Last updated 5 days ago
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
720 patients around the world
Sandoz
1Research sites
720Patients around the world
This study is for people with
Skin cancer
Melanoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male or female participants must be 18 years or older.Histologically confirmed melanoma.Unresectable or metastatic melanoma measurable by Computerized tomography (CT) or Magnetic resonance imaging (MRI).Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Known Programmed cell death ligand 1 (PD-L1) and BRAF mutational status or consent to testing.Sexually active participants must agree to use effective contraception.
- Active brain or leptomeningeal metastases unless stable for 8 weeks.Ocular melanoma.Prior active malignancy within the last year untreated or still requiring treatment.Severe and uncontrolled conditions, active Hepatitis B/C, Human immunodeficiency virus (HIV), or autoimmune diseases requiring systemic treatment.Previous treatment with specific immune checkpoint inhibitors, systemic anticancer therapy, or radiotherapy for melanoma.
Sites
Centro Oncológico y Tratamiento Oncología - CDIEM
Recruiting
StudyCJPB898A12301
SponsorSandoz
Study typeInterventional
Conditions
Melanoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06587451
