[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regeneron Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":680},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,46,70,98,126,141,166,192,217,244,270,297,323,352,382,405,434,458,482,511,538,565,591,631,659],{"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":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100627993","phase-1-a-trial-to-study-if-regn17372-in-combination-with-linvoseltamab-is-tolerable-for-adult-participants-with-relapsedrefractory-multiple-myeloma-100627993",false,"NCT07455851","A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed\u002FRefractory Multiple Myeloma","A FIH Phase 1\u002F2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed\u002FRefractory Multiple Myeloma","Key Inclusion Criteria:\n\n1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol\n2. ECOG performance status score ≤1\n3. Participants must have measurable disease for response assessment as described in the protocol\n4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol\n2. Participants who have known MM brain lesions or CNS involvement\n3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening\n4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and\u002For prior treatment with a BCMAxCD3 bispecific antibody (phase 2)\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.\n\nThe aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone.\n\nThe study is looking at:\n\n* What side effects may happen from taking REGN17372 with linvoseltamab\n* How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma\n* What is the best dose of REGN17372 when given with linvoseltamab\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)\n* If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)",[28],"Relapsed Refractory Multiple Myeloma (RRMM)",[30,31,32],"B-cell maturation antigen (BCMA)","Anti-CD3 monoclonal antibodies (mAbs)","G-protein-coupled receptor class C group 5 member D (GPRC5D)","RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":37},"2026-03-26",{"date":41,"type":21},"2033-09-30",{"name":43,"class":44},"Regeneron Pharmaceuticals","INDUSTRY",7,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100575239","phase-2-a-study-to-see-if-giving-fianlimab-and-cemiplimab-together-is-better-than-cemiplimab-alone-at-treating-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100575239","NCT06769698","A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression","Key Inclusion Criteria:\n\n1. Have histologically confirmed (by local pathology) R\u002FM HNSCC that is considered incurable by local therapies\n2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol\n3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol\n4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol\n5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions\n\n1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol\n2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)\n3. Head and neck SCC with unknown primary site as described in the protocol\n4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol\n5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management\n6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.\n\n   Prior\u002FConcomitant Therapy\n7. Participants who have received prior systemic anticancer therapy in the R\u002FM HNSCC setting as described in the protocol\n8. Participants with a condition requiring corticosteroid therapy (\\>10 mg prednisone\u002Fprednisolone\u002Fday or equivalent) within 14 days of the first dose of study drug as described in the protocol\n\nNote: Other protocol defined Inclusion\u002F Exclusion Criteria apply",{"count":54,"type":21},120,[25],"This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called \"study drugs\" in this form.\n\nThe study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC).\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much of each study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)\n* Compatible research to better understand the study drugs and HNSCC",[58],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[60,61,62],"Recurrent or Metastatic (R\u002FM)","Positive for Programmed Death Ligand 1 (PD-L1) Expression","Human Papillomavirus (HPV)",{"date":36,"type":37},{"date":65,"type":37},"2026-04-14",{"date":67,"type":21},"2030-12-28",{"name":43,"class":44},35,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100638612","phase-4-adult-outpatient-linvoseltamab-with-tocilizumab-prophylaxis-to-mitigate-the-risk-of-cytokine-release-syndrome-crs-100638612","NCT07609940","Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)","A Phase 4, Single-Arm, Multicenter Study of Prophylactic Tocilizumab in Participants With Relapsed\u002FRefractory Multiple Myeloma Treated With Linvoseltamab in the Outpatient Setting","POPLIN","Key Inclusion Criteria:\n\n1. Disease progression on or after at least 4 prior lines of therapy including a(n) Protease Inhibitor (PI), Immunomodulatory imide Drug (IMiD), and anti-CD 38 antibody\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n\nKey Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome\n2. Known myeloma brain lesions or meningeal involvement\n3. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy \\[PML\\], or Central Nervous System (CNS) movement disorder\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":79,"type":21},30,[81],"PHASE4","This study is researching whether the use of tocilizumab before the first dose of linvoseltamab will decrease the risk of Cytokine Release Syndrome (CRS) in participants who have Relapsed or Refractory Multiple Myeloma (RRMM) who have already been treated with at least four lines of treatment for their multiple myeloma, including medicines called a proteasome inhibitor, an immunomodulatory drug, and an anti-Cluster of Differentiation (CD) 38 antibody.\n\nThe aim of the study is to see how safe, tolerable and effective linvoseltamab is when given after tocilizumab.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking tocilizumab before the first dose of linvoseltamab\n* Whether tocilizumab has an impact on CRS, including whether participants require hospital care and, if so, how many hospital visits occur and how long they last\n* How frequently other medications (for example, corticosteroids or additional doses of tocilizumab) are used to support participants' care if needed",[84],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)",[86,87,88,89],"Cytokine Release Syndrome (CRS)","Linvoseltamab","Tocilizumab","Bispecific antibodies","2026-08-19",{"date":34,"type":37},{"date":93,"type":37},"2026-07-15",{"date":95,"type":21},"2028-12-06",{"name":43,"class":44},3,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100523149","phase-3-a-study-to-compare-how-well-odronextamab-combined-with-chemotherapy-works-and-how-safe-it-is-against-rituximab-combined-with-chemotherapy-in-adult-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-100523149","NCT06091865","A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma","A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)","OLYMPIA-3","Key Inclusion Criteria:\n\n1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)\n2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n4. Life expectancy ≥ 12 months\n5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only\n6. Adequate hematologic and organ function, as defined in the protocol.\n\nKey Exclusion Criteria:\n\n1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology\n2. Another active malignancy, significant active disease or medical condition, as described in the protocol\n3. Peripheral neuropathy Grade ≥3\n4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed\u002FRefractory (R\u002FR) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.\n5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment\n6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol\n7. Allergy\u002Fhypersensitivity to study drugs, as described in the protocol\n8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":107,"type":21},904,[109],"PHASE3","This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called \"previously untreated\"). Patients with DLBCL that have come back after treatment (called \"relapsed\"), or have not responded to treatment (called \"refractory\"), can also participate in this study.\n\nThis study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.\n\nThe aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug when combined with chemotherapy\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* The impact from the study drug on quality of life and ability to complete routine daily activities",[112],"Diffuse Large B-cell Lymphoma (DLBCL)",[114,115,116,117,118],"Non-Hodgkin Lymphomas (NHL)","B-cell Non-Hodgkin Lymphomas (B-NHL)","Diffuse Large B-cell Lymphoma","Odronextamab","Anti-CD20 × anti-CD3 bispecific antibody",{"date":34,"type":37},{"date":121,"type":37},"2023-12-13",{"date":123,"type":21},"2029-09-12",{"name":43,"class":44},178,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":4,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":140,"locationsCount":4},"100652861","compassionate-use-of-vonsetamig-100652861","NCT07780110","Compassionate Use of Vonsetamig","Eligibility will be determined during the application review process.","EXPANDED_ACCESS","Provide Compassionate Use of Vonsetamig",[135,136],"Plasma Cell Mediated","Antibody Mediated","AVAILABLE","2026-08-18",{"date":36,"type":37},{"name":43,"class":44},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},"100647009","phase-2-study-of-olatorepatide-in-adult-participants-living-with-overweight-or-obesity-without-diabetes-100647009","NCT07685808","Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes","A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1\u002FGIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity","Key Inclusion Criteria:\n\n1. Body Mass Index (BMI) ≥30.0 kg\u002Fm\\^2 to \\\u003C45.0 kg\u002Fm\\^2 at screening OR\n2. BMI ≥27.0 kg\u002Fm\\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening\n2. Change in body weight \\>5 kg within approximately 3 months before screening as described in the protocol\n3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol\n4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones\n5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply",{"count":149,"type":21},360,[25],"This study will test an experimental drug called olatorepatide (\"study drug\") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.\n\nThe study is looking at:\n\n* What side effects the study drug might cause\n* How much study drug is in the blood at different times\n* How well the study drug works\n* What effects the study drug may have on the body at different dosing schedules\n* If the body makes antibodies to the study drug as this may cause the study drug to not work as well",[153],"Overweight or Obesity",[155,156,157,158],"Body weight","Glucagon-Like Peptide-1 (GLP-1)\u002FGastric inhibitory polypeptide (GIP) receptor agonist","Dose-finding","Control appetite",{"date":34,"type":37},{"date":161,"type":37},"2026-07-28",{"date":163,"type":21},"2028-01-21",{"name":43,"class":44},5,{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100630871","phase-3-treatment-and-secondary-prevention-of-venous-thromboembolism-vte-in-adult-participants-with-solid-and-hematologic-cancers-100630871","NCT07493304","Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers","A 2-Part, Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against Factor XI, for the Treatment and Secondary Prevention of Venous Thromboembolism in Participants With Solid and Hematologic Cancers (ROXI-CAT-II)","ROXI-CAT-II","Key Inclusion Criteria:\n\n1. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at the time of screening and day 1 prior to first dose of study intervention\n2. In Part 1 participants with cancer and Part 2 participants: Histologically confirmed diagnosis of malignant solid or select hematologic tumor (other than basal-cell or squamous-cell carcinoma of the skin alone) as described in the protocol\n3. Part 1 additional criteria:\n\n   1. Has newly diagnosed symptomatic lower extremity DVT or incidentally-detected proximal lower extremity DVT (eg, popliteal or femoral) within 5 days (120 hours) of randomization (with imaging confirmation)\n   2. Anticoagulation therapy with a therapeutic dose of a Direct Oral Anticoagulant (DOAC) for at least 3 months is indicated for the newly diagnosed proximal lower extremity DVT\n4. Part 2 additional criteria:\n\n   1. Newly diagnosed VTE within 5 days (120 hours) of randomization (with imaging confirmation) as described in the protocol\n   2. Anticoagulation therapy with a therapeutic dose of a DOAC for at least 6 months is indicated for newly diagnosed VTE\n\nKey Exclusion Criteria:\n\n1. Is at high risk of intracranial bleeding in the opinion of the investigator\n2. Known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)\n3. Contraindication to anticoagulation in the opinion of the investigator\n4. Life expectancy of \\\u003C 6 months\n5. Part 1 participants with cancer and Part 2 additional exclusion criteria:\n\n   1. Has acute leukemia or myelodysplastic syndrome\n   2. Has primary brain tumor\n   3. Has brain metastases as described in the protocol\n6. Part 1 additional exclusion criteria:\n\n   1. Has a symptomatic PE\n   2. Has an asymptomatic (incidentally-diagnosed) PE in a segmental or larger pulmonary artery\n7. Part 2 additional exclusion criteria: PE leading to hemodynamic instability as described in the protocol\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply",{"count":175,"type":21},1600,[109],"This study is researching an experimental drug called REGN7508 (called \"study drug\") and will consist of 2 parts: Part 1 and Part 2. The study is focused on participants with or without cancer who develop blood clots in certain veins (called Deep Vein Thrombosis \\[DVT\\]) that block blood flow (Part 1) or focused on participants with cancer who develop blood clots in certain veins (DVT) or the lungs (also called Pulmonary Embolism \\[PE\\]) (Part 2).\n\nThe aim of the study is to see how safe and effective the study drug is at treating and preventing further blood clots in participants with or without cancer (Part 1) or in participants with cancer (Part 2) compared with another treatment (apixaban).\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[179],"Venous Thromboembolism (VTE)",[181,182,183,184],"Cancer-Associated Thrombosis (CAT)","Deep Vein Thrombosis (DVT)","Pulmonary Embolism (PE)","Cancer",{"date":90,"type":37},{"date":187,"type":21},"2026-08-31",{"date":189,"type":21},"2031-07-08",{"name":43,"class":44},6,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},"100624475","phase-3-regn7508-in-adult-participants-for-prevention-of-cancer-associated-thrombosis-100624475","NCT07410117","REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of REGN7508, a Monoclonal Antibody Against FXI, for Primary Prophylaxis of Cancer-Associated Thrombosis for Participants With Solid Tumors Undergoing Cancer Treatment (ROXI-CAT-I)","ROXI-CAT-I","Key Inclusion Criteria:\n\n1. Has a histologically confirmed diagnosis of malignant solid tumors which are locally advanced or metastatic as described in the protocol\n2. Has a Khorana thromboembolic risk score ≥2 during screening period or harbors a somatic documented tumor genetic variant known to be associated with a similar increased risk of VTE as described in the protocol\n3. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 at the time of screening and day 1 prior to the first dose of study intervention\n\nKey Exclusion Criteria:\n\n1. Has known bleeding conditions (eg, Hemophilia A or B, von Willebrand's disease), hemorrhagic tumor sites, or other conditions with a high risk for bleeding (eg, hepatic disease associated with coagulopathy)\n2. Has a cancer diagnosis consisting solely of basal cell or squamous cell skin carcinoma\n3. Has a primary brain tumor or brain metastases as described in the protocol\n4. Has proximal lower extremity DVT locally detected by Compression Ultrasound (CUS) during screening period\n5. Has any condition that, as judged by the investigator, may confound the results of the study or would place the participant at increased risk of harm if he\u002Fshe participated in the study\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply",{"count":201,"type":21},1120,[109],"This study is researching an experimental drug called REGN7508 (called \"study drug\"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants.\n\nThe aim of the study is to see how effective the study drug is in preventing blood clots in participants with solid tumors who are currently receiving anticancer treatment or planning to start anticancer treatment within a month of being assigned to a study treatment, or recovering from surgery, and how the study drug compares to placebo for CAT.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[181],[179,182,183,206,207,208,209],"Arterial Thromboembolism (ATE)","Solid tumors (cancers)","Clinically Relevant Non-Major (CRNM) bleeding","International Society of Thrombosis and Hemostasis (ISTH)",{"date":34,"type":37},{"date":212,"type":37},"2026-03-09",{"date":214,"type":21},"2030-05-06",{"name":43,"class":44},14,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100617436","phase-2-study-of-regn13335-in-adult-participants-with-pulmonary-arterial-hypertension-pah-100617436","NCT07318597","Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension","ILLUMINATE","Key Inclusion Criteria:\n\n1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))\n2. WHO functional class II or III (slight to marked limitation of functional status due to PAH)\n3. Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol\n4. PVR ≥400 dynes∙sec\u002Fcm\\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period\n5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and\u002For hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and\u002For multifactorial mechanisms) PH according to the 7th WSPH\n2. Pulmonary Arterial Wedge Pressure (PAWP) \\>15 mm Hg by RHC during the screening period\n3. History of left-sided heart disease and\u002For clinically significant cardiac disease, as described in the protocol\n4. Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)\u002FForced Vital Capacity \\\u003C0.7 and FEV1 \\\u003C70% of the predicted value as described in the protocol\n5. Evidence of interstitial lung disease as defined in the protocol\n6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol\n7. Participants requiring anticoagulation and\u002For antiplatelet therapy for an underlying medical condition as described in the protocol\n8. Has any history of intracranial bleeding or any history of elevated intracranial pressure\n9. Has any history of bleeding meeting criteria as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":226,"type":21},99,[25],"This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN13335\n* How much REGN13335 is in the blood at different times\n* Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)",[230],"Pulmonary Arterial Hypertension (PAH)",[230,232,233,234,235,236],"Pulmonary Hypertension (PH)","Elevated Pulmonary Vascular Resistance (PVR)","World Health Organization (WHO) functional class II or III","Platelet-Derived Growth Factor-B (PDGF-B)","REGN13335",{"date":90,"type":37},{"date":239,"type":37},"2026-05-06",{"date":241,"type":21},"2028-09-17",{"name":43,"class":44},27,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100606428","phase-2-safety-in-adult-participants-with-atrial-fibrillation-who-are-treated-with-anticoagulation-100606428","NCT07175428","Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation","A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)","ROXI-ATLAS","Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol\n2. Meets one of the following:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve or\n   2. CHA2DS2-VA score ≥3 or\n   3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol\n3. Must have an International Normalization Ratio (INR) \\\u003C2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Has known moderate-to-severe mitral stenosis\n3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion\u002Fexclusion, or planned ablation or LAA occlusion\u002Fexclusion as described in the protocol\n4. Had an ischemic stroke within 2 days prior to randomization\n5. Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol\n6. Has a history of central nervous system bleeding within 30 days prior to randomization\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":253,"type":21},1200,[25],"This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.\n\nThe aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well do the study drugs reduce the risk of having a stroke\n* How much of REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)",[257],"Atrial Fibrillation (AF)",[259,260,261,262],"Bleeding","Stroke","Systemic embolism","Blood clots",{"date":34,"type":37},{"date":265,"type":37},"2025-10-20",{"date":267,"type":21},"2027-04-21",{"name":43,"class":44},77,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100601583","phase-3-a-study-of-dupilumab-in-small-children-with-an-allergic-condition-of-the-esophagus-food-pipe-eosinophilic-esophagitis-100601583","NCT07112378","A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis","A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to \u003C15 kg With Active Eosinophilic Esophagitis","EoE-TOTs","Key Inclusion Criteria:\n\n1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \\\u003C15 kg at screening with active EoE\n2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol\n3. Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab\n2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study\n3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)\n4. Active Helicobacter pylori infection\n5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery\n6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening\n7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure\n8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy\n\nNOTE: Other Protocol-Defined Inclusion\u002FExclusion Criteria Apply","6 Months","6 Years",{"count":281,"type":21},20,[109],"This study is researching an experimental drug called dupilumab (called \"study drug\"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[285],"Eosinophilic Esophagitis (EoE)",[287,288,289],"Type 2 Inflammatory","Allergic\u002Fimmune-mediated","Esophageal dysfunction",{"date":34,"type":37},{"date":292,"type":37},"2025-11-10",{"date":294,"type":21},"2028-10-09",{"name":43,"class":44},13,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},"100535060","phase-3-a-study-with-combinations-of-anti-lag-3-and-anti-pd-1-antibodies-in-adult-participants-with-advanced-or-metastatic-melanoma-harmony-head-to-head-100535060","NCT06246916","A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)","A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma","Key Inclusion Criteria:\n\n1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.\n2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.\n3. Measurable disease per RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate bone marrow, hepatic, and kidney function\n6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions:\n\n1. Uveal, acral or mucosal melanoma.\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.\n3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.\n\n   Prior\u002FConcomitant Therapy:\n4. Prior immune checkpoint inhibitor therapy other than anti-PD1\u002FPD-L1 as described in the protocol\n5. Systemic immune suppression as described in the protocol.\n\n   Other Comorbidities:\n6. Participants with a history of myocarditis.\n7. Troponin T (TnT) or troponin I (TnI) \\>2x institutional upper limit of normal (ULN).\n8. Active or untreated brain metastases or spinal cord compression as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply.",{"count":305,"type":21},560,[109],"This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called \"study drugs\". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs.\n* How much study drug is in the blood at different times.\n* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)",[309],"Melanoma",[311,312,313,314,315],"Unresectable Melanoma","Metastatic Melanoma","Advanced Melanoma","Stage III","Stage IV",{"date":90,"type":37},{"date":318,"type":37},"2024-09-09",{"date":320,"type":21},"2033-07-10",{"name":43,"class":44},111,{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":330,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":340,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100407815","phase-1-a-study-to-find-out-how-safe-regn5668-is-and-how-well-it-works-in-adult-women-when-given-with-either-cemiplimab-or-cemiplimab--fianlimab-or-ubamatamab-100407815","NCT04590326","A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab","A Phase 1\u002F2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific Antibody) Administered in Combination With Other Agents in MUC16 + Malignancies","Key Inclusion Criteria:\n\n1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined in the protocol\n2. Expansion cohorts only: Has at least 1 lesion that is measurable by RECIST 1.1 as described in the protocol.\n3. Has a serum CA-125 level ≥2x ULN (in screening, not applicable to endometrial cohorts)\n4. Has adequate organ and bone marrow function as defined in the protocol\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has a life expectancy of at least 3 months\n7. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-PD-1 therapy and platinum-based chemotherapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Current or recent (as defined in the protocol) treatment with an investigational agent, systemic biologic therapy, or anti-cancer immunotherapy\n2. Has had another malignancy within the last 5 years that is progressing, requires active treatment, or has a high likelihood of recurrence as defined in the protocol\n3. Prior treatment with a Mucin 16 (MUC16)-targeted therapy\n4. Ovarian Expansion cohorts only: More than 5 prior lines of systemic therapy\n5. Has any condition that requires ongoing\u002Fcontinuous corticosteroid therapy as defined in the protocol within 1 week prior to the first dose of study drug\n6. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol\n7. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol\n8. Has history of clinically significant cardiovascular disease as defined in the protocol\n9. Has known allergy or hypersensitivity to cemiplimab and\u002For components of study drug(s).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply","FEMALE",{"count":332,"type":21},612,[24,25],"This study is researching an investigational drug called REGN5668 :\n\n* alone or,\n* combined with cemiplimab (also known as REGN2810) or,\n* combined with both cemiplimab and fianlimab (also known as REGN3767), or\n* combined with ubamatamab (also known as REGN4018), with or without sarilumab.\n\nThe main purposes of this study are to:\n\n* Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus\n* Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus\n\nThis study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2.\n\nThe study is looking at several other research questions, including:\n\n* Side effects that may be experienced by participants taking REGN5668 alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How REGN5668 works in the body either alone and\u002For in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab\n* How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood\n* To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer",[336,337,338,339],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer","Endometrial Cancer",[341,342,343,344],"Progressive","Recurrent","Refractory","Serum CA-125 levels >= 2x ULN",{"date":34,"type":37},{"date":347,"type":37},"2020-12-08",{"date":349,"type":21},"2027-11-30",{"name":43,"class":44},28,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":97},"100623180","phase-3-a-study-to-compare-linvoseltamab-and-daratumumab-treatment-in-high-risk-smoldering-multiple-myeloma-hr-smm-100623180","NCT07393282","A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)","A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma","LINKER-SMM2","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status score ≤1\n2. SMM diagnosis per IMWG criteria as defined in the protocol\n3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol\n2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma\n3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder\n4. History of a seizure within the 12 months of randomization\n5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":361,"type":21},270,[109],"This study is researching an experimental drug called linvoseltamab (also called \"study drug\") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.\n\nThe aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[365],"High Risk Smoldering Multiple Myeloma (HR-SMM)",[87,367,368,369,370,371,372,373,374],"Multiple Myeloma (MM)","B Cell Maturation Antigen (BCMA)","Bispecific antibody","Smoldering Multiple Myeloma (SMM)","Smoldering Myeloma","HR-SMM","Linozyfic","Darzalex","2026-08-17",{"date":138,"type":37},{"date":378,"type":37},"2026-05-21",{"date":380,"type":21},"2033-07-27",{"name":43,"class":44},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},"100617437","phase-3-reducing-adverse-vascular-outcomes-with-factor-xi-inhibition-in-adult-participants-with-peripheral-artery-disease-100617437","NCT07318610","Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease","A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)","ROXI-PALISADE","Key Inclusion Criteria:\n\n1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol\n2. At least 1 of the following enrichment factors for major thrombotic vascular events:\n\n   1. Bypass with prosthetic graft\n   2. Endovascular treatment with stenting\n   3. Target lesion length \\>15 cm\n   4. History of LER or amputation for PAD prior to qualifying LER\n   5. Type 2 diabetes mellitus requiring pharmacologic treatment\n   6. Comorbid symptomatic coronary artery disease as described in the protocol\n   7. Chronic kidney disease as described in the protocol\n   8. Age ≥75 years\n\nKey Exclusion Criteria:\n\n1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome\n2. Has known bleeding diathesis, platelet count \\\u003C50,000\u002Fmm\\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations\n3. Has recent coronary revascularization as described in the protocol\n4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization\n5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period\n6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply",{"count":391,"type":21},7050,[109],"This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet.\n\nThe aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)\n* If the study drugs affect the ability of the blood to clot normally",[395],"Peripheral Artery Disease (PAD)",[262,397],"Lower Extremity Revascularization (LER)",{"date":90,"type":37},{"date":400,"type":37},"2026-07-10",{"date":402,"type":21},"2029-11-16",{"name":43,"class":44},17,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":413,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":165},"100609915","phase-3-efficacy-and-safety-of-mibavademab-in-adult-and-pediatric-patients-with-generalized-lipodystrophy-100609915","NCT07220785","Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy","A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients With Generalized Lipodystrophy (LAGO)","LAGO","Key Inclusion Criteria:\n\n1\\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines\n\nFor Part A only:\n\n1. Participants ≥2 years of age at screening\n2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screening period)\n\n   * HbA1c ≥7%\n   * Fasting TG ≥500 mg\u002FdL\n   * Fasting TG value of ≥300 mg\u002FdL and the presence of another complication of GLD consistent with leptin deficiency (history of diabetes mellitus, hyperphagia, Metabolic Associated Fatty Liver Disease (MAFLD), polycystic ovary syndrome, etc)\n3. Weight ≥15 kg at screening\n4. Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting TG from at least 6 months prior to screening, as described in the protocol\n\nFor Part B only:\n\n1. Participants \\\u003C12 years of age at screening\n2. Weighing ≥7 kg at screening\n3. No metabolic criteria for study entry is required, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus\n2. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol\n3. eGFR of \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once\n4. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol\n5. Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit\n\nFor Part A only:\n\n1. Treatment with metreleptin within 3 months of the screening visit\n2. Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and\u002For dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol\n3. Significant changes to lifestyle and diet, as described in the protocol\n4. Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","2 Years",{"count":351,"type":21},[109],"This study is researching a new drug called mibavademab (called \"study drug\"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times.\n\nThis is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in pediatric participants.\n\nThe study is researching several other questions, including:\n\n* How mibavademab affects the amount of sugar in the blood\n* How mibavademab affects the amount of fat (triglycerides) in the blood\n* How mibavademab affects the amount of fat that has built up in the liver\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[418],"Generalized Lipodystrophy",[420,421,422,423,424,425,426,427],"Subcutaneous (SC) adipose tissue","GLD","Berardinelli-Seip Syndrome","Congenital Generalized Lipodystrophy","CGL","Lawrence Syndrome","Acquired Generalized Lipodystrophy","AGL",{"date":138,"type":37},{"date":430,"type":37},"2026-03-13",{"date":432,"type":21},"2028-09-08",{"name":43,"class":44},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100609376","phase-3-regn7508-versus-acetylsalicylic-acid-asa-for-venous-thromboprophylaxis-after-total-knee-arthroplasty-in-adult-participants-100609376","NCT07213778","REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants","A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)","ROXI-ASPEN","Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency)\n3. History of thromboembolic disease or thrombophilia\n4. History of platelet dysfunction\n5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":443,"type":21},2000,[109],"This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[447],"Symptomatic Venous Thromboembolism (VTE)",[449,450,182,183],"Total Knee Arthroplasty (TKA)","Elective Unilateral TKA",{"date":90,"type":37},{"date":453,"type":37},"2025-11-24",{"date":455,"type":21},"2027-07-16",{"name":43,"class":44},34,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":472,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":481},"100538587","phase-1-a-trial-to-learn-if-linvoseltamab-is-safe-and-works-in-adults-with-relapsed-or-refractory-systemic-light-chain-amyloidosis-al-amyloidosis-100538587","NCT06292780","A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)","A Phase 1\u002F2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis","LINKER-AL2","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of AL amyloidosis, as described in the protocol\n2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol\n3. Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator\n4. N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng\u002FL during screening\n5. Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening\n\nKey Exclusion Criteria:\n\n1. History of other non-AL amyloidosis\n2. Greater than 60% plasmacytosis on a bone marrow biopsy and\u002For aspirate during screening\n3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening\n4. Myocardial infarction within the past 6 months prior to the first screening visit\n5. Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":467,"type":21},220,[24,25],"This study is researching an experimental drug called linvoseltamab (\"study drug\").\n\nThis study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again.\n\nThe study consists of 2 phases (Phase 1 and Phase 2):\n\n* In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2.\n* In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis.\n\nThe study is looking at several other research questions, including:\n\n* How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long\n* How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long\n* What the right dosing regimen is for linvoseltamab\n* What side effects may happen from taking linvoseltamab\n* How much linvoseltamab is in the blood at different times\n* Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)",[471],"Relapsed\u002FRefractory Systemic Light Chain Amyloidosis",[473,367,474],"Amyloid light-chain (AL)","Pathogenic light chains",{"date":138,"type":37},{"date":477,"type":37},"2024-08-07",{"date":479,"type":21},"2035-02-20",{"name":43,"class":44},21,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":510},"100561073","phase-3-study-of-intralesional-cemiplimab-in-adult-patients-with-early-stage-cutaneous-squamous-cell-carcinoma-100561073","NCT06585410","Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma","A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)","Key Inclusion Criteria:\n\n1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol\n2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and \\>0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol\n3. Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate hepatic, renal and bone marrow functions, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)\n2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated Adverse Events (imAEs), as described in the protocol\n3. History of non-infectious pneumonitis within the last 5 years\n4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply.",{"count":490,"type":21},369,[109],"This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells.\n\nThe main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.\n\nThe study is looking at:\n\n* The side effects cemiplimab might cause\n* How well cemiplimab works compared to surgery",[494],"Cutaneous Squamous Cell Carcinoma (CSCC)",[496,497,498,499,500,501,502],"Dermato-Oncology","Cemiplimab","Early Stage","Skin Cancer","Non-Melanoma Skin Cancer","UV Skin Damage","Chronic Sun Exposure","2026-08-14",{"date":375,"type":37},{"date":506,"type":37},"2025-01-02",{"date":508,"type":21},"2030-05-03",{"name":43,"class":44},52,{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":519,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":537},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":522,"type":21},975,[109],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[526,527],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[529],"GA secondary to AMD","2026-08-13",{"date":375,"type":37},{"date":533,"type":37},"2024-10-30",{"date":535,"type":21},"2033-04-09",{"name":43,"class":44},224,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100591081","phase-1-dose-escalation-study-with-bispecific-antibodies-in-adult-participants-with-lupus-nephritis-100591081","NCT06975787","Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis","A Dose Escalation Study Investigating Bispecific Antibody Therapy in Patients With Lupus Nephritis","Key General Inclusion Criteria:\n\n1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol\n2. Participant must have refractory or relapsed disease, as described in the protocol\n\nKey General Exclusion Criteria:\n\n1. History of or active severe or unstable lupus-associated neuropsychiatric disease that is likely to require acute or emergent medical treatment or hospitalization\n2. Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening\n3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","60 Years",{"count":547,"type":21},90,[24],"This study is researching a particular group of experimental drugs administered for a short period in the treatment of participants with Lupus Nephritis (LN).\n\nThe main aim of the current study is to see how safe and tolerable the study drugs are in a long-term follow-up.\n\nThis is a main study, called an umbrella study, which includes several independent smaller sub-studies. Each of these smaller main sub-studies tests different drugs at the same time, all aimed at treating LN.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[551],"Lupus Nephritis (LN)",[553,554,555,556],"Bispecific Antibodies (bsAb)","Double-stranded DNA (dsDNA)","LN class III or IV","Systemic Lupus Erythematosus (SLE)","2026-08-12",{"date":530,"type":37},{"date":560,"type":37},"2025-12-22",{"date":562,"type":21},"2029-09-10",{"name":43,"class":44},18,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":590},"100527555","phase-3-a-trial-to-find-out-if-odronextamab-combined-with-lenalidomide-is-safe-and-works-better-than-rituximab-combined-with-lenalidomide-in-adult-participants-with-follicular-lymphoma-and-marginal-zone-lymphoma-100527555","NCT06149286","A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma","A Phase 3, Open Label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Combination With Lenalidomide Versus Rituximab in Combination With Lenalidomide in Relapsed\u002FRefractory Participants With Follicular Lymphoma and Marginal Zone Lymphoma (OLYMPIA-5)","OLYMPIA-5","Key Inclusion Criteria:\n\n1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.\n2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol.\n3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \\[CT\\], or Magnetic Resonance Imaging \\[MRI\\] imaging, as described in the protocol.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. Adequate hematologic and organ function, as described in the protocol.\n6. All study participants must:\n\n   1. Have an understanding that lenalidomide could have a potential teratogenic risk.\n   2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.\n   3. Agree not to share study medication with another person.\n   4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.\n\nKey Exclusion Criteria:\n\n1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.\n2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.\n3. History of or current relevant CNS pathology, as described in the protocol.\n4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.\n5. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.\n6. Allergy\u002Fhypersensitivity to study drugs or excipients. as described in the protocol.\n7. Active infection as defined in the protocol.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":574,"type":21},580,[109],"This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) that has come back after treatment (called \"relapsed\") or did not respond to treatment (called \"refractory\"). FL and MZL are subtypes of Non-Hodgkin 's Lymphoma (NHL).\n\nThis study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled).\n\nThe aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered \"first-in-human\" as it has not been tested as a combination treatment in humans before.\n\nThe aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called \"the comparator drug\") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed\u002Frefractory FL and\u002For MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug in combination with lenalidomide\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* The impact from the study drug on quality-of-life and ability to complete routine daily activities",[578,579],"Relapsed\u002FRefractory Follicular Lymphoma","Relapsed\u002FRefractory Marginal Zone Lymphoma (R\u002FR MZL)",[578,581,582,583,117],"Relapsed\u002FRefractory Marginal Zone Lymphoma","Non-Hodgkin lymphomas","Indolent lymphomas",{"date":503,"type":37},{"date":586,"type":37},"2023-12-28",{"date":588,"type":21},"2031-04-30",{"name":43,"class":44},171,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":607,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":630},"100604805","phase-2-a-study-to-investigate-ubamatamab-with-and-without-regn7075-in-adult-participants-with-advancedmetastatic-non-small-cell-lung-cancer-nsclc-100604805","NCT07154290","A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced\u002FMetastatic Non-Small Cell Lung Cancer (NSCLC)","A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced\u002FMetastatic Non-Small Cell Lung Cancer (NSCLC)","Key Inclusion Criteria:\n\n1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC\n2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol\n3. If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate\n4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol\n5. Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nKey Exclusion Criteria:\n\n1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy\n2. Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone replacement therapy)\n3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol\n4. Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical study\n5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention\n6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol\n7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention\n8. Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply",{"count":599,"type":21},300,[25],"This study will evaluate two study drugs called ubamatamab and marlotamig, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab.\n\nThe study is looking at:\n\n* How well ubamatamab and marlotamig work(s)\n* The side effects that ubamatamab and marlotamig might cause\n* How much ubamatamab and marlotamig is in the blood at different times\n* If the body makes antibodies to ubamatamab and\u002For marlotamig, this may cause the ubamatamab to not work as well",[603,604,605,606],"Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung",[608,609,610,611,612,613,614,615,616,617,618,619,620,621,622],"Mucin-16 (MUC16)","Ubamatamab","Epidermal Growth Factor Receptor (EGFR)","REGN7075","Stage IIIB, IIIC or IV","Marlotamig","NSCLC","Advanced NSCLC","Metastatic NSCLC","Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","Stage IV NSCLC","Recurrent NSCLC","Unresectable NSCLC","2026-08-11",{"date":530,"type":37},{"date":626,"type":37},"2026-03-18",{"date":628,"type":21},"2030-06-10",{"name":43,"class":44},15,{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":638,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":658},"100644994","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-fel-d-1-monoclonal-antibodies-in-adult-and-pediatric-participants-with-allergic-conjunctivitis-due-to-cat-allergy-100644994","NCT07675811","A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy","A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy","Key Inclusion Criteria:\n\n1. Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and \\\u003C18 years, and adult participants aged 18 years and older.\n2. Positive SPT to cat allergen extract\n3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1\n4. Positive CAC criteria\n\nKey Exclusion Criteria:\n\n1. Significant and\u002For severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments\n2. Presence of any ophthalmic disease\u002F abnormality\u002F condition that may interfere with study assessments, affect the study outcomes or participant safety\n3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply","8 Years",{"count":640,"type":21},570,[109],"This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called \"REGN-2Cat\". These medicines are also known as the \"study drugs\".\n\nThe aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair\u002Fdander compared with a placebo.\n\nThe study is looking at several other research questions, including:\n\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)\n* How long the study drug effect lasts",[644],"Allergic Conjunctivitis",[646,647,648,649,650],"Cat allergy","Eye allergy","Cat-induced eye allergy","Ocular allergy signs\u002Fsymptoms","Allergic conjunctivitis signs\u002Fsymptoms","2026-08-10",{"date":557,"type":37},{"date":654,"type":37},"2026-07-31",{"date":656,"type":21},"2029-09-20",{"name":43,"class":44},1,{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":330,"minAge":18,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":671,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":679},"100576616","phase-2-investigation-of-ubamatamab-combination-therapy-in-adult-participants-with-platinum-resistant-ovarian-cancer-100576616","NCT06787612","Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)\n2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Adequate organ and bone marrow function, as described in the protocol\n5. Platinum-Resistant Ovarian Cancer, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)\n2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)\n3. Another malignancy that is progressing or requires active treatment, as described in the protocol\n4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol\n5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency\n6. Moderate to large or ascites, as described in the protocol\n7. Bowel obstruction within last 3 months or current need for parenteral nutrition\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":667,"type":21},297,[25],"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on participants who have advanced ovarian cancer.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin \\[PLD\\]), referred to as \"combination drugs'.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug and its experimental combinations\n* How much study drug and fianlimab is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations",[336,337,338],[672],"Platinum Resistance",{"date":557,"type":37},{"date":675,"type":37},"2025-05-28",{"date":677,"type":21},"2028-06-30",{"name":43,"class":44},55,""]