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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135408

Enrollment

115

Registered

2005-08-26

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

Unresectable Stage III or IV Malignant Melanoma

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.

Interventions

DRUGIpilimumab+ Placebo

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

DRUGIpilimumab+ 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Rate of Grade 2,3,4 Diarrhea - patients on study drug.	—

Secondary

Measure	Time frame
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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026