A Pharmacokinetic Comparison of JPB898 and Nivolumab in Patients with Resected Stage IIB, IIC, or III Melanoma in the Adjuvant Setting

The primary objective of this study is to evaluate the pharmacokinetics of JPB898, a proposed nivolumab biosimilar, in comparison to the US-licensed Opdivo. This assessment is conducted in participants diagnosed with resected melanoma at stage IIB, IIC, or III who require adjuvant treatment. The evaluation aims to establish the comparative performance of the biosimilar in a clinically relevant population.

The study involves a total of 73 patients. The population includes both males and females within the age ranges corresponding to adults and the elderly. Participants are characterized by having resected melanoma classified as stage IIB, IIC, or III that necessitates adjuvant treatment. The sponsor did not provide information regarding specific lifestyle considerations or general health status beyond the specified diagnosis.

This Phase 3 study utilizes a pharmacokinetic design to compare JPB898, a proposed nivolumab biosimilar, with the US-licensed Opdivo in patients diagnosed with resected melanoma of stage IIB, IIC, or III requiring adjuvant treatment. The clinical trial involves a sequence of study visits beginning with a screening visit to evaluate eligibility. Subsequent follow-up visits and an end-of-study visit are scheduled to monitor the participants throughout the protocol. The total duration of participant involvement is determined by the study design and clinical requirements. Early termination from the study may occur based on predefined clinical conditions or safety criteria.

Efficacy in this phase 3 clinical trial is evaluated based on the clinical status of patients with resected stage IIB, IIC, or III melanoma requiring adjuvant treatment.