[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Switzerland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":694},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1583,0,25,[9,41,66,87,109,135,164,196,218,240,275,297,330,358,381,415,448,475,505,527,555,578,616,636,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054056","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100054056",false,"NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","ALL","12 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[27],"Proteinuric Kidney Diseases","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-03-23",{"date":36,"type":21},"2028-02-17",{"name":38,"class":39},"Boehringer Ingelheim","INDUSTRY",161,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE","18 Years",{"count":51,"type":21},1440,[53],"PHASE3","Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[56,57],"Prostate Cancer","Prostatic Neoplasms",{"date":31,"type":32},{"date":60,"type":32},"2025-05-13",{"date":62,"type":21},"2031-01-06",{"name":64,"class":39},"Merck Sharp & Dohme LLC",290,{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100054181","patient-retrospective-outcomes-pro-100054181","NCT01550575","Patient Retrospective Outcomes (PRO)","PRO","Key Inclusion Criteria:\n\n* Previously treated with or eligible for use with Boston Scientific Systems\n* 18 years of age or older at the start of Baseline",{"count":74,"type":21},15000,"OBSERVATIONAL","This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.",[78],"Chronic Pain",{"date":31,"type":32},{"date":81,"type":32},"2012-04-03",{"date":83,"type":21},"2030-12",{"name":85,"class":39},"Boston Scientific Corporation",144,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100053627","phase-3-a-study-to-test-the-efficacy-and-safety-of-riliprubart-against-the-usual-treatment-of-intravenous-immunoglobulin-ivig-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100053627","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":96,"type":21},160,[53],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[100],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":31,"type":32},{"date":103,"type":32},"2024-08-21",{"date":105,"type":21},"2029-01-12",{"name":107,"class":39},"Sanofi",129,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100053362","phase-1-a-study-of-inlexisertib-dcc-3116-in-combination-with-anticancer-therapies-in-participants-with-advanced-malignancies-100053362","NCT05957367","A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies","A Master Protocol for the Multi-Cohort, Phase 1\u002F2 Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Module A: Part 1 and Part 2:\n\nModule A Part 1 and Part 2 inlexisertib combination closed on January 8, 2024, with no participants enrolled.\n\n* Module B: Only for Part 1 (Safety\u002FDose-finding):\n\n  * Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation\n  * Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it\n  * Must not have received prior ripretinib treatment\n* Module B: Only for Part 2 (Expansion)\n\n  * Pathologically confirmed GIST with documented mutation in KIT exon 11\n  * Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST\n* Must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST)\n* Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1\n* Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening\n* Must provide a fresh tumor biopsy, if able\n\nExclusion Criteria:\n\n* Must not have received the following within the specified time periods prior to the first dose of study drug:\n\n  1. Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer)\n  2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter)\n  3. Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days\n  4. Grapefruit or grapefruit juice: 14 days\n* Have not recovered from all clinically relevant toxicities from prior therapy\n* New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug\n* Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease\n* Malabsorption syndrome\n* Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug\n* Major surgery within 4 weeks of the first dose of study drug\n* Active HIV, Hepatitis B or Hepatitis C infection",{"count":117,"type":21},94,[119,24],"PHASE1","This is a Phase 1\u002F2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of inlexisertib in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of inlexisertib with other anticancer agents.",[122],"GIST",[124,125,126],"Advanced gastrointestinal stromal tumors","gastrointestinal stromal tumors","ripretinib",{"date":31,"type":32},{"date":129,"type":32},"2023-09-28",{"date":131,"type":21},"2029-03",{"name":133,"class":39},"Deciphera Pharmaceuticals, LLC",27,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":161,"locationsCount":163},"100053355","study-of-the-use-of-venetoclax-in-participants-with-chronic-lymphocytic-leukemia-cll-under-real-life-setting-100053355","NCT03342144","Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting","Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland","VeRVe","Inclusion Criteria:\n\n\\- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.\n\nExclusion Criteria:\n\n\\- None",{"count":144,"type":21},500,"An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.",[147],"Chronic Lymphocytic Leukemia (CLL)",[147,149,150,151,152,153,154,155,156],"Cancer","Leukemia","venetoclax","rituximab","obinutuzumab","ABT-199","venclexta","venclyxto",{"date":31,"type":32},{"date":159,"type":32},"2017-12-04",{"date":83,"type":21},{"name":162,"class":39},"AbbVie",70,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100053250","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100053250","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":173,"type":21},450,[53],"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).",[177,178],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[180,181,182,183,184,185,186,187],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":31,"type":32},{"date":190,"type":32},"2025-07-17",{"date":192,"type":21},"2029-12",{"name":194,"class":39},"Nuvalent Inc.",156,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100054283","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":204,"type":21},1046,[53],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[208],"Diffuse Large B-Cell Lymphoma",[210],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":32},{"date":213,"type":32},"2025-01-27",{"date":215,"type":21},"2032-03-29",{"name":64,"class":39},266,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100053298","phase-1-a-study-evaluating-the-safety-activity-and-pharmacokinetics-of-divarasib-as-a-single-agent-or-in-combination-with-other-anti-cancer-therapies-in-participants-with-previously-untreated-advanced-or-metastatic-non-small-cell-lung-cancer-with-a-kras-g12c-mutation-100053298","NCT05789082","A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","A Phase Ib\u002FII, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","KRAScendo 170","Inclusion Criteria:\n\n* Confirmation of Biomarker eligibility\n* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy\n* No prior systemic treatment for advanced unresectable or metastatic NSCLC\n* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.\n\nExclusion Criteria:\n\n* Known concomitant second oncogenic driver with available targeted treatment\n* Squamous cell histology NSCLC\n* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)\n* Prior treatment with a KRAS G12C inhibitor\n* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment\n* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia\n* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids\n* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.\n* Participants with brain metastases for whom complete surgical resections is clinically appropriate",{"count":227,"type":21},320,[119,24],"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).",[231],"Non-Small Cell Lung Cancer",{"date":31,"type":32},{"date":234,"type":32},"2023-06-20",{"date":236,"type":21},"2032-01-29",{"name":238,"class":39},"Hoffmann-La Roche",71,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":274},"100054096","phase-2-a-trial-to-evaluate-multiple-regimens-in-newly-diagnosed-and-recurrent-glioblastoma-100054096","NCT03970447","A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma","GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II\u002FIII Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM","GBM AGILE","Newly Diagnosed Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.\n* Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from definitive surgery or biopsy.\n\nRecurrent Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).\n* Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.\n* Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.\n* Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from initial definitive surgery and\u002For, recurrent surgery, if performed.\n\nNewly Diagnosed Exclusion Criteria:\n\n* Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n\nRecurrent Exclusion Criteria:\n\n* Early disease progression prior to 3 months (12 weeks) from the completion of RT.\n* More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)\n* Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.\n* Any prior treatment with prolifeprospan 20 with carmustine wafer.\n* Any prior treatment with an intracerebral agent.\n* Receiving additional, concurrent, active therapy for GBM outside of the trial\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\\u003C 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.",{"count":249,"type":21},2250,[24,53],"Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II\u002FIII response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.\n\nAll institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\\*).",[253],"Glioblastoma",[253,255,256,257,258,259,260,261,262,263,264,265],"Newly diagnosed","recurrent","O6-methylguanine-DNA-methyltransferase (MGMT) methylated","MGMT unmethylated","isocitrate dehydrogenase (IDH) wild-type","Bayesian","adaptive randomization","Master Protocol","Platform Trial","Phase 2","Phase 3",{"date":31,"type":32},{"date":268,"type":32},"2019-07-30",{"date":270,"type":21},"2030-06",{"name":272,"class":273},"Global Coalition for Adaptive Research","OTHER",63,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":285,"type":21},1200,[53],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[289],"Crohn's Disease",{"date":31,"type":32},{"date":292,"type":32},"2024-06-05",{"date":294,"type":21},"2029-11-12",{"name":64,"class":39},499,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100053454","phase-3-a-study-to-investigate-the-efficacy-safety-and-tolerability-of-votoplam-in-participants-with-huntingtons-disease-100053454","NCT07326709","A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease","A Randomized, Placebo-controlled, Double-blind Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease","INVEST-HD","Inclusion Criteria:\n\n* Signed informed consents must be obtained prior to participation in the study\n* Ambulatory male or female participants between 21 to 70 years of age, inclusive, on the day of Informed Consent signature\n* Genetically confirmed HD diagnosis with a cytosine-adenine-guanine (CAG) repeat length of 40 or above. Participants must have prior genetic confirmation and known CAG repeat length obtained prior to screening.\n* Meets all of the following criteria:\n\n  * UHDRS IS score ≥90\n  * UHDRS TFC score = 13\n  * UHDRS TMS score = 7-25, inclusive\n  * CAP100 ≥ 70 Calculation: CAP = Age at study entry × (CAG length - 30) \u002F 6.49\n\nExclusion Criteria:\n\n* History of gene therapy or cell transplantation or any other experimental brain surgery for the treatment of HD\n* Serologic evidence for active viral hepatitis as indicated by:\n\n  * positive anti-HBc IgM\n  * positive anti-HBc IgG confirmed by positive HBsAg and\u002For HBV DNA\n  * positive HCV ab test confirmed by positive HCV RNA\n  * Immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result\n* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:\n\n  * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker\n  * History of familial long QT syndrome or known family history of Torsade de Pointes\n* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment.\n\n  o WOCBP are excluded unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for 8 months after stopping study treatment.\n* Pregnant or nursing (breastfeeding) women\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply","21 Years","70 Years",{"count":308,"type":21},770,[53],"The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntington's disease (HD) compared to the control arm.\n\nHTT227 - current compound code (former code is PTC518 from PTC Therapeutics), HTT227 is Novartis code under Novartis sponsorship.",[312],"Huntington Disease",[314,303,315,316,317,318,319,320],"HD","HTT227","VOTOPLAM","HUNTINGTON DISEASE","UHDRS","mHTT","NfL","2026-07-09",{"date":31,"type":32},{"date":324,"type":32},"2026-03-24",{"date":326,"type":21},"2030-04-30",{"name":328,"class":39},"Novartis Pharmaceuticals",41,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100053717","phase-3-study-of-efficacy-and-safety-of-iptacopan-in-participants-with-ic-mpgn-100053717","NCT05755386","Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)","APPARENT","Inclusion Criteria:\n\n* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).\n* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization\n* UPCR ≥ 1.0 g\u002Fg (≥ 113 mg\u002Fmmol) sampled from the first morning void urine sample at Day -75 and Day -15\n* Estimated GFR (using the chronic kidney disease \\[CKD\\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.\n* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.\n\nExclusion Criteria:\n\n* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.\n* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:\n* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including\n\n  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);\n  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections\n  * Protozoa\u002Fother infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis\n\nRenal deposition of immune complexes as a result of a systemic autoimmune disease:\n\n* Systemic lupus erythematosus (SLE)\n* Sjögren syndrome\n* Rheumatoid arthritis\n* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n\nFibrillary glomerulonephritis\n\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.\n* Kidney biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.\n* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.\n* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.\n* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.\n* Body mass index (BMI) \\>38 kg\u002Fm2 at screening and randomization. Body weight \\\u003C35 kg at screening and randomization","60 Years",{"count":340,"type":21},106,[53],"This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.",[344],"IC-MPGN",[346,344,347,348,349,350],"LNP023","iptacopan","UPCR","eGFR","proteinuria",{"date":31,"type":32},{"date":353,"type":32},"2023-10-02",{"date":355,"type":21},"2029-05-31",{"name":328,"class":39},131,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":338,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},"100053840","phase-3-study-of-efficacy-and-safety-of-iptacopan-in-patients-with-c3-glomerulopathy-100053840","NCT04817618","Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.","APPEAR-C3G","Inclusion Criteria:\n\n* Male and female participants age ≥ 12 and ≤ 60 years at screening.\n* Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization.\n* Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.\n* UPCR ≥ 1.0 g\u002Fg sampled from the first morning void urine sample at Day -75 and Day -15.\n* Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.\n* If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated.\n\nExclusion Criteria:\n\n* Participants who have received any cell or organ transplantation, including a kidney transplantation.\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.\n* Renal biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%\n* Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration\n* The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.\n* The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar medication) within 90 days of study drug administration.\n* Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.",{"count":367,"type":21},98,[53],"The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.\n\nThe study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.",[371],"C3G",[346,347,371,348,349,350,373],"Quality of life",{"date":31,"type":32},{"date":376,"type":32},"2021-07-28",{"date":378,"type":21},"2027-01-29",{"name":328,"class":39},87,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100054119","linezolid-plus-standard-of-care-100054119","NCT06958835","Linezolid Plus Standard of Care","Combination Antibiotic Treatment With Linezolid for Staphylococcus Aureus Bacteraemia: a Randomised Controlled Trial","LIPS","Inclusion criteria:\n\n* Staphylococcus aureus (S. aureus) grown from at least one blood culture\n* Hospitalised at a participating centre\n* ≥18 years old\n* Written informed consent or fulfilling criteria for an emergency exception from informed consent requirements\n\nExclusion criteria:\n\n* Administration of the initial drug treatment not feasible within 72 hours since the collection of the first positive blood culture with S. aureus\n* Documented history of positive blood cultures for S. aureus occurring between 72 hours and 180 days prior to the eligibility assessment\n* Necrotising fasciitis\n* Currently receiving linezolid or clindamycin\n* Use of any monoamine oxidase A or B inhibitor within the last two weeks\n* Known hypersensitivity to linezolid or any other ingredients of the study drugs\n* Current severe thrombocytopenia (i.e. \\\u003C30 x 10\\^9\u002FL)\n* Application of study drug not possible (per mouth or per gastric tube)\n* Currently breastfeeding\n* Local treating team believes that death is imminent and inevitable\n* Patient is receiving end of life care and antibiotic treatment is not considered appropriate\n* Local treating team believes that participation in the study is not in the best interest of the patient\n* Any indication that the patient is unwilling to participate in the study including an advance directive stating such unwillingness",{"count":390,"type":21},606,[392],"NA","The aim of the study is to assess whether targeting virulence factors by administering linezolid in addition to standard antibiotic treatment improves outcomes in patients with Staphylococcus aureus bacteraemia.",[395],"Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)",[397,398,399,400,401,402,403,404,405,406],"Virulence factors","Linezolid","Bloodstream Infection","Hierarchical composite endpoint","Staphylococcus aureus","Bacteremia","Bacteraemia","Methicillin-resistant Staphylococcus aureus (MRSA)","Penicillin-susceptible Staphylococcus aureus (PSSA)","Methicillin-susceptible Staphylococcus aureus (MSSA)",{"date":31,"type":32},{"date":409,"type":32},"2025-10-06",{"date":411,"type":21},"2028-10",{"name":413,"class":273},"University Hospital, Basel, Switzerland",12,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":426,"briefSummary":427,"conditions":428,"keywords":430,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100053289","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-remibrutinib-in-secondary-progressive-multiple-sclerosis-100053289","NCT07225504","A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis","REMASTER","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply","65 Years",{"count":425,"type":21},1275,[53],"The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[429],"Secondary Progressive Multiple Sclerosis (SPMS)",[431,432,433,434,435,436,437,438,439,440],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria",{"date":31,"type":32},{"date":443,"type":32},"2025-11-11",{"date":445,"type":21},"2034-01-02",{"name":328,"class":39},236,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":458,"conditions":459,"keywords":463,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100053816","lucinae-registry-thoracic-cancers-during-pregnancy-100053816","NCT07699861","LUCINAE Registry: Thoracic Cancers During Pregnancy","LUCINAE: LUng and Thoracic Cancers In pregNAncy rEgistry","LUCINAE","Inclusion Criteria:\n\n* 1\\. All patients with a diagnosis of thoracic cancer (including lung cancer, mesothelioma, thymic epithelial tumors, neuroendocrine tumors or sarcoma of the thorax and other rare thoracic entities) and pregnancy (positive pregnancy test) including:\n\n  1. Patients receiving a diagnosis of thoracic cancer during pregnancy\n  2. Patients who became pregnant while having active thoracic cancer\n  3. Patients previously treated for a thoracic cancer and becoming pregnant in the 5 years following end of treatment OR Men with a diagnosis of thoracic cancer (including lung cancer, mesothelioma, thymic epithelial tumors, neuroendocrine tumors or sarcoma of the thorax and other rare thoracic entities), who were undergoing active oncological treatment at the time their partner conceived their child.\n* 2\\. Available information about pregnancy outcomes\n* 3\\. Age ≥ 18 years\n\nExclusion Criteria:\n\n* 1\\. Patient missing data about thoracic cancer stage and diagnosis\n* 2\\. For retrospective patients, documented refusal to the use of clinical data for research purposes",{"count":457,"type":21},100,"The LUCINAE Registry is an international, multicenter observational study collecting data on patients with thoracic cancers (including lung cancer) who are expecting a child. This includes women diagnosed during pregnancy, women who become pregnant during or after cancer, and men receiving cancer treatment at the time their partner conceives.\n\nBecause thoracic cancers during pregnancy are rare, there is limited information to guide clinical decisions. This registry aims to describe patient characteristics, diagnostic approaches, treatments, and maternal and fetal outcomes. Data are collected retrospectively and prospectively from participating centers.\n\nThe results of this registry are expected to improve understanding of thoracic cancers in this setting and support the development of future clinical recommendations.",[460,461,462],"Lung Cancer","Thoracic Cancer","Cancer During Pregnancy",[464,465],"thoracic cancers during pregnancy","Lung cancer during pregnancy","2026-07-07",{"date":31,"type":32},{"date":469,"type":21},"2026-06",{"date":471,"type":21},"2035-12",{"name":473,"class":273},"Oncology Institute of Southern Switzerland",4,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":482,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":497,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":504},"100053737","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100053737","NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","75 Years",{"count":484,"type":21},2000,[24],"Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[289,488],"Ulcerative Colitis",[490,491,492,493,494,495,496],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","NOT_YET_RECRUITING",{"date":31,"type":32},{"date":500,"type":21},"2026-07-24",{"date":502,"type":21},"2031-10",{"name":162,"class":39},30,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":526},"100624093","phase-1-a-clinical-trial-of-ifinatamab-deruxtecan-in-people-with-advanced-esophageal-cancer-mk-3475-06f-100624093","NCT07405151","A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L\u002F3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)\n* Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC\n* Has measurable disease\n* If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention\n* Has clinically significant corneal disease\n* Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event\n* If infected with HIV, has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has uncontrolled or significant cardiovascular disease\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 any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has active infection requiring systemic therapy other than those permitted.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen",{"count":513,"type":21},60,[119,24],"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.",[517],"Oesophageal Squamous Cell Carcinoma","2026-07-01",{"date":520,"type":32},"2026-07-02",{"date":522,"type":32},"2026-03-27",{"date":524,"type":21},"2028-06-12",{"name":64,"class":39},19,{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":543,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":554},"100620446","phase-3-a-phase-3-study-of-pelabresib-dak539-and-ruxolitinib-in-myelofibrosis-mf-100620446","NCT07357727","A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)","A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive","MANIFEST-3","Key Inclusion Criteria:\n\n* Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022\n* DIPSS risk category of intermediate-1, intermediate-2 or high-risk\n* Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)\n* Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)\n* Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2\n* Blasts \\\u003C5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening\n* Platelet count ≥ 100 x 10\\^9\u002FL in the absence of growth factors or transfusions for the previous 4 weeks\n\nKey Exclusion Criteria:\n\n* Prior splenectomy at any time or splenic irradiation in the previous 6 months\n* Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization\n* Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation\n* History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment\n* Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer\n* Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":536,"type":21},460,[53],"The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.",[540,541,542],"Primary Myelofibrosis (PMF)","Post-polycythemia Vera Myelofibrosis (PPV-MF)","Post-essential Thrombocythemia Myelofibrosis (PET-MF)",[544,545,546,547],"Pelabresib (DAK539)","Ruxolitinib","Adult participants","Myelofibrosis (MF)",{"date":520,"type":32},{"date":550,"type":32},"2026-05-27",{"date":552,"type":21},"2030-12-27",{"name":328,"class":39},20,{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":48,"minAge":49,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":577},"100603775","phase-1-study-evaluating-the-safety-tolerability-and-efficacy-of-xaluritamig-in-combination-with-androgen-receptor-pathway-inhibitors-in-participants-with-metastatic-hormone-sensitive-prostate-cancer-100603775","NCT07140900","Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer","Inclusion Criteria:\n\n* Participants must have histological, pathological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.\n* Participants must have at the time of diagnosis:\n\n  * De novo (synchronous) mHSPC, defined as metastatic disease with no prior diagnosis of localized prostate cancer, AND started ADT (LHRH agonist\u002Fantagonist or orchiectomy) with or without ARPI (defined as abiraterone OR darolutamide) as SOC, first treatment with ADT should be no longer than 12 weeks before screening. Prior docetaxel treatment is not permitted.\n* Participants must have at the time of diagnosis:\n\n  * High-volume metastatic disease defined as presence of visceral metastasis or metastases, and\u002For ≥ 4 bone metastases with at least one outside of the vertebral column and pelvis.\n* Documented metastatic disease either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast enhanced abdominal\u002Fpelvic\u002Fchest computed tomography (CT) or magnetic resonance imaging (MRI) scan.\n* No documented PSA progression following the initial PSA nadir after starting ADT.\n\nExclusion Criteria:\n\n* Prior history of central nervous system (CNS) metastases. Note: Participants with asymptomatic and clinically stable dural metastases are eligible.\n* Unresolved toxicities from prior anti-tumor therapy (excluding those related to ongoing ADT and ARPI) not having resolved to Common Terminology Criteria for Adverse events (CTCAE) version 5.0 grade 1 or baseline, with the exception of alopecia or toxicities that are stable and well-controlled AND there is an agreement to allow inclusion by both the investigator and the sponsor.\n* Autoimmune disease requiring systemic immunosuppression within the past 2 years.\n* Participant with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active or systemic infection within 7 days prior to the first dose of study treatment.\n* Prior six-transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy.\n* Prior radioligand therapy (RLT), poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, cytotoxic chemotherapy, aminoglutethimide or ketoconazole for prostate cancer, or any prior systemic biologic therapy, including immunotherapy for prostate cancer.\n* Prior enzalutamide or apalutamide within 15 days prior to enrolment.\n* Requirement for chronic systemic corticosteroid therapy (prednisone dose greater than 10 mg per day or local equivalent) or any other immunosuppressive therapies (including anti TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing.\n* Prior radiotherapy to all metastatic sites of disease. Radiotherapy to some sites of metastatic disease for palliation will be permitted.",{"count":513,"type":21},[119],"The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.",[566],"Metastatic Hormone-sensitive Prostate Cancer (mHSPC)",[568,569],"Prostate cancer","Xaluritamig",{"date":520,"type":32},{"date":572,"type":32},"2025-10-07",{"date":574,"type":21},"2030-03-30",{"name":576,"class":39},"Amgen",16,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":597,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":615},"100598968","a-study-to-evaluate-the-safety-and-effectiveness-of-the-rapidlink-device-when-used-in-patients-undergoing-an-open-surgical-procedure-to-repair-the-aorta-100598968","NCT07078383","A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta","Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta","RAPID","Inclusion Criteria:\n\n* Patient is aged 18 years or over on date of consent\n* Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB \u002F EC approved)\n* Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU\n* Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and\u002For IA during the open surgical repair\n* Patient has an 8-15 mm inner diameter (target SAV)\n* The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU\n\nExclusion Criteria:\n\n* Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus.\n* Patient does not have a sealing zone free from tortuosity.\n* Patient has significant angulation (\\>79° with an internal radius of less than 6mm) for the full implantable stent length\n* Patient cannot receive anticoagulation \u002F antiplatelet therapy during or after the index procedure as per the protocol\n* Patient has uncontrolled hypercoagulation\n* Patient has a condition which may compromise or prevent the necessary imaging requirements\n* Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and\u002For otherwise revascularized)\n* Patient is unfit for open surgical repair involving circulatory arrest per the study investigator\n* Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin\n* Patient has a ruptured aorta\n* Patient has active endocarditis or an active infective disorder of the aorta\n* Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure\n* Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study\n* Patient is female and is pregnant or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception during the course of the study.\n* Patient has an uncorrectable bleeding anomaly\n* Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg\u002FdL)\n* Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated\n* Patient has a co-morbidity causing expected survival to be less than 1 year\n* Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure\n* Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)",{"count":587,"type":21},150,[392],"The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta.\n\nThis study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels.\n\nThe first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in a planned surgery.\n\nAfter the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in an emergency setting.\n\nData will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.",[591,592,593,594,595,596],"Aortic Aneurysm","Aortic Aneurysm and Dissection","Aortic Diseases","Aneurysm of Aorta, Thoracic","Aneurysmal Disease","Aorta, Thoracic Pathologies",[598,599,600,601,602,603,604,605,606,607],"Vascular Prosthesis","Replacement or bypass of disease vessels","aneurysmal disease","Aortic branch vessels","Open aortic arch repair","aneurysm","dissection","Supra-aortic Vessels","Frozen Elephant Trunk","Left Subclavian Artery",{"date":520,"type":32},{"date":610,"type":32},"2025-12-19",{"date":612,"type":21},"2028-11",{"name":614,"class":39},"Vascutek Ltd.",22,{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":635},"100576853","phase-3-a-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-cdk46-inhibitor-and-letrozole-vs-placebo--cdk46i-and-letrozole-in-participants-with-endocrine-sensitive-pik3ca-mutated-hormone-receptor-positive-her2-negative-advanced-breast-cancer-100576853","NCT06790693","A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4\u002F6 Inhibitor and Letrozole vs Placebo + CDK4\u002F6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4\u002F6 Inhibitor and Letrozole Versus Placebo Plus a CDK4\u002F6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","INAVO123","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast\n* Documented ER-positive and\u002For progesterone receptor-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines\n* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant\u002Fadjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment\n* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative\n* Confirmation of biomarker eligibility\n* Consent to provide fresh or archival tumor tissue specimen\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\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* Metaplastic breast cancer\n* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Prior hematopoietic stem cell or bone marrow transplantation\n* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment",{"count":173,"type":21},[53],"This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) and letrozole versus placebo plus a CDK4\u002F6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).",[628],"Breast Cancer",{"date":520,"type":32},{"date":631,"type":32},"2025-04-09",{"date":633,"type":21},"2032-05-30",{"name":238,"class":39},232,{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":649,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":661},"100535501","phase-3-study-of-sotorasib-panitumumab-and-folfiri-versus-folfiri-with-or-without-bevacizumab-awwb-in-treatment-nave-participants-with-metastatic-colorectal-cancer-with-kras-pg12c-mutation-100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":173,"type":21},[53],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[648],"Metastatic Colorectal Cancer",[650,651,652,653,654],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":520,"type":32},{"date":657,"type":32},"2024-07-17",{"date":659,"type":21},"2032-04-25",{"name":576,"class":39},292,{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":17,"minAge":670,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":22,"phases":673,"briefSummary":674,"conditions":675,"keywords":677,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":693},"100512168","phase-2-alpelisib-in-pediatric-and-adult-patients-with-lymphatic-malformations-associated-with-a-pik3ca-mutation-100512168","NCT05948943","Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.","A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.","EPIK-L1","Key inclusion criteria:\n\n1. Signed informed consent and assent (when applicable) from the participant, parent, legal authorized representative or guardian.\n2. Participant must be willing to remain at the clinical site as required by the protocol and be willing to adhere to study restrictions and examination schedules.\n3. Participant has a physician confirmed and documented diagnosis of a symptomatic LyM at the time of informed consent (Note: the physician must confirm that the LyM cannot be included under the PROS diagnostic criteria).\n4. Participant is not considered as a candidate for or is not willing to receive non-drug therapies including but not limited to sclerotherapy, embolization, and surgery until the completion of Week 24 in Stage 1 and 2.\n5. Participant has evidence of a somatic mutation(s) in the PIK3CA gene prior to randomization.\n6. Participant has at least one measurable LyM lesion confirmed by BIRC assessment prior to randomization.\n7. Participants must be able to ingest study drug (either in tablet form or as a drinkable suspension \\[Groups 1 to 4\\] or granules or as an oral suspension \\[Group 5\\]) as assessed within 7 days before study treatment start. Drug administration via feeding tubes is allowed.\n\nKey exclusion criteria:\n\n1. Participant has a physician-confirmed and documented diagnosis of PROS at the time of informed consent.\n2. Participant has a physician-confirmed and documented diagnosis of a Central Conducting Lymphatic Anomaly, General Lymphatic Anomaly, Gorham-Stout disease, Kaposiform lymphangiomatosis at the time of informed consent.\n3. Participant has a known history of Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis at the time of informed consent.\n4. Participant has an established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus at the time of informed consent.\n5. Participant had previous treatment with alpelisib and\u002For any other PI3K inhibitors with treatment duration longer than 2 weeks at the time of informed consent.\n\nOther inclusion\u002Fexclusion criteria may apply","0 Years","100 Years",{"count":635,"type":21},[24,53],"The main purpose of this study in participants with PIK3CA-mutated LyM is to assess the change in radiological response and symptom severity upon treatment with alpelisib film-coated tablets (FCT) as compared to placebo.",[676],"Lymphatic Malformations",[678,679,680,681,682,683,684,685,686],"Lymphatic malformations (LyM)","Cystic lymphangioma","Cystic hygroma","Lymphangioma circumscriptum","Cavernous lymphangioma","Lymphangioma","Macrocystic lymphatic malformation","Microcystic lymphatic malformationn","Alpelisib",{"date":520,"type":32},{"date":689,"type":32},"2023-11-24",{"date":691,"type":21},"2033-05-02",{"name":328,"class":39},59,""]