Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT06687369
Status:
RECRUITING
Last Update Posted:
2025-10-28
First Post:
2024-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 726}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-12', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate the pharmacokinetic (PK) bioequivalence of MB12, EU-sourced Keytruda® and US-sourced Keytruda® in combination with chemotherapy', 'timeFrame': 'Week 1 - Week 24', 'description': 'Area under the concentration-time curve (AUC) between Cycle 1 and Cycle 2 (AUC from time 0 to 504 hours postdose \\[AUC0-504\\]. AUC at steady state (AUCss) between Cycle 7 and Cycle 8.'}, {'measure': 'To demonstrate the efficacy equivalence of MB12 and Keytruda® in combination with chemotherapy administered as first-line treatment in patients with advanced/metastatic non-squamous NSCLC (any PD-L1 expression type).', 'timeFrame': 'Week 1 - Week 24', 'description': 'Objective response rate (ORR), up to and including 24 weeks (end of Cycle 8)'}], 'secondaryOutcomes': [{'measure': 'To assess the efficacy of MB12 as compared with Keytruda® based on other efficacy parameters and timepoints over the study period.', 'timeFrame': 'Week 1 - Week 52', 'description': 'Objective response rate (ORR), Progression-free survival (PFS), Duration of response (DOR) and Overall survival (OS)'}, {'measure': 'To compare the PK profile based on other PK parameters and timepoints (not covered by the primary PK endpoints) of MB12 as compared with Keytruda® over the study period.', 'timeFrame': 'Week 1 - Week 52', 'description': 'Maximum concentration (Cmax), Time to maximum concentration (Tmax), Minimum concentration (Ctrough), Clearance (CL), Elimination half-life (t1/2), Distribution volume (Vd)'}, {'measure': 'To assess the safety and tolerability of MB12 as compared with Keytruda®', 'timeFrame': 'Week 1 - Week 52', 'description': 'Treatment-emergent adverse events (TEAEs)'}, {'measure': 'To assess the immunogenicity of MB12 as compared with Keytruda®', 'timeFrame': 'Week 1 - Week 52', 'description': 'Anti-drug antibodies (ADAs) and Neutralizing antibodies (NAbs) in ADA-positive samples'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Squamous Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult male/female 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/or 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/or 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.'}, 'identificationModule': {'nctId': 'NCT06687369', 'briefTitle': 'A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'mAbxience Research S.L.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'MB12-C-02-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MB12 (Proposed Pembrolizumab Biosimilar)', 'description': 'MB12 (Proposed Pembrolizumab Biosimilar) + Pemetrexed + Carboplatin/ Cisplatin', 'interventionNames': ['Drug: MB12 (Proposed Pembrolizumab Biosimilar)', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU- sourced Keytruda®', 'description': 'EU- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin', 'interventionNames': ['Drug: EU-sourced Keytruda®', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Drug: Cisplatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US- sourced Keytruda®', 'description': 'US- sourced Keytruda® + Pemetrexed + Carboplatin/ Cisplatin', 'interventionNames': ['Drug: US-sourced Keytruda®', 'Drug: Pemetrexed', 'Drug: Carboplatin', 'Drug: Cisplatin']}], 'interventions': [{'name': 'MB12 (Proposed Pembrolizumab Biosimilar)', 'type': 'DRUG', 'description': '200mg IV, every 3 weeks on Day 1', 'armGroupLabels': ['MB12 (Proposed Pembrolizumab Biosimilar)']}, {'name': 'EU-sourced Keytruda®', 'type': 'DRUG', 'description': '200mg IV, every 3 weeks on Day 1', 'armGroupLabels': ['EU- sourced Keytruda®']}, {'name': 'US-sourced Keytruda®', 'type': 'DRUG', 'description': '200mg IV, every 3 weeks on Day 1', 'armGroupLabels': ['US- sourced Keytruda®']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': '500 mg/m2 IV, every 3 weeks on Day 1', 'armGroupLabels': ['EU- sourced Keytruda®', 'MB12 (Proposed Pembrolizumab Biosimilar)', 'US- sourced Keytruda®']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Area under the curve (AUC) 5 IV, every 3 weeks on Day 1 for 4 cycles.', 'armGroupLabels': ['EU- sourced Keytruda®', 'MB12 (Proposed Pembrolizumab Biosimilar)', 'US- sourced Keytruda®']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75 mg/m2 IV, every 3 weeks on Day 1 for 4 cycles', 'armGroupLabels': ['EU- sourced Keytruda®', 'MB12 (Proposed Pembrolizumab Biosimilar)', 'US- sourced Keytruda®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'facility': 'Site 101001', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'facility': 'Site 101002', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'facility': 'Site 101003', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'facility': 'Site 101004', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Sarajevo', 'status': 'RECRUITING', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 103001', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'city': 'Tuzla', 'status': 'RECRUITING', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 103002', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}, {'city': 'Zenica', 'status': 'RECRUITING', 'country': 'Bosnia and Herzegovina', 'facility': 'Site 103003', 'geoPoint': {'lat': 44.20169, 'lon': 17.90397}}, {'city': 'Batumi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108004', 'geoPoint': {'lat': 41.64077, 'lon': 41.6306}}, {'city': 'Kutaisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108005', 'geoPoint': {'lat': 42.26791, 'lon': 42.69459}}, {'city': 'Marneuli', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108011', 'geoPoint': {'lat': 41.48758, 'lon': 44.79845}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108001', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108002', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108003', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108006', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108007', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108008', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108009', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Site 108010', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Hakodate-shi', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Site 207002'}, {'city': 'Okayama', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Site 207012', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Shinagawa-Ku', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Site 207010'}, {'city': 'Shizuoka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Site 207001', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Cheras', 'status': 'RECRUITING', 'country': 'Malaysia', 'facility': 'Site 202001', 'geoPoint': {'lat': 3.108, 'lon': 101.726}}, {'city': 'Kota Bharu', 'status': 'RECRUITING', 'country': 'Malaysia', 'facility': 'Site 202002', 'geoPoint': {'lat': 6.12361, 'lon': 102.24333}}, {'city': 'Kuala Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'facility': 'Site 202003', 'geoPoint': {'lat': 3.35, 'lon': 101.25}}, {'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'facility': 'Research site 116001', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'facility': 'Site 304001', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'facility': 'Site 304002', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'status': 'RECRUITING', 'country': 'Panama', 'facility': 'Site 304003', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Site 119001', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Matosinhos Municipality', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Site 119002', 'geoPoint': {'lat': 41.18207, 'lon': -8.68908}}, {'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'facility': 'Site 119003', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Site 121001', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Site 121002', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Kamenitz', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Site 121004', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}, {'city': 'Kragujevac', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Site 121003', 'geoPoint': {'lat': 44.01667, 'lon': 20.91667}}, {'city': 'Užice', 'status': 'RECRUITING', 'country': 'Serbia', 'facility': 'Site 121005', 'geoPoint': {'lat': 43.85861, 'lon': 19.84878}}, {'city': 'Bardejov', 'status': 'RECRUITING', 'country': 'Slovakia', 'facility': 'Site 122003', 'geoPoint': {'lat': 49.29175, 'lon': 21.27271}}, {'city': 'Partizánske', 'status': 'RECRUITING', 'country': 'Slovakia', 'facility': 'Site 122002', 'geoPoint': {'lat': 48.62861, 'lon': 18.38455}}, {'city': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124006', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124013', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124011', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124012', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124008', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124016', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Oviedo', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124003', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Palma de Mallorca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124001', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Pontevedra', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124014', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}, {'city': 'Santiago de Compostela', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124010', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Site 124015', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206004', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206005', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206001', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Chiang Rai', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206007', 'geoPoint': {'lat': 19.90858, 'lon': 99.8325}}, {'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206003', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Nakhon Nayok', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206002', 'geoPoint': {'lat': 14.20463, 'lon': 101.21295}}, {'city': 'Songkhla', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Site 206006', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'city': 'Aryanah', 'status': 'RECRUITING', 'country': 'Tunisia', 'facility': 'Site 112002', 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}, {'city': 'Aryanah', 'status': 'RECRUITING', 'country': 'Tunisia', 'facility': 'Site 112003', 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}, {'city': 'Aryanah', 'status': 'RECRUITING', 'country': 'Tunisia', 'facility': 'Site 112004', 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}, {'city': 'Sfax', 'status': 'RECRUITING', 'country': 'Tunisia', 'facility': 'Site 112001', 'geoPoint': {'lat': 34.74056, 'lon': 10.76028}}, {'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'facility': 'Site 112005', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'Susana Millán, PhD', 'role': 'CONTACT', 'email': 'Susana.Millan@mabxience.com', 'phone': '+34917711500'}, {'name': 'Camino Huerga', 'role': 'CONTACT', 'email': 'Camino.Huerga@mabxience.com', 'phone': '+34917711500'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mAbxience Research S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}