[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"mAbxience Research S.L.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100568910","phase-3-a-study-to-compare-pharmacokinetics-efficacy-safety-and-immunogenicity-of-mb12-proposed-pembrolizumab-biosimilar-to-keytruda-in-non-small-cell-lung-cancer-benito-study-100568910",false,"NCT06687369","A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)","Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)","Inclusion Criteria:\n\n1. Adult male\u002Ffemale patients ≥18 years old at the time of signing the informed consent form (ICF).\n2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \\[TNM\\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.\n4. Known status of PD-L1 expression.\n5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.\n\nExclusion Criteria:\n\n1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.\n2. Known history of central nervous system metastases and\u002For carcinomatous meningitis.\n3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).\n4. Major surgery within 3 weeks of the first dose of study treatment.\n5. Active autoimmune disease that has required systemic treatment in the last 2 years.\n6. Contraindication and\u002For intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.\n7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.","ALL","18 Years",{"count":19,"type":20},726,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.",[26],"Non Squamous Non Small Cell Lung Cancer","RECRUITING","2026-03-10",{"date":30,"type":31},"2026-03-11","ACTUAL",{"date":33,"type":31},"2024-12-30",{"date":35,"type":20},"2027-09",{"name":37,"class":38},"mAbxience Research S.L.","INDUSTRY",151,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100609988","phase-3-study-to-compare-pharmacokinetics-efficacy-safety-and-immunogenicity-of-mb11-versus-eu-us-opdivo-in-subjects-with-previously-untreated-advanced-unresectable-or-metastatic-melanoma-100609988","NCT07221734","Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-\u002FUS-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma","Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-\u002FUS-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)","Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established \\>18 years).\n2. Body weight ≥50 kg at baseline.\n3. Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.\n4. ECOG performance status of 0 or 1.\n5. Life expectancy for at least 3 months.\n6. Untreated, histologically confirmed advanced unresectable Stage III or Stage IV melanoma, as per AJCC 8th Edition staging system. Prior melanoma systemic therapy for earlier stages is allowed for patients who have been disease-free for at least 1 year after end of therapy, except if therapy included use of prohibited medications. Prior use of immune therapies (adjuvant or neoadjuvant) is not allowed as per Exclusion Criteria #2.\n7. At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.\n8. Tumour tissue from an unresectable or metastatic site of disease, collected within 90 days prior to randomisation, must be available and provided for PD-L1 testing. All samples must be classified as PD-L1 positive (≥1% to \\\u003C5% or ≥5%). If only the old sample \\>90 days is available and there is no possibility of having a new biopsy sample, then the subject will be excluded.\n9. In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug administration. No adjuvant radiation therapies are allowed.\n10. Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).\n11. Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:\n\n    1. Haematologic function: absolute neutrophil count ≥1.5 × 109\u002FL, platelets 9≥100 × 10 \u002FL, and haemoglobin ≥9 g\u002FdL.\n\n       \\*\\* Subjects should not have received RBC transfusion prior to 14 days beforescreening labs.\n    2. Renal function: serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL\u002Fmin (using the Cockcroft-Gault formula).\n    3. Liver function: total bilirubin level ≤1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C3.0 mg\u002FdL), albumin level ≥LLN, AST\u002FALT ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases).\n    4. Endocrine function: TSH within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.\n    5. Coagulation: INR and aPTT ≤1.5 × ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days preceding the start of the study drug.\n12. Female subjects of childbearing potential and their partners, as well as male subjects with female partners of childbearing potential and their partners, must agree to adhere to the use of a highly effective method of contraception during the study and for at least 5 months after the last dose of nivolumab. Refer to Appendix 15.1 for contraception guidance.\n13. Non-fertile females can be included.\n\nExclusion Criteria:\n\n1. Subjects receiving any prior systemic therapy for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9).\n2. Subjects receiving any prior immunotherapy (regardless of the melanoma stage), such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-LAG or anti-CTLA-4 therapy (including ipilimumab or any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints) and\u002For BRAF-targeted therapy.\n3. Participation in another clinical study or treatment with another investigational agent within 4 weeks or 5 elimination half-lives prior to randomisation (whichever is longer)\n4. Brain metastases or leptomeningeal metastases. A negative brain imaging of less than 90 days prior to screening is required.\n5. Peritoneal melanomatosis.\n6. Ocular melanoma, mucosal melanoma and acral lentiginous melanoma.\n7. History of another malignancy or a concurrent malignancy. Exceptions include subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.\n8. Active autoimmune disease that has required systemic treatment in the last 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency \\[daily prednisone at a dose of ≤10 mg or equivalent\\]) is not considered a form of systemic treatment.\n9. Subjects with hyperthyroidism or hypothyroidism are excluded but those subjects who are stable on hormone replacement will be allowed.\n10. Any diagnosis of immunodeficiency, systemic steroid therapy (replacement therapy outlined in Exclusion Criteria #8, inhaled, intranasal, intraocular, or topical steroids are allowed) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug.\n11. Any major surgery (eg, hip or spine surgery) less than 28 days prior to the first dose of the study drug.\n12. Having received a solid organ\u002Ftissue allogeneic or haematopoietic transplant.\n13. History and\u002For current interstitial lung disease or pneumonitis (non-infectious) requiring oral or IV steroids or another immunosuppressive drug.\n14. Any active or previous infection requiring therapy (oral or systemic) within 30 days prior to the first dose of the study drug.\n15. Have received or are about to receive a live virus vaccination within 30 days prior to the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n16. Known active TB or untreated latent TB.\n17. Positive serology for human immunodeficiency virus (HIV 1\u002F2), hepatitis B (HBsAg positive and\u002For HBcAb positive, and HBV DNA positive, refer to Section 8.3.2.1) or hepatitis C (HCVAb positive and HCV RNA positive). In addition, subjects with untreated positive serology for Strongyloides spp will be excluded.\n18. At the time of signing the informed consent, the subject is a regular user (including \"recreational use\") of any illicit drug or have a recent history (within the past year) of substance abuse (including alcohol).\n19. Be pregnant or lactating or expecting to conceive during the study or up to 5 months after the last dose of the study drug.\n20. Immediate family member who is at the research site or sponsoring staff who is directlyninvolved in this study.\n21. Inability to comply with protocol procedures and\u002For any other acute or chronic medical condition that may increase the risk for the subject associated with study participation or study drug administration, that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.",{"count":48,"type":20},632,[23],"This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma",[52],"Advanced (Unresectable or Metastatic) Melanoma","2026-01-19",{"date":55,"type":31},"2026-01-21",{"date":57,"type":31},"2025-12-29",{"date":59,"type":20},"2029-02",{"name":37,"class":38},19,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100561946","phase-3-a-study-to-compare-efficacy-pharmacokinetics-safety-and-immunogenicity-of-mb04-proposed-etanercept-biosimilar-to-enbrel-eu-sourced-in-rheumatoid-arthritis-100561946","NCT06596772","A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis","A Prospective, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of MB04 and EU-sourced Enbrel® in Patients with Moderate to Severe Rheumatoid Arthritis","Inclusion\n\n* Documented history of RA diagnosis consistent with the 2010 ACR\u002FEULAR classification criteria ≥6 months prior to randomization (but not exceeding 15 years prior to screening).\n* Moderately to severe RA despite appropriate MTX at baseline therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm\u002Fh or serum C-reactive protein \\> 5.0 mg\u002FdL and positive rheumatoid factor and\u002For CCP at screening\n* Stable dose MTX between 10 to 25 mg weekly during ≥12 weeks, since ≥8 weeks prior to randomization\n* Stable dose of NSAID and \u002For other analgesics for at least 4 weeks prior to randomization, when used\n* Stable dose ≤10 mg prednisone daily or equivalent for ≥4 weeks prior to randomization, when used\n* Patients who are otherwise medically stable according to investigator\\'s discretion\n* Agree to use highly effective contraceptive methods up to 6 months after las dose Exclusion\n* Previously treated with any biologic or targeted synthetic DMARD\n* Previously treated with any monoclonal antibody for other condition than RA\n* Hypersensitivity to any component of study drug and\u002For prefilled syringe components\n* Arthritis with onset prior to age 16 years or current diagnosis of inflammatory joint disease other than RA\n* Systemic manifestations of RA other that rheumatoid nodules or secondary Sjogren\\'s syndrome\n* Active infection or potentially relapsing infections that could have a severe outcome. Latent tuberculosis infection detected during screening should start an approved treatment regimen according to standard of care and rescreened\n* Solid or hematologic malignancy within the past 5 years\n* Pregnant and breastfeeding women\n* Any medical condition in the opinion of the investigator that would be a risk for safety, cooperation in the study or interferes with the interpretation of the study results","75 Years",{"count":71,"type":20},458,[23],"A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 \\[proposed etanercept biosimilar\\] to Enbrel® \\[EU-sourced\\] in rheumatoid arthritis",[75],"Rheumatoid Arthritis (RA)",[77],"Rheumatoid Arthritis","2025-03-21",{"date":80,"type":31},"2025-03-24",{"date":82,"type":31},"2024-10-03",{"date":84,"type":20},"2026-01",{"name":37,"class":38},60,""]