[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"South Africa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":658},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,284,0,25,[9,42,75,106,134,159,184,203,227,255,277,303,326,365,395,419,442,467,490,512,534,555,576,611,638],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100555869","phase-1-safety-and-pharmacokinetics-study-of-pgt121414ls-alone-and-in-combination-with-vrc07-523ls-in-infants-exposed-to-hiv-1-100555869",false,"NCT06517693","Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Inclusion Criteria:\n\n* Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.\n* Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.\n* Infant was singleton or twin.\n* Infant's gestational age at birth was at least 36 weeks.\n* At birth, infant's weight was at least 2 kg.\n* At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.\n* At screening, infant has the following laboratory test results:\n\n  * Hemoglobin, normal or grade 1 (≥13 g\u002FdL or ≥8.05 mmol\u002FL)\n  * Platelets, normal or grade 1 (≥100,000 cells\u002Fmm3 or ≥100.000 x10\\^9 cells\u002FL)\n  * Absolute neutrophil count (ANC), normal or grade 1\n\n    1. ≤24 hours old (≥4,000 cells\u002Fmm3 or ≥4.000 x10\\^9 cells\u002FL)\n    2. \\>24 hours old (≥1,250 cells\u002Fmm3 or ≥1.250 x10\\^9 cells\u002FL)\n  * Alanine transaminase (ALT), normal (\\\u003C1.25 x ULN)\n* At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.\n* Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.\n* Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.\n* At entry, infant is at increased risk of HIV acquisition.\n\nCohorts 1 and 2, Strata FF only:\n\n* Birthing parent had acute HIV during this pregnancy; or\n* Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies\u002FmL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies\u002FmL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or\n* Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.\n\nCohorts 1 and 2, BF only:\n\n* Per birthing parent's report, intends to breastfeed\n\nExclusion Criteria:\n\n* Birthing parent has received any investigational product during this pregnancy.\n* Infant has received any active or passive HIV immunotherapy or any investigational product.\n* At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.\n* Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.",true,"ALL","72 Hours",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.",[28],"HIV-1","RECRUITING","2026-08-24",{"date":32,"type":33},"2026-08-25","ACTUAL",{"date":35,"type":33},"2026-01-05",{"date":37,"type":22},"2028-06-30",{"name":39,"class":40},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",17,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment","18 Years",{"count":51,"type":22},626,[53,54],"PHASE2","PHASE3","The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[57,58],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[60,61,62,58,63,64,65],"KRAS G12C","Non-small cell lung cancer","NSCLC","Adagrasib","Krazati","TPS",{"date":32,"type":33},{"date":68,"type":33},"2020-12-02",{"date":70,"type":22},"2029-10-31",{"name":72,"class":73},"Mirati Therapeutics Inc.","INDUSTRY",770,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100652673","phase-3-open-label-phase-3b-study-to-evaluate-the-long-term-efficacy-and-safety-of-lerodalcibep-in-children-and-adolescents-6-to-17-years-of-age-with-heterozygous-familial-hypercholesterolemia-on-stable-diet-and-oral-lipid-lowering-therapy-100652673","NCT07775339","Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia (LIBerate-Kids OLE)","Inclusion Criteria:\n\n1. Provision of written and signed informed consent\u002Fassent of the LIB003-016 trial prior to any study-specific procedure;\n2. Completion of the LIB003-008 study having received the last dose of study drug at Week 20 and completed the Week 24 visit;\n3. Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit of the LIB003-008 study;\n4. Weight of \\>18 kg (40 lbs) and BMI \\\u003C17 and \\>42 kg\u002Fm2;\n5. On stable diet and lipid-lowering oral drug therapy (statins, ezetimibe, bile-acid sequestrants) or combinations thereof (excluded oral lipid-lowering agents are include mipomersen, lomitapide, and gemfibrozil);\n\nExclusion Criteria:\n\n1. History of any prior or active clinical condition or acute and\u002For unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;\n2. Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception during the study and until 60 days after last dose of study drug, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;\n3. Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;\n4. A history, during the LIB003-008 study of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;\n5. Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study;","6 Years","17 Years",{"count":85,"type":22},150,[54],"The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)\u002Fpre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial.\n\nThe main question\\[s\\] it aims to answer are:\n\nHow effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns?\n\nParticipants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.",[89],"Heterozygous Familial Hypercholesterolemia (HeFH)",[91,92,93,94,95],"PCSK9 inhibitor","LDL-C","HeFH","lerodalcibep","pediatric","NOT_YET_RECRUITING","2026-08-21",{"date":32,"type":33},{"date":100,"type":22},"2027-01-20",{"date":102,"type":22},"2031-12-31",{"name":104,"class":73},"LIB Therapeutics LLC",5,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":115,"type":22},7140,[54],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[119,120],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[122,123,124,125],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":30,"type":33},{"date":128,"type":33},"2025-12-01",{"date":130,"type":22},"2031-08",{"name":132,"class":73},"Eli Lilly and Company",567,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":17,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100605263","phase-3-beatrix-a-study-to-learn-about-a-group-b-streptococcus-vaccine-in-healthy-pregnant-women-and-their-babies-100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details","1 Day","49 Years",{"count":144,"type":22},6000,[54],"BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[148],"Healthy",[150],"group B streptococcus, maternal immunization, vaccine",{"date":30,"type":33},{"date":153,"type":33},"2025-08-25",{"date":155,"type":22},"2029-03-02",{"name":157,"class":73},"Pfizer",206,{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":17,"sex":166,"minAge":167,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"100598448","phase-3-a-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-010-100598448","NCT07071623","A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)\n* Was assigned female sex at birth and is cisgender.\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1","FEMALE","16 Years","30 Years",{"count":170,"type":22},4580,[54],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[174,175],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis",{"date":30,"type":33},{"date":178,"type":33},"2025-11-10",{"date":180,"type":22},"2027-10-18",{"name":182,"class":73},"Merck Sharp & Dohme LLC",30,{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":17,"sex":18,"minAge":167,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100596349","a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study",{"count":192,"type":22},4390,[54],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[174,175],{"date":30,"type":33},{"date":198,"type":33},"2025-07-31",{"date":200,"type":22},"2027-07-22",{"name":182,"class":73},81,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":212,"type":22},15100,[54],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[216],"Cardiovascular Disease",[218],"Atherosclerotic Cardiovascular Disease",{"date":30,"type":33},{"date":221,"type":33},"2025-06-04",{"date":223,"type":22},"2029-10-26",{"name":225,"class":73},"AstraZeneca",1452,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100526296","phase-2-a-study-to-determine-if-bhv-7000-is-effective-and-safe-in-adults-with-refractory-focal-onset-epilepsy-100526296","NCT06132893","A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy","A Phase 2\u002F3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy","RISE 2","Key Inclusion Criteria:\n\n1. Male and Female participants 18 to 75 years of age at time of consent.\n2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.\n\n   a. Focal seizures i. Focal aware seizures with clinically observable signs and\u002For symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures\n3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n4. Ability to keep accurate seizure diaries\n5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total\n\nKey Exclusion Criteria:\n\n1. History of status epilepticus (convulsive status epilepticus for \\> 5 minutes or focal status epilepticus with impaired consciousness for \\> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n2. History of repetitive\u002Fcluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.\n3. Resection neurosurgery for seizures \\\u003C4 months prior to the screening visit.\n4. Radiosurgery performed \\\u003C2 years prior to the screening visit.\n5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.\n6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and\u002For confound the interpretation of safety or efficacy data from the study, as judged by the Investigator","75 Years",{"count":237,"type":22},390,[53,54],"The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.",[241],"Focal Epilepsy",[241,243,244,245,246],"Epilepsy","Seizure","Refractory Epilepsy","Partial Epilepsy",{"date":30,"type":33},{"date":249,"type":33},"2024-03-14",{"date":251,"type":22},"2026-12",{"name":253,"class":73},"Biohaven Therapeutics Ltd.",124,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye",{"count":264,"type":22},230,[54],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[268],"Metastatic Breast Cancer",{"date":32,"type":33},{"date":271,"type":33},"2023-09-08",{"date":273,"type":22},"2032-12-28",{"name":275,"class":73},"Hoffmann-La Roche",192,{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":285,"type":22},3500,[54],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[289,290],"Solid Tumors","Hematologic Malignancies",[292,293,294,295],"PD1","PD-1","PDL1","PD-L1",{"date":32,"type":33},{"date":298,"type":33},"2018-08-21",{"date":300,"type":22},"2043-08-04",{"name":182,"class":73},782,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944","NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening",{"count":183,"type":22},[53],"This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[315,316,317],"Lupus","Systemic Lupus Erythematosus","Lupus Nephritis","2026-08-20",{"date":97,"type":33},{"date":321,"type":33},"2026-05-25",{"date":323,"type":22},"2028-08-31",{"name":275,"class":73},21,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":337,"briefSummary":338,"conditions":339,"keywords":356,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":364},"100637347","phase-3-a-study-of-orforglipron-ly3502970-in-participants-with-type-2-diabetes-who-observe-ramadan-fasting-100637347","NCT07613307","A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting","A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)","ACHIEVE-RAM","Inclusion Criteria:\n\n* Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.\n* Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol\u002Fmol)) to less than 9.5% (91 mmol\u002Fmol) at screening.\n* Intend to be compliant with the fast during the Ramadan period.\n* Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.\n* Have body mass index (BMI) of 25 kilograms per meter square (kg\u002Fm2) or higher at screening.\n\nExclusion Criteria:\n\n* Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes\n* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of chronic or acute pancreatitis any time prior to screening\n* Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.\n* Have a history of cholecystectomy (surgically removed gallbladder)\n* Have New York Heart Association Functional Classification IV congestive heart-failure.","65 Years",{"count":336,"type":22},130,[54],"The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.",[340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355],"Diabetes Mellitus, Type 2","Diabetes Melletus","Glucose Metabolism Disorders","Metabolic Disorders","Nutritional and Metabolic Diseases","Endocrine System Diseases","Feeding Behavior","Behavior","Fasting","Glucagon-Like Peptide-1 Receptor","Glucagon-Like Peptide Receptors","Receptors, G-Protein-Coupled","Receptors, Cell Surface","Membrane Proteins","Proteins","Receptors, Peptide",[357,348],"Ramadan",{"date":97,"type":33},{"date":360,"type":33},"2026-07-15",{"date":362,"type":22},"2027-05",{"name":132,"class":73},40,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":17,"sex":166,"minAge":49,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":376,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":386,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":394},"100632840","protecting-against-lenacapavir-misinformation-with-young-women-in-gauteng-south-africa--protect-l-100632840","NCT07518914","Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)","Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa","PROTECT-L","Inclusion Criteria:\n\n* Female (cisgender or transgender)\n* Age 18-29 years\n* Self-reported history of sexual activity in the past 12 months\n* Self-reported HIV-negative status or unknown HIV status at enrolment\n* Willing and able to provide consent\n* Able to read and understand English\n\nExclusion Criteria:\n\nUnwilling or unable to provide consent for study participation.","29 Years",{"count":375,"type":22},1500,[377],"NA","Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women. Lenacapavir (LEN), the first long-acting injectable PrEP administered twice yearly, offers a promising alternative that could improve persistence and protection. However, LEN's potential may be undermined by misinformation, particularly around safety and trust, which has been shown in other HIV prevention contexts to reduce uptake and demand. Proactive strategies, such as psychological inoculation, are therefore needed to prebunk misinformation and support future LEN implementation among AGYW.\n\nPrimary objective: To compare changes in intentions to receive Lenacapavir following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost.\n\nSecondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioural economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a two-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about Lenacapavir in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.",[380,381],"Misinformation","Lenacapavir",[383,381,384,385],"South Africa","Adolescent Girls and Young WOmen","PrEP",{"date":30,"type":33},{"date":388,"type":33},"2026-05-19",{"date":390,"type":22},"2029-04",{"name":392,"class":393},"University of Pennsylvania","OTHER",1,{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854","NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization","80 Years",{"count":405,"type":22},1431,[53],"The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[409,410,411],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":97,"type":33},{"date":414,"type":33},"2026-03-26",{"date":416,"type":22},"2031-07",{"name":132,"class":73},259,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":426,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100610646","phase-2-study-of-abbv-142-to-assess-adverse-events-and-change-in-disease-activity-in-adult-participants-with-idiopathic-pulmonary-fibrosis-100610646","NCT07230288","Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis","A Phase 2a Multicenter Platform Study of Investigational Products for the Treatment of Adult Subjects With Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n\\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.\n\nExclusion Criteria:\n\n* History of stroke within 6 months prior to screening\n* In the opinion of the investigator, other clinically significant pulmonary abnormalities\n* History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.","40 Years",{"count":428,"type":22},165,[53],"Idiopathic Pulmonary Fibrosis (IPF) is a rare, long-lasting lung disease that causes scarring of lung tissue, shortness of breath, and loss of lung function. IPF leads to significant loss of quality of life and shortened lifespan. This study is a platform study evaluating different types of treatments in patients with IPF. A platform study is a type of study that uses a single master protocol to evaluate different study treatments allowing for new study treatments or substudies to be added or closed over time. The main goals of the study are to evaluate the safety, tolerability (the degree to which the adverse symptoms can be handled by the patients during the study) and efficacy (how well study treatment works) of the study treatments, including ABBV-142 in Substudy 1 (SS1).\n\nABBV-142 is an investigational drug being developed for the treatment of IPF. In SS1, participants will be randomly assigned to one of the 2 groups to receive either ABBV-142 or a matching placebo. This study is \"double-blind\", meaning that neither the participants nor the study doctors know who is given which study treatment. Approximately 165 adult participants with IPF will be enrolled in approximately 125 sites across the world.\n\nParticipants will receive ABBV-142 or matching placebo for 52 weeks during the double-blind treatment period. Eligible participants may receive ABBV-142 for 52 weeks in open-label treatment period. All participants will be followed for 120 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[432],"Idiopathic Pulmonary Fibrosis",[432],{"date":30,"type":33},{"date":436,"type":33},"2026-01-23",{"date":438,"type":22},"2029-09",{"name":440,"class":73},"AbbVie",49,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":166,"minAge":49,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100609601","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-combination-with-pembrolizumab-mk-3475-as-first-line-maintenance-treatment-of-cervical-cancer-mk-2870-036trofuse-036gog-3123engot-cx22-100609601","NCT07216703","A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036\u002FTroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix\n* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \\[FIGO\\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and\u002For radiation)\n* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy\n* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has HIV infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has received prior systemic anticancer therapy other than what is specified in this protocol\n* Is currently receiving a strong inducer\u002Finhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT\n* Has a diagnosis of immunodeficiency\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":450,"type":22},1023,[54],"Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.\n\nResearchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and\n* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment",[454],"Cervical Cancer",[456,457,458,459],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Trophoblast Cell Surface Antigen 2 (TROP2)",{"date":30,"type":33},{"date":462,"type":33},"2026-01-19",{"date":464,"type":22},"2031-10-29",{"name":182,"class":73},160,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":482,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":475,"type":22},2400,[54],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[479,480,481],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[456,457,458],{"date":30,"type":33},{"date":485,"type":33},"2025-06-30",{"date":487,"type":22},"2034-12-29",{"name":182,"class":73},321,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":497,"minAge":49,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":511},"100587234","a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100587234","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":499,"type":22},1440,[54],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[503,504],"Prostate Cancer","Prostatic Neoplasms",{"date":97,"type":33},{"date":507,"type":33},"2025-05-13",{"date":509,"type":22},"2031-01-06",{"name":182,"class":73},294,{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100571215","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100571215","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":520,"type":22},1046,[54],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[524],"Diffuse Large B-Cell Lymphoma",[526],"Lymphoma, Large B-Cell, Diffuse",{"date":97,"type":33},{"date":529,"type":33},"2025-01-27",{"date":531,"type":22},"2032-03-29",{"name":182,"class":73},268,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":554},"100564690","liverage---cirrhosis-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-cirrhosis-100564690","NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply",{"count":542,"type":22},1590,[54],"This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[546],"Metabolic Dysfunction Associated Steatohepatitis",{"date":97,"type":33},{"date":549,"type":33},"2024-11-12",{"date":551,"type":22},"2029-06-05",{"name":553,"class":73},"Boehringer Ingelheim",445,{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":575},"100564689","liverage-a-study-to-test-whether-survodutide-helps-people-with-a-liver-disease-called-nashmash-who-have-moderate-or-advanced-liver-fibrosis-100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":563,"type":22},1800,[54],"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[567,568],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":97,"type":33},{"date":571,"type":33},"2024-10-14",{"date":573,"type":22},"2031-12-27",{"name":553,"class":73},528,{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":497,"minAge":49,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100564484","phase-3-a-study-to-learn-how-pf-06821497-mevrometostat-works-in-men-with-metastatic-castration-resistant-prostate-cancer-100564484","NCT06629779","A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.","A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT\u002FMRI scan.\n* Progressive disease in the setting of medical or surgical castration.\n* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.\n* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.\n* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4\u002F6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:\n\n  1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;\n  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.\n* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).\n* Inadequate organ function.",{"count":584,"type":22},900,[54],"This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.",[588],"Metastatic Castration-Resistant Prostate Cancer",[590,591,592,593,594,595,596,597,598,599,600,601,602,603],"MEVROMETOSTAT","METASTATIC CASTRATION RESISTANT PROSTATE CANCER","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","mCRPC","Prostrate Cancer","castrate resistant prostate cancer","prostatecancer-study.com","efficacy","safety","pharmacokinetics","pharmacodynamics",{"date":30,"type":33},{"date":606,"type":33},"2024-10-22",{"date":608,"type":22},"2028-11-30",{"name":157,"class":73},236,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":624,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":630,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":637},"100554453","phase-3-a-study-of-elritercept-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100554453","NCT06499285","A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)","Inclusion Criteria:\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and\u002For protected personal data in accordance with national and local study participant data protections and privacy regulations.\n* Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.\n* Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow aspirate, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease.\n* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:\n\n  a. Low-transfusion burden (LTB), defined as 4 to 7 red blood cells (RBC) units per 16 weeks; or b. High-transfusion burden (HTB), defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (\\\u003C)10 grams per deciliter (g\u002FdL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.\n* Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:\n\n  a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor \\[G-CSF\\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥40,000 international units per week (IU\u002Fweek) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥4 doses or equivalent.\n\n  b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.\n\n  c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\\>)200 units per liter (U\u002FL).\n* Less than 5% blasts in an evaluable bone marrow aspirate collected at Screening, read by an independent central reader.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.\n* In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).\n\nExclusion Criteria:\n\n* Del(5q) MDS or therapy-related (secondary) MDS.\n* Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and\u002For folate).\n* Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.\n* Clinically significant cardiovascular disease defined as:\n\n  1. New York Heart Association heart disease class III or IV;\n  2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;\n  3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or\n  4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.\n* Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.\n* Child-Pugh class C hepatic impairment.\n* Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.\n* Any known history of acute myeloid leukemia (AML).\n* Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 5 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n  1. Basal or squamous cell carcinoma of the skin;\n  2. Carcinoma in situ of the cervix;\n  3. Carcinoma in situ of the breast; and\u002For\n  4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n* History of solid organ or bone marrow transplantation.\n* Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.\n* History of or known active chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n* Body mass index ≥ 40 kilograms per meter square (kg\u002Fm\\^2).\n* Major surgery within 28 days before randomization.\n* History of allergy\u002Fanaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.\n* Prior use of elritercept, luspatercept, or sotatercept.\n* Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.\n* Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable doses of iron chelation therapy for ≥ 8 weeks are allowed.\n* Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n* Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.\n* High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed.\n* Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.\n* Ongoing participation in another interventional clinical study.\n* Serum EPO level \\>500 U\u002FL.\n* Platelet count ≥450 × 10\\^9\u002FL or ≤25 × 10\\^9\u002FL.\n* Absolute neutrophil count ≤ 500\u002FµL.\n* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).\n* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome.\n* Ferritin ≤ 50 micrograms per litre (μg\u002FL).\n* Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n* Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n* Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.\n* Pregnant or lactating female.\n* Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.\n* Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or contract research organization (CRO) directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).\n* For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \\[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\\]).",{"count":619,"type":22},225,[54],"The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.",[623],"Myelodysplastic Syndromes",[625,626,627,628,629],"Anemia","Elritercept","Myelodysplastic neoplasms","KER-050","MDS",{"date":97,"type":33},{"date":632,"type":33},"2025-05-06",{"date":634,"type":22},"2032-05-01",{"name":636,"class":73},"Takeda",177,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":18,"minAge":167,"maxAge":403,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":657},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).",{"count":646,"type":22},1200,[54],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[650],"Crohn's Disease",{"date":97,"type":33},{"date":653,"type":33},"2024-06-05",{"date":655,"type":22},"2029-11-12",{"name":182,"class":73},499,""]