[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Colombia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,274,0,25,[9,46,83,117,146,174,203,227,251,279,301,327,350,376,398,422,444,465,490,510,530,550,572,599,620],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652278","molecular-ovarian-cancer-assessment-in-latinoamerican-patients-100652278",false,"NCT07771400","Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients","MOANA","Inclusion Criteria:\n\n1. Participants ≥18 years-old.\n2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:\n\n   1. advanced stages stage III or IV by FIGO disease stage\n   2. new diagnosis and persistent or recurrent disease\n3. Diagnosed from 2018 to 2024.\n4. Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.\n5. Accept to participate in the project and sign the informed consent (if applicable).\n6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy\u002Fsurgery is mandatory.\n\nExclusion Criteria:\n\n1. Histological ambiguous diagnosis upon review.\n2. Diagnosis based on cytology and without any biopsy or surgical specimen.\n3. Patients diagnosed and staged but not receiving any treatment.\n4. Patients without medical records available (lost, empty or irretrievable clinical information).","FEMALE","18 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.\n\nAll data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).\n\nThe study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.",[25,26,27,28,29,30],"Ovarian Cancer by FIGO Stage","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage III","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancers",[32],"Peritonial Cancer","NOT_YET_RECRUITING","2026-08-24",{"date":36,"type":37},"2026-08-25","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Latin American Cooperative Oncology Group","OTHER",17,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100622055","phase-2-study-to-evaluate-the-pharmacodynamics-safety-and-efficacy-of-sky-0515-in-participants-with-huntingtons-disease-100622055","NCT07378644","Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","A Phase 2\u002F3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","FALCON-HD","Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain\u002Fspinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","ALL","25 Years",{"count":57,"type":21},400,"INTERVENTIONAL",[60,61],"PHASE2","PHASE3","The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.",[64],"Huntington Disease",[66,67,68,69,64,70,71,72],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein","RECRUITING",{"date":36,"type":37},{"date":76,"type":37},"2026-01-06",{"date":78,"type":21},"2029-08",{"name":80,"class":81},"Skyhawk Therapeutics, Inc.","INDUSTRY",22,{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":58,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":91,"type":21},500,[60,61],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[95],"Non-Small Cell Lung Cancer",[97,98,99,100,101,102,103,104,105,106,107,108],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed",{"date":36,"type":37},{"date":111,"type":37},"2025-11-05",{"date":113,"type":21},"2030-11-15",{"name":115,"class":81},"Bristol-Myers Squibb",186,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":58,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":20},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":126,"type":21},590,[60,61],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[130],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[132,133,134,135,136,137,138,139],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":36,"type":37},{"date":142,"type":37},"2026-01-02",{"date":144,"type":21},"2031-08-12",{"name":115,"class":81},{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":58,"phases":155,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"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",{"count":154,"type":21},626,[60,61],"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.",[158,159],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[161,162,134,159,163,164,165],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":36,"type":37},{"date":168,"type":37},"2020-12-02",{"date":170,"type":21},"2029-10-31",{"name":172,"class":81},"Mirati Therapeutics Inc.",770,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":54,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":58,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"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":183,"type":21},7140,[61],"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.",[187,188],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[190,191,192,193],"Heart Disease","Kidney Disease","Outcomes","Stroke","2026-08-21",{"date":34,"type":37},{"date":197,"type":37},"2025-12-01",{"date":199,"type":21},"2031-08",{"name":201,"class":81},"Eli Lilly and Company",567,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":210,"sex":54,"minAge":211,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":58,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"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",true,"16 Years",{"count":213,"type":21},4390,[61],"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",[217,218],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis",{"date":34,"type":37},{"date":221,"type":37},"2025-07-31",{"date":223,"type":21},"2027-07-22",{"name":225,"class":81},"Merck Sharp & Dohme LLC",81,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":58,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"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":236,"type":21},15100,[61],"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.",[240],"Cardiovascular Disease",[242],"Atherosclerotic Cardiovascular Disease",{"date":34,"type":37},{"date":245,"type":37},"2025-06-04",{"date":247,"type":21},"2029-10-26",{"name":249,"class":81},"AstraZeneca",1452,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":58,"phases":262,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.","100 Years",{"count":261,"type":21},348,[61],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[265],"Lupus Nephritis",[267,268,269,270],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736",{"date":34,"type":37},{"date":273,"type":37},"2025-05-19",{"date":275,"type":21},"2035-08-01",{"name":277,"class":81},"Novartis Pharmaceuticals",47,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":58,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"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":288,"type":21},230,[61],"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).",[292],"Metastatic Breast Cancer",{"date":36,"type":37},{"date":295,"type":37},"2023-09-08",{"date":297,"type":21},"2032-12-28",{"name":299,"class":81},"Hoffmann-La Roche",192,{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":58,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"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":309,"type":21},3500,[61],"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.",[313,314],"Solid Tumors","Hematologic Malignancies",[316,317,318,319],"PD1","PD-1","PDL1","PD-L1",{"date":36,"type":37},{"date":322,"type":37},"2018-08-21",{"date":324,"type":21},"2043-08-04",{"name":225,"class":81},782,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":58,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},"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":336,"type":21},30,[60],"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).",[340,341,265],"Lupus","Systemic Lupus Erythematosus","2026-08-20",{"date":194,"type":37},{"date":345,"type":37},"2026-05-25",{"date":347,"type":21},"2028-08-31",{"name":299,"class":81},21,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":58,"phases":360,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":375},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. 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 Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":359,"type":21},324,[61],"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[363,364],"Myelofibrosis","Anemia",[366,367],"TAK-226","Drug therapy",{"date":34,"type":37},{"date":370,"type":21},"2026-09-02",{"date":372,"type":21},"2034-03-30",{"name":374,"class":81},"Takeda",195,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":58,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":397},"100628557","phase-2-a-study-to-evaluate-efficacy-and-safety-of-mk-8690-in-participants-with-moderately-to-severely-active-ulcerative-colitis-mk-8690-002-100628557","NCT07463183","A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)","A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis","The main inclusion criteria include but are not limited to the following:\n\n* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization\n* Has moderately to severely active UC\n* Has a weight ≥40 kg\n* Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments\n* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment\n* Has a current diagnosis of fulminant colitis and\u002For toxic megacolon\n* Has UC limited to the rectum\n* Has a current or impending need for colostomy or ileostomy\n* Has had a total proctocolectomy or partial colectomy\n* Has UC exacerbation requiring hospitalization within 2 weeks before Screening\n* Has any active infection as specified in the protocol\n* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters\n* Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Randomization or has a history of colorectal cancer at any time\n* Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed\n* Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study\n* Has received protocol-specified prohibited medications","75 Years",{"count":385,"type":21},100,[60],"The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.",[389,390],"Colitis Ulcerative","Ulcerative Colitis",{"date":194,"type":37},{"date":393,"type":37},"2026-03-24",{"date":395,"type":21},"2028-12-21",{"name":225,"class":81},28,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":58,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":421},"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":408,"type":21},1431,[60],"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.",[412,413,414],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe",{"date":194,"type":37},{"date":417,"type":37},"2026-03-26",{"date":419,"type":21},"2031-07",{"name":201,"class":81},259,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":58,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":443},"100617433","phase-3-a-clinical-trial-of-sac-tmt-in-people-with-non-hrd-positive-advanced-ovarian-cancer-mk-2870-021-100617433","NCT07318558","A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)","A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021\u002FENGOTov85\u002FGOG-3102)","TroFuse-021","The main inclusion criteria include but are not limited to the following:\n\n* Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\\>50%) Grade 3 features are present.\n* Has completed primary debulking surgery or interval debulking surgery.\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.\n* Has provided tumor tissue that is not previously irradiated.\n* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV\n* Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n* Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has a history of severe eye disease.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD), which required steroids, has current pneumonitis\u002FILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.\n* Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.\n* Had a live or live-attenuated vaccine within 30 days of randomization.\n* Has a known additional malignancy that is progressing or required active treatment within the past 3 years.\n* Has active infection requiring systemic therapy.\n* Has concurrent and active HBV and HCV infections.\n* Has HIV infection and a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* Has not recovered from major surgery or has ongoing surgical complications.\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.\n* Active or ongoing stomatitis of any grade.",{"count":431,"type":21},900,[61],"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\n* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n* Observation, which is watching to see if cancer grows or worsens\n\nThe study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.",[435,436],"Ovarian Neoplasms","Ovarian Cancer",{"date":194,"type":37},{"date":439,"type":37},"2026-02-16",{"date":441,"type":21},"2033-02-25",{"name":225,"class":81},155,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":58,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":464},"100609703","a-clinical-study-of-sotatercept-mk-7962-in-people-with-pulmonary-arterial-hypertension-mk-7962-038-100609703","NCT07218029","A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)","An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)","SOTERIA","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early\n* Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements\n* Must have the ability to understand and provide documented informed consent\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Did not participate in a sotatercept PAH parent study\n* Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.\n* Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept\n* Is a female who is pregnant or breastfeeding\n* Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study\n* Is currently enrolled in another investigational product study other than a sotatercept study\n* Is incapacitated",{"count":453,"type":21},815,[61],"Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.\n\nSotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.\n\nThis is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.",[457],"Pulmonary Arterial Hypertension",{"date":194,"type":37},{"date":460,"type":37},"2021-05-12",{"date":462,"type":21},"2028-12-07",{"name":225,"class":81},134,{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":58,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"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":473,"type":21},1023,[61],"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",[477],"Cervical Cancer",[479,480,481,482],"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":34,"type":37},{"date":485,"type":37},"2026-01-19",{"date":487,"type":21},"2031-10-29",{"name":225,"class":81},160,{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":58,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"100607568","phase-3-a-clinical-study-of-calderasib-mk-1084-and-other-treatments-for-participants-with-non-small-cell-lung-cancer-mk-1084-007kandlelit-007-100607568","NCT07190248","A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007\u002FKANDLELIT-007)","A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed\u002FPlatinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c\n* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a gastrointestinal disorder affecting absorption\n* Is HIV positive and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy except those specified by protocol\n* Has history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":498,"type":21},675,[61],"Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.\n\nThe goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.",[502],"Non-small Cell Lung Cancer",{"date":194,"type":37},{"date":505,"type":37},"2025-10-08",{"date":507,"type":21},"2032-08-06",{"name":225,"class":81},200,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":406,"enrollmentInfo":517,"targetDuration":4,"studyType":58,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":529},"100603216","phase-2-a-clinical-study-of-tulisokibart-mk-7240-to-treat-radiographic-axial-spondyloarthritis-mk-7240-013-100603216","NCT07133633","A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset \\\u003C45 years\n* Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening\n* Has active disease at Screening and Randomization\n* Has a history of inadequate response (IR)\u002Fintolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR\u002Fintolerance to up to a maximum of 2 bDMARD classes\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA\n* Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years\n* Has any active infection\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients",{"count":518,"type":21},315,[60],"Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.\n\nThis study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.\n\nResearchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.",[522],"Radiographic Axial Spondyloarthritis",{"date":194,"type":37},{"date":525,"type":37},"2025-09-26",{"date":527,"type":21},"2030-02-05",{"name":225,"class":81},104,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":58,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":549},"100597616","phase-3-a-clinical-study-of-patritumab-deruxtecan-to-treat-breast-cancer-mk-1022-016-100597616","NCT07060807","A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent\n* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)\n* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4\u002F6 inhibitor + endocrine therapy (ET) with one of the following:\n\n  * Radiographic disease progression, as assessed by the investigator, on CDK4\u002F6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+\u002FHER2- breast cancer. CDK4\u002F6 inhibitor + ET must be the only line of therapy received in the advanced setting, or\n  * Disease recurrence, either radiographic and\u002For confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4\u002F6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4\u002F6 inhibitor\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option\n* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and\u002For other life-threatening complications\n* Has any of the following: a pulse oximeter reading \\\u003C92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has ≥Grade 2 peripheral neuropathy.\n* Has clinically significant corneal disease\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Has received prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy\n* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4\u002F6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered\n* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002Finterstitial lung disease, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening\n* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and\u002For any of its excipients\n* Has severe hypersensitivity (≥Grade 3) to all the available TPC and\u002For any of their excipients",{"count":538,"type":21},1000,[61],"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) and either unresectable locally advanced or metastatic.\n\n* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread\n* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2\n* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles\n* Metastatic means the cancer has spread to other parts of the body\n\nTreatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing\u002Fspreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.",[542],"Breast Neoplasms",{"date":34,"type":37},{"date":545,"type":37},"2025-07-21",{"date":547,"type":21},"2033-07-14",{"name":225,"class":81},199,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":54,"minAge":557,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":58,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},"100597406","a-study-of-enlicitide-decanoate-mk-0616-an-oral-pcsk9-inhibitor-in-children-and-adolescents-with-heterozygous-familial-hypercholesterolemia-mk-0616-029-100597406","NCT07058077","A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)","An Operationally Seamless Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia","Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results\n* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg\u002FdL\n* Is receiving either:\n\n  * An optimized daily dose of statin (± nonstatin LLT)\n  * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative\n* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH\n* Has a history of nephrotic syndrome\n* Has any clinically significant malabsorption condition based on investigator assessment\n* Was previously treated\u002Fis being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) inhibitors without adequate washout","6 Years","17 Years",{"count":560,"type":21},153,[60,61],"This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.\n\nThe goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.",[564],"Heterozygous Familial Hypercholesterolemia (HeFH)",{"date":194,"type":37},{"date":567,"type":37},"2025-08-21",{"date":569,"type":21},"2037-01-23",{"name":225,"class":81},41,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":58,"phases":581,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":598},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":580,"type":21},162,[60],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[584],"Chronic Inflammatory Demyelinating Polyneuropathy",[584,586,587,588,589,590],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","CIDP","Imeroprubart",{"date":194,"type":37},{"date":593,"type":37},"2025-03-18",{"date":595,"type":21},"2030-05",{"name":597,"class":81},"Immunovant Sciences GmbH",141,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":58,"phases":608,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},"100592750","phase-3-a-clinical-study-of-calderasib-mk-1084-with-targeted-therapy-and-chemotherapy-in-people-with-colorectal-cancer-mk-1084-012kandlelit-012-100592750","NCT06997497","A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012\u002FKANDLELIT-012)","A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American Joint Committee on Cancer \\[AJCC\\] eighth edition) colorectal adenocarcinoma\n* Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period\n* Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants 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\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy\n* Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis or leptomeningeal disease\n* Has active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease",{"count":607,"type":21},477,[61],"Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.\n\nStandard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.\n\nThe goals of this study are to learn:\n\n* About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments\n* If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.",[611,612],"Colon Adenocarcinoma","Rectal Adenocarcinoma",{"date":194,"type":37},{"date":615,"type":37},"2025-07-16",{"date":617,"type":21},"2030-10-27",{"name":225,"class":81},228,{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":54,"minAge":18,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":58,"phases":629,"briefSummary":630,"conditions":631,"keywords":634,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":641},"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":628,"type":21},2400,[61],"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",[542,632,633],"Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[479,480,481],{"date":34,"type":37},{"date":637,"type":37},"2025-06-30",{"date":639,"type":21},"2034-12-29",{"name":225,"class":81},321,""]