[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-primary-peritoneal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-primary-peritoneal-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,76,85,115,148,176,202,233,262,286,326,353],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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",false,"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","FEMALE","18 Years",{"count":19,"type":20},165,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2023-04-25",{"date":38,"type":20},"2028-10-01",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",296,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"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":52,"type":20},2900,[23],"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.",[56,57,58,59,60,61,62,26,27,63,64,28,29,65,66],"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","2026-07-01",{"date":69,"type":34},"2026-07-02",{"date":71,"type":34},"2023-04-07",{"date":73,"type":20},"2030-07-01",{"name":40,"class":41},481,{"id":77,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":24,"conditions":80,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":84,"locationsCount":42},"100481846",{"count":19,"type":20},[23],[26,27,28,29],{"date":69,"type":34},{"date":36,"type":34},{"date":38,"type":20},{"name":40,"class":41},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100366775","phase-2-onc201-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-resistant-ovarian-cancer-100366775","NCT04055649","ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer","Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients With Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Progressed within 6 months of completing at least 1 cycle of last platinum containing regimen. Patients with refractory disease (progression during platinum-containing therapy) are eligible. This includes both adjuvant therapy and in the recurrent setting.\n* No more than 4 prior treatment regimens defined as investigational, chemotherapy, hormonal, biologic, or targeted therapy in the platinum resistant setting and total of 7 prior regimens in all settings will be allowed. Prior maintenance therapy with biologic or targeted agent does NOT count as a treatment regimen (e.g. Maintenance bevacizumab, Parpi, or immunotherapy).\n* At least one measurable lesion according to RECIST v1.1.\n* For the eight patients enrolled for PK\u002FPD. Availability of tissue from carcinoma. For most patients this will be archival tissue. If there is no archival tissue available, biopsy of lesion MUST be performed prior to initiation of therapy. Lesions must be available for biopsy as well in these patients.\n* Any prior palliative radiation therapy must be completed at least 7 days prior to start of study treatment and patients must have recovered from any acute adverse effects prior to start of study treatment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n* Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 3 days prior to start of study treatment.\n* Patients must have adequate (at baseline):\n\n  1. Bone marrow function: Absolute neutrophil count (ANC) ≥1,500\u002FµL. Platelets\n\n     ≥100,000\u002FµL and hemoglobin \\> 8.0 gm\u002FdL, transfusion allowed up to 1 week prior to maintain Hgb \\>8.\n  2. Renal function: Calculated creatinine clearance (CrCl) ≥35 mL\u002Fmin\u002F1.73 mm2\n  3. Hepatic function: Bilirubin less than or equal to 1.5 x ULN; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 x ULN. AP, AST and ALT less than or equal to 5 x ULN is acceptable if patient has known hepatic metastasis\n\nExclusion Criteria:\n\n* Use of a study drug (approved or investigational drug therapy) ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of current study treatment is required.\n* Major surgical procedures ≤21 days of beginning study treatment, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement, ureteral stent placement, percutaneous nephrostomy tube placement.\n* No other (chemotherapy, immunotherapy, hormonal anti-cancer therapy, radiotherapy \\[except for palliative local radiotherapy\\]), biological therapy or other novel agent is to be permitted while the patient is receiving study medications\n* Grade \\>1 toxicity from prior therapy (except alopecia or anorexia or above hematologic criteria) unless controlled by medications.\n* Inability to swallow oral medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN) on this trial.\n* Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression after treatment for at least 4 weeks (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.\n* Patient has had prescription or non-prescription drugs or other products (i.e. grapefruit juice) known to be moderate to strong inhibitors or inducers of CYP3A4, which cannot be discontinued 1 week prior to Day 1 of dosing and withheld throughout the study until 1 weeks after the last dose of study drug.\n* Any known hypersensitivity or contraindication to the components of study treatment\n* Pregnant or lactating\n* Serious active infection at the time of enrollment, or another serious underlying medical condition at discretion of the enrolling physician that would impair the ability of the patient to receive study treatment. HIV or other immunodeficiency disease that is well controlled and that does not impact baseline lab values (i.e. outside of above noted parameters for inclusion) are NOT considered exclusion criteria.\n* Presence of other active cancers other than ovarian cancer except those that do not require active therapy (i.e. on surveillance) and known non-invasive cancers and in situ cancers (e.g. non-melanoma skin cancers).\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.",{"count":93,"type":20},62,[23],"This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the first in its class of drugs that antagonize some specific cell receptors on cancer cells, leading to their destruction. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ONC201 and paclitaxel may work better in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel alone.",[97,98,99,100,27,28,29,101,102,103],"Malignant Ovarian Epithelial Tumor","Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Ovarian Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Refractory Fallopian Tube Carcinoma","Refractory Ovarian Carcinoma","Refractory Primary Peritoneal Carcinoma","2026-06-15",{"date":106,"type":34},"2026-06-17",{"date":108,"type":34},"2020-01-21",{"date":110,"type":20},"2027-05-28",{"name":112,"class":113},"Ira Winer","OTHER",2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":114},"100457017","phase-2-pembrolizumab-combined-with-bevacizumab-with-or-without-agonist-anti-cd40-cdx-1140-for-the-treatment-of-patients-with-recurrent-ovarian-cancer-100457017","NCT05231122","Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer","Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years of age.\n* Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of treatment, and BRCA status must be known.\n\nNeoadjuvant + adjuvant is considered one line.\n\n* Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance.\n* Participants may have received a prior anti-PD1\u002Fanti-PDL1 therapy or bevacizumab, these will not be considered a separate line of therapy.\n* Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.\n* Hormonal therapy for OC (e.g. Tamoxifen, aromatase inhibitors etc.) will not count as a separate line of prior therapy.\n\n  * Anticipated lifespan greater than 6 months.\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.\n  * All residual toxicity related to prior anti-cancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must be resolved to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n  * Absolute neutrophil count (ANC): \\>= 1,500 \u002FmcL.\n  * Platelets: \\>= 100,000 \u002F mcL.\n  * Hemoglobin: \\>= 8 g\u002FdL or 5.0 mmol\u002FL transfusion allowed with adequate bone marrow function\n  * Creatinine clearance \\>= 50 mL\u002Fmin.\n  * Total bilirubin: =\\\u003C 2 X upper limit of normal (ULN) except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin =\\\u003C 3 mg\u002FdL.\n  * Aspartate aminotransferase (AST) ( serum glutamic-oxaloacetic transaminase \\[SGOT\\] ) and alanine aminotransferase (ALT) ( serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases.\n  * Albumin: \\> 2.5 mg\u002FdL.\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (APTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n  * Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 7 days prior to the first dose of investigational product and after 3 cycles of treatment(prior to cycle 4-day 1: mandatory only if available) and, at the end of treatment (optional). Participants for whom newly obtained samples cannot be provided at baseline (e.g., inaccessible or subject safety concern), may submit an archived specimen, only upon agreement from the Prinicipal Investigator, if available).\n  * A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year). 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  * Participant (or legal representative) must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Primary platinum-refractory patients are excluded\n* Has a nonepithelial cancer (germ cell tumors, sex cord-stromal tumors), borderline tumors, mucinous or seromucinous that is predominately mucinous, malignant Brenner's tumor, carcinosarcoma or undifferentiated carcinoma.\n* Receipt of any antibody targeting T cell checkpoint or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Has received prior systemic anticancer therapy (including investigational agents or maintenance therapy) within 28 days prior to the planned start of study treatment.\n\nHormonal therapy is allowed until the time of randomization\n\n* Progression on prior immune checkpoint blockade therapy.\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks prior to the first dose of study treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Known or prior malignancy requiring active treatment in the past 2 years. Exception: basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases. Patients with brain metastases identified at screening may be rescreened after the lesion(s) have been appropriately treated; patients with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before administration of study drugs, and treated lesions should demonstrate no new growth on the re-screening scan.\n* History of (non-infectious) pneumonitis or has current pneumonitis, including grade 1 (asymptomatic; clinical or diagnostic observations only; intervention not indicated) pneumonitis.\n* History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\n* Prior therapy with any anti-CD40 antibody.\n* Hypersensitivity to bevacizumab, pembrolizumab, or any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months.\n* Has an acute infection requiring systemic therapy\n* Known immunodeficiency or active human immunodeficiency virus (HIV)\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA)and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has an active infection requiring systemic therapy\n* Known immunodeficiency or active HIV\n* Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.\n\nInvestigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n* Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.\n* Subject has a serious, non-healing wound, ulcer, or bone fracture.\n* Subject has a clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension \\\u003C 150\u002F90 mmHg (may be rescreened after adequate control)\n  * Myocardial infarction or unstable angina within 6 months prior to enrollment\n  * New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* New onset on thromboembolic event or hemorrhage within 6 weeks prior to randomization\n* Subject has organ allografts.\n* Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or require parenteral hydration and\u002For nutrition.\n* Pregnant or nursing female participants.\n* Known active alcohol or drug abuse.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.",{"count":123,"type":20},80,[23],"This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolong survival, and improve quality of life in patients with ovarian cancer.",[127,128,129,27,130,131,28,132,133,134,135,29,136,137,138],"Ovarian Clear Cell Adenocarcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Fallopian Tube Endometrioid Adenocarcinoma","Recurrent Fallopian Tube Serous Adenocarcinoma","Recurrent Ovarian Clear Cell Adenocarcinoma","Recurrent Ovarian Endometrioid Adenocarcinoma","Recurrent Ovarian Serous Adenocarcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","Recurrent Primary Peritoneal Clear Cell Adenocarcinoma","Recurrent Primary Peritoneal Endometrioid Adenocarcinoma","Recurrent Primary Peritoneal Serous Adenocarcinoma","2026-05-28",{"date":141,"type":34},"2026-06-01",{"date":143,"type":34},"2024-03-12",{"date":145,"type":20},"2027-03-15",{"name":147,"class":113},"Roswell Park Cancer Institute",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":50,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100538832","clonal-hematopoiesis-and-therapy-emergent-myeloid-neoplasms-in-patients-with-cancers-chances-study-100538832","NCT06295965","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study","Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)","Inclusion Criteria:\n\n* Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:\n\n  * Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy\n\nOR\n\n* Subjects who have or have had a solid tumor diagnosis and any of the following:\n\n  * At least 4 months of exposure to a PARP inhibitor\n  * Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm\n\nExclusion Criteria:\n\n* Individuals with a life expectancy of less than 6 months",{"count":156,"type":20},2000,"OBSERVATIONAL","This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is\u002Fare a genetic\u002Fenvironmental component(s) to developing blood cancer.",[27,28,29,64,160,161,162,163,164,165],"Clonal Cytopenia of Undetermined Significance","Clonal Hematopoiesis","Idiopathic Cytopenia of Undetermined Significance","Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder","Ovarian Carcinoma","Myeloid Neoplasm Post Cytotoxic Therapy","2026-04-14",{"date":168,"type":34},"2026-04-17",{"date":170,"type":34},"2024-01-02",{"date":172,"type":20},"2031-12-31",{"name":174,"class":113},"University of Washington",1,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":175},"100332134","phase-1-serial-imaging-of-the-novel-radiotracer-18f-fluorthanatrace-18f-ftt-by-petctf-100332134","NCT03604315","Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET\u002FCTF","Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET\u002FCT","Inclusion Criteria:\n\n* History of known or suspected solid tumor.\n* At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \\[CT\\], magnetic resonance imaging \\[MRI\\], ultrasound, fludeoxyglucose \\[FDG\\] PET\u002FCT).\n\nExclusion Criteria:\n\n* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential \\\u003C 2 weeks prior to screening as standard of care.\n* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n* Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",{"count":184,"type":20},300,[186],"PHASE1","This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)\u002Fcomputed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET\u002FCT uses a scanner to make detailed, computerized pictures of areas inside the body. PET\u002FCT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.",[189,190,164,191,27,28,29,192],"Breast Carcinoma","Fallopian Tube Carcinoma","Primary Peritoneal Carcinoma","Solid Neoplasm","2026-04-10",{"date":195,"type":34},"2026-04-15",{"date":197,"type":34},"2018-12-18",{"date":199,"type":20},"2027-06-30",{"name":201,"class":113},"M.D. Anderson Cancer Center",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100510004","phase-1-vaccine-therapy-plus-pembrolizumab-in-treating-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cavity-cancer-100510004","NCT05920798","Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer","MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)","FRAPPE","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha. Mixed carcinomas, including carcinosarcomas, with \\>= 50% of the tumor comprised of high grade serous; and\u002For endometrioid; and\u002For clear cell carcinoma are eligible\n* Ovarian cancer (OC) recurrence - Platinum sensitivity\u002Fresistance\n\n  * Platinum-refractory (defined as recurrence or progression of OC =\\\u003C 30 days of the last dose of platinum-based chemotherapy)\n  * Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy)\n  * Platinum-sensitive (defined as recurrence or progression \\>=181 days after the last dose of platinum-based chemotherapy).\n\nNOTE: Any number of prior therapies or maintenance regimens for OC are allowed\n\n* At least one of the following:\n\n  * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND\u002FOR\n  * CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Hemoglobin \\>= 8.5 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Platelet count \\>= 75,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Lymphocytes \\>= 0.3 x 10\\^9\u002FL (obtained =\\\u003C 15 days prior to registration)\n* Monocytes \\>= 0.25 x 10\\^9\u002FL (obtained =\\\u003C 15 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =\\\u003C ULN (obtained =\\\u003C 15 days prior to registration)\n* Aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Creatinine clearance \\>= 30 mL\u002Fmin per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willing to provide mandatory blood and tissue specimens for correlative research\n* Willing to provide archival tissue specimen for correlative research\n* Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)\n* Willing to undergo a tetanus vaccination (if not performed =\\\u003C 365 days prior to registration)\n* Willing to have a temporary central access line placed for apheresis, if needed\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody\n* Treatment with IV anti-cancer therapy =\\\u003C 3 weeks prior to registration or with oral anti-cancer therapy =\\\u003C 1 week prior to registration NOTE: Since treatment will begin no sooner than 4 weeks after registration due to the need for apheresis and manufacturing of the FRαDC product, a \"wash-out\" period prior to registration will cause a gap of at least 5 weeks between the last anti-cancer treatment and initiation of protocol therapy\n* Grade 2 or higher symptoms attributed to OC OR disease measuring \\> 5 cm in long axis (non-nodal lesions), or \\> 5 cm in short axis (nodal lesions) OR disease that, in the judgement of the treating investigator, is likely to become symptomatic in the next 8 weeks (ex. moderate ascites)\n\n  * NOTE: Since patients will not receive therapy for cancer until 3-4 weeks after apheresis--which is potentially 6-8 weeks after registration --patients with symptomatic OC or an elevated tumor burden may experience significant progression prior starting therapy and should not be treated on this protocol).\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 and toxicity of the prescribed regimens\n* Uncontrolled human immunodeficiency virus (HIV) infection and\u002For HIV-infected patients with a history of Kaposi's sarcoma and\u002For multicentric Castleman disease.\n\n  * NOTE: HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:\n\n    * Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 at the time of screening\n    * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the lower limit of quantification derivation technique (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n    * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months\n    * Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study\n  * NOTE: No HIV testing is required unless mandated by local health authority\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active serious infections (e.g., pneumonia, sepsis) requiring systemic therapy\n  * Current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids\n  * Active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) =\\\u003C 2 years prior to registration\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Concurrent active hepatitis B \\[defined as hepatitis B surface antigen (HBsAg) positive and\u002For detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \\] and Hepatitis C virus \\[defined as anti-hepatitis C virus (HCV) antibody (Ab) positive and detectable HCV RNA\\] infection. EXCEPTIONS:\n\n    * For patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive), patients must have completed at least 4 weeks of hepatitis B virus (HBV) antiviral therapy and the HBV viral load must be undetectable at the time of registration\n\n      * NOTE: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention\n    * Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load.\n\n      * NOTE: Patients must have completed curative anti-viral treatment \\>= 4 weeks prior to registration\n  * NOTE: Patients without symptoms or prior history do not require testing prior to registration unless mandated by local health authority\n* Other active malignancy either requiring palliative systemic therapy =\\\u003C 3 years prior to registration, or likely to require treatment in the next 2 years EXCEPTIONS: Patients with non-melanotic skin cancer, papillary thyroid cancer not requiring therapy or carcinoma-in-situ are eligible for this trial. 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* History of myocardial infarction =\\\u003C 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias NOTE: 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* Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone \\>10 mg\u002Fday or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[TNF\\]-alpha agents) =\\\u003C 7 days prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study NOTE: Patients who have received acute, low-dose systemic steroids (=\\\u003C 10 mg\u002Fday oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., =\\\u003C 48 hours of corticosteroids for a contrast allergy) are eligible for the study NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed\n* History of allogeneic stem cell transplant",{"count":211,"type":20},40,[186,23],"This phase I\u002FII trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. While the majority of patients achieve a remission from ovarian cancer with the combination of aggressive cytoreductive surgery and cytotoxic chemotherapy, over 80% of patients develop recurrence within 3 years of completion of treatment. Additional treatments are needed for recurrence, but the standard treatment modalities are non-curative in nature due to the development of drug resistance. As such, there is a great unmet need for treatment strategies that utilize new mechanisms to which drug resistance does not develop. FRalphaDC is a dendritic cell vaccine that is made from the white blood cells collected from a procedure call apheresis. The white blood cells are treated to make dendritic cells, which will then be incubated with peptides, which are pieces of a protein known as \"folate receptor alpha\" (FRalpha), a protein that is found in high levels on ovarian cancer cells. Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the tumor cells by targeting the FRalpha protein. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FRalphaDC vaccine with pembrolizumab may be a safe and effective treatment for recurrent ovarian cancer.",[215,216,27,217,130,218,28,219,132,133,220,29,136,137,221,222],"Fallopian Tube Carcinosarcoma","Primary Peritoneal Carcinosarcoma","Recurrent Fallopian Tube Clear Cell Adenocarcinoma","Recurrent Fallopian Tube High Grade Serous Adenocarcinoma","Recurrent Ovarian Carcinosarcoma","Recurrent Ovarian High Grade Serous Adenocarcinoma","Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma","Recurrent Primary Peritoneal Carcinosarcoma","2026-03-31",{"date":225,"type":34},"2026-04-06",{"date":227,"type":34},"2023-09-28",{"date":229,"type":20},"2028-06-30",{"name":231,"class":113},"Mayo Clinic",3,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":175},"100433092","phase-2-apl-2-and-pembrolizumab-versus-apl-2-pembrolizumab-and-bevacizumab-versus-bevacizumab-alone-for-the-treatment-of-recurrent-ovarian-fallopian-tube-or-primary-peritoneal-cancer-and-malignant-effusion-100433092","NCT04919629","APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion","Randomized Phase 2 Trial of APL-2 With Pembrolizumab vs. APL-2 With Pembrolizumab and Bevacizumab vs. Bevacizumab Alone in Patients With Recurrent Ovarian Cancer and Persistent Malignant Effusion","Inclusion Criteria:\n\n* Age \\>= 18 years of age on day of signing informed consent\n* Recurrent epithelial ovarian\u002Ffallopian tube or primary peritoneal cancer (serous, clear cell, endometrioid, mixed or poorly differentiated or carcinosarcoma) based on imaging or synchronous primary ovarian and uterine cancer patients with any of the histology subtypes mentioned above regardless of platinum sensitivity, prior stage or number of prior treatment lines\n* Symptomatic ascites or pleural effusion or both requiring \\>= 1 drainage within 4-weeks of study entry or has a peritoneal\u002Fpleural drainage catheter in place to control symptoms\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment\n* Life expectancy of \\>= 3 months\n* Absolute neutrophil count (ANC): \\>= 1,500\u002FµL\n* Platelets: \\>= 75,000\u002FµL\n* Hemoglobin: \\>= 9 g\u002FdL or 5.6 mmol\u002FL (within 7 days of assessment)\n* Creatinine: =\\\u003C 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \\>= 60 mL\u002Fmin (Cockcroft-Gault Equation) for participant with creatinine levels \\> 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl)\n* Total bilirubin: =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases\n* Albumin: \\> 2.5 gm\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT): =\\\u003C 1.5 unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants\n* Activated Partial Thromboplastin Time (aPTT): =\\\u003C 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year). 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* Willing and able to self-administer APL-2 (administration by caregiver will be allowed)\n* No known absolute contraindication to bevacizumab and\u002For pembrolizumab treatment per enrolling provider\n* Willing to receive vaccination against Neisseria meningitidis, Streptococcus pneumoniae, and Hemophilus influenzae if randomized into an APL-2 receiving arm, if not already vaccinated\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Is currently receiving any additional cancer therapy or participating or used an investigational drug or device within 3 weeks of the first dose of treatment\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or, is taking any other medication that might affect immune function\n* Has active autoimmune disease that has required systemic treatment in the past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Participant has clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension, defined as systolic \\>150 mmHg or diastolic \\>90 mmHg\n  * Myocardial infarction or unstable angina within 6 months prior to enrollment\n  * New York Heart Association (NYHA) Grade II or greater congestive heart failure\n  * Participant has a Grade II (NYHA) or greater peripheral vascular disease\n  * Participant has a clinically significant peripheral artery disease (e.g. those with claudication), within 6 months prior to study enrollment\n* Pregnancy or lactation\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Concurrent active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and hepatitis C virus (HCV) (defined as anti-HCV Ab positive and detectable HCV ribonucleic acid \\[RNA\\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are modified ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for emergency use) are not allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded",{"count":241,"type":20},60,[23],"This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.",[215,245,246,247,248,127,249,250,216,251,252,253,27,28,29],"Fallopian Tube Clear Cell Adenocarcinoma","Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube Serous Adenocarcinoma","Ovarian Carcinosarcoma","Ovarian Endometrioid Adenocarcinoma","Ovarian Serous Adenocarcinoma","Primary Peritoneal Clear Cell Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal Serous Adenocarcinoma","2026-03-19",{"date":256,"type":34},"2026-03-23",{"date":258,"type":34},"2023-04-27",{"date":260,"type":20},"2028-04-30",{"name":147,"class":113},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":175},"100553204","phase-1-muc1-activated-t-cells-for-the-treatment-of-relapsed-and-resistant-ovarian-cancer-100553204","NCT06483048","MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer","Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET\u002FCT\n\n  * Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler\n* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1\u002F2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \\\u003C 183 days after the last dose of platinum-based chemotherapy:\n\n  * Development of measurable disease (per RECIST 1.1)\n  * Progression of radiographic disease (per RECIST 1.1)\n  * Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \\[WNL\\] at the completion of platinum-based chemotherapy)\n  * Increase in CA-125 level to ≥ 2 x nadir (if nadir \\> ULN)\n  * If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma\n* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study\n* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months\n* REGISTRATION: Willingness and ability to provide written informed consent\n* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study\n* REGISTRATION: Willing to undergo leukapheresis for blood component collection\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Lymphocyte count ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (performed ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 30,000\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 2.0 mg\u002FdL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \\[DVT\\]\u002Fpulmonary embolism \\[PE\\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)\n* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air\n* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration\n\nExclusion Criteria:\n\n* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \\> 30 days, and not requiring steroid therapy for \\> 14 days\n* Prior treatment targeting MUC1\n* Subjects with known plasma cell leukemia (PCL)\n* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and\u002For teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate birth control measures\n* History of myocardial infarction ≤ 6 months prior to registration, and\u002For congestive heart failure requiring ongoing treatment such as medications and\u002For an implanted defibrillator to control life-threatening arrhythmias\n* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Inability to clear an ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled psychiatric problems\n  * Inability to have a caregiver for active oversight during treatment period\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements\n* Evidence of clinical immunocompromise and\u002For HIV positivity and currently receiving antiretroviral therapy\n* Patients requiring chronic supraphysiologic daily doses of steroids (\\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)\n* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm\n* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence\n* Diagnosis of autoimmune disease\n\n  * Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",{"count":270,"type":20},12,[186],"This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.",[98,99,100,27,274,275,28,219,276,135,29,222,101,277,102,103],"Recurrent Fallopian Tube Carcinosarcoma","Recurrent Female Reproductive System Carcinoma","Recurrent Platinum-Resistant Fallopian Tube Carcinoma","Refractory Female Reproductive System Carcinoma","2026-03-13",{"date":280,"type":34},"2026-03-16",{"date":282,"type":34},"2024-09-20",{"date":284,"type":20},"2028-09-30",{"name":231,"class":113},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":114},"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":294,"type":20},24,[186],"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.",[60,298,26,27,28,29,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317],"Recurrent Cervical Carcinoma","Recurrent Vaginal Carcinoma","Stage IV Cervical Cancer AJCC v8","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":320,"type":34},"2026-03-11",{"date":322,"type":34},"2019-09-26",{"date":324,"type":20},"2027-10-01",{"name":201,"class":113},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":352,"locationsCount":175},"100581853","an-automated-personalized-physical-activity-intervention-to-improve-immune-function-and-clinical-outcomes-in-stage-ii-iv-ovarian-primary-peritoneal-or-fallopian-tube-cancer-and-newly-diagnosed-endometrial-cancer-life-on-the-go-3-study-100581853","NCT06855706","An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study","Life on the Go 3: A Randomized Controlled Trial of Automated, Personalized Physical Activity Intervention Using Wearable Devices to Improve Immune Function and Clinical Outcomes in Ovarian and Endometrial Cancer Patients","Inclusion Criteria:\n\n* Age ≥ 18 years old on day of signing informed consent\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participant must satisfy one of the following conditions:\n\n  * Have a clinically suspected or confirmed diagnosis of stage II-IV ovarian, primary peritoneal, or fallopian tube cancer by clinical presentation and elevated CA-125 and may be awaiting staging surgery or tumor tissue biopsy followed by neoadjuvant chemotherapy. Inclusion of clinically suspected ovarian cancer cases is because we want to capture data starting from the earliest point of the diagnostic pathway and before definitive staging surgery. This allows us to assess the impact of physical activity and the feasibility of wearable device monitoring as patients transition into neoadjuvant chemotherapy and potential surgery\n  * Have recurrent ovarian, primary peritoneal, or fallopian tube cancer at any time point of their recurrence, if they meet eligibility criteria (any histology accepted). Inclusion of recurrent ovarian cancer cases is because ovarian cancer often recurs, and understanding physical activity patterns and interventions in patients experiencing recurrence is critical for comprehensive insights. This ensures the study includes the continuum of disease management beyond initial diagnosis\n  * Have pre-operative biopsy-proven endometrial cancer (endometrioid, serous, mucinous, or clear cell, poorly differentiated) with plans for surgical resection using a minimally invasive approach or medical management with chemotherapy combination, hormonal treatment or radiation. Inclusion of biopsy-proven endometrial cancer cases but not clinically suspected or recurrent cases is because we are focusing on confirmed, newly diagnosed patients who will undergo surgical resection or medical management\n* willing to wear the activity tracking device for at least 70% of their waking hours each day (11 hours\u002Fday) throughout the 6-month study period\n* under the care of Roswell Park Comprehensive Cancer Center during the study period, which includes one or more of the following:\n\n  * Receiving cancer treatment at Roswell Park Comprehensive Cancer Center\n  * Undergoing surgery at Roswell Park Comprehensive Cancer Center\n  * Participating in surveillance visits at Roswell Park Comprehensive Cancer Center\n  * Receiving adjuvant treatment at an outside facility but returning to Roswell Park Comprehensive Cancer Center for periodic consultation visits and agreeing to comply with all study procedures, including data sharing from external providers\n* willing to participate in questionnaires and blood and stool collection throughout the study for translational research purposes\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n* Have a smartphone with daily internet access that is compatible with the wearable devices and applications used in the study (e.g., Fitbit Sense 2 and CGM applications)\n\n  * NOTE: Patients who are already achieving or exceeding the goal of 150 minutes of physical activity per week are eligible for this study. This inclusion is intentional, as the study aims to evaluate the full spectrum of physical activity levels-both baseline activity and changes over time-and their relationship with clinical outcomes, metabolic measures (e.g., glucose levels), inflammation, and physical function\n\nExclusion Criteria:\n\n* serious psychiatric illness that is not currently stabilized, including but not limited to:\n\n  * Schizophrenia or other psychotic disorders\n  * Bipolar disorder\n  * Sever major depressive disorder\n  * Severe personality disorders diagnosed by a qualified mental health professional\n  * Recent suicide attempt or psychiatric hospitalization within the previous 12 months\n* Life expectancy of less than 12 months, as determined by the Investigator based on clinical judgment and available prognostic tools\n* history of other invasive malignancies within the last two years, except for:\n\n  * Non-melanoma skin cancer\n  * In situ cervical cancer\n* resting heart rate greater than 120 beats per minute after 10 minutes of seated rest, confirmed on two separate measurements\n* systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 100 mmHg, measured after 10 minutes of seated rest, confirmed on two separate measurements\n* Unstable angina or myocardial infarction within the past 3 months.\n\n  * Unstable Angina: Chest pain at rest or chest pain of increasing frequency, severity, or duration that requires medical attention\n  * Myocardial Infarction: Heart attack diagnosed by a medical professional\n* Pregnant or nursing participants will be excluded, as confirmed via urine test during screening procedures.\n* unwilling or unable to follow the protocol requirements, including but not limited to:\n\n  * Cognitive impairment that affects the ability to provide informed consent or comply with study procedures\n  * Language barriers without access to adequate translation services\n  * Lack of access to necessary technology (e.g., smartphones compatible with study devices)\n  * Other factors that would prevent adherence to study protocols\n* Any condition which, in the Investigator's opinion, makes the patient unsuitable for participation in the study or may interfere with the patient's ability to comply with the study requirements or the safety of the patient. Conditions may include, but are not limited to:\n\n  * Severe pulmonary disease\n  * Uncontrolled metabolic disorders\n  * Other significant medical conditions that pose a risk during increased physical activity\n* Participants who do not provide a valid cell phone number or do not consent to receive SMS messages from Fitabase for motivational and compliance monitoring purposes will be excluded from the study.",{"count":334,"type":20},120,[336],"NA","This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.",[339,27,28,29,340,341,342,343,344,345,301,302,303],"Endometrial Carcinoma","Stage II Fallopian Tube Cancer AJCC v8","Stage II Ovarian Cancer AJCC v8","Stage II Primary Peritoneal Cancer AJCC v8","Stage III Fallopian Tube Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","2026-01-02",{"date":348,"type":34},"2026-01-06",{"date":350,"type":34},"2025-06-04",{"date":260,"type":20},{"name":147,"class":113},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":175},"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":361,"type":20},32,[23],"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.",[26,27,28,29],"2025-07-25",{"date":367,"type":34},"2025-07-29",{"date":369,"type":34},"2020-10-16",{"date":371,"type":20},"2027-07-01",{"name":373,"class":113},"Jonsson Comprehensive Cancer Center"]