[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-cervical-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-cervical-carcinoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,98],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100528160","phase-2-prgn-2009-in-combination-with-pembrolizumab-in-patients-with-recurrent-or-metastatic-cervical-cancer-100528160",false,"NCT06157151","PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer","A Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab in Patients With Recurrent or Metastatic Cervical Cancer.","Inclusion Criteria:\n\n* Age 18 years and older.\n* Recurrent or metastatic cervical cancer (histologically or cytologically confirmed)\n* Must have been treated with pembrolizumab, either as monotherapy or in combination, for atleast 6 weeks.\n* Subjects must have histologically or cytologically confirmed HPV positive disease\n* Measurable disease that can be accurately measured by RECIST v1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks from the time of enrollment.\n* Must have adequate organ function\n* Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.\n* All patients must have the ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Prior chemotherapy, targeted therapy within 14 days; monoclonal antibody within 4 weeks; unresolved AEs.\n* Immunodeficiency, active autoimmune disease on immunosuppression, or immunosuppressive therapy within 7 days. HIV eligible with disease control.\n* Active hepatitis B (HBsAg+) or hepatitis C (HCV RT-PCR+) within 30 days of enrollment.\n* History of non-infectious pneumonitis or interstitial lung disease.\n* History of endocrine autoimmune disease (exceptions: treated Graves' disease; hypothyroidism on replacement).\n* Live vaccine within 30 days prior to first dose.\n* Patients with presence of other active malignancy within 1 year prior to study entry\n* Known Central Nervous System (CNS) disease\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Known history of active tuberculosis (TB, Bacillus tuberculosis).\n* Pregnant and lactating women are excluded from this study.\n* Patients with a history of solid organ transplant.\n* Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.\n* Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This Phase 2 study will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.",[26,27,28,29,30],"Cervical Cancer","HPV-Related Carcinoma","HPV-Related Malignancy","Recurrent Cervical Carcinoma","Metastatic Cervical Cancer",[32,26,33,34,35,36],"Human Papilloma Virus","Pembrolizumab","Therapeutic Vaccine","Cervix Cancer","Resistance to Checkpoint Inhibitors","RECRUITING","2026-04-20",{"date":40,"type":41},"2026-04-23","ACTUAL",{"date":43,"type":41},"2025-11-11",{"date":45,"type":20},"2030-11-30",{"name":47,"class":48},"Precigen, Inc","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"100542959","immune-checkpoint-inhibitor-response-in-solid-tumors-using-a-live-tumor-diagnostic-platform-100542959","NCT06349642","Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform","Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform","ELEPHAS-04","Inclusion Criteria:\n\nSubjects must meet one of the following criteria:\n\n* Subjects suspected of or diagnosed with the following Stage IV\u002Fmetastatic or recurrent malignancies:\n\n  * Lung: Non-small Cell Lung Cancer (NSCLC)\n  * Skin: Cutaneous Malignancy, excluding Uveal Melanoma\n  * Esophageal Cancer\n  * Cervical Cancer\n  * Endometrial Cancer\n  * Colon Cancer: Mismatch repair deficient (dMMR) CRC only\n  * All solid tumors with high tumor mutation burden (TMB)\n  * All solid tumors that are microsatellite instability high (MSI-H)\n  * All mismatch repair deficient (dMMR) solid tumors\n  * Liver Cancer\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.\n\nOR\n\n* Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV\u002Fmetastatic malignancies:\n\n  * Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)\n  * Bladder: Urothelial Carcinoma (UC)\n  * Any solid tumor with measurable disease that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n\nOR\n\n* Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:\n\n  * Breast Cancer: Triple negative breast cancer (TNBC)\n  * Lung: Non-small cell lung cancer (NSCLC)\n\n    * NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion\n  * Any solid tumor that is eligible for pure ICI therapy or that the clinician plans to treat with ICI therapy. NOTE: This can be in the setting of a trial, compassionate use, or the use of appropriate LDT tests that per clinician, render the patient eligible for ICI therapy, either frontline or a later line\n* LOCALLY ADVANCED\u002FMETASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.\n* NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.\n* Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.\n* Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.\n* ECOG Performance Status (PS) 0, 1 or 2.\n* Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only\n* Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.\n* Subjects must be clinically able, at investigator discretion, and willing to undergo either:\n\n  * additional biopsy passes during their standard of care biopsy, OR\n  * a biopsy for research only, if applicable.\n  * NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.\n* Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant women because this study involves a greater than minimal risk procedure (biopsy)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety for the biopsy\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * ongoing or active infection\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Subjects who are enrolled or plan to be enrolled in a blinded cancer therapeutic treatment trial",{"count":58,"type":20},324,"OBSERVATIONAL","This study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,29,81,82,83,84,85,86,87],"Early Stage Triple-Negative Breast Carcinoma","Metastatic Bladder Urothelial Carcinoma","Metastatic Cervical Carcinoma","Metastatic Clear Cell Renal Cell Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Endometrial Carcinoma","Metastatic Esophageal Carcinoma","Metastatic Liver Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Metastatic Malignant Skin Neoplasm","Metastatic Malignant Solid Neoplasm","Resectable Lung Non-Small Cell Carcinoma","Early Stage Lung Non-Small Cell Carcinoma","Resectable Malignant Solid Neoplasm","Resectable Triple-Negative Breast Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Cervical Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Recurrent Colorectal Carcinoma","Recurrent Endometrial Carcinoma","Recurrent Esophageal Carcinoma","Recurrent Liver Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Recurrent Malignant Skin Neoplasm","Recurrent Malignant Solid Neoplasm","2026-03-11",{"date":90,"type":41},"2026-03-12",{"date":92,"type":41},"2024-04-24",{"date":94,"type":20},"2027-05",{"name":96,"class":97},"Mayo Clinic","OTHER",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"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":19,"type":20},[107],"PHASE1","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.",[110,29,82,111,112,113,114,78,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Malignant Female Reproductive System Neoplasm","Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Vaginal Carcinoma","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IV Vaginal Cancer AJCC v8","Stage IVA Cervical Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVA Vaginal Cancer AJCC v8","Stage IVB Cervical Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","Stage IVB Vaginal Cancer AJCC v8","2026-03-10",{"date":88,"type":41},{"date":135,"type":41},"2019-09-26",{"date":137,"type":20},"2027-10-01",{"name":139,"class":97},"M.D. Anderson Cancer Center",2]