[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-endometrial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-endometrial-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,64,76,107,116,146,175,202,248,287,309,335,370,390],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054227","phase-3-testing-the-addition-of-an-antiangiogenic-drug-bevacizumab-to-chemotherapy-carboplatin-and-paclitaxel-combined-with-immunotherapy-pembrolizumab-for-pmmr-tp53-mutated-endometrial-cancer-100054227",false,"NCT07198074","Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer","A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Documentation of disease:\n\n  * Stage III and stage IVA endometrial cancers (with measurable disease),\n  * Stage IVB endometrial cancer (with or without measurable disease), or\n  * Recurrent endometrial cancer (with or without measurable disease)\n* In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI\n* Histologic confirmation of the original primary tumor is required (submission of pathology report\\[s\\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated\u002Fundifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients must have:\n\n  * Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND\n  * P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted\n* A pathology report demonstrating results of institutional MMR IHC and p53 IHC and\u002For TP53 by next-generation sequencing\n* Patients may have received:\n\n  * NO prior chemotherapy for treatment of endometrial cancer OR\n  * Prior adjuvant chemotherapy (e.g., paclitaxel\u002Fcarboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara-aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function\n* Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration\n* NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)\n* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8 g\u002Fdl\n* Creatinine clearance (CrCl) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal\u002Fpelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and\u002For need for drainage nasogastric or gastrostomy tube\n* No clinically significant bleeding within 28 days prior to registration\n* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg\n* No major surgery within 28 days of initiation of bevacizumab\n* No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease\n\n  * Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n  * Topical or inhaled steroids are allowed\n  * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n* No history of stem cell or solid organ transplant\n* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","FEMALE","18 Years",{"count":19,"type":20},255,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adding bevacizumab to the combination of carboplatin, paclitaxel and pembrolizumab may be more effective than the usual treatment combinations of carboplatin and paclitaxel with or without pembrolizumab in treating patients with advanced or recurrent pMMR and TP53 mutated endometrial cancer.",[26,27],"Advanced Endometrial Carcinoma","Recurrent Endometrial Carcinoma","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-01-27",{"date":36,"type":20},"2028-07-01",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",232,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100054262","phase-2-testing-the-use-of-the-combination-of-selumetinib-and-olaparib-or-selumetinib-alone-targeted-treatment-for-ras-pathway-mutant-recurrent-or-persistent-ovarian-and-endometrial-cancers-a-combomatch-treatment-trial-100054262","NCT05554328","Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial","A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial","Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191\n* Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191\n* Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment\n\n  * Cohort 1: Patients with histologically confirmed RAS pathway mutant ovarian, primary peritoneal, or fallopian tube (\"ovarian\") cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)\n  * Cohort 2: Patients with histologically confirmed RAS pathway mutant endometrial cancer (activating mutations in KRAS, NRAS, HRAS, BRAF, MEK1, MEK2, or inactivating mutations in NF1)\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have progressed after first-line treatment for recurrent or persistent disease\n* Patients with ovarian cancer should not be eligible for further platinum-based therapy\n* Patients with endometrial cancer must have received or been offered an immune oncology agent (alone or in combination with lenvatinib) unless there are existing contraindications for immune oncology agents or lenvatinib\n* Patients may have received unlimited prior therapy\n* Patients must have measurable and biopsiable disease. Measurable disease is defined by RECIST 1.1 as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \\> 10 mm when measured by CT, magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \\> 20 mm when measured by chest x-ray. Lymph nodes must be \\> 15 mm in short axis when measured by CT or MRI\n\n  * Patients must have at least one \"target lesion\" separate from the lesion to be biopsied to be used to assess response on this protocol as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as \"non-target\" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy\n* Prior therapy must have been completed at least four weeks prior to registration\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n* Hemoglobin (Hgb) \\>= 9.5 g\u002FdL with no blood transfusion in the past 28 days (within 14 days prior to registration)\n* Platelets \\>= 100,000\u002Fmcl (within 14 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmcl (within 14 days prior to registration)\n* Patients must have creatinine clearance estimated of \\>= 50 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test (within 14 days prior to registration)\n* Total bilirubin level =\\\u003C 1.5 x institutional upper limit of normal (ULN) or =\\\u003C 3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x ULN (within 14 days prior to registration)\n* Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of selumetinib or olaparib\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence) during the study and for 6 months after completing treatment\n\n  * Non-sterilized male partners of WOCBP (including males sterilized by a method other than bilateral orchidectomy e.g., vasectomy) who intend to be sexually active with a female partner must be using an acceptable method of contraception such as male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening throughout the total duration of the study and the drug washout period (at least 6 months after the last dose of study intervention) to prevent pregnancy in a partner. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Vasectomized (i.e., sterile) males are considered fertile and should still use a male condom plus spermicide as indicated above during the clinical study\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* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated\n\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 treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy\n\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Extra caution should be taken with olaparib, as it crosses the blood brain barrier and can cause edema in brain metastases\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* Patients who have received any MEK inhibitors\n* Patients who have progressed while receiving a PARP inhibitor\n* Patients who have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients with uncontrolled intercurrent illness\n* Patients with \\>= grade 2 neuropathy within 14 days of registration\n* Patients with severe (Child-Pugh C) liver dysfunction\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib and selumetinib or any excipients thereof\n* Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents\n\n  * Supplementation with vitamin E greater than 100% of the daily recommended dose. Any multivitamin containing vitamin E must be stopped prior to study enrollment even if less than 100% of the daily recommended dosing for vitamin E\n  * Vitamin E must not be taken in the 7 days prior to initiation of treatment with selumetinib\n* Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or known moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, Fluconazole, verapamil). The required washout period prior to starting olaparib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication\n* Concomitant use of strong CYP2C19 inhibitors (e.g., ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole). The required washout period prior to starting selumetinib is at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication\n* Have received or are receiving an investigational medicinal product (IMP) or other systemic anti-cancer treatment (including chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) within 4 weeks prior to registration, or within a period during which the IMP or systemic target treatment has not been cleared from the body (e.g., a period of 5 'half-lives'), whichever is longer\n* Known myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML)\n* Patients who have had previous organ transplant, allogenic bone marrow transplant or double umbilical cord blood transplantation\n* Patients who have had whole blood transfusion within 28 days prior to registration\n* Patients with ophthalmological conditions as follows:\n\n  * Current or past history of retinal pigment epithelial detachment\u002Fcentral serous retinopathy or retinal vein occlusion.\n  * Intraocular pressure \\> 21 mmHg (or ULN adjusted by age) or uncontrolled glaucoma (irrespective of intraocular pressure \\[IOP\\]). Subjects with known glaucoma and increased IOP who do not have meaningful vision (light perception only or no light perception) and are not experiencing pain related to the glaucoma, may be eligible after discussion with the study chair\n  * Patients with any other significant abnormality on ophthalmic examination should be discussed with the study chair for potential eligibility\n  * Ophthalmological findings secondary to long-standing optic pathway glioma (such as visual loss, optic nerve pallor or strabismus) or longstanding orbito-temporal plexiform neurofibroma (PN) (such as visual loss, strabismus) will NOT be considered a significant abnormality for the purposes of the study\n* Patients with severe, active co-morbidity defined as any of the following:\n\n  * History and\u002For confirmed pneumonitis\n  * Uncontrolled hypertension (blood pressure \\[BP\\] \\>= 150\u002F90 mmHg despite medical therapy)\n  * Acute coronary syndrome within 6 months prior to registration\n  * Uncontrolled atrial fibrillation\n  * Known family history of long QT syndrome\n* Women who are pregnant or unwilling to discontinue nursing",{"count":49,"type":20},165,[51],"PHASE2","This phase II ComboMATCH treatment trial compares selumetinib plus olaparib to selumetinib alone in women with endometrial or ovarian (fallopian tube and primary peritoneal) cancer that has come back (recurrent) or that remains despite treatment (persistent) and harbors a mutation in the RAS pathway. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. The addition of olaparib to selumetinib could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to selumetinib alone.",[27,54,55,56],"Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma",{"date":31,"type":32},{"date":59,"type":32},"2023-04-25",{"date":61,"type":20},"2028-10-01",{"name":38,"class":39},296,{"id":65,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":67,"briefSummary":24,"conditions":68,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":74,"locationsCount":75},"100608170",{"count":19,"type":20},[23],[26,27],"2026-07-01",{"date":71,"type":32},"2026-07-02",{"date":34,"type":32},{"date":36,"type":20},{"name":38,"class":39},223,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100482618","phase-2-targeted-therapy-directed-by-genetic-testing-in-treating-patients-with-locally-advanced-or-advanced-solid-tumors-the-combomatch-screening-trial-100482618","NCT05564377","Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","Molecular Analysis for Combination Therapy Choice (ComboMATCH)","Inclusion Criteria:\n\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \\>= 50% or Karnofsky performance status of \\>= 50%\n* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider\n* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)\n* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:\n\n  * Patients must have progressed on at least one line of standard systemic therapy OR\n  * Patients whose disease has no standard treatment that has been shown to prolong overall survival\n* Patient must meet one of the following requirements:\n\n  * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR\n  * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial\n    * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \\[CR\\] or partial response \\[PR\\]) to any intervening therapy after collection of the tissue\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR\n  * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available\n  * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only\n* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial","ALL",{"count":85,"type":20},2900,[51],"This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.",[89,90,91,92,93,94,95,27,54,96,97,55,56,98,99],"Advanced Malignant Solid Neoplasm","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Malignant Solid Neoplasm","Malignant Female Reproductive System Neoplasm","Metastatic HER2-Negative Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","Unresectable HER2-Negative Breast Carcinoma","Unresectable Malignant Solid Neoplasm",{"date":71,"type":32},{"date":102,"type":32},"2023-04-07",{"date":104,"type":20},"2030-07-01",{"name":38,"class":39},481,{"id":108,"slug":4,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":52,"conditions":111,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":115,"locationsCount":63},"100481846",{"count":49,"type":20},[51],[27,54,55,56],{"date":71,"type":32},{"date":59,"type":32},{"date":61,"type":20},{"name":38,"class":39},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100512285","phase-1-testing-different-amounts-of-the-combination-of-drugs-m1774-and-zen-3694-for-the-treatment-of-recurrent-ovarian-and-endometrial-cancer-100512285","NCT05950464","Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer","A Phase 1B Study of Combination ATR (M1774) and BET Inhibition (ZEN003694) to Exploit ARID1A Loss in Recurrent Ovarian and Endometrial Cancer","Inclusion Criteria:\n\n* Patients must have pathologically confirmed:\n\n  * PART I: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% morphology of clear cell and endometrioid required), recurrent clear cell and low grade endometrioid endometrial carcinoma (The International Federation of Gynecology and Obstetrics \\[FIGO\\] grade 1), or recurrent platinum resistant high grade serous ovarian carcinoma\n  * NOTE: platinum-resistant disease is defined as progression within \\\u003C 6 months from completion of platinum-based therapy. The date should be calculated from the last administered dose of platinum therapy\n  * NOTE: Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.\n  * NOTE: Patients with recurrent endometrial carcinoma must not be eligible for or decline treatment with curative intent.\n  * PART II: Recurrent clear cell or endometrioid ovarian carcinoma (at least 50% tumor morphology of clear cell and endometrioid required). Recurrent clear cell or FIGO Grade 1 endometrioid endometrial carcinoma. Next Generation Sequencing (NGS) by Clinical Laboratory Improvement Act (CLIA) approved lab required for ARID1A status. Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II). The number of patients in PART II cohort with clear cell or endometrioid EMCA will be capped at 33% (5 patients per cohort). Institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian cancer.\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of =\\\u003C 2\n* Prior Treatment\n\n  * 1-3 prior cytotoxic therapies\n\n    * NOTE: For platinum-resistant HGSOC (PART 1) may have received up to 3 prior cytotoxic therapies after developing platinum resistant disease.\n  * Subjects with microsatellite instability- high (MSI-H) and\u002For mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.\n  * Unlimited prior hormonal therapy, targeted therapy (including immunotherapy), and\u002For antiangiogenic therapy will be permitted.\n* Washout periods (due to risk of myelosuppression):\n\n  * Cytotoxic chemotherapy - 3 weeks.\n  * Radiation therapy - 2 weeks (NOTE: patients with radiation to \\> 25% of the bone marrow are NOT eligible).\n* Disease status:\n\n  * For PART I, evaluable disease or measurable disease required. NOTE: evaluable disease: defined as disease related abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions.\n  * For PART II, measurable disease by RECIST 1.1 is required. Patients will be required to undergo biopsy, which may be a non-target lesion but should not be the only RECIST measurable lesion.\n\nNOTE: Patients for PART II are required to undergo paired tumor biopsies. If at time of biopsy the biopsy is deemed unsafe by interventional radiology or attempted and is unsuccessful, patients may still enroll.\n\n* Hemoglobin \\>= 9 g\u002FdL (in the absence of transfusion within 28 days prior to dosing)\n* Absolute neutrophil count \\>= 1,500 cells\u002Fmm\\^3\n* Platelet count \\>= 100,000 cells\u002Fmm\\^3\n* Calculated creatinine clearance (CrCL) of \\>= 50 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level =\\\u003C 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents should be New York Heart Association (NYHA) Functional Classification of class I or II.\n* The effects of M1774 and ZEN003694 on the developing human fetus are unknown. For this reason and because BETi agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Women of reproductive potential should use effective contraception treatment with M1774 and ZEN003694 and for at least 6 months following the last dose. Women should be advised not to breastfeed while taking M1774 and ZEN003694 and for 1 month after cessation of treatment.\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* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression, are off steroids, and are stable for at least 1 month.\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.\n* PART II only: Participants must have known mutational status (wild-type or pathogenic or likely pathogenic alteration) for ARID1A by Next-Generation Sequencing. This can be determined according to local testing generated by an assay with appropriate regulatory status.\n* Patients must be able to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the product formulation.\n* Patients with co-morbidities:\n\n  * Human immunodeficiency virus (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 treatment, they are eligible if they have an undetectable HCV viral load.\n* Resolution of all toxicities of prior therapy or surgical procedures to baseline or grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade =\\\u003C 2), alopecia, and other toxicities considered clinically nonsignificant and\u002For stable on supportive therapy as determined by the investigator).\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents.\n* Patients who have received prior ATR, ATM, CHK, BET, EZH2, and\u002For PI3K inhibitors.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or M1774 used in study.\n* Patients taking proton pump inhibitors given decreased solubility of M1774 with increased pH. Proton pump inhibitors must be discontinued 7 days prior to initiating the trial.\n* Patients with corrected QT (QTc) over 450msec that does not correct with correction of electrolyte abnormalities or family history of long QT syndrome.\n* Patients with severe, active co-morbidity defined as follows:\n\n  * No active infection requiring parenteral antibiotics.\n  * Known hereditary diseases characterized by genetic defects of DNA repair mechanisms, including ataxia telangiectasia, Nijmegen breakage syndrome, Werner syndrome, Bloom Syndrome, Fanconi anemia, xeroderma pigmentosum, Cockayne syndrome, and trichothiodystrophy.\n* Pregnant and breastfeeding women are excluded from this study because ZEN003694 has the potential for teratogenic or abortifacient effects and M1774 is genotoxic in in vivo nonclinical studies. Patients who discontinue breastfeeding are eligible for enrollment and may not resume breastfeeding until 1 month off treatment.\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. Moderate inhibitors of CYP3A4 should be avoided. If alternative is not available, the use of moderate CYP3A4 inhibitors is permitted with careful monitoring and approval by study team. At the discretion of the provider, additional monitoring (labs, toxicity checks) may be implemented for use of moderate CYP3A4 inhibitors. Substrates of CYP1A2 with narrow therapeutic window also must be avoided white taking ZEN003694. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* Patients receiving any medications or substances that are Factor Xa inhibitors are discouraged given concerns for thrombocytopenia (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed. If patients are not willing to switch to low molecular heparin, they must obtain approval by study team.\n* Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting, uncontrolled diarrhea, known malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes, presence of drainage gastrostomy tube, other chronic gastrointestinal disease, and\u002For other situations that may preclude absorption of oral medications M1774 and\u002For ZEN003694.\n* M1774 restrictions:\n\n  * Patients who cannot discontinue drugs that are strong inhibitors of CYP3A4 or CYP1A2.\n  * Patients who cannot discontinue drugs that use hMATE1 or hMATE2-K substrates.",{"count":124,"type":20},65,[126],"PHASE1","This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.",[27,129,130,131,132,133,134,135,136],"Recurrent Endometrial Clear Cell Adenocarcinoma","Recurrent Endometrial Endometrioid Adenocarcinoma","Recurrent Endometrial Low Grade Endometrioid Adenocarcinoma","Recurrent Ovarian Clear Cell Adenocarcinoma","Recurrent Ovarian Endometrioid Adenocarcinoma","Recurrent Ovarian High Grade Serous Adenocarcinoma","Recurrent Ovarian Low Grade Endometrioid Adenocarcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","2026-06-26",{"date":139,"type":32},"2026-06-29",{"date":141,"type":32},"2023-12-18",{"date":143,"type":20},"2027-06-30",{"name":38,"class":39},14,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100447912","phase-2-testing-nivolumab-with-or-without-ipilimumab-in-deficient-mismatch-repair-system-dmmr-recurrent-endometrial-carcinoma-100447912","NCT05112601","Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma","A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System Recurrent Endometrial Carcinoma","Inclusion Criteria:\n\n* Patients with measurable or non-measurable (detectable) recurrent endometrial cancer\n* Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \\>= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \\>= 15 mm in short axis when measured by CT or MRI\n* Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:\n\n  * All other lesions (or sites of disease), including small lesions (longest diameter \\\u003C10 mm or pathological lymph nodes with \\>= 10 to \\\u003C 15 mm short axis), are considered non-measurable disease\n  * Ascites and\u002For pleural effusion attributed to tumor\n  * Solid and\u002For cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions\n* Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and\u002For microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and\u002For presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing \\[NGS\\] panel)\n\n  * Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with \"equivocal\" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal\u002Findeterminate MSI results\n* Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated\u002Fundifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients may have received 1-2 prior lines of systemic therapy:\n\n  * Prior anti-PD1\u002FPD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic\u002Frecurrent settings. Patients must have had a complete response and have disease progression\u002Frelapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration\n* Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration\n* Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Platelets \\>= 100,000\u002Fmcl\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmcl\n* Creatinine =\\\u003C 1.5 x institutional\u002Flaboratory upper limit of normal (ULN)\n* Total serum bilirubin level =\\\u003C 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\\\u003C3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \\\u003C grade 2 within 28 days prior to registration)\n* Thyroid-stimulating hormone (TSH) within normal limits (TSH \\\u003C ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated\n* Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery\n* As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval \\\u003C 450 msec\n* The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\n\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\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* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load 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 treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n* Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n\nExclusion Criteria:\n\n* Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma\n* Patients who received prior anti-PD1\u002FPD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities\n* Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents\n* Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent\n* Patients on immunosuppressive therapy, with the exception of:\n\n  * Intra-nasal, inhaled, topical or local steroid injections\n  * Premedication for hypersensitivity reaction\n* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease\n* Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody\n* Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Women who are pregnant or unwilling to discontinue nursing\n* Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and\u002For ipilimumab including severe hypersensitivity reactions to any monoclonal antibody",{"count":154,"type":20},81,[51],"This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.",[158,159,160,161,162,163,164,165,27],"Endometrial Adenocarcinoma","Endometrial Clear Cell Adenocarcinoma","Endometrial Dedifferentiated Carcinoma","Endometrial Endometrioid Adenocarcinoma","Endometrial Mixed Cell Adenocarcinoma","Endometrial Mucinous Adenocarcinoma","Endometrial Undifferentiated Carcinoma","Endometrioid Adenocarcinoma","2026-06-18",{"date":168,"type":32},"2026-06-22",{"date":170,"type":32},"2022-06-02",{"date":172,"type":20},"2032-07-30",{"name":38,"class":39},137,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":201},"100643692","phase-2-elacestrant-with-everolimus-for-the-treatment-of-recurrent-advanced-or-metastatic-er-positive-endometrial-cancer-100643692","NCT07634601","Elacestrant With Everolimus for the Treatment of Recurrent Advanced or Metastatic ER-Positive Endometrial Cancer","A Phase II Study of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD) Combined With Everolimus in Patients With Recurrent or Metastatic ER-Positive (ER+) Endometrial Cancer (ELAVERA)","Inclusion Criteria:\n\n* Must be ≥ 18 years of age\n* Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Participants must have histologically confirmed advanced (International Federation of Gynecology and Obstetrics \\[FIGO\\] stage III or IV), persistent, or recurrent endometrial cancer (histologic documentation of recurrence not required) that has\n\n  * Patient's archival endometrial cancer tumor specimen has positive hormone receptor expression defined as \"positive\" or ≥ 1% by immunohistochemistry (IHC) performed at any Clinical Laboratory Improvement Act (CLIA)-certified laboratory\n  * Can be any histologic subtype including endometrioid, mixed, serous, clear cell, carcinosarcoma\n* Prior treatment with at least one line of platinum-based chemotherapy is required (can be in the adjuvant setting):\n\n  * Patients with mismatch repair deficiency (dMMR) tumors must have received at least one prior line of immunotherapy. An exception may be made for patients with documented contraindications to immunotherapy, including but not limited to severe autoimmune conditions, solid organ transplantation, or lack of access to immunotherapy.\n  * Prior exposure to to progestins, aromatase inhibitors, tamoxifen, selective estrogen receptor down regulator (SERD) is allowed if the last dose was ≥ 4 weeks before enrollment Availability of adequate archival tumor tissue (from initial biopsy, surgical specimen, or repeat biopsy) is preferred but not required for study entry. When available, archival tissue should consist of either one unstained slide cut at 4-5 µm or one formalin-fixed paraffin-embedded (FFPE) tissue block with one corresponding H\\&E slide, submitted per the Lab Manual. If archival tissue is not available, the participant may still be enrolled with Principal Investigator approval prior to study entry\n* No prior history of other malignancies within past 2 years (besides endometrial cancer as per Inclusion #4). Individuals with the following cancers are eligible if diagnosed and treated within the past 2 years: ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin, early stage breast cancer or cervical cancer, early stage renal cell carcinoma or any other likely curatively treated early stage malignancy. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Patients who received chemotherapy or hormonal therapy 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 enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy)\n* 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 cycle 1 day 1. Radiation therapy that is given for palliative purposes, e.g. for pain control or prevention of a tumor associated complication is allowed during the study, with the exclusion of thoracic radiation. However, study medication should be held during the duration of the radiation therapy and the radiated tumor lesion cannot be used for assessment of treatment response. Radiation therapy should not be administered before the first response assessment\n* Able to take study medication by mouth\n* Pre- and postmenopausal women are eligible. Premenopausal women of childbearing potential must have a negative serum pregnancy test at time of screening. Woman of childbearing potential (WOCBP) is defined as follows:\n\n  * Any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) OR\n  * Any female who is not postmenopausal defined as:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; OR\n    * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation.\n\nIn the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential\n\n* Women of child-bearing potential must use highly effective methods of contraception throughout the study and for 120 days after study drug discontinuation. Highly effective contraception methods include:\n\n  * Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.\n\nUse of non-hormonal methods of contraception or placement of an nonhormonal intrauterine device (IUD) or intrauterine system (IUS)\n\n* Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL (at screening)\n* Platelets ≥ 100 × 10\\^9\u002FL (at screening)\n* Hemoglobin ≥ 8.0 g\u002FdL (at screening)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3 x institutional upper limit of normal (ULN) (at screening)\n* Total serum bilirubin \\\u003C 1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN (at screening)\n* Patients with type 2 diabetes are eligible if on stable therapy and hemoglobin A1c ≤ 8%\n* Patients fasting triglycerides must be ≤ 300 mg\u002FdL\n* No evidence of clinically significant, active interstitial lung disease or pneumonitis on history or baseline imaging. Patients with pneumonitis related to radiation or prior therapies may be eligible at investigator discretion discretion if recovered at the time of study initiation\n* Patient can safely discontinue strong and moderate CYP3A4 inhibitors or inducers (e.g., certain azole antifungals, rifampin, some anticonvulsants) at least 14 days or 5 half lives whichever is shorter prior to first dose of study drug, or switch to acceptable alternatives\n\nExclusion Criteria:\n\n* Patients who have previously received everolimus or any another mTOR (mammilian target of rapamycin) inhibitor (eg. sirolimus, temsirolimus) for the treatment of endometrial cancer and are no longer receiving therapy with washout\n* Participants who are receiving any other anti-cancer approved or investigational agents within \\\u003C 21 days or 4 weeks if fulvestrant prior to cycle 1 day 1. Participation in other observational studies is permitted\n* Symptomatic brain metastases or carcinomatous meningitis. Patients with treated brain metastases may be eligible if they are asymptomatic and neurologically stable, and demonstrate radiographic stability at screening, confirmed at least 28 days following completion of definitive treatment (e.g., surgery and\u002For radiation therapy)\n* History of other malignancies within past 2 years, except ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, basal cell or squamous cell carcinoma of the skin or early stage cancers deemed curable by investigator. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Herbal preparations\u002Fmedications are prohibited throughout the study. These herbal medications include, but are not limited to: St. John's wort, Kava, ephedra (ma huang), gingko biloba, black cohosh, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Patients should stop using these herbal medications 7 days prior to first dose of study drug\n* Patients receiving chronic treatment with systemic steroids (\\> 10mg prednisone equivalent) or another immunosuppressive agent\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), symptomatic angina pectoris, cardiac arrhythmia, a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n  * Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea) are ineligible\n  * Patient with 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\\])\n  * Screening for HIV and hepatitis is not required for enrollment\n* The patient has a 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* Any of the following within 6 months prior to trial registration: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism\n* History of hypersensitivity or intolerance to elacestrant, everolimus, other rapamycin analogs (eg. temsirolimus, sirolimus) or any of the components in either medication\n* Pregnant women are excluded from this study because embryo-fetal toxicity is a potential side effect of elacestrant and everolimus. For this reason, women of child-bearing potential (WOCBP) must agree to use highly effective contraception prior to study entry, for the duration of treatment, and for at least 120 days after the completion of treatment. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy\n* Women of child-bearing potential, who will not use a highly effective method of contraception\n* Women who are lactating\n* Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial\n* Patients must be able to follow concomitant medication restrictions:\n\n  * Strong CYP3A4 inhibitor drugs, food and herbal products, including but not limited to: ceritinib, clarithromycin, cobicistat, danoprevir, dasabuvir, elvitegravir, idelalisib, itraconazole, ketoconazole, lopinavir, nefadozone, nelfinavir, ombitasvir, paritaprevir, posaconazole, ritonavir, saquinavir, telithromycin, tipranavir, troleandomycin, voriconazole\n  * Moderate CYP3A4 inhibitor drugs, food and herbal products, including but not limited to: amprenavir, aprepitant, atazanavir, casopitant, cimetidine, ciprofloxacin, conivaptan, crizotinib, cyclosporine, darunavir, darunavir\u002Fritonavir, diltiazem, dronedarone, erythromycin, faldaprevir, fluconazole, fluvoxamine, fosamprenavir, imatinib, isavuconazole, letermovir, netupitant, nilotinib, octreotide, tofisopam, verapamil\n  * Strong CYP3A4 inducer drugs, food and herbal products, including but not limited to: carbamazepine, enzalutamide, lumacaftor, mitotane, phenobarbital, phenytoin, rifampin, rifabutin\n  * Moderate CYP3A4 inducer drugs, food and herbal products, including but not limited to: bosentan, dabrafenib, efavirenz, etravirine, lesinurad, lopinavir, metamizole, modafinil, nafcillin, thioridazine, tipranavir\u002Fritonavir, telotristat ethyl\n  * Herbal preparations, including, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, and ginseng\n  * Grapefruit, grapefruit juice, and grapefruit-containing beverages and other foods known to inhibit CYP3A4 and P-gp activity\n* Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a (Typhoid Vaccine Live Oral Ty21a) typhoid vaccines\n* Patients with rare hereditary disorders of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption are excluded, as everolimus contains lactose\n* Patients who require use of systemic corticosteroids is prohibited with the following exceptions:\n\n  * Participants on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis.\n  * Low dose systemic corticosteroids are needed to manage certain conditions (e.g., rheumatoid arthritis) if the dose is not expected to lead to moderate or strong CYP3A4 induction.\n  * Single doses, topical applications (including mouthwashes), inhaled sprays, eye drops, and local injections are allowed.\n  * Systemic short-term steroids are also allowed for treatment of adverse events (AEs)",{"count":183,"type":20},50,[51],"This phase II trial tests how well elacestrant with everolimus works for the treatment of estrogen receptor (ER) positive endometrial cancer that has come back after a period of improvement (recurrent), that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Estrogen can cause the growth of cancer cells. Elacestrant lowers the amount of estrogen made by the body. This may help stop the growth of cancer cells that need estrogen to grow. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping cancer cells from reproducing and by decreasing blood supply to the cancer cells. Giving elacestrant with everolimus may be effective for treating patients with recurrent, advanced or metastatic ER positive endometrial cancer.",[26,187,27,188,189],"Metastatic Endometrial Carcinoma","Stage III Endometrial Cancer","Stage IV Endometrial Cancer","NOT_YET_RECRUITING","2026-06-05",{"date":193,"type":32},"2026-06-09",{"date":195,"type":20},"2026-12-18",{"date":197,"type":20},"2029-12-18",{"name":199,"class":200},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100542959","immune-checkpoint-inhibitor-response-in-solid-tumors-using-a-live-tumor-diagnostic-platform-100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":211,"type":20},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[215,216,217,218,219,187,220,221,222,223,95,224,225,226,227,228,229,230,231,232,233,27,234,235,236,237,97],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Skin Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Cervical Carcinoma","Recurrent Colorectal Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","2026-03-11",{"date":240,"type":32},"2026-03-12",{"date":242,"type":32},"2024-04-24",{"date":244,"type":20},"2027-05",{"name":246,"class":200},"Mayo Clinic",3,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100360076","phase-1-talazoparib-and-radiation-therapy-in-treating-patients-with-locally-recurrent-gynecologic-cancers-100360076","NCT03968406","Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gynecologic Cancers","Phase I Study of Talazoparib in Combination With Radiation Therapy for Locally Recurrent Gynecologic Cancers","Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Histologically-confirmed recurrent ovarian, fallopian tube, primary peritoneal cancer, endometrial, vaginal, or cervical cancer in the abdomen and pelvis\n* Subjects with stage IV disease are eligible as long as disease elsewhere (other than the site(s) to receive radiation therapy \\[RT\\]) is undetectable or stable (\\>= 3 months) and immediate chemotherapy is not required. Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks prior to start of investigational therapy\n* Hemoglobin \\>= 10.0 g\u002FdL and no blood transfusions in the 28 days prior to entry\u002Frandomization (choose whichever is most applicable to the study) (within 28 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* No features suggestive of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) on peripheral blood smear (within 28 days prior to administration of study treatment)\n* White blood cells (WBC) \\> 3 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Platelet count \\>= 100 x 10\\^9\u002FL (within 28 days prior to administration of study treatment)\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be =\\\u003C 5 x ULN (within 28 days prior to administration of study treatment)\n* Serum creatinine =\\\u003C 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\n  * Note: If cannot fulfill ECOG 0-1, must fulfill inclusion criteria below (minimum life expectancy of \\>= 16 weeks)\n* Patients must have a life expectancy \\>= 16 weeks\n* Evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50, radiation-induced oophorectomy with last menses \\> 1 year ago, chemotherapy-induced menopause with \\> 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Patient of child-bearing potential is willing to adhere to using two forms of highly effective birth control. Condoms with spermicide and one of the following are acceptable: oral contraceptive or hormonal therapy or placement of an intrauterine device (IUD). Acceptable non-hormonal birth control methods include: total sexual abstinence, vasectomized sexual partner plus male condom, tubal occlusion plus male condom with spermicide, IUD plus male condom+spermicide. Acceptable hormonal methods include: etonogestrel implants (i.e. Implanon, Norplan), normal and low dose combined oral pills, norelgestromin\u002Fethinyl estradiol (EE) transdermal system, intravaginal device (i.e. EE and etonogestrel) or cerazette (desogestrel). All of these would need to be combined with male condom with spermicide\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* At least one lesion, not previously irradiated, that can be accurately measured at baseline as \\>= 10 mm in the longest diameter (except lymph nodes which must have short axis \\>= 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements\n* For inclusion in biomarker endpoint, patients must fulfill the following criterion:\n\n  * Provision of informed consent for tumor biopsies \\* If a patient declines to participate in tumor biopsies, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to that part\n\nExclusion Criteria:\n\n* Ascites, peritoneal carcinomatosis, hepatic metastases\n* Prior radiotherapy in the region of planned radiotherapy\n* Chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 3 weeks prior to start of therapy\n* Previous enrollment in the present study\n* Participation in another clinical study with an investigational product during the last 4 weeks\n* Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \\>= 5 years (will require discussion with study physician)\n* Patients receiving any systemic chemotherapy, radiotherapy\n* Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir\n* Concomitant use of known P-gp inhibitors (i.e. dronedarone, quinidine, ranolazine, verapamil, ketoconazole, itraconazole), P-glycoprotein (P-gp) inducers (i.e. rifampin, tipranavir, ritonavir), or breast cancer resistance protein (BCRP) inhibitors (i.e. elacridar \\[GF120918\\]) should be avoided. If patients are taking any P-gp inhibitors, P-gp inducers, or BRCP inhibitors, they will need to stop them prior to enrolment on the study\n* Persistent toxicities (\\>= Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade 2) with the exception of alopecia, caused by previous cancer therapy\n* Resting electrocardiogram (ECG) with corrected QT (QTc) \\> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia\n* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment\n* Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on high resolution computed tomography (CT) scan or any psychiatric disorder that prohibits obtaining informed consent\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication\n* Breast feeding women\n* Patients with a known hypersensitivity to talazoparib or any of the excipients of the product\n* Patients with uncontrolled seizures\n* Patients requiring pelvic and para-aortic radiotherapy (defined as levels L1\u002FT12)\n* Patients with isolated vaginal relapse (i.e. no disease in lymph nodes or else where in pelvis\u002Fabdomen)",{"count":256,"type":20},24,[126],"This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.",[93,232,27,54,55,56,260,229,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277],"Recurrent Vaginal Carcinoma","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVA Vaginal Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Stage IVB Vaginal Cancer AJCC v8","2026-03-10",{"date":238,"type":32},{"date":281,"type":32},"2019-09-26",{"date":283,"type":20},"2027-10-01",{"name":285,"class":200},"M.D. Anderson Cancer Center",2,{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":201},"100485656","phase-1-phase-1-clinical-trial-of-lenvatinib-pembrolizumab-and-hypofractionated-pelvic-radiation-therapy-for-pmmr-recurrentunresectable-endometrial-carcinoma-100485656","NCT05603910","Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent\u002FUnresectable Endometrial Carcinoma","Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for Mismatch Repair Proficient (pMMR) Recurrent\u002FUnresectable Endometrial Carcinoma","Inclusion Criteria:\n\n1. Biopsy-proven recurrent pMMR EC following surgery alone or de novo unresectable pMMR EC for whom External beam radiation therapy (EBRT) has been determined as an appropriate therapeutic approach. Eligible tumor histologies include the following: endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies as determined by tissue from an archival sample or newly obtained core or excisional biopsy of a tumor lesion. For patients with recurrent disease greater than six months (\\>6 months), a fresh biopsy must be obtained.\n2. Measurable disease of at least 1.0 cm in size defined by RECIST 1.1 on imaging studies with at least one (1) site located in the pelvis and\u002For vagina without any foci of extra-pelvic disease (including the para-aortic region or inguinal-femoral lymph nodes).13\n3. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Karnofsky score ≥50).\n4. Patients must have pMMR tumor subtype(s).\n5. Patients must have normal organ and marrow function as defined below:\n\n   1. Absolute neutrophil count (ANC) ≥1,500 cells\u002Fmm³\n   2. Platelets ≥100,000 cells\u002Fmm³\n   3. Hemoglobin ≥9.0 g\u002FdL\n   4. Serum creatinine or Measured or calculated a creatinine clearance glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl) ≤ 1.5 x upper limit of normal (ULN) or CrCl ≥ 40 mL\u002Fmin\n   5. Serum total bilirubin \\\u003C1.0 ULN\n   6. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) Aminotransferase (AST and ALT) ≤ 2.5 x ULN or 5 X ULN for patients with liver metastases\n   7. Albumin ≥2.5 mg\u002FdL\n\n   CrCl should be calculated per institutional standard.\n6. Female participants of childbearing potential (those who have not been surgically sterilized or have not been without menses for \\>1 year) should be willing to use 2 methods of birth control at the same time or be surgically sterile or abstain from heterosexual activity for the course of the study and for at least 120 days after the last study dose.\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Women age ≥18 years old.\n\nExclusion Criteria:\n\n1. Patients who are currently in or have participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study treatment.\n2. Patients with Mismatch repair deficient (dMMR) and endometrial carcinomas.\n3. Patients with dMMR and uterine carcinosarcomas.\n4. Patients with known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n   EXCEPTION: Patients with previously treated brain metastases, including receiving prior brain irradiation, may participate provided they are stable (without evidence of progression by imaging for at least 3 months prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, are not using steroids for at least 28 days prior to study treatment, and have not received prior cranial irradiation for at least 3 months prior to study treatment.\n5. Patients with a known additional malignancy that is progressing or requires active treatment.\n\n   EXCEPTIONS include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n6. Prior treatment with lenvatinib, anti-programmed cell death-1(PD)-1, anti-PD-L1, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n7. Patients who are planned to receive vaginal brachytherapy as their pelvic boost course of radiation as determined by their treating physician(s).\n8. No prior radiation therapy to the vagina, pelvis, or abdomen will be allowed.\n9. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other serious medical condition or social situations that in the judgement of the Investigator(s) would interfere or limit compliance with study requirements\u002Ftreatments.\n10. Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of study treatment.\n\n    Note: Patients with active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs) and\u002For requiring replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n11. Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n12. Evidence of uncontrolled hypertension as documented in the patient's medical record.\n13. Known psychiatric illness\u002Fcondition or substance abuse disorders that in the judgement of the Investigator(s) would interfere with cooperation with requirements of the study.\n14. Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment.\n15. Patients with uncontrolled human immunodeficiency virus (HIV) infection, which is defined as follows:\n\n    1. Antiviral therapy treatment for \\\u003C4 weeks AND\n    2. Have an HIV viral load ≥400 copies\u002FmL prior to enrollment.\n16. Patients with uncontrolled hepatitis B virus (HBV) infection or who are chronic carriers of hepatitis B infection, which is defined as:\n\n    1. Hepatitis B surface antigen reactive (HbsAg-positive), undetectable or low HBV DNA, and with normal ALT levels who are not on HBV therapy\n    2. Individuals who have serologic evidence of a resolved prior HBV infection (ie, HBSAg-negative and anti-core hepatitis B antibody positive (anti-Hepatitis B core -positive)\n17. Patients with active, untreated hepatitis C virus (HCV) infection or who have not completed their HCV antiviral regimen. Patients with a history of HCV infection may participate in this study if their HCV ribonucleic acid (RNA) level is below the limit of quantification.\n18. Received live vaccine within 30 days prior to the first dose of study treatment.\n19. Patient has active Mycobacterium tuberculosis infection (tuberculosis or TB).\n20. A QT interval corrected for heart rate using Bazett's formula (QTcB) ≥ 480msec.\n21. Patient receiving concurrent additional biologic therapy.\n22. Patients with impaired decision-making capacity.\n23. Patients who have not recovered from major surgery.",{"count":295,"type":20},18,[126],"The purpose of this research study is to see if it is feasible to combine a fixed dose of pembrolizumab and a daily dose of oral lenvatinib, along with daily treatments of an abbreviated course of pelvic external beam radiation therapy, to support cancer cells in multiplying and spreading to other body sites.",[27,299],"Unresectable Endometrial Carcinoma","2026-02-20",{"date":302,"type":32},"2026-02-24",{"date":304,"type":32},"2023-04-15",{"date":306,"type":20},"2030-04-15",{"name":308,"class":200},"Aaron Wolfson",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":286},"100555936","phase-2-avelumab-and-m1774-in-arid1a-mutated-endometrial-cancer-100555936","NCT06518564","Avelumab and M1774 in ARID1A-mutated Endometrial Cancer","A Phase 2 Study of Avelumab in Combination With ATR Inhibitor M1774 in Patients With ARID1A-mutated Recurrent Endometrial Cancer Who Have Received Prior Immunotherapy","Inclusion Criteria:\n\n* Participants must have endometrial cancer that is ARID1A-mutated \\[loss of function (LOF) mutations\\] determined by any CLIA-certified next-generation sequencing assay. ARID1A LOF mutation status must be confirmed by the principal investigator prior to participant enrollment.\n* Participants must have measurable disease per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions). Each lesion must be \\>= 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or \\>= 20 mm when measured by chest x-ray. Lymph nodes must be \\> 15 mm in short axis when measured by CT or MRI.\n* Prior Therapy: There is no upper limit of prior therapies, but patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma. Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and\u002For consolidation\u002Fmaintenance therapy. Furthermore, patients who have only received chemotherapy with immunotherapy in the adjuvant setting will be eligible for the study.\n\n  --Prior hormonal therapy is allowed (no washout period is required after hormonal therapy).\n* Participants must have received prior immunotherapy targeting the PD-1\u002FPD-L1 pathway either in the adjuvant, first-line or recurrent setting. Up to 50% of participants (i.e. a maximum of 12 participants) who do not meet this requirement may enroll in the study.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of the combination of avelumab and M1774 in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0, 1, or 2 (reference Appendix A for ECOG performance status criteria).\n* Availability of a formalin fixed paraffin embedded (FFPE) block of cancer tissue OR 15 unstained 5-micron slides from the original surgery or biopsy or from a biopsy of recurrent disease.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Hemoglobin ≥ 9.0 g\u002FdL (with no erythropoietin or red blood cell transfusion within the last 14 days)\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) in the case of documented Gilbert's syndrome, total bilirubin ≤3 x ULN is allowed\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 × institutional ULN in patients with documented hepatic involvement, AST\u002FALT ≤ 5 x ULN is allowed\n  * Creatinine clearance ≥ 60 mL\u002Fmin as estimated by the Cockcroft-Gault formula or institutional standard method OR\n  * Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin by measured 24-hour urine collection\n* The effects of avelumab and M1774 on the developing human fetus are unknown. For this reason and because these agents are known to be teratogenic, women of child-bearing potential must have a negative serum pregnancy test at screening. Women of child- bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 30 days after last avelumab treatment administration and at least 6 months after last M1774 treatment administration. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n\n  --Women of child-bearing potential are defined as those who are not surgically sterile (i.e., bilateral tubal ligation or salpingectomy, bilateral oophorectomy, or total hysterectomy) or post-menopausal (defined as ≥ 12 months with no menses without an alternative medical cause)\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy, immunotherapy, other investigational therapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. There is no required washout period for hormonal therapy.\n* Participants whose adverse events due to prior anti-cancer therapy have not recovered to ≤ Grade 1, unless toxicity does not constitute a safety risk and\u002For is stable on supportive therapy in the opinion of the investigator (e.g., alopecia, sensory neuropathy ≤ Grade 2, etc.)\n* Participants who are receiving any other investigational agents.\n* Participants with clinically controlled brain metastases, which is defined as individuals with central nervous system metastases that have been treated for, are asymptomatic, and have discontinued corticosteroids for \\> 14 days or are on a stable or decreasing steroid dose (for the treatment of brain metastases) may be enrolled. Participants with meningeal carcinomatosis are excluded.\n* Known prior severe hypersensitivity to avelumab or M1774 or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (≥ Grade 3), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n* Active and\u002For uncontrolled infection. The following exceptions apply:\n\n  * Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction\n  * Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels \\\u003C ULN, and provided there is no expected drug- drug interaction\n* Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels \\\u003C ULN.\n* Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day.\n* Current or prior use of immunosuppressive medication within 7 days prior to enrollment with the following exceptions to this exclusion criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent;\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.\n* History of prior organ transplantation including allogeneic stem-cell transplantation.\n* Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.\n* Participants with psychiatric conditions (including active or recent \\[within the past year\\] suicidal ideation of behavior)\u002Fsocial situations that, in the judgment of the investigator, would make the participant inappropriate for study entry.\n* Participants with uncontrolled or poorly controlled arterial hypertension, symptomatic congestive heart failure (≥ New York Heart Association Classification Class III), uncontrolled cardiac arrhythmia, unstable angina pectoris, myocardial infarction or a coronary revascularization procedure, cerebral vascular incident, transient ischemic attack, or any other significant vascular disease within 180 days of study intervention start.\n* Known alcohol or drug abuse.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years or if they are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: breast cancer in situ, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.\n* All other severe acute or chronic medical conditions (for example, immune colitis, inflammatory bowel disease, uncontrolled asthma, immune pneumonitis, or pulmonary fibrosis) or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration in the opinion of the investigator and would make the participant inappropriate for entry into the study.\n* Vaccination within 4 weeks of treatment initiation and while on trial is prohibited except for administration of inactivated vaccines.\n* Patients may not use natural herbal products or other \"folk remedies\" while participating in this study. Herbal medications include, but are not limited to St. John's Wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.\n* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or CYP1A2 enzymes, proton pump inhibitors, or other prohibited concomitant medications within 7 days prior to treatment initiation are ineligible. Examples are provided in Appendix B. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Pregnant women are excluded from this study because avelumab and M1774 are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated with either agent. Women should not breastfeed during the study and for at least 1 month after last treatment administration.\n* Calculated QTc average (using the Fridericia correction calculation) of \\> 470 msec that does not resolve with correction of electrolyte abnormalities.",{"count":317,"type":20},25,[51],"The purpose of this research study is to see if the combination of study drugs avelumab and M1774 is effective and safe for participants with endometrial cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Avelumab (a type of human IgG1 antibody)\n* M1774 (a type of ATR inhibitor)",[321,322,27],"Endometrial Cancer","ARID1A Gene Mutation",[321,324,325],"ARID1A Mutated Recurrent Endometrial Cancer","Recurrent Endometrial Cancer","2026-01-05",{"date":328,"type":32},"2026-01-07",{"date":330,"type":32},"2024-11-14",{"date":332,"type":20},"2029-08-31",{"name":334,"class":200},"Panagiotis Konstantinopoulos, MD, PhD",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":83,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":351,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":369},"100515861","phase-2-trial-of-nab-sirolimus-in-combination-with-letrozole-in-patients-with-advanced-or-recurrent-endometrioid-endometrial-cancer-100515861","NCT05997017","Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer","A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer","Inclusion Criteria:\n\n1. Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is suggested but not required.\n2. All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging \\[MRI\\] if CT scans are contraindicated) as defined by RECIST version 1.1.\n3. Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.\n4. Prior treatment history:\n\n   1. Adjuvant setting - treatment with chemotherapy, hormonal therapy,checkpoint inhibitors, and\u002For other therapy is permitted as long as theadjuvant therapy ended ≥6 months from enrollment.\n   2. Recurrent\u002Fadvanced\u002Fmetastatic setting - treatment with 0-1 prior chemotherapy regimens is permitted (patients may be naïve to chemotherapy); chemotherapy must have been completed ≥3 months prior to enrollment. Patients are permitted to have received adjuvant chemotherapy and no more than 1 line of chemotherapy in the recurrent\u002Fadvanced\u002Fmetastatic setting.\n   3. Non-chemotherapy-based treatment (eg, checkpoint inhibitors, hormonal therapy, and\u002For small molecule agents) is permitted at any point as long as therapy ended ≥4 weeks prior to enrollment.\n   4. Patients who have received prior therapy in the recurrent\u002Fadvanced\u002Fmetastatic setting must have achieved a complete or partial response(investigator-assessed) to at least 1 therapy.\n5. Age: 18 years or older.\n6. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate liver function:\n\n   1. Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome, then ≤3 × ULN)\n   2. Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)\n8. Adequate renal function: creatinine clearance (CrCL) ≥30 mL\u002Fmin based on Cockcroft-Gault\n9. Adequate hematologic parameters:\n\n   1. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factor support allowed)\n   2. Platelet count ≥100,000\u002Fmm3 (100 × 109\u002FL) (transfusion and\u002For growth factor support allowed)\n   3. Hemoglobin ≥8.0 g\u002FdL (transfusion and\u002For growth factor support allowed)\n10. Fasting serum triglyceride must be ≤300 mg\u002FdL; fasting serum cholesterol must be less than or equal to 350 mg\u002FdL.\n11. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1.\n12. Non-pregnant and non-breastfeeding female:\n\n    1. Females of childbearing potential must agree to use effective contraception or abstinence without interruption from 28 days prior to starting nab-Sirolimus through 3 months after the last dose of nab-Sirolimus and have a negative serum pregnancy test (beta human chorionic gonadotropin \\[β-hCG\\]) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.\n    2. Sexual abstinence is considered a highly effective contraceptive method only if defined as refraining from heterosexual intercourse from 28 days prior to starting study medication throughout 3 months after last dose of study medication. The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.\n13. The patient understands and signs the informed consent.\n14. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.\n15. Patients with a known history of human immunodeficiency virus (HIV)infection are eligible if:\n\n    1. There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.\n    2. The patient has been receiving an antiretroviral therapy regimen for≥4 weeks and the HIV viral load is \\\u003C400 copies\u002FmL prior to enrollment.\n    3. Antiretroviral therapy regimen does not include strong cytochrome(CYP)3A4 inhibitors or inducers\n\nExclusion Criteria:\n\n1. Prior treatment with an mTOR inhibitor, including nab-sirolimus.\n2. Patients with known inactivating TSC1 or TSC2 alterations (based on tissue or liquid next generation sequencing \\[NGS\\]) unless the PRECISION 1 study (NCT05103358) has been closed to enrollment.\n3. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.\n4. Patients with primary refractory disease (ie, those who have never achieved a complete or partial response to prior therapy) are not permitted on study.\n5. Patients with the following are excluded:\n\n   1. Known or suspected brain metastases.\n   2. Severe heart disease defined as unstable angina pectoris, New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.\n   3. Severe lung disease defined as a diffusing capacity for carbon monoxide (DLCO) that is ≤50% of normal predicted value and\u002For an O2 saturation ≤88% at rest on room air (Note: spirometry and pulmonary function tests \\[PFTs\\] are not required to be performed unless clinically indicated).\n   4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy.\n   5. A history of malignancies other than the one under treatment unless the patient is disease-free for more than 5 years from completion of therapy administered with curative intent. Controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low grade hematologic malignancies (eg, chronic lymphocytic leukemia \\[CLL\\], follicular lymphoma, etc), or other adequately treated carcinoma in situ may be eligible, after discussion with the Medical Monitor.\n   6. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg\n   7. Patients with history of interstitial lung disease and\u002For pneumonitis, or pulmonary hypertension.\n   8. Active hepatitis B and\u002For hepatitis C infection and detectable viral load despite antiviral therapy\n6. Required use of concomitant medications with strong CYP3A4 interactions (induction or inhibition) should be discontinued (strong inhibitors include ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin; strong inducers include rifampin and rifabutin). These agents must be discontinued prior to first dose of nab-sirolimus.",{"count":343,"type":20},29,[51],"A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer",[321,347,348,349,27,350],"Endometrioid Tumor","Cancer","Tumor","Endometrioid Endometrial Cancer",[352,353,354,355,356,357,358,347,321,27,350],"nab-Sirolimus","FYARRO","Letrozole","Endometrial","Recurrent","ABI-009","Endometrial Carcinoma","2025-11-12",{"date":361,"type":32},"2025-11-13",{"date":363,"type":32},"2023-12-28",{"date":365,"type":20},"2027-06",{"name":367,"class":368},"Aadi Bioscience, Inc.","INDUSTRY",9,{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":21,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":201},"100398563","phase-2-abemaciclib-for-the-treatment-of-recurrent-ovarian-or-endometrial-cancer-100398563","NCT04469764","Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer","An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4\u002F6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer","Inclusion Criteria:\n\n* Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) cancer or endometrial cancer\n* Molecular tumor board confirms that patient's archival ovarian cancer tumor specimen has been assessed using standard of care genomic profiling and demonstrates CDK4\u002F6 activation features\n* Molecular tumor board confirms that patient's archival endometrial cancer tumor specimen has been assessed using standard of care genomic profiling and is of endometrioid histology, has positive hormone receptor expression and lack of Cyclin E gene (CCNE) amplification or retinoblastoma susceptibility gene product (RB) loss\n* At least one prior chemotherapy regimen for the treatment of recurrent ovarian or endometrial cancer\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade =\\\u003C 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and study initiation\n* 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 study initiation\n* The patient is able to swallow oral medications\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n* Informed consent must be obtained in writing for all patients prior to performing study\u002Fscreening procedures and prior to registration into the study\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\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* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin =\\\u003C 2.0 times ULN and direct bilirubin within normal limits are permitted\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib\n\nExclusion Criteria:\n\n* Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial\n* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast\n* Treatment with chemotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrollment\n* Any of the following within 6 months prior to trial registration: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism\n* Unstable brain metastases or carcinomatous meningitis\n* Patient of child-bearing potential is evidently pregnant or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months\n* Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner\n* The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, 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* The patient has active 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* The patient has a 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* Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delaviridine)\n* Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial",{"count":378,"type":20},32,[51],"This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4\u002F6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.",[27,54,55,56],"2025-07-25",{"date":384,"type":32},"2025-07-29",{"date":386,"type":32},"2020-10-16",{"date":388,"type":20},"2027-07-01",{"name":199,"class":200},{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":398,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":21,"phases":401,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":419},"100554719","phase-2-first-line-carboplatin-and-paclitaxel-in-combination-with-pembrolizumab-followed-by-maintenance-pembrolizumab-with-or-without-nesuparib-in-patients-with-newly-diagnosed-advanced-or-recurrent-mmr-proficient-pmmr-endometrial-cancer-100554719","NCT06502743","First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer","Phase 2 Study of First-line Carboplatin and Paclitaxel in Combination With Pembrolizumab, Followed by Maintenance Pembrolizumab With or Without Nesuparib, in Patients With Newly Diagnosed Advanced or Recurrent MMR-proficient (pMMR) Endometrial Cancer","PENELOPE","Inclusion Criteria:\n\n1. Patient must be female ≥ 19 years of age\n2. Histologic confirmation of the original primary tumor is required. Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.).\n3. Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.\n4. MMR proficient confirmed by institutional (local) MMR IHC testing.\n5. Patient must provide the institutional (local) P53 IHC result.\n6. Prior Therapy;\n\n   * Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if provided adjuvant chemotherapy was completed ≥ 12 months prior to randomization.\n\n     a. Note : For Part A(Safety lead in phase), patient who used Paclitaxel, Carboplatin and Pembrolizumab for first line systemic therapy can participate if they meet all of the following conditions. Patient must have had 6 cycles of chemotherapy; patient must have physician assessed stable disease (SD), partial response (PR), or complete response (CR) after 6 cycles of therapy and patient must be enrolled within 9 weeks of their last dose of chemotherapy (last dose is the day of the last infusion)\n   * Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara-aortic radiation therapy, and\u002For intravaginal brachytherapy. All radiation therapy must be completed at least 4 weeks prior to randomization.\n   * Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to randomization.\n7. Archival tumor tissue available or a fresh biopsy must be obtained prior to randomization.\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n9. Have adequate organ function. Specimens must be collected within 7days prior to the start of study intervention.\n\n   \\- Hematology Absolute neutrophil count (ANC) ≥1,500\u002FμL without growth factor support within 2 weeks before screening test.\n\n   Platelet ≥100,000\u002FμL without transfusion within 2 weeks prior to screening test.\n\n   Hemoglobin ≥10.0 g\u002FdL without transfusion within 2 weeks prior to screening test.\n   * Kidney function Creatinine or measured or calculated creatinine clearance (GFR may also be used in place of creatinine or CrCl a) ≤1.5 × ULN or ≥30 mL\u002Fmin for subjects with creatinine levels \\>1.5 × institutional ULN.\n   * liver function Total bilirubin ≤1.5×ULN or direct bilirubin ≤ULN for subjects whose total bilirubin exceeds 1.5 times the normal value.\n\n   AST (SGOT) and ALT (SGPT) ≤3 × ULN (≤5 × ULN in subjects with liver metastases)\n   * Coagulation International normalized ratio (INR) or prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5\n   * Thyroid function Thyroid stimulating hormone (TSH) within normal limits (WNL); In euthyroid subjects receiving thyroid replacement therapy, TSH \\\u003C ULN; If an abnormal TSH result is shown, free T4 is normal, and glandular function (euthyroid) is clinically normal, registration is possible.\n10. Patient has voluntarily agreed to participate by giving written informed consent\u002Fassent for the trial.\n11. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal method or abstinence, contraceptive procedure (IUD, Mirena, etc.)) from up to 14 days prior to randomization (for oral contraceptives), during treatment, and for 6 months after the last dose of Paclitaxel + Carboplatin, for 4 months after the last dose of Pembrolizumab, for 3 months after the last dose of Nesuparib, whichever occurs last.\n12. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either:\n\n    * Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR\n    * Have a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to randomization; OR Have a congenital or acquired condition that prevents childbearing.\n\nExclusion Criteria:\n\n1. Patient has undergone prior treatment with a known PARP inhibitor.\n2. Patient has a known hypersensitivity to nesuparib, pembrolizumab or combination cytotoxic chemotherapy components or excipients.\n3. MMR deficiency confirmed by institutional MMR IHC testing.\n4. Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to randomization.\n5. Patient has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with treated brain metastases may be eligible if follow-up brain imaging after CNS directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to randomization and remain clinically stable.\n6. Patient has a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.\n7. Patient has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n8. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization.\n\n   * Patients who have received steroids as CT scan contrast premedication may be enrolled.\n   * The use of inhaled or topical corticosteroids is allowed.\n   * The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.\n   * The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.\n9. Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n10. Patient with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, noninfectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n11. Patient has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies)\n12. History of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]) infection. Note: Testing for Hepatitis B or C is not required unless mandated by local health authority.\n13. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n14. Patient has known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).\n15. Patients with systemic autoimmune disease such as Systemic Lupus Erythematosus.\n16. Has not adequately recovered from major surgery or has ongoing surgical complications.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n19. Is pregnant or breastfeeding or expecting to be pregnant or conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of Paclitaxel + Carboplatin, 4 months after the last dose of Pembrolizumab, 3 months after the last dose of Nesuparib, whichever occurs last.\n20. Has had an allogenic tissue\u002Fsolid organ transplant.","19 Years",{"count":400,"type":20},92,[51],"The goal of this study is listed below.\n\nPart A (Safety Run-in Phase) : To determine feasibility of pembrolizumab and nesuparib combination as maintenance therapy in patients with MMR-proficient advanced and recurrent endometrial cancer. Feasibility is defined as a dose-limiting toxicity (DLT) rate less than or equal to 33%.\n\nPart B (Randomization Phase)\n\n: To evaluate the efficacy of pembrolizumab and nesuparib combination\u002F pembrolizumab monotherapy as maintenance therapy in patients with MMR-proficient advanced stage and recurrent endometrial cancer. Efficacy will be assessed by investigator assessed progression free survival (PFS) as assessed by RECIST 1.1.",[321,27,358,404,405],"Gynecologycal Cancer","Endometrial Neoplasms",[407,408,409],"Nesuparib","pMMR","MMR-proficient","2025-03-30",{"date":412,"type":32},"2025-04-03",{"date":414,"type":32},"2024-09-12",{"date":416,"type":20},"2027-12",{"name":418,"class":200},"Yonsei University",6]