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Comparison of Ipilimumab Manufactured by 2 Different Processes in Participants With Advanced Melanoma

NCT00920907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2014-06-20

Study results available
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Summary

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes

Conditions

Interventions

BIOLOGICAL

Ipilimumab

Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00920907 on ClinicalTrials.gov