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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipilimumab+ Placebo
Ipilimumab+ Budesonide
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Unresectable Stage III or IV Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma) Flexible Sigmoidoscopy and colonic biopsy required Exclusion Criteria: Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

Rate of Grade 2,3,4 Diarrhea - patients on study drug.

Secondary Outcome Measures

Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis

Full Information

First Posted
August 25, 2005
Last Updated
September 26, 2016
Sponsor
Bristol-Myers Squibb
Collaborators
Medarex
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1. Study Identification

Unique Protocol Identification Number
NCT00135408
Brief Title
A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Official Title
Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Medarex

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Unresectable Stage III or IV Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ipilimumab+ Placebo
Other Intervention Name(s)
BMS-734016, (MDX-010)
Intervention Description
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab+ Budesonide
Other Intervention Name(s)
BMS-734016, (MDX-010)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Secondary Outcome Measure Information:
Title
Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis
Time Frame
at Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma) Flexible Sigmoidoscopy and colonic biopsy required Exclusion Criteria: Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Kitchener
Country
Canada
Facility Name
Local Institution
City
Moncton
Country
Canada
Facility Name
Local Institution
City
Tel Aviv
Country
Israel
Facility Name
Local Institution
City
Forli
Country
Italy
Facility Name
Local Institution
City
Lima
Country
Peru
Facility Name
Local Institution
City
Hull
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25667295
Citation
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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