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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00135408

Collaborator

Medarex (Industry)

115

Enrollment

Locations

Arms

Duration (Months)

11.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma	Drug: Ipilimumab+ Placebo Drug: Ipilimumab+ Budesonide	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A1	Drug: Ipilimumab+ Placebo Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response. Other Names: BMS-734016 (MDX-010)
Active Comparator: A2	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. Other Names: BMS-734016 (MDX-010)

Arm

Intervention/Treatment

Active Comparator: A1

Drug: Ipilimumab+ Placebo

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

Other Names:

BMS-734016

(MDX-010)

Active Comparator: A2

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.

Other Names:

BMS-734016

(MDX-010)

Outcome Measures

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 [at Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1		Los Angeles	California	United States
2		San Francisco	California	United States
3		Charlotte	North Carolina	United States
4		Seattle	Washington	United States
5	Local Institution	Kitchener		Canada
6	Local Institution	Moncton		Canada
7	Local Institution	Tel Aviv		Israel
8	Local Institution	Forli		Italy
9	Local Institution	Lima		Peru
10	Local Institution	Hull		United Kingdom