Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-06 @ 8:53 PM
Study NCT ID:
NCT06587451
Status:
SUSPENDED
Last Update Posted:
2025-08-07
First Post:
2024-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
Sponsor:
Organization:
Raw JSON
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'Therapeutics'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 720}}, 'statusModule': {'whyStopped': 'In light of the evolving regulatory landscape and growing indications that major Health Authorities will move towards a streamlined clinical development, Sandoz took a strategic decision and is winding down its CJPB898A12301 clinical study.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-08-30', 'studyFirstSubmitQcDate': '2024-09-06', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU', 'timeFrame': 'Days 1 to 22', 'description': 'Area under the serum concentration-time curve measured from the time of dosing of the first dose to the second dose (AUCtrunc) after the first dose'}, {'measure': 'Demonstrate PK similarity between JPB898, Opdivo-US, and Opdivo-EU between JPB898 and Opdivo-US/-EU', 'timeFrame': 'Days 64 to 85', 'description': 'Area under the serum concentration-time curve measured from the time of dosing to the last measurable serum concentration in the dosing interval, tau (AUCtau) after the fourth dose'}, {'measure': 'Demonstrate efficacy similarity for Best overall response (BOR) between JPB898 and Opdivo-US/-EU defined as the best overall response based on blinded central tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria', 'timeFrame': 'BOR (Complete response (CR) or partial response (PR)) from baseline up to 28 weeks', 'description': 'The assessment of response for the primary efficacy is based on tumor response data as per blinded independent central review and according to RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate similar PK and efficacy and to show comparable safety and immunogenicity between JPB898, Opdivo-EU, and Opdivo-US, all administered in combination with Yervoy-EU (induction phase only), in participants with advanced (unresectable Stage III or metastatic Stage IV) melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male or female participants must be 18 years or older.\n* Histologically confirmed melanoma.\n* Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.\n* Sexually active participants must agree to use effective contraception.\n\nExclusion Criteria\n\n* Active brain or leptomeningeal metastases unless stable for 8 weeks.\n* Ocular melanoma.\n* Prior active malignancy within the last year untreated or still requiring treatment.\n* Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.\n* Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.'}, 'identificationModule': {'nctId': 'NCT06587451', 'briefTitle': 'Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sandoz'}, 'officialTitle': 'A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of JPB898 (Proposed Nivolumab Biosimilar) and US-licensed and EU-authorized Opdivo® in Combination With Yervoy® in Participants With Untreated Advanced (Unresectable/Metastatic) Melanoma', 'orgStudyIdInfo': {'id': 'CJPB898A12301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JPB898', 'description': 'Participants will receive JPB898 combined with Yervoy-EU during the induction phase. Participants will receive JPB898 during maintenance phase.', 'interventionNames': ['Drug: JPB898 (Induction and Maintenance)', 'Drug: Yervoy-EU (Induction)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opdivo-EU', 'description': 'Participants will receive Opdivo-EU combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.', 'interventionNames': ['Drug: Opdivo-EU (Induction)', 'Drug: Yervoy-EU (Induction)', 'Drug: Opdivo-EU (Maintenance)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opdivo-US', 'description': 'Participants will receive Opdivo-US combined with Yervoy-EU during the induction phase. Participants will receive Opdivo-EU during the maintenance phase.', 'interventionNames': ['Drug: Opdivo-US (Induction)', 'Drug: Yervoy-EU (Induction)', 'Drug: Opdivo-EU (Maintenance)']}], 'interventions': [{'name': 'JPB898 (Induction and Maintenance)', 'type': 'DRUG', 'description': 'Induction and Maintenance: Intravenous (IV)', 'armGroupLabels': ['JPB898']}, {'name': 'Opdivo-EU (Induction)', 'type': 'DRUG', 'description': 'Induction: Intravenous (IV)', 'armGroupLabels': ['Opdivo-EU']}, {'name': 'Opdivo-US (Induction)', 'type': 'DRUG', 'description': 'Induction: Intravenous (IV)', 'armGroupLabels': ['Opdivo-US']}, {'name': 'Yervoy-EU (Induction)', 'type': 'DRUG', 'description': 'Induction: Intravenous (IV)', 'armGroupLabels': ['JPB898', 'Opdivo-EU', 'Opdivo-US']}, {'name': 'Opdivo-EU (Maintenance)', 'type': 'DRUG', 'description': 'Maintenance: Intravenous (IV)', 'armGroupLabels': ['Opdivo-EU', 'Opdivo-US']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 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