Study to Compare Two Formulations of CP-675,206 Monoclonal Antibody

An Open Label, Randomized Clinical Comparability Study Of The Current Liquid And Commercial Liquid Formulations

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00431275

Enrollment

Registered

2007-02-05

Start date

2006-06-30

Completion date

2008-02-29

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Brief summary

This is an open-label, 2-arm study in which patients are randomized to receive either the formulation that is being used in clinical trials or the formulation that will be used when if the drug becomes commercially available. The purpose of this study is to compare the pharmacokinetics of the two formulations.

Interventions

DRUGCP-675,206

CP-675,206 15 mg/kg iv single dose on Day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stage III or Stage IV melanoma * No evidence of disease following resection of melanoma lesions * Recovered from all prior surgical or adjuvant treatment-related toxicities

Exclusion criteria

* History of chronic inflammatory or autoimmune disease * History of inflammatory bowel disease

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: maximum plasma concentration of CP-675,206	1 hour
Pharmacokinetics: AUC, defined as the area under the concentration -time curve	Time 0 to Day 85

Secondary

Measure	Time frame
Human-anti-human antibodies	1 year
Adverse events	1 year
Safety laboratory tests	1 year
Proportion of patients alive and free of disease at 1 year	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026