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A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

NCT00135408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2016-09-28

No results posted yet for this study

Summary

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Ipilimumab+ Placebo

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

DRUG

Ipilimumab+ Budesonide

Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States
  • Canada
  • Israel
  • Italy
  • Peru
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00135408 on ClinicalTrials.gov