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NCT00135408 Clinical Trial

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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00135408
Other study ID # CA184-007
Secondary ID
Status Completed
Phase Phase 2
First received August 25, 2005
Last updated September 26, 2016
Start date December 2005
Est. completion date July 2007

Study information
Verified date September 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 115
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ipilimumab+ Placebo
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
• 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.

Locations
Country Name City State
Canada Local Institution Kitchener
Canada Local Institution Moncton
Israel Local Institution Tel Aviv
Italy Local Institution Forli
Peru Local Institution Lima
United Kingdom Local Institution Hull

Sponsors (2)
Lead Sponsor Collaborator
Bristol-Myers Squibb Medarex

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Italy,  Peru,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Secondary 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
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