[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-endometrial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-endometrial-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,53,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100054253","phase-2-pembrolizumab-and-lenvatinib-in-mismatch-repair-proficient-recurrent-endometrial-cancer-after-failure-of-first-line-therapy-with-platinum-based-doublet-and-immunotherapy-100054253",false,"NCT07594015","Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy","Phase 2 Open-Label Trial Investigating the Efficacy and Safety of Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy","Inclusion Criteria:\n\n1. Histologically confirmed recurrent endometrial carcinoma, including serous, endometrioid, carcinosarcoma, clear cell subtypes, with measurable disease per RECIST 1.1 criteria.\n2. Mismatch repair (MMR) proficient status confirmed by IHC (Immunohistochemistry) or molecular testing.\n3. Patients must have failed first-line therapy with platinum based doublet with prior immunotherapy.\n4. Patient must have completed next-generation sequencing on either primary or recurrent tumor.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.\n6. Age ≥ 18 years.\n7. Female participants must be of non-childbearing potential or for females of child bearing potential (FOCBPs), must agree to use contraception as described in Section 5.6. FOCBPs must not be pregnant or breastfeeding.\n8. At least one measurable lesion according to RECIST 1.1.\n9. Adequate organ function, including:\n\n   * Hemoglobin ≥ 8 g\u002FdL (blood transfusions are permitted)\n   * Absolute neutrophil count ≥ 1000\n   * Platelet count ≥ 100 x 10⁹\u002FL\n   * Glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin\n   * Bilirubin ≤ 1.5 x ULN (upper limit of normal)\n10. Written informed consent obtained from the patient.\n11. At least 3 weeks must have elapsed from any prior therapy\n\nExclusion Criteria:\n\n1. Uterine sarcoma\n2. Active central nervous system metastases or leptomeningeal disease.\n3. History of severe allergic reactions to pembrolizumab, lenvatinib, or any components of the formulations.\n4. Active autoimmune disease requiring chronic systemic steroids for \\> 3 months in the last 6 months prior to enrollment.\n5. Pregnancy or breastfeeding at the time of enrollment.\n6. Previous treatment with lenvatinib or other VEGFR inhibitors.\n7. Concurrent treatment with other investigational drugs or anti-cancer therapies except for adjuvant hormonal therapy for breast cancer.\n8. Uncontrolled concurrent illness, such as active infections that could interfere with study participation.\n9. Blood pressure \\>160 systolic or \\>110 diastolic averaged over last 3 documented measurements.\n10. History of significant cardiovascular events within 12 months prior to enrollment, including myocardial infarction, unstable angina, or congestive heart failure (NYHA Class III or IV).\n11. History of organ transplant or immune suppressive therapy that would interfere with the efficacy or safety of the investigational drugs.\n12. Other malignancies within the past 2 years except for non-melanoma skin cancer.","FEMALE","18 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to determine the efficacy and safety of Pembrolizumab in combination with Lenvatinib in recurrent, mismatch repair-proficient endometrial cancer after failure of first-line therapy with a platinum-based doublet chemotherapy and immunotherapy.",[26],"Recurrent Endometrial Cancer","RECRUITING","2026-07-09",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":20},"2026-09-01",{"date":35,"type":20},"2031-09-01",{"name":37,"class":38},"University of Miami","OTHER",1,{"id":41,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":42,"targetDuration":4,"studyType":21,"phases":43,"briefSummary":24,"conditions":44,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":39},"100637920",{"count":19,"type":20},[23],[26],"2026-05-11",{"date":47,"type":31},"2026-05-18",{"date":49,"type":20},"2026-06-01",{"date":51,"type":20},"2031-06-01",{"name":37,"class":38},{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"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","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",{"count":61,"type":20},890,[63,23],"PHASE1","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)",[66,67,68,26,69,70],"Recurrent Ovarian Cancer","Recurrent Fallopian Tube Cancer","Recurrent Primary Peritoneal Cancer","Endometrial Cancer","Low-grade Serous Ovarian Cancer","2026-05-07",{"date":73,"type":31},"2026-05-08",{"date":75,"type":31},"2018-05-21",{"date":77,"type":20},"2027-05-10",{"name":79,"class":80},"Regeneron Pharmaceuticals","INDUSTRY",52,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":89,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100544243","phase-2-alpine-maintenance-letrozoleabemaciclib-100544243","NCT06366347","ALPINE: Maintenance Letrozole\u002FAbemaciclib","A Phase 2 Trial of Maintenance Abemaciclib\u002FLetrozole After Systemic Therapy in Patients With Advanced or Recurrent Estrogen Receptor Positive, Mismatch Repair Proficient, TP53 Wildtype Endometrial Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component.\n* Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory.\n* Tumor must be TP53 wild-type as determined by immunohistochemistry (IHC) or via CLIA-certified targeted Next-Generation Sequencing (NGS); IHC assessment of p53 status is included in the NCCN guidelines of uterine neoplasms for the molecular analysis of endometrial carcinoma.\n* Participants must have mismatch repair proficient (MMRP) endometrial cancer as determined by immunohistochemistry (IHC) or polymerase chain reaction (PCR) or any CLIA-certified next generation sequencing assay.\n* No known tumor mutational burden ≥ 10 mutations\u002Fmegabase (Mb).\n* No known RB1 mutations or two-copy RB1 deletion.\n* Participants must have just completed a minimum of 4 cycles and a maximum of 10 cycles of a combination of carboplatin and taxane or a combination of taxane and anti-PD-(L)1 inhibitor therapy (e.g., pembrolizumab, or dostarlimab, or durvalumab).\n* Participants must have had measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.\n* Participants are permitted to have received:\n\n  * a. Prior adjuvant chemotherapy (e.g., paclitaxel\u002Fcarboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\])\n  * b. Prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fparaaortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must have been completed at least 4 weeks prior to registration.\n  * c. Prior hormonal therapy for treatment of endometrial cancer.\n* Must be able to initiate study drug between 3 to 8 weeks (or 21 to 56 days) after completion of their final dose of chemotherapy and anti-PD-(L)1 blockade (if they were receiving anti-PD-(L)1 blockade).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix A)\n* Age ≥ 18 years\n* Participants must have normal organ and bone marrow function within 2 weeks before starting protocol therapy as defined below:\n\n  * System Laboratory Value\n  * Hematologic\n\n    * ANC ≥1.5 × 109 \u002FL\n    * Platelets ≥100 × 109 \u002FL\n    * Hemoglobin ≥8 g\u002FdL Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n  * Hepatic\n\n    * Total bilirubin ≤1.5 × ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.\n    * ALT and AST ≤3 × ULN\n    * Creatinine ≤ 1.5 × institutional ULN, OR\n    * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5 x institutional ULN.\n    * Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase; ULN = upper limit of normal.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to swallow and retain oral medication.\n* Participants must be willing to release archival tissue if available. Please see section 9.1.2 and the laboratory manual for tissue requirements.\n\nExclusion Criteria:\n\n* Participants who have received previous treatment with CDK4\u002F6 inhibitors, including but not limited to previous abemaciclib therapy.\n* Any gastrointestinal dysfunctions that could interfere with the absorption of study drugs (e.g., bowel obstruction, inability to swallow tablets, malabsorption syndrome, unresolved nausea, vomiting, diarrhea CTCAE v 5.0 \\> grade 1).\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to starting study treatment.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* Major injuries or surgery within 14 days prior to start of study treatment and\u002For planned major surgery during the on-treatment study period. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and starting study treatment.\n* Other malignant disease with disease-free ≤ 3 years except: curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or ductal carcinoma in situ (DCIS) of the breast or any other cancer deemed by the investigator to be at low risk for recurrence of that malignancy.\n* Active brain metastases (e.g., stable for \\\u003C 8 weeks, no adequate previous treatment with radiotherapy and\u002For surgery, symptomatic, requiring treatment with anti-convulsant therapy. Corticoid therapy is allowed if administered as stable dose for at least 1 month before starting study treatment).\n* Females who are pregnant or lactating. The effects of the study agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of study agent. Contraceptive methods may include an intrauterine device (IUD) or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. A negative serum pregnancy test is required for study entry from women of childbearing potential.\n* The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease\u002Fpneumonitis, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Participants who at the time of study enrollment are known to require concomitant therapy with strong CYP3A4 inducers, or strong inhibitors of CYP3A4. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment on trial. Participants are eligible for study entry if an appropriate substitution is made prior to the first dose of study medication.\n* Participants with personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 3 years prior to study enrollment, or individuals who are deemed by the treating investigator to be at low risk for disease recurrence.","ALL",{"count":91,"type":20},32,[23],"The purpose of this research study is to see if the study drugs abemaciclib and letrozole are effective and safe for participants with estrogen-receptor positive (ER+), mismatch repair proficient, tumor protein p53 (TP53) wild-type endometrial cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)\n* Letrozole (a type of aromatase inhibitor)",[69,26,95],"TP53",[97,69,98],"TP53 wild-type endometrial cancer","Recurrent endometrial cancer","2026-02-09",{"date":101,"type":31},"2026-02-11",{"date":103,"type":31},"2024-09-25",{"date":105,"type":20},"2029-03-01",{"name":107,"class":38},"Dana-Farber Cancer Institute",6]