Last updated 22 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
María Luisa Santander 485, 7500859 Providencia, Región Metropolitana, Chile
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