[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,299,0,25,[9,59,87,114,134,163,206,244,264,296,317,341,369,397,415,437,463,491,511,553,575,604,625,684,716],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545",false,"NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","RECRUITING","2026-07-01",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2026-02-11",{"date":54,"type":21},"2027-08-31",{"name":56,"class":57},"Alliance for Clinical Trials in Oncology","OTHER",18,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256","NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).",{"count":67,"type":21},63,[69],"PHASE1","This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[30,41,33,72,73,74,75,76,31],"PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","2026-06-30",{"date":49,"type":50},{"date":80,"type":21},"2026-06",{"date":82,"type":21},"2028-10",{"name":84,"class":85},"Regor Pharmaceuticals Inc.","INDUSTRY",5,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100609601","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-combination-with-pembrolizumab-mk-3475-as-first-line-maintenance-treatment-of-cervical-cancer-mk-2870-036trofuse-036gog-3123engot-cx22-100609601","NCT07216703","A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036\u002FTroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix\n* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \\[FIGO\\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and\u002For radiation)\n* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy\n* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has HIV infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has received prior systemic anticancer therapy other than what is specified in this protocol\n* Is currently receiving a strong inducer\u002Finhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT\n* Has a diagnosis of immunodeficiency\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","FEMALE",{"count":96,"type":21},1023,[98],"PHASE3","Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.\n\nResearchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and\n* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment",[31],[102,103,104,105],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Trophoblast Cell Surface Antigen 2 (TROP2)",{"date":49,"type":50},{"date":108,"type":50},"2026-01-19",{"date":110,"type":21},"2031-10-29",{"name":112,"class":85},"Merck Sharp & Dohme LLC",138,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100540316","phase-1-a-clinical-trial-to-assess-pvx7-immunotherapy-regimens-in-advanced-cervical-cancer-patients-100540316","NCT06315257","A Clinical Trial to Assess PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients","A Randomized, Open-label Clinical Trial to Assess the Safety, Feasibility and Immunogenicity of Adjuvant PVX7 Immunotherapy Regimens in Advanced Cervical Cancer Patients","Inclusion Criteria:\n\n* Female subjects age 18 years or older with diagnosis of advanced (stage IB1-IVA) HPV+ cervical cancer and have completed primary treatment (consisting of any of the following as per NCCN guideline standard of care: surgical resection, radiation, and\u002For platinum-based chemotherapy) within the past 12 months.\n\nPatients who are recommended to receive anto-PD-1 or anti-PD-L1 therapy after chemoradiation are eligible to enroll and can continue to receive such therapy while receiving study drug.\n\n* No history of or current evidence of residual disease or disease recurrence based on imaging and clinical assessments within 8 weeks of enrollment\n* HIV uninfected\n* Hepatitis B surface antigen negative\n* Anti-hepatitis C (HCV) antibody negative or negative HCV polymerase chain reaction (PCR)\n* Patients who are able and willing to comply with all study procedures and voluntarily sign an informed consent form\n* Adequate organ function as defined by the following parameters:\n* white blood cell count ≥ 3,000 cells\u002Fcu mm\n* lymphocyte number ≥ 500 cells\u002Fcu mm\n* absolute neutrophil count ≥ 1,000 cells\u002Fcu mm\n* platelets ≥ 90,000\u002Fcu mm\n* hemoglobin ≥ 9 g\u002FdL\n* total bilirubin \\\u003C1.5 X upper limit of normal (ULN), \\\u003C3 x ULN if Gilbert's disease\n* Aspartate Transferase(AST) and Alanine Transaminase (ALT) \\\u003C3 X ULN\n* creatinine \\\u003C 1.5 X ULN or estimated creatinine clearance ≥ 60 ml\u002Fmin per Modified Cockcroft-Gault Formula\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* All clinically significant toxicities related to prior therapy should be less than or equal to Grade 1 at time of enrollment\n* Ability and willingness for one month post vaccination to follow vaccine inoculation site care and avoid close social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection\n\nExclusion Criteria:\n\n* Women of child-bearing potential (i.e., those who have had fertility-sparing procedures for the management of cervical cancer) will be excluded unless agreed to remain sexually abstinent or have a partner who is sterile (i.e. vasectomy), or use methods of contraception (e.g., oral contraception, barrier methods, spermicide, intrauterine device (IUD)), throughout the first 6 months of the study.\n* Because there is a risk for adverse events in nursing infants, breastfeeding must be discontinued if the mother is treated on study.\n* Diagnosed with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients diagnosed with acquired, hereditary, or congenital immunodeficiencies\n* Diagnosis with a medical condition that requires systemic treatment with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), alkylating agents, antimetabolites, radiation, Tumor Necrosis Factor (TNF) inhibitors, or systemic corticosteroids, either chronically or within 30 days of first PVX7 vaccination.\n* Administration of any blood product within 30 days of signing informed consent.\n* Need for ongoing therapeutic anticoagulation during the study period due to concern for increased risk of bleeding.\n* Previous severe allergic reaction or hypersensitivity to a vaccine or any of its components\n* Participation in a study with an investigational compound or device within 30 days of signing informed consent\n* Known active central nervous system disease\n* Surgery within 30 days of first PVX7 vaccination, excluding minor procedures\n* Diagnosis with an uncontrolled intercurrent illness including, but not limited to, ongoing, or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Diagnosis with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)\n* History of myocarditis or pericarditis.\n* Known underlying heart disease (e.g., cardiomyopathy, congestive heart failure, symptomatic arrhythmia not controlled by medication, unstable angina, history of acute myocardial infarction or cerebrovascular accident within the past 6 months).\n* Patients and the patients close social, sexual, or domestic contacts may not have non-healed wounds or active exfoliative skin conditions such as: Eczema, Burns, Impetigo, Varicella-zoster virus infection, Herpes simplex virus infection, Severe acne, Severe diaper dermatitis with extensive areas of denuded skin, Psoriasis, Lichen planus, Darier disease (keratosis follicularis).\n* History or presence of atopic dermatitis\n* Inability or unwillingness to for one month post vaccination follow vaccine inoculation site care and avoid social contact with children under 1 year old or close social or domestic contact with a pregnant woman or individuals at high risk of serious adverse effects of vaccinia virus, for instance, those with past or present eczema, or immunodeficiency states including HIV infection",{"count":122,"type":21},32,[69],"A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.",[31],{"date":47,"type":50},{"date":128,"type":50},"2025-07-23",{"date":130,"type":21},"2030-06",{"name":132,"class":57},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",2,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":94,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100471048","urine-hpv-testing-for-cervical-cancer-screening-among-women-living-with-hiv-in-south-africa-100471048","NCT05413798","Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa","Clinical Performance Validation of Urine HPV Testing for Cervical Cancer Screening Among Women Living With HIV in South Africa","Inclusion Criteria:\n\nIn order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n1. Confirmed HIV-1 infection\n2. Age 25 years and older.\n3. Be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or intend to become pregnant within 90 days of enrollment\n2. Have been screened for cervical cancer within the preceding year (365 days)\n3. Have an active sexually transmitted infection (STI; women may participate once treated)\n4. Have a surgically absent cervix\n5. Have a history of cervical cancer\n6. have been vaccinated against HPV.","25 Years",{"count":143,"type":21},300,[24],"The purpose of this study explores the usefulness of urine samples for cervical cancer screening in human immunodeficiency virus (HIV)-infected women.\n\nCervical cancer occurs when women are infected with the human papillomavirus (HPV), which can cause changes in the cells that lead to cervical precancer and, eventually, cervical cancer if untreated. However, urine HPV testing has not been well validated low- and middle-income country settings, with no data available to guide its use in HIV-infected women.",[31,147,148],"CIN2","CIN3",[150,151,152,153],"cervical cancer","HPV","urine test","HIV","2026-06-29",{"date":47,"type":50},{"date":157,"type":50},"2023-05-11",{"date":159,"type":21},"2026-08",{"name":161,"class":57},"UNC Lineberger Comprehensive Cancer Center",1,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":186,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":171,"type":21},1109,[69,173],"PHASE2","The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[31,176,177,178,179,180,181,182,183,184,185],"Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[187,31,188,189,190,176,191,177,192,193,178,194,195,179,180,181,182,183,184,185,196,197],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig",{"date":77,"type":50},{"date":200,"type":50},"2021-05-27",{"date":202,"type":21},"2031-08-31",{"name":204,"class":85},"Bristol-Myers Squibb",47,{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":216,"type":21},100,"OBSERVATIONAL","This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[220,28,221,31,33,34,35,222,40,38,183,223,224,225,41,42,43,226,227,45,228,229,230,231,232,233,234],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-06-26",{"date":154,"type":50},{"date":238,"type":50},"2025-09-18",{"date":240,"type":21},"2028-03-30",{"name":242,"class":85},"AstraZeneca",17,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":162},"100538474","non-invasive-plasma-treatment-for-cervical-infections-targeting-high--and-low-risk-hpv-variants-100538474","NCT06291311","Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants","Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma","Inclusion Criteria:\n\n* Inclusion criteria for NIPP treatment\n\n  * Age ≥ 18 years\n  * mRNA or DNA-based virus detection by smear (also external findings)\n  * Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1\u002FT2\n  * Written informed consent to participate in the study\n* Inclusion criteria for control group\n\n  * Age ≥ 18 years\n  * Swab-based mRNA or DNA-based virus detection (also external findings)\n  * Clearly visible transformation zone of the cervix corresponding to T1\u002FT2\n  * Written informed consent to participate in the study\n\nExclusion criteria:\n\nThe following exclusion criteria apply to both groups of patients (NIPP treatment and control group).\n\n* Transformation zone not fully visible\n* Evidence of invasive disease\n* Serious cardiovascular diseases",{"count":252,"type":21},50,"This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.",[255,31],"HPV Infection","2026-06-25",{"date":77,"type":50},{"date":259,"type":50},"2023-12-27",{"date":261,"type":21},"2026-12",{"name":263,"class":57},"University Hospital Tuebingen",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":272,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":275,"conditions":276,"keywords":279,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":162},"100644983","oral-fecal-and-intratumoral-microbiome-atlas-in-colombian-patients-with-advanced-solid-tumors-receiving-first-line-immunotherapy-100644983","NCT07676461","Oral, Fecal and Intratumoral Microbiome Atlas in Colombian Patients With Advanced Solid Tumors Receiving First-Line Immunotherapy","Atlas of the Oral, Fecal and Intratumoral Microbiome of Colombian Patients With Advanced Solid Tumors Candidates for First-Line Immunotherapy - Initial Phase of a Project With Latin American Projection","ATLAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Histologically confirmed advanced (stage III unresectable or IV) gastric, colorectal, breast, cervical or head-and-neck cancer.\n* Candidate for first-line immunotherapy per current clinical guidelines.\n* Available FFPE tumor block in institutional or reference pathology archive.\n* Able to provide saliva and stool samples at V0 and follow-up.\n* ECOG performance status within protocol limits; life expectancy over 3 months.\n* Cognitive capacity to give informed consent; signed EVA-BIOBANCO and Atlas consents.\n\nInclusion Criteria (healthy controls)\n\n* No prior cancer diagnosis.\n* No active autoimmune disease; no inflammatory bowel disease.\n* No antibiotics, invasive dental treatment, immunosuppressants or corticosteroids in the prior 3 months; no severe active periodontal disease.\n\nExclusion Criteria:\n\n* Systemic antibiotics within 3 months (except short course under 5 days for uncomplicated infection).\n* Probiotics or prebiotics within 30 days.\n* Chronic proton-pump inhibitors for more than 3 continuous months.\n* Inflammatory bowel disease (Crohn, ulcerative colitis) or extensive bowel resection.\n* Pregnancy or lactation.\n* BMI under 18.5 or over 40 kg\u002Fm².\n* Uncontrolled diabetes (HbA1c at or above 9% in prior 3 months).\n* Invasive dental treatment within 3 months.\n* Patients: simultaneous randomized trial of a non-INVIMA-approved experimental immunotherapy; or no evaluable FFPE block meeting quality thresholds.\n* Inability to ensure 12-month clinical follow-up.",true,{"count":274,"type":21},150,"This is a prospective observational cohort study conducted at Fundación CTIC in Bogotá, Colombia. It characterizes the oral, fecal and intratumoral microbiome of Colombian adults with advanced solid tumors (gastric, colorectal, breast, cervical and head-and-neck cancer) who receive first-line immunotherapy as standard of care, and compares them with healthy volunteers. Using multi-omics (HiFi metagenomics, 16S, tumor RNA-Seq and untargeted metabolomics), the study aims to identify microbial signatures associated with treatment response and survival, building the initial Colombian cohort of a Cancer Microbiome Atlas with Latin American projection.",[36,277,30,31,278],"Colorectal Cancer","Head and Neck Cancer (H&N)",[280,281,282,283,284,285,286,287],"Microbiome","Cancer","Immunotherapy","Tumor microenvironment","Biomarkers","Metagenomics","Transcriptomics","Metabolomics","2026-06-24",{"date":77,"type":50},{"date":291,"type":50},"2026-06-11",{"date":293,"type":21},"2029-08-30",{"name":295,"class":57},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":316},"100643318","phase-4-pembrolizumab-registry-for-outcomes-and-treatment-evaluation-in-cervical-cancer-100643318","NCT07645625","Pembrolizumab Registry for Outcomes and Treatment Evaluation in Cervical Cancer","PROTECx","Inclusion criteria for the observation cohort:\n\n\\- Persistent, recurrent, or metastatic cervical cancer commencing treatment or currently treated with a pembrolizumab containing regimen.\n\nInclusion criteria for the early discontinuation cohort:\n\n* Previous inclusion in the observation cohort\n* Choice made to stop pembrolizumab for one of the following reasons:\n\n  1. Confirmed complete response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a CR (consistent with KEYNOTE-826 criteria) OR\n  2. Immune-related toxicity grade ≥ 3 OR\n  3. Patient's preference (e.g. chronic or invalidating grade 1-2 immune-related toxicity) OR\n  4. Confirmed partial response if they had received at least 8 cycles of 3- weekly pembrolizumab, including at least 9 weeks beyond a PR (timing consistent with KEYNOTE-826 criteria)\n* Eligible and willing to discontinue pembrolizumab (with or without discontinuing bevacizumab)\n\nExclusion criteria for all cohorts are:\n\n* Malignant other disease other than cervical carcinoma that required active treatment in the past 2 years: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or any carcinoma in situ that have undergone potentially curative therapy are not excluded\n* Any psychological, familial, sociological or geographical condition or a known psychiatric or substance abuse disorder potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. This comprises each and every condition or circumstance preventing the patient from showing up to the outpatient controls and\u002For undergoing the CT-scans, or preventing the patient from (adequately) filling out the questionnaires.",{"count":304,"type":21},261,[306],"PHASE4","This is a nationwide, multicenter, registry-based prospective cohort study to assess real-world effectiveness of treatment with a pembrolizumab containing regimen in persistent, recurrent, or metastatic cervical cancer. Patients in the observation cohort continue treatment according to standard of care. In the discontinuation cohort, patients discontinue their maintenance treatment with pembrolizumab (with or without discontinuation of bevacizumab). Patients may choose to discontinue pembrolizumab prematurely (with or without discontinuation of bevacizumab) if they achieve a confirmed CR or a confirmed PR to treatment, or on patient's request or due to toxicity. If an eligible patient chooses not to discontinue treatment early they will remain in the observation cohort. The duration of the trial for the individual patient will be until two years from the start of treatment. Survival follow-up will continue for a maximum of 10 years",[31],{"date":154,"type":50},{"date":311,"type":50},"2026-05-11",{"date":313,"type":21},"2039-02",{"name":315,"class":57},"University Medical Center Groningen",11,{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":162},"100470080","hematopoietic-stem-cell-containing-autologous-blood-reinfusion-for-bone-marrow-protection-in-cervical-cancer-patients-100470080","NCT05401175","Hematopoietic Stem Cell-containing Autologous Blood Reinfusion for Bone Marrow Protection in Cervical Cancer Patients","Stored Hematopoietic Stem Cell-containing Autologous Blood Transfusion Therapy for Bone Marrow Protection in Patients With Cervical Cancer Treated With Concurrent Chemoradiotherapy","Inclusion Criteria:\n\n1）18-60 years old; 2)there are radiotherapy and chemotherapy indicators for cervical cancer;3)pathological diagnosis of squamous, adenocarcinoma or adenosquamous carcinoma;4)the Eastern Cooperative Oncology Group (ECOG) performance status score≤1; 5)the expected survival time was more than 3 months; 6)pre-menopausal women (post-menopausal women must have been postmenopausal for at least 12 months to be considered infertile), and the serum pregnancy test results are negative;7)all patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment;8)the subjects voluntarily participate in this clinical trial sign an informed consent form and are able to complete the study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1\\) clinical diagnosis of bone marrow disease;2) imaging or pathological diagnosis of central nervous system or soft meningeal or bone or bone marrow metastases;3)patient has severe cardiac insufficiency;4)previous history of allogeneic stem cell transplantation or organ transplantation;5)patients with active bleeding and autoimmune thrombocytopenic purpura;6)patients with radiochemotherapy contraindications;7)positive for human immunodeficiency virus (HIV);8)acute or chronic active hepatitis B or hepatitis C infection;9)History of gastrointestinal perforation and\u002For fistula, clinical signs or symptoms of intestinal obstruction and\u002For gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhoea), Crohn's disease, ulcerative colitis or chronic diarrhoea within the previous 6 months;10)evidence of an intra-abdominal pneumoperitoneum that cannot be explained by puncture or recent surgical intervention.","60 Years",{"count":326,"type":21},40,[24],"The aim of this project is to promote the reconstruction of haematopoietic function after chemoradiotherapy for cervical cancer with the innovative use of autologous haematopoietic containing stem cell blood transfusion support.To explore the effect of stored hemopoietic stem cell support therapy on bone marrow protection after concurrent chemoradiotherapy, in order to promote its clinical application.",[31],[31,331,332,333],"concurrent chemoradiotherapy","blood stem cells","autologous blood transfusion",{"date":154,"type":50},{"date":336,"type":50},"2022-04-13",{"date":338,"type":21},"2029-04",{"name":340,"class":57},"Chongqing University Cancer Hospital",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":350,"studyType":217,"phases":4,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":365,"leadSponsor":367,"locationsCount":4},"100644680","circulating-cfdna-and-hpv-as-prognostic-biomarkers-for-first-line-recurrent-metastatic-cervical-cancer-100644680","NCT07673211","Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer","A Prognostic Research on First-Line Recurrent and Metastatic Cervical Cancer Using Circulating Cell-Free DNA and Human Papillomavirus Detection","Inclusion Criteria:\n\n1. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n2. Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease);\n3. Received standard first-line therapy (TP\u002FTC regimen plus immunotherapy ± bevacizumab);\n4. Achieved complete response (CR) following standard first-line treatment;\n5. Archived pathological biopsy specimens of recurrent\u002Fmetastatic lesions prior to treatment available in our hospital;\n6. Participated in clinical trials of pharmaceutical therapy for first-line recurrent\u002Fmetastatic cervical cancer conducted at our institution;\n7. Voluntarily participates in this study and provides written informed consent;\n8. Agrees to serial peripheral blood collection at scheduled time points;\n9. Willing to complete scheduled follow-up visits;\n10. Aged ≥ 18 years old.\n\nExclusion Criteria:\n\n1. History of other malignant tumors within the past 2 years;\n2. Pregnant or breastfeeding women;\n3. Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.);\n4. Refusal to sign informed consent;\n5. Refusal to undergo serial blood collection.",{"count":349,"type":21},60,"3 Years","Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.",[31,353,354],"Recurrent Cervical Cancer","Metastatic Cervical Cancer",[356,357,358,359,360],"Cervical cancer","ctDNA","HPV cfDNA","Complete response","Prognosis","NOT_YET_RECRUITING","2026-06-23",{"date":154,"type":50},{"date":80,"type":21},{"date":366,"type":21},"2029-12",{"name":368,"class":57},"Zhejiang Cancer Hospital",{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":94,"minAge":141,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100609081","secondary-cervical-cancer-prevention-of-vulnerable-women-with-hpv-and-hiv-co-infection-in-india-100609081","NCT07209917","Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India","Secondary Cervical Cancer Prevention of Vulnerable Women With Human Papillomavirus (HPV) and Human Immunodeficiency Virus (HIV) Co-infection in India","SAKHI","Inclusion Criteria:\n\n1. WLH, 25 - 50 years of age; based on HIV-based guidelines;\n2. Receiving ART for \\> 12 months to ensure medication stabilization, and ensure any impact on the cervical cancer outcomes will not be attributed solely to recent ART initiation, as validated by an ART card given to all ART patients;\n3. Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative;\n4. Have not participated in Phase I Formative Study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women due to hormonal and dietary guideline differences;\n2. Women older than age 50. These women will be immediately referred to a gynecology specialist.","50 Years",{"count":379,"type":21},348,[24],"Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV\u002FHIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV\u002FHIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health workers, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and\u002For protein-enriched food supplements. In that study, our intervention, co-delivered by our trained ASHA, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that ASHA support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P \\\u003C 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio \\[aOR\\] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39).\n\nWith a focus on secondary prevention of CC, the investigators hope to mitigate the link between HR-HPV persistence and risk of CC as well as improve the health of women co-infected with HPV\u002FHIV (W-Co-V). Our stellar team plans to build upon our prior ASHA-Nutrition intervention, using formative research to refine a nurse-led, ASHA co-delivered, nutrition-enhanced SAKHI HPV intervention, adapted for W-Co-V. This will be followed by a randomized controlled trial (RCT), assessing the efficacy of our refined comprehensive, multifaceted SAKHI HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions \\[wellness, basic nutrition and HPV\u002FHIV health promotion\\]) among 348 high-risk co-infected women to prevent CC while remaining engaged in the HIV treatment cascade, and managing nutritional health. Recruited participants will be individually randomized in a 1:1 ratio into the two study arms. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type, separated by 12-18 months). The two aims incorporating RCT interventions are as follows:\n\nAim 2. To evaluate the efficacy of SAKHI HPV intervention among 348 W-Co-V on the primary outcome (HR-HPV persistence) as compared to the Enhanced Standard of Care (SOC+) program. H2: Compared to the SOC+ participants, SAKHI participants will have lower rates of HR-HPV persistence.\n\nAim 3. Assess the impact of the SAKHI program secondarily on: 1) HIV indices (HIV viral load; CD4 count); 2) Nutritional index (serum albumin) at 6-, 12-, and 18-months.",[31,383,384],"Human Papillomavirus (HPV) Infection","Human Immunodeficiency Virus (HIV) Infection",[386,387,388],"Cervical Cancer Prevention","HPV-HIV Co-Infection","ASHA-Nutrition",{"date":235,"type":50},{"date":391,"type":50},"2026-02-01",{"date":393,"type":21},"2029-04-30",{"name":395,"class":57},"University of California, Irvine",3,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":413,"locationsCount":396},"100530089","identifying-and-addressing-barriers-to-retention-in-the-cervical-cancer-treatment-cascade-among-women-with-hiv-in-south-africa-part-2-100530089","NCT06182241","Identifying and Addressing Barriers to Retention in the Cervical Cancer Treatment Cascade Among Women With HIV in South Africa: Part 2","Inclusion Criteria:\n\n* Having a cervix\n* Aged 18+\n* Living with HIV\n* Recent high-risk abnormal Pap results within the last month (if needed, we may increase the range by up to 6 months to ensure that we meet our targets).\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* HIV-negative\n* No cervix\u002Fhistory of hysterectomy\n* Recent normal or low-risk abnormal Pap results\n* Unable to provide informed consent or assent in English or isiZulu and\u002For have a significant psychiatric illness (e.g., active psychotic disorder or untreated bipolar disorder) that could interfere with participation will be excluded. Potential participants will also be asked if they have any health conditions that make it difficult for them to travel to the clinic.",{"count":404,"type":21},80,[24],"The investigators will conduct the formative work that is necessary to develop a novel, multi-level intervention (inclusive of patient- and provider-level components), which will increase awareness of and modify the complex, intersecting factors that contribute to cervical cancer development among cisgender women with HIV (WWH). In Aim 1a, the investigators will explore the multi-level barriers and facilitators to follow-up appointment attendance among WWH who have had a recent high-risk abnormal Pap smear in the past six months, via qualitative interviews with WWH who have either attended at least one follow-up visit (n\\\u003C10) or have not yet attended a follow-up visit (n\\\u003C10). In Aim 1b, the investigators will explore provider awareness of the HIV-cervical cancer relationship and perspectives on barriers to retention in care via qualitative interviews (n\\\u003C8). For Aim 2, The study team will leverage the Aim 1 data, develop a patient-level intervention (1-2 sessions) and a provider toolkit, with the goal of increasing retention in care among WWH who are at heightened risk for cervical cancer. The study team will seek feedback on the manual and the toolkit from providers and from a community advisory board. In Aim 3a, the investigators will test the feasibility and acceptability of the intervention in a pilot randomized control trial (RCT) (n\\\u003C60). The study team will also assess (1) changes in self-efficacy to attend cervical cancer-related healthcare appointments pre-post intervention, (2) the proportion of women who attend a follow-up appointment, and, of those participants, (3) the proportion of women who complete the next phase of treatment. In Aim 3b, the investigators will explore the feasibility of intervention implementation in the clinic and acceptability of the provider-level intervention components in qualitative interviews with providers, clinic staff, the interventionalists, and other key stakeholders (n\\\u003C10).",[31,408],"Hiv",{"date":256,"type":50},{"date":411,"type":50},"2025-11-17",{"date":77,"type":21},{"name":414,"class":57},"Boston University Charles River Campus",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":133},"100644369","breast-and-cervical-cancer-stigma-in-rwanda-100644369","NCT07663006","Breast and Cervical Cancer Stigma in Rwanda","Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention in Rwanda","Aim 1 Inclusion and Exclusion Criteria Aim 1 Interviews and Surveys\n\nIndividual interviews and surveys:\n\nPotential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Patients with pathologically confirmed breast or cervical cancer\n* Patients receiving treatment at BCCOE during the study period\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInterpersonal interviews and surveys:\n\nCaregivers of the potential patients will be identified from the potential patients. Potential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Caregiver (including spouses, children, family members or other individuals as designated by patients) of patients with pathologically confirmed breast or cervical cancer who are actively receiving treatment at BCCOE during the study period\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInstitutional Focus group:\n\nAn official participation letter will be sent from BL2TH to leaders of the preselected facilities. Interested participants will be encouraged to contact the study team. Potential participants will be invited by their hospital\u002Fcenter leadership and screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Healthcare Worker\n* Working in a preselected health center, district hospital, provincial hospital in the Northern Province\n* Age 18 or older\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInstitutional surveys:\n\nFormal participation invitation will be sent to the Rwanda Medical and Dental Council, National Council of Nurses and Midwives, and the Rwanda Allied Health Professions Council. Potential participants will be screened for eligibility electronically and informed consent obtained electronically.\n\nInclusion Criteria\n\n* Healthcare Worker\n* Registered with relevant professional organization in Rwanda\n* Age 18 or older\n* Ability to provide informed consent\n* Ability to participate in surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nAim 2 Inclusion and Exclusion Criteria Aim 2 Intervention pilot (patient, caregivers and community health workers)\n\nPatient and Caregiver Pilot:\n\nInclusion Criteria\n\n* Patients with pathologically confirmed breast cancer who are actively receiving curative-intent treatment at BCCOE during the study period and a designated caregiver\n* Patients getting systemic neoadjuvant chemotherapy who are expected in the clinic on a 3-week cycle\n* Patients who have at least 4 cycles of therapy remaining\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in pilot, interview, and surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nCommunity Health Worker Pilot:\n\nInclusion Criteria\n\n* Community Health Worker registered with relevant healthcare facilities in Northern Rwanda\n* Age 18 or older\n* Willing to engage in activities related to breast and cervical cancer and to support survivors\n* Ability to provide informed consent\n* Ability to participate in pilot, interview, and surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women",{"count":423,"type":21},1116,[24],"This study aims to assess breast and cervical cancer stigma and pilot a multi-modal intervention to mitigate stigma among patients, caregivers, and community health workers in Rwanda. The elements include resilience training (patient), support group (caregivers), or exposure to survivors by video and in-person (patient, caregivers, and community health workers), and educational curriculum (community health workers).",[30,31],[30,31,428],"Cancer Stigma","2026-06-22",{"date":362,"type":50},{"date":432,"type":21},"2026-11-01",{"date":434,"type":21},"2029-12-01",{"name":436,"class":57},"Dana-Farber Cancer Institute",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":444,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":461,"locationsCount":162},"100643879","phase-1-coq10-and-vitamin-e-for-off-target-radiation-toxicity-100643879","NCT07668284","COQ10 and Vitamin E for Off-Target Radiation Toxicity","Evaluating the Safety and Efficacy of Coenzyme Q10 and Vitamin E Dual Therapy in Mitigating Chronic Off-Target Radiation Toxicity","Inclusion Criteria:\n\n1. Pathologically confirmed post-prostatectomy prostate, uterine (endometrial and cervical), or anal cancer.\n2. Scheduled for curative-intent, multi-fraction (at least 15 fractions) external-beam radiotherapy +\u002F- chemotherapy at the study site which does not involve re-irradiation to the same field.\n3. Age ≥ 19 years at the time of consent.\n4. Eastern Cooperative Oncology Group Performance Status ≤ 2.\n5. Life expectancy ≥ 6 months at the time of consent as determined by the participant's treating physician.\n6. Participants must be able to swallow soft-gel capsules.\n7. Participants must not have a disease significantly affecting drug absorption (e.g., resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction).\n8. Participants must agree to limit alcohol consumption to ≤ 2 standard drinks (14 g of pure ethanol) within 6 hours before and 6 hours after vitamin administration.\n9. Participants must agree to discontinue current vitamin\u002Fmineral supplements, including multivitamins, that contain Vitamin E (α-tocopherol) or CoQ10 (ubidecarenone) and abstain from taking these supplements while on study, including during the follow-up period. Participants must also agree to discontinue and abstain from high-dose vitamin\u002Fmineral supplementation while on-study and during the study follow-up period. NOTE: Participants for whom high-dose vitamin\u002Fmineral supplementation is medically necessary are eligible if the principal investigator determines that continuing treatment will not impact safety or study outcomes.\n10. Women of childbearing potential and male participants with partners of childbearing potential must agree to use two forms of medically effective contraception (at least one of which must be a barrier method) while on study until one month following the last dose of vitamin supplements.\n11. As determined by the enrolling physician, the participant must be able to understand and comply with study procedures for the entire length of the study. There must not be psychological, familial, sociological, or geographical conditions potentially hampering protocol compliance, including alcohol dependence or drug abuse.\n12. The participant or the participant's legally authorized representative must provide documented informed consent after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.\n13. Participant must have adequate hematological, organ, and clotting function as defined below. Screening labs must be obtained prior to the end of radiation therapy.\n\n    * Absolute Neutrophil Count (ANC) ≥ 500\u002Fmm3\n    * Platelets ≥ 50,000\u002Fmm3 • Hemoglobin ≥ 8.0 g\u002FdL. The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable.\n    * Calculated creatinine clearance (CrCl (mL\u002Fmin); Cockcroft-Gault formula) ≥ 30 mL\u002Fmin.\n    * Total bilirubin ≤ 1.5X institutional upper limit of normal (ULN) or ≤3 X ULN for patients with known Gilbert's syndrome\n    * AST (SGOT) and ALT (SGPT) ≤ 3X institutional ULN\n    * PT\u002FINR and PTT (in the absence of lupus anticoagulant) ≤ 2X institutional ULN.\n\nExclusion Criteria:\n\n1. Participants who do not receive ≥ 80% of the planned total radiation.\n2. Participants who are scheduled to receive SBRT\u002FSRS\n3. Participant's treatment plan must not include anti-cancer pharmaceutical therapies during the period of vitamin administration (\\~3 months after completion of radiation therapy).\n4. Participants must not receive any other investigational agents while on study.\n5. Participants must not have contraindications to Vitamin E or CoQ10 supplementation, including:\n\n   1. Anticoagulation or antiplatelet therapy that cannot be stopped. NOTE: To be eligible, participants must be able to discontinue contraindicated medications at least 2 weeks prior to the initiation of study treatment. These medications may be resumed 1 month after completing study treatment.\n   2. Underlying bleeding conditions (e.g., hemophilia or von Willebrand disease)\n   3. Retinitis pigmentosa\n   4. Hepatobiliary dysfunction\n   5. Vitamin K deficiency\n   6. Preexisting severe fibrosis\n   7. History of significant cerebrovascular disease\u002Fevent, including stroke or intracranial hemorrhage.\n   8. Uncontrolled Grade 2 hypertension defined as ≥ 140 mm Hg systolic blood pressure or ≥ 90 mm Hg diastolic blood pressure.\n   9. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).\n   10. Uncontrolled systemic bacterial, fungal, parasitic, mycobacterial, viral, or other infections, despite appropriate antibiotics or other treatments.\n   11. Any other uncontrolled comorbidities that, in the opinion of the treating investigator, would compromise subject safety or study outcomes.\n6. Participant must not have a history of allergic reactions to Vitamin E or CoQ10 or any of the vitamin excipients (soybean oil, soy lecithin, gelatin, glycerin).\n7. Not pregnant or lactating. A negative pregnancy test (serum hCG) is required for participants of childbearing potential. Female participants who are permanently sterilized (hysterectomy\u002Fbilateral oophorectomy) or postmenopausal (12 months of consecutive amenorrhea, \\> 45 years-of-age in the absence of other biological or physiological causes; females \\\u003C 55 years-of-age with serum FSH level \\> 40 mIU\u002FmL) are exempt","19 Years",{"count":446,"type":21},200,[69,173],"The goal of this supportive care study is to learn if high-dose Vitamin E and CoQ10 in combination can reduce the negative sub-acute and chronic side effects of radiation to the pelvis in adults treated for prostate, uterine, cervical, or anal cancer.\n\nThe main questions it aims to answer are:\n\n* Is taking high doses of Vitamin E (dl-α-tocopherol acetate, 900mg) and CoQ10 (ubidecarenone, 200 mg) each day safe and tolerable?\n* Does a 90-day course of vitamin supplementation with high-dose Vitamin E and CoQ10 reduce the incidence and severity of late radiation-associated toxicities?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 improve patient reported measure of quality of life?\n* Does high-dose vitamin supplementation with Vitamin E and CoQ10 change the trajectory of recovery after radiation therapy?\n* Is there evidence that suggests high-dose vitamin supplementation with Vitamin E and CoQ10 impairs oncologic outcomes?\n* Can longitudinal biomarkers of oxidative stress be correlated with Vitamin E and CoQ10 concentrations or radiation-associated toxicity?\n* Will subjects adhere to the vitamin administration schedule?\n* Are there demographic differences in systemic exposure to the vitamins?\n* Are there differences in toxicity outcomes across tumor types or radiation dose fractionation schemes?\n\nParticipants will be asked to:\n\n* Take Vitamin E and CoQ10 every day for 90 days by mouth.\n* Fill out quality of life questionnaires to assess treatment impacts.\n* Come for clinic visits every 2-4 weeks for around 4 months, then every 3-6 months for around 2 years.\n* Have blood draws more frequently than standard-of-care for clinical laboratory examinations and the collection of research samples.\n* Undergo Computed Tomography (CT) imaging of the chest, abdomen, and pelvis more frequently than standard of care.\n* Agree to lifestyle changes that ensure adequate vitamin absorption including intermittent abstinence from alcoholic beverages.",[43,450,31,28],"Uterine Cancer",[452,453,454,455],"radiation","toxicity","subacute","antioxidant","2026-06-19",{"date":256,"type":50},{"date":47,"type":21},{"date":460,"type":21},"2030-12-15",{"name":462,"class":57},"University of Nebraska",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":470,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":162},"100313157","phase-1-intervention-of-car-t-against-cervical-cancer-100313157","NCT03356795","Intervention of CAR-T Against Cervical Cancer","Multicenter Trial of Chimeric Antigen Receptor-Modified T Cells (CAR-T Cells) in the Treatment of Cervical Cancer","Inclusion Criteria:\n\n1. Patients with stage III, IV or relapsed cervical cancer confirmed by histology and biopsy.\n2. Age: ≥ 18 years and ≤ 70 years.\n3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.\n4. Side Effects of Chemotherapy have subsided.\n5. GD2, PSMA, Muc1, Mesothelin or other markers is expressed high (above 2+) in malignancy tissues by immuno-histochemical or flow cytometry.\n6. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n7. Expected survival ≥ 12 weeks.\n8. Initial hematopoietic reconstitution with\n\n   * neutrophils (ANC) ≥ 1×10\\^6\u002FL;\n   * platelet (PLT) ≥ 1×10\\^8\u002FL.\n9. Proper renal and hepatic functions (ULN denotes \"upper limit of normal range\") with\n\n   * serum creatinine ≤ 2×ULN;\n   * serum bilirubin ≤ 3×ULN;\n   * AST\u002FALT ≤ 2.5×ULN.\n10. Oxygen saturation ≥ 90%.\n11. Written, informed consent obtained prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Airway obstruction caused by tumor.\n2. History of epilepsy or other central nervous system diseases.\n3. Patients who require systemic corticosteroid or other immunosuppressive therapy.\n4. History of prolonged or serious heart disease during QT.\n5. history of serious cyclophosphamide toxicity.\n6. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.\n7. Inadequate liver and renal function with\n\n   * serum creatinine \\> 1.5 mg\u002Fdl;\n   * serum (total) bilirubin \\> 2.0 mg\u002Fdl;\n   * AST \\& ALT \\> 3 x ULN.\n8. Pregnant or lactating females.\n9. Serious active infection during screening.\n10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.\n11. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","70 Years",{"count":472,"type":21},20,[69,173],"The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have GD2, PSMA, Muc1, Mesothelin or other markers positive cervical cancer. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.",[31],[356,477,478,479,480,481,151,482],"CAR-T","GD2","PSMA","Muc1","Mesothelin","solid tumor","2026-06-18",{"date":362,"type":50},{"date":486,"type":50},"2026-06-01",{"date":488,"type":21},"2030-12-31",{"name":490,"class":57},"Shenzhen Geno-Immune Medical Institute",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":94,"minAge":498,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":510,"locationsCount":162},"100313604","phase-1-engineered-immune-effectors-against-cervical-cancer-100313604","NCT03362619","Engineered Immune Effectors Against Cervical Cancer","Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific Immune Effectors (EIEs)","Inclusion Criteria:\n\n1. Written, informed consent obtained prior to any study-specific procedures.\n2. Age older than 10 years.\n3. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.\n4. Expected survival ≥ 12 weeks.\n5. Not pregnant, and on appropriate birth control if of childbearing potential.\n6. Evidence of high-risk HPV infection.\n7. Stage III-IV or recurrent cervical cancer.\n8. Initial hematopoietic reconstitution with\n\n   * neutrophils (ANC) ≥ 1,000\u002Fmm\\^3;\n   * platelet (PLT) ≥ 100,000\u002Fmm\\^3.\n9. Proper renal and hepatic functions (ULN denotes \"upper limit of normal range\") with\n\n   * serum creatinine ≤ 2×ULN;\n   * serum bilirubin ≤ 2×ULN;\n   * AST\u002FALT ≤ 2×ULN;\n   * ALKP ≤ 5×ULN;\n   * serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.\n10. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.\n\nExclusion Criteria:\n\n1. Patients with\n\n   * cervical benign lesions: cervical columnar epithelium ectopic, cervical polyps, cervical endometriosis and cervical tuberculous ulcers;\n   * cervical benign tumors: cervical submucous myoma, cervical cancer, cervical papilloma.\n2. Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).\n3. Previous exposure to mouse SCC antibody.\n4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.\n5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).\n6. Pregnant or lactating females.\n7. Inadequate bone marrow function with\n\n   * absolute neutrophil count \\\u003C 1,000\u002Fmm\\^3;\n   * platelet count \\\u003C 100,000\u002Fmm\\^3;\n   * Hb \\\u003C 9 g\u002FdL.\n8. Inadequate liver and renal function with\n\n   * serum (total) bilirubin \\> 1.5 x ULN;\n   * AST \\& ALT \\> 2.5 x ULN (\\> 5 x ULN in patients with liver metastases);\n   * alkaline phosphatase \\> 2.5 x ULN;\n   * serum creatinine \\>2.0 mg\u002Fdl (\\> 177 μmol\u002FL);\n   * urine dipstick for protein uria should be \\\u003C 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \\\u003C 1 g of protein\u002F24 hr.\n9. Serious active infection requiring i.v. antibiotics at during screening.\n10. Subject actively infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.","10 Years","80 Years",{"count":472,"type":21},[69,173],"The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy.",[31],[356,505,506],"Cytotoxic lymphocyte","CC-CTL",{"date":362,"type":50},{"date":486,"type":50},{"date":488,"type":21},{"name":490,"class":57},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":532,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":552},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":520,"type":21},420,[69],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[524,525,526,527,528,529,34,42,41,31,530,43,531,221],"Metastatic Solid Tumor","Recurrent Solid Tumor","Advanced Solid Tumor","Urinary Bladder Neoplasm","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Renal Pelvis Cancer",[221,533,534,535,536,537,531,538,539,540,541,542,543],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","2026-06-17",{"date":483,"type":50},{"date":547,"type":50},"2024-07-01",{"date":549,"type":21},"2027-05",{"name":551,"class":85},"Eli Lilly and Company",34,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":162},"100542204","ask-questions-in-gynecologic-oncology-asq-gyo-100542204","NCT06339827","ASk Questions in GYnecologic Oncology (ASQ-GYO)","ASk Questions in GYnecologic Oncology (ASQ-GYO): A Randomized Controlled Trial of a Question Prompt List Communication Intervention in Outpatient Gynecologic Oncology Clinics","ASQ-GYO","Inclusion Criteria:\n\n* 18 years of age\n* Understands spoken and written English\n* Able to consent to study participation\n* Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, or vaginal cancer or Gestational Trophoblastic Disease) OR have imaging and\u002For laboratory findings highly concerning for a cancer diagnosis and have not seen a Gynecologic Oncologist\n\nExclusion Criteria:\n\n* pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)\n* History and\u002For imaging\u002Flaboratory findings more indicative of a non-cancer diagnosis\n* Previous treatment discussion with a Gynecologic Oncologist",{"count":562,"type":21},70,[24],"The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.",[41,33,31,234,233,566],"Gestational Trophoblastic Disease","2026-06-15",{"date":544,"type":50},{"date":570,"type":50},"2024-04-04",{"date":572,"type":21},"2028-05",{"name":574,"class":57},"Ira Winer",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":162},"100642492","hypofractionated-radiotherapy-in-cervical-cancer-100642492","NCT07625943","HYPOfractionated RadioTherapy in Cervical Cancer","Hypofractionated Radiotherapy in Cervical Cancer: A Non-inferiority Randomized Controlled Trial","HYPORT-CC","Inclusion Criteria:\n\nFemale participants aged 18 to 65 years.\n\nHistopathologically confirmed cervical cancer.\n\nFIGO stage IB3 to IIIC1.\n\nSuitable for definitive concurrent chemoradiation.\n\nECOG performance status 0 to 2.\n\nAdequate hematological, renal, and hepatic function.\n\nAble and willing to provide informed consent.\n\nExclusion Criteria:\n\nECOG performance status 3 or higher.\n\nFIGO stage IIIC2, IVA, or IVB.\n\nPrior pelvic radiotherapy or prior chemotherapy for cervical cancer.\n\nInflammatory bowel disease.\n\nHydronephrosis.\n\nPregnancy.\n\nSynchronous malignancy.\n\nAny serious medical condition that would interfere with protocol treatment or follow-up.","65 Years",{"count":585,"type":21},396,[24],"The study is a prospective, randomized, non-inferiority clinical trial which will test whether a short course of radiation treatment (hypofractionation) for cervical cancer works as well as the standard longer course. Cervical cancer is one of the most common cancers in women in India, and many patients have trouble completing treatment because it takes several weeks and requires many hospital visits.\n\nIn this trial, females with locally advanced cervical cancer will be randomly assigned to one of two treatment groups. One group will receive the standard radiation schedule with External Beam RadioTherapy (EBRT) over about 5 weeks, weekly cisplatin chemotherapy, and brachytherapy. The other group will receive a shorter, hypofractionated external beam radiotherapy schedule over about 3 weeks, the same chemotherapy, and brachytherapy.\n\nResearchers will compare the two groups to see whether the hypofractionated schedule is non-inferior to the standard radiation therapy schedule. The main outcomes will be tumor control in the pelvis, side effects, survival, and quality of life. If the hypofractionated schedule meets the non-inferiority limit, it could reduce treatment time, improve patient convenience, and help more people receive treatment in busy cancer centers in emerging countries.",[589,31],"Cervical Cancer Squamous Cell",[150,591,592,593,594],"chemoradiation","hypofractionation","brachytherapy","external beam radiotherapy","2026-06-12",{"date":597,"type":50},"2026-06-16",{"date":599,"type":50},"2026-01-15",{"date":601,"type":21},"2030-01-30",{"name":603,"class":57},"All India Institute of Medical Sciences",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":94,"minAge":18,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":162},"100641687","phase-2-cadonilimab-plus-chemotherapy-in-lacc-a-prospective-multicenter-randomized-phase-ii-trial-100641687","NCT07649174","Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial","Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial","Inclusion Criteria:\n\n1. Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter \\>4 cm as assessed by contrast-enhanced pelvic MRI);\n2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n3. Female patients aged ≥18 and ≤75 years;\n4. Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;\n5. Eligible for radical hysterectomy with curative intent;\n6. At least one measurable lesion according to RECIST version 1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n8. Estimated life expectancy of at least 6 months;\n9. Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment.\n\nExclusion Criteria:\n\n1. Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.\n2. Clinically significant unrecoverable hydronephrosis;\n3. CNS metastases or leptomeningeal disease;\n4. Active malignancy within 3 years prior to enrollment (with specified exceptions);\n5. Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;\n6. Major surgery within 4 weeks before study treatment;\n7. Severe cardiovascular or cerebrovascular disease;\n8. Unresolved toxicities from previous anticancer therapy (\\> Grade 1, CTCAE v5.0);\n9. Known hypersensitivity to study drugs;\n10. Serious medical or psychiatric conditions that may interfere with study participation;\n11. Pregnancy.","75 Years",{"count":613,"type":21},134,[173],"This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.",[31],[150,282,618],"Neoadjuvant therapy",{"date":597,"type":50},{"date":621,"type":21},"2026-06-06",{"date":488,"type":21},{"name":624,"class":57},"Obstetrics & Gynecology Hospital of Fudan University",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":634,"conditions":635,"keywords":653,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":396},"100491983","phase-2-e7-tcr-t-cell-immunotherapy-for-human-papillomavirus-hpv-associated-cancers-100491983","NCT05686226","E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers","A Phase II Trial of T Cell Receptor Gene Therapy Targeting Human Papillomavirus ( HPV) 16 E7 for HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically or cytologically confirmed metastatic or refractory\u002Frecurrent HPV-16+ cancer.\n2. Tumor and\u002For blood with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele as determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease as assessed by RECIST Criteria Version 1.1.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening.\n7. Must have received prior first line standard therapy or have declined standard therapy.\n8. Standard treatment options for first and second-line therapy must be presented and formally declined (Appendix VII).\n9. Patients with three or fewer brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients must be fully recovered from surgery.\n10. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n11. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n12. Seronegative for HIV antibody, hepatitis B antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by RT-PCR for hepatitis C (HCV) RNA must be negative.\n13. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate transferase (AST) (SGOT)\u002Falanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the E7 TCR cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability for the protocol.\n15. Participants must be able to understand and be willing to sign the written informed consent document.\n16. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Participants may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n2. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n5. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by clinical or research genomic profiling will not be eligible.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n11. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n\n    Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n12. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n13. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.\n14. Current treatment with another investigational agent.",{"count":472,"type":21},[173],"This is a phase II clinical trial to assess the clinical activity of immunotherapy with E7 TCR-T cells for metastatic HPV-associated cancers. HPV-associated cancers in include cervical, throat, penile, vulvar, vaginal, anal, and other cancers. Participants will receive a conditioning regimen, E7 TCR-T cells, and aldesleukin. Clinical response to treatment will be determined.",[31,230,636,28,637,233,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652],"Oropharynx Cancer","Vulva Cancer","Penile Cancer","Metastatic Cancer","HPV-Related Malignancy","HPV-Related Carcinoma","HPV-Related Cervical Carcinoma","HPV-Related Squamous Cell Carcinoma","HPV-Related Adenocarcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV-Associated Vaginal Adenocarcinoma","HPV-Related Adenosquamous Carcinoma","HPV-Related Endocervical Adenocarcinoma","HPV-Related Anal Squamous Cell Carcinoma","HPV-Related Penile Squamous Cell Carcinoma","HPV-Related Vulvar Squamous Cell Carcinoma","HPV Positive Rectal Squamous Cell Carcinoma",[654,655,656,657,658,659,660,661,662,151,663,664,665,666,667,668,150,669,670,671,672,673,674,675],"Chimeric antigen receptors (CAR-T)","Tumor infiltrating lymphocyte","TCR-T","immunotherapy","T cell","adoptive cell therapy","cellular therapy","gene therapy","human papillomavirus","E7","T cell receptor","TCR","E7 TCR","lymphocyte","cell therapy","oropharyngeal cancer","anal cancer","vulvar cancer","vaginal cancer","penile cancer","tumor infiltrating lymphocytes (TIL)","TIL therapy","2026-06-10",{"date":595,"type":50},{"date":679,"type":50},"2023-03-07",{"date":681,"type":21},"2027-01-01",{"name":683,"class":57},"Christian Hinrichs",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":22,"phases":693,"briefSummary":694,"conditions":695,"keywords":697,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":710,"startDateStruct":711,"completionDateStruct":713,"leadSponsor":715,"locationsCount":133},"100488427","phase-1-e7-t-cell-receptor-tcr--t-cell-induction-therapy-for-locoregionally-advanced-hpv-associated-cancers-100488427","NCT05639972","E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers","A Feasibility Study of E7 TCR-T Cell Induction Therapy for Locoregionally Advanced HPV-Associated Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Histologically confirmed carcinoma of a primary tumor site and stage indicated in Table 3 of the protocol.\n2. Tumor with HPV16 genotype as determined by testing performed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.\n3. HLA-A\\*02:01 allele determined by testing performed in a CLIA certified laboratory. Participants may be enrolled based on low resolution typing (i.e., HLA-A\\*02) but the HLA-A\\*02:01 allele type must be confirmed prior to apheresis.\n4. Measurable disease per RECIST Criteria Version 1.1 or PERCIST.\n5. Age ≥ 18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n7. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n8. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n9. Seronegative for HIV antibody, hepatitis B surface antigen (HBsAg), and hepatitis C antibody. If a hepatitis C antibody test is positive, then testing for antigen by reverse transcription polymerase chain reaction (RT-PCR) must be negative.\n10. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum aspartate aminotransferase (AST) (SGOT)\u002F alanine transaminase (ALT) (SGPT) \\\u003C 2.5 x upper limit of normal (ULN)\n    7. Calculated creatinine clearance (CrCl) \\>50 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or aPTT within therapeutic range and no history of severe hemorrhage.\n11. Participants must be able to understand and be willing to sign the written informed consent document.\n12. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) for biospecimen studies.\n\nNote: Patients may have undergone minor surgical procedures with the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have received prior systemic therapy or definitive chemoradiation for the cancer that is being treated on this protocol. Palliative radiation therapy for symptom management, such as to control tumor-induced bleeding, is permitted.\n2. Current treatment with another investigational agent.\n3. History of severe allergic reactions to compounds of similar chemical or biological composition to agents used in this study.\n4. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n5. Subjects with HLA-A\\*02:01 damaging mutation or allele loss detected by research or clinical sequencing will not be eligible.\n6. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age ≥ 50 years old\n7. Participants with baseline screening pulse oxygen level of ≤ 92% on room air will not be eligible. If the underlying cause of hypoxia improves, they may be reevaluated.\n8. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study.\n9. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n10. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":692,"type":21},15,[69,173],"The goal of this study is to determine the feasibility of administration of a single dose of E7 TCR-T cells as induction therapy prior to definitive treatment (chemoradiation or surgery) of locoregionally advanced HPV-associated cancers. The intent of E7 TCR-T cell treatment is to shrink or eliminate tumors and thereby facilitate definitive therapy and increase overall survival.\n\nThis study seeks to determine 1) if E7 TCR-T cells can be administered without undue delay in definitive treatment, 2) the tumor response rate to E7 TCR-T cell treatment, and 3) the disease-free survival rate at 2 and 5 years.\n\nParticipants will undergo an apheresis procedure to obtain T cells that will be genetically engineered to generate E7 TCR-T cells. They will receive a conditioning regimen, a single infusion of their own E7 TCR-T cells, and adjuvant aldesleukin. Participants will follow up to assess safety and determine tumor response and will return to their primary oncology team for definitive therapy.",[696,641,640,645,644,647,643,649,650,651,648,31,636,28,234,638,233],"HPV-Associated Cervical Carcinoma",[151,698,699,282,700,701,702,655,665,658,703,356,704,705,706,707,708,709],"Cell therapy","Adoptive cell therapy","Radiation","Chemoradiation","CAR-T, cell therapy","Gene therapy","Oropharyngeal cancer","Anal cancer","Vulvar cancer","Vaginal cancer","Penile cancer","Induction therapy",{"date":595,"type":50},{"date":712,"type":50},"2025-08-11",{"date":714,"type":21},"2026-10-01",{"name":683,"class":57},{"id":717,"slug":718,"hasResults":12,"nctId":719,"briefTitle":720,"officialTitle":721,"acronym":4,"eligibilityCriteria":722,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":22,"phases":725,"briefSummary":726,"conditions":727,"keywords":728,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":737,"startDateStruct":738,"completionDateStruct":740,"leadSponsor":742,"locationsCount":133},"100476404","phase-1-kk-lc-1-tcr-t-cell-therapy-for-gastric-breast-cervical-and-lung-cancer-100476404","NCT05483491","KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer","T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers","Inclusion Criteria: Subjects must meet all the following criteria to participate in this study.\n\n1. Signed, written informed consent obtained prior to any study procedures.\n2. Age ≥ 18 years at the time of informed consent.\n3. Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute, Department of Biorepository Services.\n4. HLA-A\\*01:01 allele by HLA haplotype test.\n5. Measurable disease per RECIST Criteria Version 1.1 at time of enrollment.\n6. Prior treatment with cancer type-specific standard of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed unsuitable for standard therapy.\n7. Subjects with ≤ 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.\n9. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy test is not required for women who have had a bilateral oophorectomy or hysterectomy.\n10. Men and women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal\u002Fbarrier method of birth control, abstinence, tubal ligation, or vasectomy) prior to study entry and for 12 months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n11. Participants must have organ and marrow function as defined below:\n\n    1. Leukocytes \\> 3,000\u002FmcL\n    2. Absolute neutrophil count \\> 1,500\u002FmcL\n    3. Platelets \\> 100,000\u002FmcL\n    4. Hemoglobin \\> 9.0 g\u002FdL\n    5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n    6. Serum AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x ULN\n    7. Calculated creatinine clearance (CrCl) \\> 50 mL\u002Fmin\u002F1.73 m² for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).\n    8. INR or aPTT ≤ 1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage.\n12. Serology:\n\n    * HIV antibody negative\n    * Hepatitis B antigen negative\n    * Hepatitis C antibody negative or HCV RNA negative (i.e., no current HCV infection)\n13. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the KK-LC-1 TCR-T cells. Adverse events from prior therapy must have resolved to ≤ grade 1 according to CTCAE Version 5.0 or have demonstrated clinical stability and meet the eligibility criteria for the protocol.\n14. Participants must agree to participate in Rutgers protocol 192103 (Pro2021002307) for gene therapy long term follow up and in Rutgers protocol 192002 (Pro2021000281) or NIH protocol 16C0061 (Rutgers 192202) for biospecimen collection study.\n\nNote: Patients may have undergone minor surgical procedures within the past three weeks, as long as all toxicities have recovered to Grade 1 or less.\n\nExclusion Criteria: Subjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Current treatment with another investigational agent.\n2. History of severe allergic reactions to compounds of similar chemical or biologic composition to agents used in study.\n3. History of coronary revascularization or ischemic symptoms unless patient has a normal cardiac stress test.\n4. Documented LVEF of less than or equal to 45% tested. The following participants will undergo cardiac evaluations:\n\n   1. Clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block or\n   2. Age greater than or equal to 50 years old\n5. Participants with baseline screening pulse oxygen level of less than or equal to 92% on room air will not be eligible. If the underlying cause of hypoxia improves, then they may be reevaluated.\n6. Uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations at the time of treatment that would limit compliance with study requirements.\n7. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with KK-LC-1 TCR-T cells, breastfeeding should be discontinued if the mother is treated with KK-LC-1 TCR cells. The potential risks may also apply to other agents used in this study.\n8. Participants with a systemic immunodeficiency including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment.\n9. Participants on immunosuppressive drugs including corticosteroids unless meeting criteria outlined in Section 6.1 (Prohibited Medications).\n10. Subjects with HLA-A\\*01:01 damaging mutation or allele loss or other molecular resistance detected by clinical or research genomic profiling will not be eligible.\n11. Participants with potentially severe autoimmune diseases such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus are not eligible. Prior history of potentially severe autoimmune diseases without a current, active diagnosis is not exclusionary. Patients with less severe autoimmune diseases such as hypothyroidism, vitiligo, and other minor autoimmune disorders are eligible.\n12. Participants with prior or concurrent malignancy whose natural history or treatment is unlikely to interfere with the safety or efficacy assessments of the investigational regimen are eligible for this trial. Examples include, but are not limited to:\n\n    1. Carcinoma in situ\n    2. Cutaneous skin cancers requiring only local excision\n    3. Low grade non-muscle invasive bladder cancer\n    4. Low grade prostate cancer Participants with prior or concurrent malignancy that do not meet the above criteria are excluded.\n13. Subjects who received a live vaccine within 30 days prior to enrollment are not eligible.\n14. Determination by the Principal Investigator that participation is not in the best interest of the research subject or may jeopardize the safety of the subject or integrity of the clinical trial data.",{"count":724,"type":21},30,[69],"This is a phase I clinical trial to determine the maximum tolerated dose (MTD) of KK-LC-1 TCR-T cells for the treatment of metastatic cancers that express KK-LC-1. Participants will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. The safety profile and clinical response to treatment will be determined.",[36,30,31,39],[477,657,729,730,731,732,733,150,668,661,734,735,736],"TIL","stomach cancer","lung cancer","breast cancer","triple negative","tumor infiltrating lymphocytes","T cells","immune",{"date":595,"type":50},{"date":739,"type":50},"2022-09-26",{"date":741,"type":21},"2028-12-31",{"name":683,"class":57}]