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Completed

NCT Number: NCT00135408

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

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

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Kitchener, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ipilimumab+ Placebo

Drug

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

Other names: BMS-734016, (MDX-010)

Ipilimumab+ Budesonide

Drug

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)

Primary outcomes

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Medarex

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 26, 2005
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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