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Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

NCT00261365 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-09-29

No results posted yet for this study

Summary

The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).

Conditions

  • Unresectable Stage III or IV Malignant Melanoma

Interventions

DRUG

Ipilimumab

Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

DRUG

Ipilimumab

Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States
  • Denmark
  • Israel
  • Italy
  • Norway
  • Peru
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT00261365 on ClinicalTrials.gov