A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection

Official Title

A Randomized, Double-Blind, Parallel, Phase 1 Study to Compare the Pharmacokinetics of BMSCHO1-Nivolumab Process D to Nivolumab Process C After Complete Resection of Stage IIIa/b/c/d or Stage IV Melanoma

Summary:

The main purpose of study is to compatibility the pharmacokinetic (PK) of Process D relative to Process C.

Trial Description

Primary Outcome:

• Area under the concentration-time curve in one dosing interval (336 h)

Secondary Outcome:

• Maximum Observed Plasma Concentration (Cmax)
• Trough Observed Serum Concentration (Ctrough)
• Volume of Distribution
• Total Body Clearance
• Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
• Number of Participants With Serious Adverse Events (SAEs) and Deaths
• Number of Participants With Adverse Events leading to Discontinuation
• Number of Participants With Adverse Events (AEs)
• Number of Participants With Clinically Significant Laboratory Abnormalities

The study is intended to compare the pharmacokinetic of Process D nivolumab to Process C nivolumab administered after complete resection of Stage IIIa/b/c/d or Stage IV melanoma.

View this trial on ClinicalTrials.gov