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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society