[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Netherlands\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,2081,0,25,[9,47,71,100,131,155,188,218,247,269,297,339,375,394,409,430,456,479,504,526,565,591,612,635,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644059","phase-1-a-study-to-investigate-the-safety-tolerability-and-pk-of-ab102-in-healthy-participants-100644059",false,"NCT07662057","A Study to Investigate the Safety, Tolerability, and PK of AB102 in Healthy Participants","A Double-Blind, Randomized, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose First-In-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AB102 in Healthy Participants","Inclusion Criteria:\n\n* Understands the study procedures in the Informed Consent Form and is willing and able to comply with the protocol.\n* BMI: 19.0 to 30.0 kg\u002Fm2, inclusive, at screening.\n* All prescribed medication must have been stopped at least 30 days prior to admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.\n* Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG, vital signs, and complete neurological examination, as judged by the Investigator.\n* Participants must follow protocol-specified contraception guidance.\n\nExclusion Criteria:\n\n* Have a history of relevant atopy, drug hypersensitivity and\u002For food allergies.\n* Using tobacco products within 3 months prior to the screening.\n* Have a significant infection or known inflammatory process on screening or admission.\n* Have received any vaccination within 14 days of admission date for non-live vaccines or 28 days of admission date for live attenuated vaccines.\n* History of alcohol abuse or drug addiction in the last 2 years (including soft drugs like cannabis products).\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":22,"type":23},130,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).",[29],"Healthy Volunteers",[31,32,33],"AB102","Healthy Volunteer","MRGPRX2 inhibitor","RECRUITING","2026-08-24",{"date":37,"type":38},"2026-08-25","ACTUAL",{"date":40,"type":38},"2026-07-09",{"date":42,"type":23},"2026-12",{"name":44,"class":45},"Arcus Biosciences, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":57,"type":23},500,[59],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[62],"Amyotrophic Lateral Sclerosis",{"date":37,"type":38},{"date":65,"type":38},"2026-02-01",{"date":67,"type":23},"2029-03",{"name":69,"class":45},"Prilenia",56,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100616972","occurrence-of-abdominal-aortic-aneurysms-in-patients-with-aneurysmal-subarachnoid-hemorrhage-100616972","NCT07312565","Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage","The Occurrence of Abdominal Aortic Aneurysms in Patients With Ruptured Intracranial Aneurysms","TRACE-aSAH","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n* Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)\n* Inclusion at least one year after aSAH\n* Written informed consent\n\nBy being a study subject of the SPARTA trial, the following criteria are applicable:\n\n* Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)\n* IA related SAH as confirmed with radiological imaging\n* Age 18 years or older at presentation\n* Written informed consent for the SPARTA-trial\n\nExclusion Criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Patient is not a study subject of the SPARTA trial\n* Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome",{"count":80,"type":23},233,"OBSERVATIONAL","Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described. Screening for aortic aneurysms (AA) in patients with intracranial aneurysms (IA) or aneurysmal subarachnoid haemorrhage (aSAH) could be cost-effective and of significant importance to decrease morbidity and mortality. The available literature on the association between the two types of aneurysms is sparse and in general of poor methodological quality. This protocol presents a study to more adequately evaluate the association between IA and AA.\n\nObjective: To investigate the occurrence of abdominal aortic aneurysms (AAA) in patients who experienced aSAH.\n\nStudy design: This single cohort prospective study will include patients who experienced aSAH. The study participants will receive an abdominal ultrasound of the aorta to detect an AAA.\n\nStudy population: aSAH patients from a prospective cohort trial in the Netherlands.\n\nMain study parameters\u002Fendpoints: The primary outcome, which will be investigated in the here above described study population, is the number of AAA detected on abdominal ultrasound.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will not receive an intervention, but only a diagnostic imaging without radiation. The burden associated with this study are considered minimal and the risks negligible. An abdominal ultrasound is a non-invasive diagnostic method with no risks for the participant. The only possible existing burden to the participant is travel and appointment time with a risk of detecting an abdominal aortic aneurysm or other (occult) intra-abdominal pathologies. When an aneurysm, sub-aneurysm or other intra-abdominal pathology is detected, surveillance or treatment according to standard of care and guidelines will follow.",[84,85],"Aneurysm Abdominal","Cerebral Aneurysm Ruptured",[87,88,89,90,91],"abdominal aortic aneurysm","aneurysmal subarachnoid hemorrhage","ruptured intracranial aneurysm","prospective single cohort study","ultrasound",{"date":37,"type":38},{"date":94,"type":38},"2026-06-01",{"date":96,"type":23},"2026-12-01",{"name":98,"class":99},"Leiden University Medical Center","OTHER",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100610417","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-belantamab-mafodotin-in-combination-with-standard-of-care-in-participants-with-relapsed-refractory-multiple-myeloma-rrmm-100610417","NCT07227311","A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)","A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)","Inclusion Criteria:\n\n• Participants are eligible to be included in the study only if all of the following criteria apply:\n\nApplicable to All Arms - BPd, BVd, BKd:\n\n* Male or female, 18 years or older (at the time consent is obtained).\n* Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.\n* Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.\n* Must have at least 1 aspect of measurable disease, defined as one the following:\n\n  1. Urine M-protein excretion ≥200 mg\u002F24 h, or\n  2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n  3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C0.26 or \\>1.65) only if patient has no measurable urine or serum M spike.\n* Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  1. ASCT was \\>100 days prior to the first dose of study medication,\n  2. No active bacterial, viral, or fungal infection(s) present.\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.\n* Adequate organ system functions as defined by the laboratory assessments.\n* Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.\n* Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.\n\nSpecific Inclusion Criteria for BPd arm:\n\n• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nApplicable for all (BPd, BVd, BKd):\n\n* Active plasma cell leukemia at Screening.\n* Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).\n* Previous or concurrent invasive malignancy other than MM, except:\n\n  1. The disease must be considered medically stable for at least 2 years; or\n  2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.\n* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n* Plasmapheresis within 7 days prior to the first dose of study intervention.\n* Patients after prior allogeneic stem cell transplant\n* Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.\n* Evidence of active mucosal or internal bleeding.\n* Intolerance or contraindications to anti-viral prophylaxis.\n* Current corneal epithelial disease except for mild punctate keratopathy.\n* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n* Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria\n* Received prior B-cell maturation antigen (BCMA)-targeted therapy.\n* Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.\n* HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.\n* Significant liver dysfunction (ALT \\>2.5x ULN, bilirubin \\>1.5x ULN, cirrhosis, unstable liver\u002Fbiliary disease).\n* Positive hepatitis B or C markers unless criteria for resolved infection are met.\n* Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI\u002FACS\u002Fangioplasty\u002Fbypass, NYHA III\u002FIV heart failure, uncontrolled hypertension, QTc prolongation.\n\nSpecific Exclusion Criteria for BPd Arm:\n\n* Received prior treatment with or intolerant to pomalidomide.\n* Active or history of venous and arterial thromboembolism within the past 3 months.\n\nSpecific Exclusion Criteria for BVd Arm:\n\n* Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg\u002Fm² twice weekly or within 60 days of completing that treatment).\n* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n\nSpecific Exclusion Criteria for BKd Arm:\n\n* Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).\n* Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.\n* Left ventricular ejection fraction \\\u003C40% as assessed by transthoracic echocardiogram.\n* Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.\n* Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n* Known pulmonary hypertension.",{"count":108,"type":23},200,[110],"PHASE2","This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.\n\nThe main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.",[113],"Multiple Myeloma",[115,116,117,118,119,120,121,122],"Relapsed-Refractory Multiple Myeloma","DREAMM-15","Belantamab Mafodotin","Blenrep","Pomalidomide","Bortezomib","Carfilzomib","Dexamethasone",{"date":37,"type":38},{"date":125,"type":38},"2026-04-15",{"date":127,"type":23},"2030-08-30",{"name":129,"class":45},"GlaxoSmithKline",59,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":142,"type":23},150,[59],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[146],"Diabetes Mellitus, Type 1",{"date":37,"type":38},{"date":149,"type":38},"2026-01-12",{"date":151,"type":23},"2031-07",{"name":153,"class":45},"Eli Lilly and Company",113,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"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":57,"type":23},[110,59],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[166],"Non-Small Cell Lung Cancer",[168,169,170,171,172,173,174,175,176,177,178,179],"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":37,"type":38},{"date":182,"type":38},"2025-11-05",{"date":184,"type":23},"2030-11-15",{"name":186,"class":45},"Bristol-Myers Squibb",186,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":24,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"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":197,"type":23},590,[110,59],"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",[201],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[203,204,205,206,207,208,209,210],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":37,"type":38},{"date":213,"type":38},"2026-01-02",{"date":215,"type":23},"2031-08-12",{"name":186,"class":45},320,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":24,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":227,"type":23},210,[110],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[231],"Graves' Disease",[233,234,235,236,237,238],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":37,"type":38},{"date":241,"type":38},"2025-06-19",{"date":243,"type":23},"2027-05",{"name":245,"class":45},"Immunovant Sciences GmbH",163,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":22},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":57,"type":23},[256],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[259,260,261],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":37,"type":38},{"date":264,"type":38},"2023-12-27",{"date":266,"type":23},"2029-08",{"name":268,"class":45},"Orchestra BioMed, Inc",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":296},"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":277,"type":23},626,[110,59],"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.",[281,282],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[284,285,205,282,286,287,288],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":37,"type":38},{"date":291,"type":38},"2020-12-02",{"date":293,"type":23},"2029-10-31",{"name":295,"class":45},"Mirati Therapeutics Inc.",770,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":24,"phases":307,"briefSummary":309,"conditions":310,"keywords":316,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":306,"type":23},100,[308],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[311,312,313,314,315],"Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma",[317,318,319,320,321,311,322,323,324,325,326,312,327,328,329,330,315],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":37,"type":38},{"date":333,"type":38},"2018-01-26",{"date":335,"type":23},"2032-12-28",{"name":337,"class":45},"Novartis Pharmaceuticals",33,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":349,"studyType":81,"phases":4,"briefSummary":350,"conditions":351,"keywords":362,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":46},"100653141","efficacy-of-irreversible-electroporation-ire-for-treating-recurrent-pelvic-tumors-pelfire-study-100653141","NCT07782164","Efficacy of Irreversible Electroporation (IRE) for Treating Recurrent Pelvic Tumors (PELFIRE Study)","Irreversible Electroporation (IRE) of Recurrent Pelvic Tumors: the PELFIRE Study.","PELFIRE","Inclusion Criteria:\n\n* Measurable disease described on pre-treatment imaging (CT\u002FMRI\u002FPET-CT) (max 6 weeks prior);\n* IRE of a recurrent pelvic tumor;\n* Unsuitable for other local therapies (surgery\u002Fstereotactic body radiation therapy) as described during the multidisciplinary tumor board;\n\nExclusion Criteria:\n\n* If the treated tumor was biopsied directly prior to MWA and pathology proves the lesion to represent a benign entity;\n* Inadequate or insufficient data registered;\n* Inadequate or insufficient follow-up;",{"count":348,"type":23},27,"5 Years","The goal of this single-center observational cohort study, based on a registry combining retrospectively and prospectively collected data, is to investigate the short- and long-term effects of irreversible electroporation (IRE) in men and women over the age of 18 who receive IRE for recurrence of pelvic tumors not suitable for other local treatment options such as surgery, thermal ablation, and radiotherapy. The main question it aims to answer is whether IRE is safe in this population, and secondarily, whether it is effective in controlling local tumor recurrence.",[352,353,354,355,356,357,358,359,360,361],"Colorectal Carcinoma","Pelvic Cancer","Pelvic Tumor Recurrence","Renal Cancer","Bladder Cancer","Cervical Cancer","Prostate Cancer","Ovarian Cancer","Lung Cancer (Including Metastatic Cancer)","Anal Cancer",[363,352,364,365,366,354],"Irreversible electroporation (IRE)","Local treatment","Tumor Ablation","Neoplasm Recurrence","2026-08-21",{"date":35,"type":38},{"date":370,"type":38},"2025-04-18",{"date":372,"type":23},"2028-07",{"name":374,"class":99},"Amsterdam UMC, location VUmc",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":382,"targetDuration":4,"studyType":24,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},"100636862","phase-1-a-master-protocol-olmp-a-study-of-ly4256984-in-participants-with-amyotrophic-lateral-sclerosis-als-100636862","NCT07571200","A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period\u002Fphase of the parent study as well as any off-treatment period\u002Fphase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.",{"count":383,"type":23},32,[26],"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.",[62],{"date":35,"type":38},{"date":389,"type":38},"2026-05-14",{"date":391,"type":23},"2029-06",{"name":153,"class":45},10,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":401,"targetDuration":4,"studyType":24,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":407,"leadSponsor":408,"locationsCount":393},"100636860","phase-1-a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosis-100636860","NCT07571174","A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period\u002Fphase as well as any off-treatment period\u002Fphase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and\u002For back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\\u003C100 GI\u002FL) is equivalent to 100,000 per cubic millimeter (100,000\u002Fmm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.",{"count":383,"type":23},[26],"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.",[62],{"date":35,"type":38},{"date":389,"type":38},{"date":391,"type":23},{"name":153,"class":45},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":24,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":429},"100633924","phase-2-a-study-of-ly4005130-in-adult-participants-with-severe-alopecia-areata-hair-loss-100633924","NCT07533006","A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)","A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate Efficacy and Safety of LY4005130 in Adult Participants With Severe Alopecia Areata","Inclusion Criteria:\n\n* Have severe Alopecia Areata (AA) that meets all of the following criteria:\n\n  * Hair loss encompassing ≥50% and ≤90% of the scalp, as measured by Severity of Alopecia Tool (SALT) score\n  * The duration of the current episode of severe AA is at least 6 months and does not exceed 4 years\n  * No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months\n  * Agree not to use any AA treatments during the study\n\nExclusion Criteria:\n\n* Primarily \"diffuse\" type of AA (characterized by diffuse hair shedding)\n* Are currently experiencing other forms of alopecia\n* Participants who, in the opinion of the investigator, are currently experiencing or have a history of unstable concomitant disease that requires frequent hospitalizations, and\u002For frequent use of systemic immunosuppressants that may interfere with participation in the study\n* Have received oral JAK Inhibitors in the past\n* Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study\n* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and\u002For unstable illness","50 Years",{"count":418,"type":23},60,[110],"The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last approximately 48 weeks, including screening.",[422],"Alopecia Areata",{"date":35,"type":38},{"date":425,"type":38},"2026-04-14",{"date":427,"type":23},"2027-10",{"name":153,"class":45},30,{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":416,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":24,"phases":439,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"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",{"count":438,"type":23},7140,[59],"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.",[442,443],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[445,446,447,448],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":35,"type":38},{"date":451,"type":38},"2025-12-01",{"date":453,"type":23},"2031-08",{"name":153,"class":45},567,{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":464,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":24,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":478},"100605586","phase-3-a-study-of-pasritamig-versus-placebo-in-late-line-metastatic-castration-resistant-prostate-cancer-mcrpc-100605586","NCT07164443","A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)","A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T Cell Engaging Agent Targeting Human Kallikrein 2, With or Without JNJ-87189401, a PSMA-CD28 Costimulatory Agent, Plus Best Supportive Care Versus Best Supportive Care for Late-line Metastatic Castration-resistant Prostate Cancer","KLK2-comPAS","Inclusion Criteria\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of other metastatic sites at the time of screening by conventional imaging with computed tomography (CT) or magnetic resonance imaging (MRI) (chest, abdomen, and pelvis) and 99m\\^Tc bone scan. Visceral disease is not allowed\n* PSA greater than or equal to (≥) 2 nanogram per milliliter (ng\u002FmL) at screening\n* In the opinion of the investigator, the next best treatment option is a clinical trial\n* Participants are required to have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following:\n\nAndrogen-receptor pathway inhibitor (ARPI): Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI\n\nTaxanes: Required to have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if:\n\n1. Cabazitaxel is not available\n2. The participant's physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period\n\nRadioligand therapy: Required to have been previously treated with at least 1 dose of Prostate-specific membrane antigen (PSMA)-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies:\n\n1. PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated.\n2. The participant's physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy.\n\nPolyadenosine diphosphate-ribose polymerase inhibitors (PARPi): Required to have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available\n\n* Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog \\[agonist or antagonist\\]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Participants are eligible if they have the following values:\n\nA) eGFR ≥ 40 milliliters per minute (mL\u002Fmin) B) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to (≤) 3 times the Upper Limit of Normal (ULN) C) Total bilirubin \\\u003C1.5 times ULN D) Absolute neutrophil count (ANC) ≥ 1.0x10\\^9\u002Fper liter (L) E) Hemoglobin ≥ 8.0 grams per deciliter (g\u002FdL) F) Platelet count ≥ 75x10\\^9\u002FL\n\nExclusion Criteria\n\n* Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤ 2) deep vein thrombosis is not exclusionary\n* Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)\n* Participants with Grade 1 or higher fever (≥38ºC) or active infection requiring systemic treatment within 7 days prior to randomization are ineligible. Participants must be afebrile (\\\u003C38ºC) at the time of study treatment dosing unless approved by medical monitor\n* Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (\\>2 liters per minute (L\u002Fmin) by nasal cannula) to maintain adequate oxygenation\n* Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Any of the following within 6 months prior to first dose of study treatment:\n\nA) Myocardial infarction B) Severe or unstable angina C) Clinically significant ventricular arrhythmias D) Congestive heart failure (New York Heart Association class II to IV) E) Transient ischemic attack F) Cerebrovascular accident\n\n\\- Prior treatment with any CD3-directed therapy","MALE",{"count":466,"type":23},1203,[59],"The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).",[470],"Metastatic Castration-resistant Prostatic Neoplasms",{"date":37,"type":38},{"date":473,"type":38},"2025-09-02",{"date":475,"type":23},"2028-08-18",{"name":477,"class":45},"Janssen Research & Development, LLC",173,{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":17,"sex":18,"minAge":486,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":24,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100605263","phase-3-beatrix-a-study-to-learn-about-a-group-b-streptococcus-vaccine-in-healthy-pregnant-women-and-their-babies-100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details","1 Day","49 Years",{"count":489,"type":23},6000,[59],"BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[493],"Healthy",[495],"group B streptococcus, maternal immunization, vaccine",{"date":35,"type":38},{"date":498,"type":38},"2025-08-25",{"date":500,"type":23},"2029-03-02",{"name":502,"class":45},"Pfizer",206,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":24,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100598128","phase-3-a-study-of-orelabrutinib-in-patients-with-primary-progressive-multiple-sclerosis-100598128","NCT07067463","A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","60 Years",{"count":513,"type":23},705,[59],"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[517],"Multiple Sclerosis (MS) Primary Progressive",{"date":35,"type":38},{"date":520,"type":38},"2026-03-23",{"date":522,"type":23},"2030-07",{"name":524,"class":45},"Zenas BioPharma (USA), LLC",48,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100593979","a-study-to-learn-about-the-study-medicine-ibuzatrelvir-in-adults-with-covid-19-who-are-severely-immunocompromised-100593979","NCT07013474","A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED","Inclusion Criteria:\n\n1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19\n2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.\n3. Severely immunocompromised due to:\n\n   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;\n   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);\n   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;\n   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.\n\nExclusion Criteria:\n\n1. Severe or critical COVID-19, or current need for supplemental oxygen.\n2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \\\u003C15 mL\u002Fmin)\n3. Active liver disease\n4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n8. Has received any other antiviral for the treatment of the current COVID-19 infection\n9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n11. Prior participation in this trial or any clinical trial of ibuzatrelvir.\n12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":534,"type":23},300,[59],"This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate COVID-19.",[538],"COVID-19 Infection",[540,541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557],"COVID-19 infection","pneumonia","respiratory tract infections","coronavirus infection","RNA virus infection","lung disease","pneumonia, viral","infections","virus","viral protease inhibitor","protease inhibitor","enzyme inhibitor","severe immunocompromise","anti-viral agents","anti-infectives","ibuzatrelvir","remdesivir","COVID-19",{"date":37,"type":38},{"date":560,"type":38},"2025-07-14",{"date":562,"type":23},"2028-02-25",{"name":502,"class":45},152,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":24,"phases":574,"briefSummary":575,"conditions":576,"keywords":582,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":46},"100587060","phase-2-neoadjuvant-gemcitabine-and-cisplatin-in-combination-with-perioperative-pembrolizumab-versus-upfront-surgery-for-patients-with-primary-resectable-and-borderline-resectable-perihilar-and-distal-cholangiocarcinoma-100587060","NCT06923475","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma","Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma (NEODISCO): A Multicentre Phase 2B\u002F3 Randomized Controlled Trial","NEODISCO","Inclusion Criteria:\n\n* Histologically or cytologically confirmed resectable or borderline resectable pCCA and dCCA. These are all the patients considered candidates for upfront surgical exploration, with intent to resect, as confirmed by local MDT and the study expert panel also taking into consideration endoscopic and radiological findings. In cases where drainage is not required, patients with a disease highly suspicious for extrahepatic cholangiocarcinoma, as determined by the expert MDT, may be included without histological proof to prevent unnecessary post-ERCP complications.\n* Successful drainage, in case of clinical significant bile duct obstruction.\n* MidCCA inclusion in the NEODISCO-trial will be permitted and will be included according to the proposed type of resection.\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n\nExclusion Criteria:\n\n* Upfront \"clearly\" unresectable pCCA: circumferential unreconstructable vascular involvement of the FLR and\u002For insufficient FLR for potential radical resection. Insufficient FLR is defined as \\\u003C30% residual volume or a function \\\u003C2.7 min\u002Fm2. Patients considered borderline resectable but, by the discretion of the MDT, not a candidate for upfront exploration\u002Fresection, are considered ineligible for NEODISCO.\n* Upfront clearly unresectable dCCA (following DPCG criteria).\n* Patients with proven N2 lymph nodes (according to the AJCC 8th edition).\n* PCCA eligible for liver transplantation.\n* Intrahepatic cholangiocarcinoma with hilar involvement.\n* Cancer suspicious for ampullary carcinoma (for instance involvement of papilla during endoscopy).\n* Local recurrence following prior resection of eCCA (patients who develop local recurrence during the study are however not excluded).\n* Patients with underlying liver diseases: PSC, untreated hepatitis, cirrhosis child-Pugh B, C.\n* Previous malignancy unless no evidence of disease, or diagnosed more than 3 years before diagnosis of eCCA, or with a life expectancy of more than 5 years from date of inclusion.\n* Has 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 co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).",{"count":142,"type":23},[110,59],"Extrahepatic cholangiocarcinoma (eCCA) is a rare and aggressive cancer with poor prognosis. ECCA can be further subcategorised in perihilar and distal cholangiocarcinoma (pCCA and dCCA). Surgical resection is the only potential cure, but only one-third of patients are eligible. Even among those deemed resectable, a significant portion (≈30%) experience disease progression before surgery, while another 30% are found unresectable during exploration. High recurrence rates and postoperative complications further limit survival, with 5-year overall survival ranging from 13% (R1 resection) to 40% (R0 resection). Given the long preoperative work-up period and lack of treatment during this phase, a neoadjuvant approach may improve outcomes by increasing R0 resections, reducing recurrence, and optimizing patient selection.\n\nThis multicenter, randomized phase 2B\u002F3 trial aims to assess whether neoadjuvant gemcitabine and cisplatin plus perioperative pembrolizumab improves event-free survival in patients with resectable and borderline resectable pCCA and dCCA.",[577,578,579,580,581],"Extrahepatic Cholangiocarcinoma","Perihilar Cholangiocarcinoma","Distal Cholangiocarcinoma","Resectable","Borderline Resectable",[583,578,579,580,584],"Extrahepatic cholangiocarcinoma","Borderline resectable",{"date":37,"type":38},{"date":587,"type":38},"2026-04-17",{"date":589,"type":23},"2028-11-06",{"name":374,"class":99},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":24,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":611},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":600,"type":23},700,[59],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[604],"Carcinoma, Non-Small-Cell Lung",{"date":35,"type":38},{"date":607,"type":38},"2025-03-27",{"date":609,"type":23},"2032-02",{"name":153,"class":45},369,{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":24,"phases":622,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":22},"100581158","phase-3-a-study-of-bgb-16673-compared-to-investigators-choice-in-participants-with-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-previously-exposed-to-both-bruton-tyrosine-kinase-btk-and-b-cell-leukemialymphoma-2-protein-bcl2-inhibitors-100581158","NCT06846671","A Study of Tacabrutideg (BGB-16673) Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia\u002FLymphoma 2 Protein (BCL2) Inhibitors","A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors","CaDAnCe-302","Inclusion Criteria:\n\n1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.\n2. Previously received treatment for CLL\u002FSLL with both a BTKi and a BCL2i.\n3. Participants with SLL must have measurable disease by computer tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2\n5. Adequate liver function\n6. Adequate blood clotting function\n\nExclusion Criteria:\n\n1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation\n2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months\n3. Known central nervous system involvement\n4. Prior exposure to any BTK protein degraders\n5. Active fungal, bacterial and\u002For viral infection requiring parenteral systemic therapy\n6. Clinically significant cardiovascular disease\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":621,"type":23},250,[59],"The purpose of this study is to investigate the efficacy and safety of tacabrutideg compared with investigator's choice (idelalisib plus rituximab \\[for CLL only\\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).",[625,626],"CLL","Chronic Lymphocytic Leukemia",[625],{"date":35,"type":38},{"date":630,"type":38},"2025-04-10",{"date":632,"type":23},"2030-02-14",{"name":634,"class":45},"BeOne Medicines",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":642,"phases":4,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":646,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":647,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":648,"locationsCount":429},"100577366","expanded-access-program-of-zidesamtinib-nvl-520-for-patients-with-advanced-ros1-nsclc-or-other-ros1-solid-tumors-100577366","NCT06797362","Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors","Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement.\n3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.\n4. Enrollment in a clinical trial of zidesamtinib is not possible.\n5. Adequate organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Prior receipt of zidesamtinib.\n2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.\n3. Ongoing anti-cancer therapy.\n4. Eligible for ongoing clinical trial with zidesamtinib","EXPANDED_ACCESS","The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib. Following FDA Approval of zidesamtinib on 22 July 2026, the Expanded Access Program is closed in the United States (US); however, it remains open at all non-US sites listed on ClinicalTrials.gov.",[312,645],"ROS1-positive Non-Small Cell Lung Cancer (NSCLC)","AVAILABLE",{"date":37,"type":38},{"name":649,"class":45},"Nuvalent Inc.",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":24,"phases":660,"briefSummary":661,"conditions":662,"keywords":665,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":678},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":659,"type":23},450,[59],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[663,664],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[205,204,666,667,668,669,670,671],"Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":37,"type":38},{"date":674,"type":38},"2025-07-17",{"date":676,"type":23},"2029-12",{"name":649,"class":45},158,""]