Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
