[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":635},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,73,0,25,[9,50,88,110,129,152,175,200,224,242,265,289,315,344,363,385,411,436,459,490,507,528,558,585,606],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054031","targeted-oligometastatic-radiation-in-pediatric-and-young-adult-patients-with-soft-tissue-and-bone-sarcoma-100054031",false,"NCT06796543","Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma","TARGET-RT","Stratum A Inclusion Criteria:\n\n* Patients must be aged \\\u003C 39 years at time of enrollment.\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan within 3 weeks from treatment start.\n\nStratum B Inclusion Criteria:\n\n* Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.\n* Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age \\\u003C 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).\n* Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as \\> 3mm with CT scan\n* Radiation to at least one site is being recommended as part of second line therapy.\n\nStratum A Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy\n\nStratum B Exclusion Criteria:\n\n* Brain or intracranial metastases, including leptomeningeal disease\n* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment\n* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.\n* Pregnancy","ALL","39 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.",[27,28,29,30],"Metastatic Sarcoma","Radiation Therapy Patient","Ewing Sarcoma","Rhabdomyosarcoma",[32,27,33,30,34,35,36],"Pediatric","Ewing sarcoma","Brain tumor","Longitudinal","Radiation Therapy","RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2025-03-25",{"date":45,"type":21},"2030-03",{"name":47,"class":48},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",3,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100614605","phase-2-capecitabineoxaliplatin-chemotherapy-and-cemiplimab-with-or-without-fianlimab-or-regn7075-in-locally-advanced-rectal-cancer-100614605","NCT07281768","Capecitabine\u002FOxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer","Combining Capecitabine\u002FOxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n* Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.\n* Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.\n* Must not have received any prior systemic treatment or radiation.\n* Candidate for sphincter-sparing surgical resection after neoadjuvant therapy according to the primary surgeon.\n* Patients have the following clinical staging:\n\n  * cT2 node-positive:\n  * T: Tumor is invading the muscularis propria but has not grown through it to the serosa\n  * N: At least 1 perirectal lymph node ≥5 mm and no more than 4 perirectal lymph nodes \\>10 mm in short axis\n  * M: No evidence of metastasis\n  * cT3 node-negative\n  * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs\n  * N: No perirectal lymph nodes ≥ 5 mm in size that suggest tumor involvement\n  * M: No evidence of metastasis\n  * cT3 node-positive\n  * T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs\n  * N: At least 1 perirectal lymph node ≥ 5 mm and no more than 4 perirectal lymph nodes \\> 10 mm in size in short axis\n  * M: No evidence of metastasis\n* Absence of distant metastases on CT or MRI imaging\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.\n* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).\n* History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason.\n* Currently using any chronic systemic steroids.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.\n* Uncontrolled infection of HIV, HBV, HCV, or Tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active autoimmune disease.\n* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.\n* Patient has a pulse oximetry of \\\u003C92% on room air.\n* Patient is on supplemental home oxygen.\n* Has clinically significant heart disease.\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.\n* Patient is pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Patient received a live vaccine within 30 days of planned start of study medication.\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.\n* Patients with T4 disease or N2 disease (as defined by \\>\u002F= 4 lymph nodes, each greater or equal to 10 mm in short axis).\n* Evidence that the tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or endorectal ultrasound or pelvic CT scan.\n* Patients with symptomatic untreated bowel obstruction due to rectal cancer.","18 Years",{"count":59,"type":21},66,[61],"PHASE2","The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab\u002Ffianlimab, or cemiplimab\u002FREGN7075 with capecitabine\u002Foxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).",[64],"Colorectal Cancer",[66,67,68,69,70,71,72,73,74,75,76,77,78],"Rectal Cancer","Cemiplimab","Fianlimab","REGEN7075","Oxaliplatin","Capecitabine","Immunotherapy","Anti-PD-1 (Programmed Death-Ligand 1)(protein immune checkpoint)","PD-L1 (Programmed Death-Ligand 1)(protein immune checkpoint)","Adenocarcinoma","Carcinoma","CAPOX","Chemotherapy","2026-06-30",{"date":81,"type":41},"2026-07-01",{"date":83,"type":21},"2026-07",{"date":85,"type":21},"2030-07",{"name":47,"class":48},1,{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":95,"minAge":57,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"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","FEMALE",{"count":97,"type":21},32,[99],"PHASE1","A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.",[102],"Cervical Cancer",{"date":81,"type":41},{"date":105,"type":41},"2025-07-23",{"date":107,"type":21},"2030-06",{"name":47,"class":48},2,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":95,"minAge":57,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":109},"100532288","phase-2-assessing-administration-of-pbi-11-via-electroporation-for-the-treatment-of-patients-with-hpv1618-100532288","NCT06210854","Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16\u002F18+","Double-Blind Randomized Phase II Clinical Trial Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16\u002F18+ \u003CCIN2","Inclusion Criteria:\n\n* Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology\n\nAND\n\n* HPV16 and\u002For 18+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test, or other FDA-approved HPV genotyping test (Co-infections with HPV types other than HPV16\u002F18 are permissible).\n* Age ≥ 18 years\n* Baseline Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of enrollment.\n* Patients must have adequate organ function at the time of enrollment as defined by the following parameters:\n* White blood cell count ≥ 3,000 cells\u002FuL\n* Absolute lymphocyte number ≥ 500 cells\u002FuL\n* Absolute neutrophil count ≥ 1,500 cells\u002FuL\n* Platelets ≥ 90,000 cells\u002FuL\n* Hemoglobulin ≥ 9 g\u002FdL\n* Total bilirubin \\\u003C 3 X the institutional limit of normal\n* Aspartate Aminotransferase (AST) and Alanine Aminotransferase(ALT) \\\u003C 3 X the institutional limit of normal\n* Creatinine \\\u003C 2.5 X the institutional limit of normal\n* Women of child-bearing potential must agree to use long acting contraception (e.g. tubal ligation, intrauterine device or hormonal implant) or two forms of contraception (e.g. barrier method, oral contraceptives) prior to study entry and for 3 months after final vaccination.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.\n* Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.\n* Patients who are receiving any other investigational agents within 28 days prior to the first dose of study vaccine.\n* Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus (SLE), but exclusive of a history of thyroiditis, psoriasis, Sjogren's, or inflammatory bowel disease.\n* Patients who are pregnant or breast feeding or plan to become pregnant within 12 months of first study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pBI-11 DNA vaccine.\n* Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).\n* History of prior malignancy with disease free interval \\\u003C5 years; however, individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.\n* Participants with metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.\n* Participants with any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child or episode of seizure in pregnancy due to eclampsia.\n* Participants with syncopal episode within 12 months of screening, excluding fainting for a known and unrelated cause such as anemia which has been resolved.\n* Administration of immunoglobulins and\u002For any blood products within the 120 days preceding study entry or planned administration during the study period.\n* Participants with a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (vastus lateralis muscles with intact lymph drainage) exceeds 50 mm.\n* Participants in whom the ability to observe possible local reactions at the injection site (lateralis region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.",{"count":118,"type":21},48,[61],"This research is being done to test the safety and feasibility of an investigational DNA vaccine called pBI-11 and to find out what effects, if any, it has on women with persistent human papillomavirus 16 (HPV16+) and\u002For human papillomavirus (HPV18+) cervical infection.\n\nThe DNA vaccine is designed to promote an immune response to treat disease caused by HPV types 16 and 18, viruses that can cause cervical cancer. The pBI-11 DNA vaccine or a placebo will be administered intramuscularly using the TriGridTM Delivery System.",[122],"HPV Infection",{"date":81,"type":41},{"date":125,"type":41},"2026-06-25",{"date":127,"type":21},"2029-05",{"name":47,"class":48},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":95,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":109},"100372592","phase-1-hpv-dna-vaccine-via-electroporation-for-hpv16-positive-cervical-neoplasia-100372592","NCT04131413","HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia","A Phase I Open Label, Dose Escalation Clinical Trial Assessing the Safety, Tolerability, and Feasibility of pNGVL4aCRTE6E7L2 HPV DNA Vaccine Administration Via Intramuscular TriGridTM Electroporation Delivery System to Patients With HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia","Inclusion Criteria:\n\n* For the HIV- patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2\u002F3) confirmed by colposcopy and biopsy who are HIV negative\n* For the HIV+ patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2\u002F3) confirmed by colposcopy and biopsy that are HIV positive\n\n  1. HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit and confirmed by western blot at any time prior to study entry.\n  2. Two HIV-1 RNA values ≤200 copies\u002FmL at least 24 hours apart performed by any laboratory that has Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent may be used to document infection.\n  3. Patients must be willing to comply with effective Antiretroviral Therapy.\n* Patients whose cervical cytologic samples are HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry.\n* Age ≥19 years. Also due to Alabama law the age a person is no longer a minor needing parental consent is 19, so all participants need to be 19 or older.\n* Life expectancy of greater than 4 months.\n* Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of multi-modality treatment administration\n* Participants must have normal organ and marrow function within 45 days of enrollment as defined below:\n\nAbsolute neutrophil count \\> 1,500\u002FmcL Cluster of differentiation (CD) 4 cell count \\> 200\u002FmcL Platelets \\> 100,000\u002FmcL Hemoglobin \\> 10.0 g\u002FdL Total bilirubin \\\u003C 1.5 X upper institutional limit of normal (patients with diagnosed Gilbert's Syndrome will not be excluded if direct bilirubin is within normal institutional limits) aspartate aminotransferase (AST) \\\u003C1.5 X the upper institutional limit of normal Alanine transaminase (ALT) \\\u003C1.5 X the upper institutional limit of normal Creatinine ≤1.5 x upper institutional limit normal\n\n* The effects of pNGVL4aCRTE6E7L2 DNA vaccine on the developing human fetus is unknown. For this reason, women of child-bearing potential must agree to use two forms of acceptable contraception, including one barrier method, prior to study entry and for 3 months after study completion. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.\n\n  1. Women of childbearing potential are defined as any female who has experienced menarche and does not meet the criteria for \"women not of childbearing potential\" defined below.\n  2. Women not of childbearing potential are defined as follows:\n\n  i. Women who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) ii. Women who have experienced total cessation of menses for at least 1 year OR who have a previous clinical follicle stimulating hormone (FSH) value \\> 40 mIU\u002FmL c. The following are acceptable forms of barrier contraception: i. Male or female condom, ii. Diaphragm, cervical\u002Fvault cap, or contraceptive sponge when used with spermicidal foam\u002Fgel\u002Fcream\u002Fsuppository.\n\n  d. The following are acceptable forms of secondary contraception, when used with a barrier method and spermicide: i. Placement of an intrauterine device (IUD) ii. Established use of oral, injected, or implanted hormonal methods of contraception\n* Ability to understand and the willingness to sign a written informed consent document.\n* Participant is able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n* Patients with high-grade cervical intraepithelial lesions (CIN2\u002F3) that are HPV16 negative\n* For the HIV+ cohort only: patients with AIDS related symptoms comprising an active AIDS-associated infectious process that, in the view of the investigator, would limit the subject's ability to comply with study procedures.\n* For the HIV+ cohort only: patients with an HIV viral load \\>200 cp\u002FmL.\n* Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry; For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg\u002Fkg\u002Fday; inhaled and topical steroids are allowed.\n* Due to interference with the immunologic measurements and compromising the analysis of the safety of the vaccine, participants with active or chronic infection of hepatitis C virus (HCV) or hepatitis B virus (HBV) are excluded as well as those who have previously received an investigational HPV vaccine.\n* Participants who are receiving or have received any other investigational agents within 30 days of registration.\n* Participants with an uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (yeast, bacterial, or viral), symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Participants with a history of autoimmune disease such as systemic lupus erythematosus, celiac disease, autoimmune hepatitis, multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.\n* Pregnant and breastfeeding women are excluded from this study because pNGVL4aCRTE6E7L2 is a vaccine with unknown potential for teratogenic or abortifacient effects.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pNGVL4aCRTE6E7L2 DNA vaccine.\n* Participants with a metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.\n* Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.\n* Syncopal episode within 12 months of screening.\n* Administration of immunoglobulins and\u002For any blood products within the 120 days preceding study entry or planned administration during the study period\n* Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid muscles with intact lymph drainage) exceeds 40 mm.\n* Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.\n* Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, previous EKG, and\u002For laboratory screening test.\n* History of prior malignancy \\\u003C 5 years; however individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.\n* Inability to understand or unwillingness to sign an informed consent document.",true,"19 Years",{"count":118,"type":21},[99],"The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+.",[142,143,144],"Human Papillomavirus Type 16","Cervical Intraepithelial Neoplasia Grade II","Cervical Intraepithelial Neoplasia, Grade III",{"date":146,"type":41},"2026-07-02",{"date":148,"type":41},"2020-09-14",{"date":150,"type":21},"2029-06",{"name":47,"class":48},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100620630","total-pancreatectomy-with-islet-autotransplantation-tpiat-for-high-risk-patients-with-pancreatic-tumors-100620630","NCT07360119","Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors","Total Pancreatectomy With Islet Autotransplantation (TPIAT) for Patients With Periampullary Neoplasms at High Risk for Pancreaticojejunostomy Leakage After Pancreaticoduodenectomy: a Single-center, Prospective, Single-Arm, Observational Study","Inclusion Criteria:\n\n* Adults aged 18 and older.\n* Patients with periampullary neoplasms requiring pancreaticoduodenectomy, including but not limited to:\n* Distal bile duct adenocarcinoma\n* Duodenal adenocarcinoma\n* Leiomyosarcoma of the duodenum\n* Pancreatic neuroendocrine neoplasms\n* Ampullary adenoma\n* Duodenal gastrointestinal stromal tumor (GIST)\n* High-risk Intraductal Papillary Mucinous Neoplasm (IPMN) as per Fukuoka criteria\n* Mucinous cystic neoplasm\n* Serous cystadenoma\n* Presence of soft pancreatic tissue and a main pancreatic duct ≤ 2 mm based on preoperative imaging.\n* Adequate islet function with measurable C-peptide preoperatively to justify islet isolation and transplant.\n\nExclusion Criteria:\n\n* Pregnancy\n* Active alcohol or illicit drug use\n* Poorly controlled psychiatric illness that limits compliance with care\n* Pre-existing insulin-dependent diabetes with absent C-peptide\n* Portal vein thrombosis or significant portal hypertension\n* Contraindications to major surgery\n* Body Mass Index (BMI) \\> 35 kg\u002Fm².",{"count":160,"type":21},30,[24],"This is a single-center, prospective, single-arm study evaluating the safety and feasibility of total pancreatectomy with islet autotransplantation (TPIAT) in carefully selected adult patients with periampullary neoplasms who are considered at high risk for postoperative pancreatic fistula after pancreaticoduodenectomy. Eligible patients will undergo open or robotic TPIAT as part of the patient's surgical management. Perioperative outcomes, postoperative complications, metabolic outcomes, and early oncologic outcomes will be collected prospectively as part of routine clinical care and analyzed to assess the safety and feasibility of this approach.",[164,165],"Periampullary Neoplasms","Pancreatic Cancer","NOT_YET_RECRUITING","2026-06-26",{"date":169,"type":41},"2026-06-29",{"date":171,"type":21},"2026-08-01",{"date":173,"type":21},"2031-02-01",{"name":47,"class":48},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":136,"sex":17,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":191,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":109},"100489869","cognitive-outcomes-after-brain-substructure-informed-radiation-planning-in-pediatric-patients-100489869","NCT05658731","Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients","CogRT","1. STRATUM A\n\n   1. Eligibility Criteria\n\n      * aged 1 to \\\u003C26 years of age\n      * tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit\n      * treatment must include radiation therapy (either proton or photon)\n      * patients must not have completed radiation therapy\n   2. Exclusion Criteria\n\n      * pregnancy\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n2. STRATUM B\n\n   1. Eligibility Criteria\n\n      * diagnosed with a brain tumor at \\\u003C26 years of age\n      * received radiation to the brain as part of therapy\n      * time from radiation start to study enrollment is ≥ 2 years\n      * there has not been disease recurrence from time of most recent radiation treatment to study enrollment\n   2. Exclusion Criteria\n\n      * patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological\u002Fneurodevelopmental disorders such as Down's syndrome or autism\n3. STRATUM C\n\n   1. Eligibility Criteria\n\n      * must be aged 5 to \\\u003C26 years of age\n      * must be able to complete research imaging without sedation\n   2. Exclusion Criteria\n\n      * must not have any major psychiatric, neurologic or medical diagnosis","1 Year","26 Years",{"count":185,"type":21},338,[24],"The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients.\n\nPatients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study.\n\nSurvivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed.\n\nHealthy children will also be enrolled and have research MRIs done.\n\nThe researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.",[189,190],"Brain Tumor","Head and Neck Cancer",[192,193],"radiation therapy","pediatric",{"date":169,"type":41},{"date":196,"type":41},"2023-05-17",{"date":198,"type":21},"2035-12",{"name":47,"class":48},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":136,"sex":17,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":87},"100440278","phase-1-mutant-kras--targeted-long-peptide-vaccine-for-patients-at-high-risk-of-developing-pancreatic-cancer-100440278","NCT05013216","Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer","Inclusion Criteria:\n\nCohort A: Must fall into one of the three categories defined as high risk of developing pancreatic cancer and are undergoing pancreatic surveillance AND 2) have documented radiographic evidence of a pancreatic abnormality such as a pancreatic cyst.\n\n* High Risk Group 1 (familial pancreatic cancer relatives):\n\n  * \\>\u002F=55 years old or 10 years younger than the age of youngest relative with pancreatic cancer, and\n  * Come from a family with 2 or more members with a history of pancreatic cancer (2 of which have a first-degree relationship consistent with familial pancreatic cancer), and\n  * Have a first-degree relationship with at least one of the relatives with pancreatic cancer.\n  * If there are 2 or more affected blood relatives, at least 1 must be a first-degree relative of the individual being screened.\n* High Risk Group 2 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~10% or higher):\n\n  * \\>\u002F=40 years old and the Patient is a carrier of FAMMM (p16\u002FCDKN2A) mutation regardless of family pancreas cancer history.\n\nOR\n\n* \\>\u002F= 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and the Patient is a carrier of a known BRCA2, ATM, PALB2 mutation.\n* Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory.\n\n  o High Risk Group 3 (Germline mutation carriers with an associated with an estimated lifetime risk of pancreatic cancer of \\~5%):\n* \\>\u002F= 50 years old or 10 years younger than the age of the youngest relative with pancreatic cancer, and\n* The patient is a carrier of a known, BRCA1, or HNPCC (hereditary non-polyposis colorectal cancer or Lynch syndrome, hMLH1, hMSH2, PMS1, hMSH6, EpCAM) gene mutation, and there is \\> 1 pancreatic cancer in the family, one of whom is a first- or second-degree relative of the subject to be screened.\n* Persons with known genetic mutation should have proof of mutation status. Those who had research-related genetic testing must have confirmation by a clinical CLIA-certified laboratory.\n* Cohort A: Patients must have a pancreatic imaging abnormality that is being followed by pancreatic imaging surveillance (EUS and\u002For MRI and \u002For CT), such as a pancreatic cyst consistent with an IPMN or parenchymal abnormalities consistent with PanIN.\n\n  * Cohort B: Patients must have clinical, radiographic, or histologic evidence of pancreatic cystic neoplasm with high-risk features warranting surgical resection per the discretion of the treating hepatobiliary surgeon.\n  * Cohort B: Patients must have cystic fluid testing that demonstrates the presence of one of the six KRAS mutations included in the study vaccine.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.\n* Ability to understand and willingness to sign a written informed consent document.\n* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.\n* Men must use acceptable form of birth control while on study.\n\nExclusion Criteria:\n\n* If expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Within 4 weeks prior to first dose of study drug.\n\n  o Any systemic or topical corticosteroids at immunosuppressive agents.\n* Within 4 weeks prior to first dose of study drug.\n\n  * Any investigational device.\n  * Has received a live vaccine.\n  * Received any allergen hyposensitization therapy.\n  * Any major surgery.\n* Infection with HIV or hepatitis B or C.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements monoclonal antibody.\n* Has a diagnosis of immunodeficiency.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Unwilling or unable to follow the study schedule for any reason.\n* Are pregnant or breastfeeding.","40 Years",{"count":208,"type":21},37,[99],"This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.",[212,165],"High Risk Cancer",[214,215,216,72,217],"KRAS Peptide Vaccine","Neoantigen Vaccines","Cancer Vaccines","Pancreatic Ductal Adenocarcinoma (PDAC)",{"date":79,"type":41},{"date":220,"type":41},"2022-04-11",{"date":222,"type":21},"2031-05-01",{"name":47,"class":48},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":87},"100430993","phase-1-combination-radiotherapy-and-radiopharmaceutical-therapy-treatment-planning-for-thyroid-cancer-100430993","NCT04892303","Combination Radiotherapy and Radiopharmaceutical Therapy Treatment Planning for Thyroid Cancer","Inclusion:\n\n* 18 and 85 years, inclusive.\n* Histologically confirmed papillary or follicular thyroid carcinoma, collectively referred to as differentiated thyroid carcinoma (DTC), that is incompletely responsive to initial surgery +\u002F- 131-Iodine as established by anatomic imaging (CT, MRI, and Ultrasound).\n* DTC that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and\u002For non-resectable distant metastases.\n* Iodine avid residual disease, but with a sub-therapeutic level of lesional radioiodine uptake demonstrated in either a pre-treatment diagnostic scan or a previous post-treatment radioiodine scan, making it unlikely that the patient would benefit from radioiodine therapy alone.\n* Adequate organ function, including: a) adequate renal function, defined as a measured creatinine clearance \\>70 ml\u002Fmin\u002F1.73 m2 or normal radioisotope glomerular filtration rate (GFR); and b) adequate hematologic function, defined as a platelet count \\> 50,000 cells\u002Fmm3 and an absolute neutrophil count (ANC) \\> 500 cells\u002Fmm3\n* Life expectancy of at least 8 weeks.\n* Karnofsky performance status (KPS) \\> 50%\n* Patients must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade 2 or better.\n* Patients with previously identified cardiac disease will be eligible, as Sodium Iodide I-131 (131I NaI) is not expected to cause cardiac dysfunction\n\nExclusion:\n\n* Patient is pregnant or breastfeeding.\n* Patient is sexually active, premenopausal, and does not agree to use accepted, effective forms of contraception.\n* Any criteria that would contraindicate radioiodine therapy or external beam radiotherapy.\n* Patient having alimentary toxic aleukia (ATA) low and intermediate risk tumors, not meeting the guidelines for either radioactive iodine (RAI) treatment or External beam radiotherapy (EBRT).\n* Patient with advanced central nervous system (CNS) metastatic disease, critical lesions in the hip and spine, etc. that would make RAI treatment prior to EBRT potentially harmful, with respect to worsening of disease as a result of the recombinant thyroid-stimulating hormone (TSH) stimulation.\n* Patients having recent exposure to iodinated contrast (within 6 weeks, that could render RAI treatment ineffective).","85 Years",{"count":118,"type":21},[99],"The goal of this study is to evaluate combined radioactive iodine (RAI, 131-I) and external beam radiotherapy (XRT) to optimize the radiation dose delivered to treat well differentiated thyroid cancers (DTC) with iodine-avid metastases. The investigators hypothesize that precise dosimetric planning will permit this combined RAI-XRT radiotherapeutic approach to be safe and permit higher tumor radiation doses than could otherwise be delivered. Patients with metastatic well-differentiated DTC) that is not completely resectable with macroscopic invasion of tumor into cervical soft tissues and\u002For non-resectable distant metastases, are the target study population. The primary objective is to evaluate safety as defined by the incidence of maximum grade 3 or greater NCI CTCAE toxicity observed during the treatment period and for the first 30 days following completion of radiotherapy. Secondary endpoints will evaluate efficacy at 6 months and feasibility of this combination to deliver a minimum cumulative dose of 80 Gy to the index tumors selected prior to treatment initiation. The investigators plan to enroll 48 subjects at an accrual rate of 1 subject per month over a study duration of 4 years.",[235],"Recurrent Thyroid Cancer",{"date":79,"type":41},{"date":238,"type":41},"2021-03-17",{"date":240,"type":21},"2030-12",{"name":47,"class":48},{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":248,"enrollmentInfo":249,"targetDuration":251,"studyType":252,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100391380","proton-radiation-therapy-registry-100391380","NCT04376229","Proton Radiation Therapy Registry","Inclusion Criteria:\n\n* All patients treated at the proton center.\n\nExclusion Criteria:\n\n* Any other than what is supplied in the inclusion criteria","100 Years",{"count":250,"type":21},5000,"15 Years","OBSERVATIONAL","The Johns Hopkins Proton Therapy center is establishing a registry to capture the full 3D radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The goal is to have all patients treated at the proton center to be included in the registry to enable future comparisons of treatment outcomes to assist in understanding which patients can benefit from the use of protons.",[255],"Cancer, Therapy-Related",[257],"proton therapy",{"date":79,"type":41},{"date":260,"type":41},"2020-04-07",{"date":262,"type":21},"2040-12",{"name":47,"class":48},4,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":272,"minAge":57,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":87},"100579640","7-days-water-only-fasting-or-ketone-supplementation-trial-in-prostate-cancer-100579640","NCT06826924","7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer","A Study of 7-days Water-only Fasting or Ketone Supplementation in Patients With Prostate Cancer","Inclusion criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Age ≥18 years\n* Diagnosis of adenocarcinoma of the prostate\n* If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies.\n* If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -. Prostate-specific antigen (PSA) is not currently declining, as determined by most recent 2 measurements taken at least 1 week apart in previous 2 months.\n* BMI between 20 and 35 kg\u002Fm2\n* Prior treatment with any prostate cancer therapy is permitted if \\>2 weeks from last dose. Patients are not required to have received prior treatment for prostate cancer.\n* Prior treatment with steroids is permitted if \\>2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible.\n* Acceptable liver function:\n\n  1. Bilirubin \\\u003C 2.5 times institutional upper limit of normal (ULN)\n  2. Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) \\\u003C 2.5 times ULN\n* Acceptable renal function: glomerular filtration rate (GFR) of 50 mL\u002Fmin\u002F1.73 m2 or higher. GFR will be estimated by the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation1 using the online calculator found on UpToDate.\n* Acceptable hematologic status:\n\n  1. Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3 (1.5 ×109\u002FL)\n  2. Platelet count ≥ 100,000 platelet\u002Fmm3 (100 ×109\u002FL)\n  3. Hemoglobin ≥ 8 g\u002FdL.\n* Acceptable electrolyte and acid\u002Fbase status:\n\n  1. Sodium 135-148 millimoles (mM)\n  2. Potassium 3.5-5.1mM\n  3. Carbon Dioxide 21-31mM\n  4. Phosphorus 2.7-4.5mM\n  5. Magnesium ≥1.6mM\n  6. Lactate ≤2mM\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion criteria:\n\n* ECOG Performance status ≥2\n* Unintentional weight loss greater than or equal to 5% in previous 3 months\n* Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes\n* Active uncontrolled infection. Patients with a history of HIV\u002FAIDS may be eligible if CD4+ T cell counts are ≥ 350 cell\u002Ful, the patients have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, and the HIV viral load is less than 400 copies\u002Fml prior to enrollment. Patients with a history of hepatitis C virus (HCV) infection are eligible if the patients have completed curative antiviral treatment and the HCV viral load is below the limit of quantification.\n* Use of immunosuppressive medications including steroids\n* Use of diuretics or beta blockers\n* History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension\n* Abnormal screening EKG\n* Daily alcohol consumption\n* Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator","MALE",{"count":274,"type":21},40,[24],"Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer. In animal models of cancer, fasting can reprogram the body's metabolism and immune cell function to help immune cells kill cancer cells likely by increasing ketosis. The purpose of this study is to determine whether 7 days of water-only fasting or a ketogenic very low-calorie diet or ketone supplementation is safe and feasible for patients with prostate cancer. This will help the investigators develop future studies to test whether incorporating periods of fasting or very low calorie diets or a ketone supplement into treatment plans for prostate cancer can improve outcomes from this disease.",[278,279],"Prostate Cancer","Prostate Cancer Metastatic",[281,282],"fasting","ketone supplementation",{"date":79,"type":41},{"date":285,"type":41},"2025-06-03",{"date":287,"type":21},"2027-06-03",{"name":47,"class":48},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":4},"100625560","phase-1-ruxolitinib-for-immune-effector-cell-associated-hemophagocytic-lymphohistiocytosis-like-syndrome-rise-100625560","NCT07424222","Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)","RISE","Inclusion Criteria:\n\n* Patients of age 18 or older\n* Diagnosis of for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) per ASTCT consensus criteria\n* Patients must have an elevated ferritin (\\>2 × ULN) at time of infusion and\u002For have a ferritin count that is rapidly rising (per clinical assessment) and at least 2 of the following manifestations as described in the ASTCT consensus criteria:\n* Onset with resolving\u002Fresolved CRS or worsening inflammatory response after initial improvement with CRS-directed therapy\n* Hepatic transaminase elevation§ (\\>5 × ULN (if baseline was normal) or \\>5 × baseline if baseline was abnormal)\n* Hypofibrinogenemia (\\\u003C150 mg\u002FdL or \\\u003CLLN)\n* Hemophagocytosis in bone marrow or other tissue\n* Grade 1 cytopenias (new onset, worsening, or refractory) defined as:\n\n  * Anemia (Hgb) \\\u003CLLN\\* - 10.0 g\u002FdL(gr1)\n  * Neutropenia (ANC) 1,000 - 1,499\u002FµL (Gr1)\n  * Thrombocytopenia \\\u003CLLN - 75,000\u002FµL (Gr1)\n* Lactate dehydrogenase elevations (\\>ULN)\n* Other coagulation abnormalities (e.g. elevated PT\u002FPTT)\n* Direct hyperbilirubinemia\n* New-onset splenomegaly that is palpable ≥5 cm below costal margin or \\>450cc on imaging\n* Fever of 100.4 or greater (new or persistent)\n* Neurologic changes greater than baseline that are consistent with a grade 1 Immune Effector Cell Encephalopathy (ICE) Score or greater\n* Pulmonary manifestations\n\n  * Gr 2 Hypoxia with decreased oxygen saturation with exercise (e.g. pulse ox \\\u003C88%)\n  * pulmonary infiltrates\n  * pulmonary edema with radiologic findings and moderate dyspnea on exertion\n* New onset renal insufficiency defined by:\n\n  * an absolute increase in serum creatinine of ≥0.3 mg\u002FdL within 48 hours.\n  * A baseline increase in serum creatinine of ≥1.5 times within the prior 7 days.\n  * Oliguria defined as urine volume \\\u003C0.5 mL\u002Fkg\u002Fh for at least 6 hours.\n\n    * Hypertriglyceridemia (fasting level, \\>265 mg\u002FdL‖)\n* Patients who have received a CAR T product, commercially available or investigational, will be allowed to enroll\n* Eastern Cooperative Oncology Group (ECOG) Performance Score43 of 0-2\n* Patients may be treatment naïve for the IECH-HS diagnosis or may have received prior or ongoing treatment. Corticosteroids can be continued along with RUX initiation as noted above.\n* Patient is able to take oral medication or is willing to have an NG tube placed if unable to take oral medication. Patients in whom NG tube was placed due to acute decompensation (resulting in an ECOG of \\>2), will be excluded.\n* Willing and able to sign an informed consent form\n\nExclusion Criteria:\n\n* Life expectancy greater than 6 months\n* Patients with known active malignancy or known progressive underlying disease\n* Women who are pregnant or breastfeeding. Women must also refrain from breastfeeding during the course of study and for 60 days after the last dose of study treatment.\n* Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment. Participants with acute infection requiring antibiotic, antifungal, or antiviral treatment use should delay screening\u002Fenrollment until the course of antibiotic antifungal, or antiviral therapy has been completed and the infection is not active anymore.\n\nNote: If a participant has a positive screening test result for SARS-CoV-2 infection, the participant should be excluded until test normalization and clinical recovery.\n\n* Any prior investigational agent used to treat IEC-HS\n* Patient on treatment with rifampin, St Johns wart or other JAK inhibitors\n* Patient is unable to tolerate medicine administration either orally or via NG tube.\n* Known history of allergic reaction to ruxolitinib\n* History of clinically significant or uncontrolled cardiac disease, including recent (within the last 12 months) unstable angina or acute myocardial infarction, or New York Heart Association Class III or IV congestive heart failure, or clinically significant arrhythmias not controlled by medication. Participants with a pacemaker and well-controlled rhythm for at least 1 month before the first dose of study treatment will be allowed.\n* Any major surgery within 28 days before the first dose of study treatment.\n* Active HBV (or at risk of reactivation), defined as follows: positive HBsAg result (laboratory test required at screening), and\u002For positive total anti-HBc result (laboratory test required at screening), and\u002For quantitative HBV DNA test result greater than the lower limits of detection of the assay (if known; laboratory test not required for eligibility purpose, but can be done as part of screening if available locally). Note: Participants with no prior history of HBV infection who have been vaccinated against HBV and who have a positive anti-HBs as the only evidence of prior exposure may participate in the study.\n* Active HCV, defined as follows: positive anti-HCV result (laboratory test required at screening) and quantitative HCV RNA test result greater than the lower limits of detection of the assay (laboratory test only required if anti-HCV-positive, can be done as part of screening if available locally).\n\nNote: Anti-HCV-positive participants who received and completed treatment for HCV that was intended to eradicate the virus may participate if HCV RNA levels are undetectable at least 12 weeks after the last dose of therapy. Anti-HCV-positive participants with no available confirmatory negative HCV RNA test results will be excluded.\n\n* Known history of HIV (1\u002F2 antibodies).\n* Any condition or circumstance that would, in the investigator's judgment, interfere with full participation in the study (eg, unable, unlikely, or unwilling to comply with the dose schedule and study evaluations, active alcohol or drug addiction), including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.","99 Years",{"count":298,"type":21},16,[99],"This is a pilot study to gather information about safety and efficacy of using ruxolitinib (RUX) to treat Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurring after CAR-T therapy. In addition, correlative studies will be done to 1) estimate the optimal duration of RUX therapy, 2) to identify immunological biomarkers associated with response (3) To evaluate the dynamics of CAR T expansion following RUX treatment.\n\nOral RUX will be administered twice daily, with dosing determined by the participant's baseline platelet count. Treatment will continue for up to 8 weeks unless significant adverse events occur or the treating physician concludes that the therapy is no longer providing clinical benefit.\n\nThe study expects to accrue 16 evaluable patients diagnosed with IEC-HS over 2 years.",[302],"Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS)",[304,305,306],"CAR T","IEC-HS","ruxolitinib","2026-06-23",{"date":309,"type":41},"2026-06-24",{"date":311,"type":21},"2026-07-15",{"date":313,"type":21},"2029-02-01",{"name":47,"class":48},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":109},"100463282","phase-2-atezolizumab-plus-etoposide-and-platinum-in-small-cell-bladder-cancer-100463282","NCT05312671","Atezolizumab Plus Etoposide and Platinum in Small Cell Bladder Cancer","Atezolizumab With Platinum and Etoposide Chemotherapy Followed by Cystectomy for Patients With Localized Small Cell Neuroendocrine Bladder Cancer","Inclusion Criteria:\n\n* Histologically confirmed invasive carcinoma of the bladder with pure, or any component of, small cell or high grade neuroendocrine features with or without urothelial cancer - localized ≥ cT1-T4aN1\n\nA formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If less than 15 slides are available, the patient may still be eligible for the study, after Principal Investigator confirmation has been obtained.\n\nIf archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening.\n\n* Medically fit to undergo chemotherapy, immunotherapy and cystectomy\n* 18 years old at time of consent\n* ECOG performance status of 0 or 1\n* Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to randomization:\n* ANC ≥ 1500 cells\u002FμL without granulocyte colony-stimulating factor support\n* Lymphocyte count ≥ 500\u002FμL\n* Platelet count ≥ 100,000\u002FμL without transfusion\n* Hemoglobin ≥ 9.0 g\u002FdL -patients may be transfused to meet this criterion.\n* INR or aPTT ≤ 1.5 × upper limit of normal (ULN) This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n* AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN\n* Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert disease who have serum bilirubin level ≤3 × ULN may be enrolled.\n* Serum albumin \\>= 25 g\u002FL (2.5 g\u002FdL)\n* Negative HIV test at screening (with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>= 200\u002FµL, and have an undetectable viral load)\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening The HBV DNA test will be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.\n* Creatinine clearance \\>30. Patients receiving cisplatin must have creatinine clearance \\>50\n* For women of childbearing potential (WOCBP): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n* Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 30 days after the final dose of cisplatin\u002F carboplatin and etoposide. Women must refrain from donating eggs during this same period.\n* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\\>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n* Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential who is not pregnant, or a pregnant female partner men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 8 months after the final dose of atezolizumab and 120 days after the final dose of etoposide. Men must refrain from donating sperm during this same period.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* Patients who give a written informed consent obtained according to local guidelines\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n\nExclusion Criteria:\n\n* No prior systemic treatment for small-cell bladder cancer (SCBC)\n* Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible). Individual cases will be discussed at investigator discretion.\n* Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.\n* Patients who have received prior systemic chemotherapy for urothelial bladder cancer.\n\nPrior BCG and intravesical chemotherapy are allowed\n\n* Any metastatic disease including leptomeningeal disease or brain metastasis on baseline brain imaging\n* Uncontrolled tumor-related pain - Patients requiring pain medication must be on a stable regimen at study entry.\n\nPatients requiring pain medication must be on a stable regimen at study entry.\n\nUncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN\n\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Individual cases can be discussed at investigator discretion. Refer to Appendix H for more details\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Patients who have undergone major surgery (e.g. intra-thoracic, intra- abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury\n* History of malignancy other than small cell bladder cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with a live, attenuated vaccine (e.g., FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of Atezolizumab\n* Current treatment with anti-viral therapy for HBV\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or other immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti- TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment.\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of Cisplatin, carboplatin or etoposide\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months of atezolizumab after the final dose of study treatment. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.\n* Patients who have had radiotherapy to the bladder, or radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities",{"count":323,"type":21},63,[61],"This is a single arm, Phase II trial involving the use of atezolizumab plus platinum and etoposide for patients with locally advanced urothelial cancer. The primary goal of this trial is to assess the pathologic complete response rate at cystectomy in patients after being treated with a combination therapy of atezolizumab, platinum, and etoposide.",[327,328,329],"Small Cell Neuroendocrine Carcinoma of Bladder","Bladder Cancer","Urothelial Carcinoma Bladder",[331,332,333,334,335,336,337],"Small Cell Bladder Cancer","Atezolizumab","Cisplatin","Carboplatin","Platinum","Etoposide","Cystectomy",{"date":125,"type":41},{"date":340,"type":41},"2022-06-27",{"date":342,"type":21},"2029-10",{"name":47,"class":48},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":272,"minAge":57,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":87},"100635271","phase-2-psma-high-ebrt-psma617-adt-vs-ebrt-adt-100635271","NCT07550517","PSMA-High: EBRT\u002F PSMA617\u002F ADT vs. EBRT\u002F ADT","A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer","Inclusion Criteria:\n\n* Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \\> 20 ng\u002FmL.\n* Histologic confirmation of adenocarcinoma of the prostate.\n* Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \\>10mm short axis by conventional CT size criteria.\n* Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \\> 10.\n* Patient must qualify for definitive treatment of prostate cancer including EBRT as well as ADT (up to 45 days of prior ADT is allotted).\n* Patient must be ≥ 18 years of age.\n* Patient must have a life expectancy ≥ 24 months.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 6 weeks demonstrating:\n\n  1. Platelet count of \\>100 x109\u002FL\n  2. White blood cell (WBC) count \\> 3,000\u002FmL\n  3. Neutrophil count of \\> 1,500\u002FmL\n  4. Hemoglobin ≥ 10 g\u002FdL\n  5. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin based upon Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA-617, patients with estimated GFR between 50 - 60 mL\u002Fmin will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.\n  6. Total bilirubin \\\u003C 3 x ULN (except if confirmed history of Gilbert's disease)\n  7. Serum albumin \\> 30 g\u002FL\n  8. Aspartate aminotransferase (AST) \\\u003C 3 times the ULN\n* For male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA-617.\n* Patient must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Presence of a very high-risk feature: cT3b to T4 OR primary pattern 5 OR 2 to 3 high-risk features OR \\>4 cores with Grade Group 4 or 5.\n* Any prior pharmacotherapy (with the exception of up to 45 days of ADT prior to randomization), radiation therapy, or surgery as treatment for prostate cancer. Any prior radiopharmaceutical therapy.\n* Any prior radiation to the pelvis.\n* Presence of N1 or M1 disease by conventional imaging (CT, MRI, and\u002For bone scan) or M1 disease by PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL). Lymph nodes with short axis \\> 8 mm by CT will be considered N1 by conventional imaging.\n* Castration-resistant prostate cancer (CRPC).\n* Patient receiving any other investigational agents.\n* Patient is participating in a concurrent treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.\n* Inadequate bone marrow reserve and organ function as detailed in 5.1.10.\n* Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or EBRT.\n* Concurrent serious medical condition that, in the opinion of the Investigator, would impair study participation.\n* Contraindication to receiving pelvic radiation, including history of or active inflammatory bowel disorders.\n* Refusal to sign informed consent.",{"count":352,"type":21},60,[61],"This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.",[356],"High-Risk Localized Prostate Cancer","2026-06-22",{"date":309,"type":41},{"date":83,"type":21},{"date":361,"type":21},"2033-07",{"name":47,"class":48},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":87},"100468971","cardiometabolic-screening-program-100468971","NCT05386719","Cardiometabolic Screening Program","A Cardiometabolic Screening Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* Diagnosis of early stage breast cancer\n* Completed local and\u002For systemic therapy at least 3 months ago\n* Receiving medical oncology care at through the breast cancer clinics at Johns Hopkins Medical Institute, including the Sidney Kimmel Comprehensive Cancer Center in Baltimore MD and Green Spring Station in Lutherville-Timonium MD, and Sibley Memorial Hospital in Washington D.C.\n* Read and speak English\n\nExclusion Criteria:\n\n* Metastatic breast cancer",{"count":371,"type":21},450,[24],"This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and\u002For hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.",[375,376],"Breast Cancer","Early-stage Breast Cancer",[378],"Survivor",{"date":125,"type":41},{"date":381,"type":41},"2022-06-03",{"date":383,"type":21},"2027-08-01",{"name":47,"class":48},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":87},"100621851","music-therapy-in-newly-diagnosed-glioblastoma-after-chemoradiation-therapy-melody-gbm-100621851","NCT07375992","Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)","Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556","MELODY","Inclusion Criteria:\n\n* Glioblastoma (Newly Diagnosed)\n* Cognitive capacity to respond to surveys\n* Access to computer and web access\n* Ability to attend virtual music therapy sessions\n* Audibly process music\n* Proficient in English\n\nExclusion Criteria:\n\n* Not planning to undergo standard of care radiation therapy and concurrent and adjuvant temozolomide.\n* A life expectancy of less than 6 months.\n* Concurrent use of any other standard or investigational agents (excepting tumor treating fields).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit adherence with study requirements.",{"count":394,"type":21},35,[24],"The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.",[398],"Glioblastoma (GBM)",[400,401,402],"newly diagnosed","Glioblastoma","Music Therapy","2026-06-17",{"date":405,"type":41},"2026-06-18",{"date":407,"type":41},"2026-05-26",{"date":409,"type":21},"2029-02-28",{"name":47,"class":48},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":272,"minAge":57,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":87},"100586971","phase-2-the-cosmyc-trial-combined-suppression-of-myc-100586971","NCT06922318","The COSMYC Trial (COmbined Suppression of MYC)","A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.\n2. Age ≥18 years.\n3. Histologically-confirmed adenocarcinoma of the prostate.\n4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist\u002Fantagonist).\n5. Documented castrate level of serum testosterone (\\\u003C50 ng\u002Fdl).\n6. Metastatic disease radiographically documented by CT or bone scan. While CT scan is preferred, Prostate-Specific Membrane Antigen (PSMA) scan (e.g. Pylarify) may be substitute for CT scan if evidence of metastatic disease observed on the CT portion of the PSMA scan.\n7. Must have had disease progression while on a second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) based on:\n\n   PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart i. And\u002F Or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease\n8. Screening PSA must be ≥ 1.0 ng\u002FmL.\n9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis.\n10. Prior treatment with Provenge vaccine, 223 Radium (Xofigo), poly(ADP-ribose) polymerase (PARP) inhibitors, taxane chemotherapy, Pluvicto, antiandrogens (including enzalutamide, darolutamide, and apalutamide), and radiation is allowed if \\>4 weeks from last dose.\n11. Prior treatment with BAT is allowed if the patient has progressed on an AR-axis inhibitor (i.e. abiraterone or antiandrogen) since BAT treatment.\n12. Patients must be withdrawn from second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) for ≥ 2 weeks.\n13. Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.\n14. Acceptable liver function:\n\n    1. Bilirubin \\\u003C 2.5 times institutional upper limit of normal (ULN)\n    2. Aspartate Transferase (AST) (SGOT) and Alanine Transaminase (ALT) (SGPT) \\\u003C 2.5 times ULN\n15. Acceptable renal function:\n\n    a. Serum creatinine \\\u003C2.5 times ULN\n16. Acceptable hematologic status:\n\n    1. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3 (1.5 ×109\u002FL)\n    2. Platelet count ≥ 100,000 platelet\u002Fmm3 (100 ×109\u002FL)\n    3. Hemoglobin ≥ 7.5 g\u002FdL.\n17. Ability to understand and willingness to sign a written informed consent document.\n18. Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow 1 of the following methods of contraception consistently, starting from screening, during the study and for at least 3 months after the last dose of ZEN-3694 and\u002For enzalutamide:\n\n    i. Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\n    ii. Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); iii. Agree to use a male condom and have their partner use a contraceptive method with a failure rate of \\\u003C1% per year as described below when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.\n\n    b. In addition, participants must refrain from donating sperm starting from Screening, during the study and for at least 3 months after the last dose of ZEN-3694 and\u002For enzalutamide.\n19. Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study\n20. Patients with soft-tissue disease amenable to biopsy as determined by Interventional Radiology must agree to serial biopsies as per the study schedule to be eligible.\n\nExclusion Criteria:\n\n1. Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.\n2. ECOG Performance status ≥3\n3. Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.\n4. Active uncontrolled infection. Patients with a history of HIV\u002FAIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell\u002Ful, they have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, the HIV viral load is less than 400 copies\u002Fml prior to enrollment, and there is no significant drug-drug interaction with ART and the study drugs. Patients with chronic hepatitis B virus (HBV) infection with active disease who meet criteria for anti HBV therapy are eligible if they are on a suppressive antiviral therapy prior to enrollment and there is no drug-drug interaction with the study drugs. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and the hepatitis C virus (HCV) viral load is below the limit of quantification.\n5. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.\n6. Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. \\[Patients on enoxaparin or edoxaban are eligible for study. Patients on warfarin, rivaroxaban, or apixaban, who can be transitioned to one of these alternative agents prior to starting study treatments will be eligible\\].\n7. Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.\n8. Hematocrit \\>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \\[per Endocrine Society Clinical Practice Guidelines (34)\\]\n9. Patients allergic to sesame seed oil or cottonseed oil are excluded.\n10. Major surgery (i.e. as defined by treating physician) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n\nPatients with history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma, brain arteriovenous malformation).",{"count":419,"type":21},50,[61],"This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.",[423],"Metastatic Castration-resistant Prostate Cancer",[278,425,426,427,428],"ZEN-3694","Bipolar androgen therapy","testosterone cypionate","enzalutamide","2026-06-16",{"date":405,"type":41},{"date":432,"type":41},"2025-08-19",{"date":434,"type":21},"2031-08-30",{"name":47,"class":48},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":109},"100526693","patient-navigation-program-to-improve-clinical-trial-enrollment-in-cancer-patients-100526693","NCT06138067","Patient Navigation Program to Improve Clinical Trial Enrollment in Cancer Patients","A Pilot Study of Low Versus High Intensity Patient Navigation Program to Improve the Enrollment on Clinical Trials Among Cancer Patients","1. Age ≥ 18 years\n2. Patient with a current diagnosis of a primary solid tumor including: prostate cancer and kidney cancer\n3. Being seen at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins University (JHU) or Wellspan Health Center\n4. Available therapeutic trial for the patient as determined through pre-screening\u002Fmedical record review",{"count":444,"type":21},90,[24],"The goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. Patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. The primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. Participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.",[278,448],"Kidney Cancer",[450],"clinical trials enrollment rate","2026-06-03",{"date":453,"type":41},"2026-06-05",{"date":455,"type":41},"2025-12-01",{"date":457,"type":21},"2027-01",{"name":47,"class":48},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":87},"100603730","phase-1-dk222-study-at-hopkins-100603730","NCT07140315","DK222 Study at Hopkins","An Open-label, Single-center Clinical Trial of [18F]DK222 PET\u002FCT for Imaging of Patients With Non-Small-Cell Lung Cancer (NSCLC) and Urothelial Cancer Who Are Eligible for Treatment With Anti-PD(L)-1","Inclusion Criteria:\n\n* Subjects must sign informed consent prior to inclusion in this trial.\n* Subjects must be ≥18 years of age and competent to give informed consent.\n* Subjects must be diagnosed with histologically confirmed NSCLC or UC and eligible for anti-PD(L)-1 therapy.\n* PD-L1 immunohistochemistry result using a Clinical Laboratory Improvement Amendments (CLIA) assay must be available or if not available then sufficient tissue must be available to perform PD-L1 testing.\n* Subjects must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Subjects must have adequate organ function as defined by the following laboratory values (determined within 28 days prior to randomization\u002Fregistration) or as deemed not clinically significant by physician on record:\n\n  * White blood cells (WBC) ≥ 2000 \u002FμL\n  * Absolute neutrophil count (ANC) ≥ 1500 \u002FμL\n  * Platelets ≥ 100 x103 \u002FμL\n  * Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n  * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance greater than or equal to 60 ml\u002Fmin (using the Cockcroft-Gault formula)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN\n  * Bilirubin ≤ 1.5 times ULN (Except patients with the Gilbert Syndrome, for whom a maximum of ≤ 3.0 mg\u002FdL is acceptable)\n* Women of childbearing potential (WOCBP) should have a negative serum pregnancy test within 24 hours prior to receiving the first administration \\[18F\\]DK222. Women with non-childbearing potential may be included if either surgically sterile or have been postmenopausal for ≥ 1 year.\n* WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.\n\nExclusion Criteria:\n\n* Prior treatment, in either de novo disease or during this recurrence, with an anti-PD-L1 or anti-PD-L2 antibody. A minimum of 4 month washout period is required for patients treated with anti-PD-L1 or anti-PD-L2 therapy. Patients with disease that was previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, but now have a new recurrence, would be eligible.\n* Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1 or better from the adverse events due to previous cancer therapy.\n* Treatment with corticosteroids in an increasing dosage in the 7 days prior to the first administration of anti-PD1. (A stable or decreasing dosage of ≤ 10 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)\n* A severe hypersensitivity reaction to prior treatment with a monoclonal antibody, or known hypersensitivity to study drugs components.\n* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patients to receive protocol therapy.\n* Women of childbearing potential with a positive serum or urine pregnancy test (minimum sensitivity 10 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of imaging.\n* Breastfeeding women.\n* Inability to comply with other requirements of the protocol.",{"count":467,"type":21},6,[99],"This Phase 1 clinical trial will test a new drug called \\[18F\\]DK222 in people with cancer. The goal is to see if the drug is safe, how it spreads through the body, how long it stays in the body, and how much radiation it gives off. \\[18F\\]DK222 is designed to attach strongly and specifically to a protein called PD-L1, which helps cancer hide from the immune system.\n\nThis is a first in human study to collect preliminary safety and toxicity data of \\[18F\\]DK222.",[471,472],"Non-Small Cell Lung Cancer","Urothelial Cancer",[474,475,476,477,478,479,480,481,482],"PD-L1","PD-1","PET","Imaging","MSCLC","UC","bladder cancer","lung cancer","radiotracer","2026-05-21",{"date":485,"type":41},"2026-05-22",{"date":81,"type":21},{"date":488,"type":21},"2027-07-01",{"name":47,"class":48},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":506,"locationsCount":87},"100638680","phase-2-combining-dcsz11-with-radiation-and-chemotherapy-as-neoadjuvant-treatment-for-pmmr-locally-advanced-rectal-cancer-100638680","NCT07580339","Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer","Combining CD93 Inhibition (DCSZ11) With Short Course Radiation and Chemotherapy as Part of Total Neoadjuvant Treatment (TNT) for High-risk Mismatch Repair Proficient (pMMR) Locally Advanced Rectal Cancer (LARC)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n* Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.\n* Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.\n* Must not have received any prior systemic treatment or radiation.\n* Patients have the following clinical staging:\n\n  * cT4 any node status\n  * Any T stage cN2 node status\n  * Any T or N status, evidence of suspicious lateral lymph nodes \\> 10 mm in size in short axis\n  * Evidence of extramural vascular invasion on MRI pelvis\n* Absence of distant metastases on CT or MRI imaging\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* Left ventricular ejection fraction (LVEF) assessment with documented LVEF ≥ 50% by either TTE or Multigated Acquisition (MUGA) (TTE preferred) within 6 months from first study drug administration.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.\n* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.\n* Uncontrolled infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or Tuberculosis.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.\n* Patient has a pulse oximetry of \\\u003C92% on room air.\n* Patient is on supplemental home oxygen.\n* Has clinically significant heart disease.\n* Conditions, including alcohol or drug dependence that would affect the patient's ability to comply with study visits and procedures.\n* Patient is pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Patient received a live vaccine within 30 days of planned start of study medication.\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.",{"count":160,"type":21},[61],"The purpose of this study is to evaluate the safety and clinical activity of combining DCSZ11 with radiation and capecitabine\u002Foxaliplatin (CAPOX) for the neoadjuvant treatment of patients with mismatch repair proficient (pMMR) high risk locally advanced rectal cancer.",[66],"2026-05-11",{"date":503,"type":41},"2026-05-12",{"date":83,"type":21},{"date":85,"type":21},{"name":47,"class":48},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":87},"100632320","precision-radiotherapy-enabled-by-molecular-mri-100632320","NCT07512154","Precision Radiotherapy Enabled by Molecular MRI","Inclusion Criteria:\n\n* Histologic confirmation of glioblastoma or grade 4 astrocytoma\n* Age \\>18\n* KPS at least 60\n* Patients must have normal organ and marrow function as defined below:\n\n  * leukocytes \\>3,000\u002FmcL\n  * absolute neutrophil count \\>1,500\u002FmcL\n  * platelets \\>100,000\u002FmcL\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C2.5\n  * institutional upper limit of normal\n  * creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n* Patients of child-bearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are unable to receive MRIs will be excluded from the study.\n* Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment.\n* Patients may not have previously been treated with an overlapping course of radiotherapy to the brain.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and\u002For breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.",{"count":514,"type":21},20,[24],"This is a research study to determine if a novel molecular magnetic resonance imaging (MRI) technique, called amide proton transfer (APT) imaging, is useful in identifying the most aggressive areas of tumor needed for radiotherapy of brain tumors.",[518],"Brain Cancer",[401],"2026-05-05",{"date":522,"type":41},"2026-05-06",{"date":524,"type":41},"2026-04-29",{"date":526,"type":21},"2032-05",{"name":47,"class":48},{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":535,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":166,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":87},"100626020","phase-1-a-dnajb1-prkaca-fusion-kinase-peptide-vaccine-combined-with-glutamine-antagonist-drp-104-nivolumab-and-ipilimumab-in-patients-with-advanced-stage-fibrolamellar-carcinoma-flc-100626020","NCT07430202","A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)","A Phase 1b Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab for Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)","Inclusion Criteria:\n\n* Must have histologically confirmed FLC that is metastatic or unresectable.\n* Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.\n* Must have demonstrated radiographic progression on prior or current immunotherapy.\n* Age ≥ 12 years.\n* Patients \\\u003C 18 years old must have a body weight ≥ 40 kg.\n* ECOG (Eastern Cooperative Oncology Group) performance status of ≤2\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients must have adequate kidney and liver function defined by study-specified laboratory tests.\n* Must have measurable disease per RECIST 1.1\n* Willingness to provide tissue and blood samples for mandatory translational research.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies.\n* Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:\n\n  * Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.\n  * Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.\n  * Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug.\n* Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the IND Sponsor.\n* Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.\n* Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and\u002For DRP-104 and\u002For nivolumab and\u002For ipilimumab.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* Has an active autoimmune disease.\n* Prior allogeneic stem cell transplantation or organ transplantation.\n* Has a diagnosis of immunodeficiency.\n* Systemic corticosteroids at immunosuppressive doses.\n* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Has a pulse oximetry of \\\u003C92% on room air or is on supplemental home oxygen.\n* Active or untreated brain metastases or leptomeningeal metastases.\n* Uncontrolled intercurrent active medical and\u002For psychiatric illness\u002Fsocial psychosocial problems that that would limit compliance with study requirements.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding.\n* Has a known history of Human Immunodeficiency Virus (HIV)\u002FAIDS.\n* Has active hepatitis B. Patients with chronic or acute HBV infection.\n* Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.\n* Unwilling or unable to follow the study schedule for any reason.\n* Patient is at the time of signing informed consent a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n* Evidence of clinical ascites.\n* Patients with QTc prolongation \\> 470 ms according to Fridericia formula.\n* Patients receiving potent inducers of CYP 3A4\u002F5 (including but not limited to apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin and St. John's Wort) who cannot safely discontinue drug at least 14 days prior to Cycle 1 Day 1.\n* Have had an allergen hyposensitization therapy within 2 weeks prior to initiation of study treatment.","12 Years",{"count":537,"type":21},27,[99],"The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).",[541],"Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))",[543,544,545,546,547,548,72,549,550,76,551],"Fibrolamellar Carcinoma (FLC)","Liver Cancer","DNAJB1-PRKACA Fusion Kinase Peptide Vaccine","DRP-104 (glutamine antagonist peptide)","Nivolumab","Ipilimumab","Anti PD-L1 (Anti-Programmed Death Ligand 1)","PD-L1 (Programmed Death Ligand 1)","Glutamine antagonist",{"date":522,"type":41},{"date":554,"type":21},"2026-08",{"date":556,"type":21},"2030-08",{"name":47,"class":48},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":87},"100559476","phase-1-targeting-driver-oncogenes-with-a-peptide-vaccine-plus-durvalumab-and-tremelimumab-for-patients-with-biliary-tract-cancers-btc-100559476","NCT06564623","Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)","A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers","Inclusion Criteria:\n\n* Age ≥18 years\n* Must have a histologically- or cytologically, proven biliary tract cancer (BTC) previously treated with gemcitabine\u002Fcisplatin\u002Fanti-PD(L)1 therapy.\n* Must have evidence of radiological disease, must accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.\n* Must have sufficient archival tumor tissue for next-generation sequencing (NGS) and immune-phenotyping.\n* Have a BTC containing at least one of the oncogenic mutation\u002Falterations targeted by the vaccine.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Must have body weight of \\>30 kg.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have disease controlled prior to enrollment.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Must have a life expectancy of at least 12 weeks.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational product during the last 2 weeks.\n* Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Any of the following procedures or medications within 2 weeks prior to initiation of study treatment:\n\n  * Systemic or topical steroids at immunosuppressive doses (\\> 10 mg\u002Fday of prednisone or equivalent). The following are exceptions to this criterion:\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n  * Palliative or adjuvant radiation or gamma knife radiosurgery.\n  * Chemotherapy or checkpoint inhibitor targeting anti-Pd1\u002FPD-L1.\n* Within 4 weeks prior to initiation of study treatment:\n\n  * Any investigational cytotoxic drug.\n  * Any investigational device.\n  * Non-oncology vaccines containing live virus.\n  * Allergen hyposensitization therapy.\n  * Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin.\n  * Major surgery.\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n* All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n* Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.\n* Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.\n* History of severe hypersensitivity reaction to any monoclonal antibodies or related compounds or to any of its components.\n* History of leptomeningeal carcinomatosis.\n* Patient has a known history or evidence of brain metastases.\n* Has an active known or suspected autoimmune disease or which has required systemic therapy in the last 5 years.\n* Known history of interstitial lung disease or of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Has a pulse oximetry \\\u003C 92% on room air.\n* Requires the use of home oxygen.\n* Has a known history of Human Immunodeficiency Virus (HIV)\u002FAIDS\n* Has active co-infection with HBV (hepatitis B virus) and HCV (hepatitis C virus) or coinfected with HBV and hepatitis delta virus (HDV)\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years requiring systemic therapy or expected to require active therapy within the clinical study period.\n* Has a diagnosis of immunodeficiency.\n* Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoietic stem cell transplant will be excluded.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Patient is at the time of signing informed consent a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n* Patient is unwilling or unable to follow the study schedule for any reason.\n* Pregnant or breastfeeding.\n* WOCBP and men with female partners (WOCBP) who are not willing to use contraception.\n* Evidence of clinical ascites requiring paracentesis in the last 4 weeks.\n* History of malignant bowel obstruction.",{"count":7,"type":21},[99],"The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.",[569],"Biliary Tract Cancers",[571,572,573,72,574,575,576,577,76],"Biliary Tract Cancer","Duvalumab","Tremelimumab","mBTCvax (peptide vaccine + Poly-ICLC (Hiltonol))","Anti PD-L1","Anti-Cytotoxic T-lymphocyte antigen 4 (CTLA-4)","Hiltonol",{"date":579,"type":41},"2026-05-08",{"date":581,"type":41},"2025-05-27",{"date":583,"type":21},"2029-03",{"name":47,"class":48},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":87},"100531902","phase-2-cemiplimab-with-or-without-fianlimab-to-treat-older-patients-with-localized-or-locally-advanced-msi-h-colorectal-cancer-100531902","NCT06205836","Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer","Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer","Inclusion Criteria for Cohort A and B:\n\n* Age ≥70 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 -2\n* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.\n* Must not have received any prior systemic treatment or radiation.\n* Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.\n* Patient's acceptance to have a tumor biopsy.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nInclusion Criteria for Cohort C and D:\n\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 -3.\n* Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.\n* Patient deemed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery.\n* Must not have received any prior systemic treatment or radiation.\n* Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.\n* Patient's acceptance to have a tumor biopsy.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Cohorts A and B:\n\n* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.\n* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).\n* History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.\n* Currently using any chronic systemic steroids.\n* Patient has received a live vaccine within 30 days of the first dose of study drug.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active autoimmune disease.\n* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.\n* Patient has a pulse oximetry of \\\u003C92% on room air.\n* Patient is on supplemental home oxygen.\n* Has clinically significant heart disease.\n* Cohort B Only: Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.\n* Unwilling or unable to follow the study schedule for any reason\n\nExclusion for Cohort C and D:\n\n* Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.\n* Have expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Currently using any chronic systemic steroids.\n* Patient has received a live vaccine within 30 days of the first dose of study drug.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.\n* Patient is pregnant or breastfeeding.\n* Cohort D Only: Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.\n* Participation deemed not in the best interest of the patient.\n* Unwilling or unable to follow the study schedule for any reason.",{"count":593,"type":21},44,[61],"The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab\u002Ffianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.",[64],[64,67,68,72,598,599,75,76],"Anti-PD-1 therapy","Anti-Lag-3",{"date":522,"type":41},{"date":602,"type":41},"2024-06-13",{"date":604,"type":21},"2030-05",{"name":47,"class":48},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":87},"100588473","phase-2-nc410-and-folfirinox-in-combination-with-nivolumab-with-or-without-ipilimumab-in-patients-with-untreated-metastatic-pancreatic-cancer-100588473","NCT06941857","NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer","A Phase 2 Study of NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Treatment-naïve, Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.\n* Metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.\n* Have metastatic disease\n* Must not have received prior systemic treatment for pancreatic cancer.\n* Have measurable disease based on RECIST 1.1.\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Must understand the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* Have had prior chemotherapy for pancreatic cancer or prior chemotherapy within 5 years of enrollment for other cancer diagnoses.\n* Has received radiotherapy for pancreatic cancer.\n* Are receiving or have received any investigational agent or used an investigational device within 28 days prior to Day 1 of treatment in this study.\n* Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to Day 1 of treatment in this study.\n* Is expected to require any other form of systemic or localized antineoplastic therapy while on study.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies.\n* Has received a live vaccine or live-attenuated vaccine within 28 days prior to the first dose of study drug.\n* Prior tissue or organ allograft regardless of need for immunosuppression, including corneal allograft.\n* Has uncontrolled acute or chronic medical illness.\n* Has history of central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has known additional malignancy that is progressing and requires active treatment.\n* Has active autoimmune disease.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Requirement for daily supplemental oxygen.\n* History of interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases, chronic obstructive pulmonary disease (COPD), asthma requiring medication, etc.\n* Known history of human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C.\n* Unable to undergo venipuncture and\u002For tolerate venous access.\n* Has known psychiatric or substance use disorder that would interfere with cooperation with the requirements of the trial.\n* Pregnant or breastfeeding\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study drug initiation.",{"count":514,"type":21},[61],"The purpose of this study is to evaluate safety of the treatment regimen and identify any novel toxicities.",[165],[547,548,618,70,619,620,621,622,72,623,624,625,626,165,217,76,627],"NC410 (NextCure LAIR-2 (Leukocyte-Associated Immunoglobulin-like Receptor-2) fusion protein)","Irinotecan","Folinic Acid","5-Fluorouracil","Folfirinox","Anti-PD-1 (anti-check point inhibitor)","PD-L1 (check point inhibitor)","Anti-CTLA-4 (anti-cytotoxic T-lymphocyte-associated antigen 4)","Metastatic Pancreatic Cancer","Pancreas","2026-04-30",{"date":520,"type":41},{"date":631,"type":41},"2025-09-04",{"date":633,"type":21},"2028-12",{"name":47,"class":48},""]