative Group (ECOG) performance status ≤ 1.\n7. Adequate organ function.\n8. Adequate recovery from toxicities related to prior treatments.\n9. For patients with reproductive potential, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.\n10. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.\n2. Co-existing high-grade serous ovarian cancer or mixed histology.\n3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.\n4. History of prior malignancy with recurrence \\\u003C3 years from the time of enrollment.\n5. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.\n6. Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.\n7. An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.\n8. History of medically significant rhabdomyolysis.\n9. For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.\n10. Symptomatic bowel obstruction within 3 months of the first dose of study intervention\n11. Concurrent ocular disorders.\n12. Concurrent heart disease or severe obstructive pulmonary disease.\n13. Active or past medical history of interstitial lung disease\u002Fpneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).\n14. Subjects with the inability to swallow oral medications.\n15. History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.\n16. Pregnant or breastfeeding.\n17. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.",{"count":85,"type":20},270,[87],"PHASE3","This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.",[90],"Low Grade Serous Ovarian Cancer",[90,92,93,94],"KRAS","KRAS wt","KRAS mt","2026-04-01",{"date":97,"type":37},"2026-04-02",{"date":99,"type":37},"2024-03-18",{"date":101,"type":20},"2031-02-09",{"name":103,"class":44},"Verastem, Inc.",106]