NCT00135408

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2005

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

August 25, 2005

Last Update Submit

September 26, 2016

Conditions

Malignant Melanoma

Keywords

Unresectable Stage III or IV Malignant Melanoma

Outcome Measures

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

    at Week 24

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Ipilimumab+ Placebo

A2

ACTIVE COMPARATOR
Drug: Ipilimumab+ Budesonide

Interventions

Ipilimumab+ PlaceboDRUG

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

Also known as: BMS-734016, (MDX-010)
A1
Ipilimumab+ BudesonideDRUG

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.

Also known as: BMS-734016, (MDX-010)
A2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
  • Flexible Sigmoidoscopy and colonic biopsy required

You may not qualify if:

  • Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Local Institution

Kitchener, Canada

Location

Local Institution

Moncton, Canada

Location

Local Institution

Tel Aviv, Israel

Location

Local Institution

Forlì, Italy

Location

Local Institution

Lima, Peru

Location

Local Institution

Hull, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25667295DERIVED

Related Links

MeSH Terms

Conditions

Melanoma

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 26, 2005

Study Start

December 1, 2005

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

PE(1)GB(1)IT(1)CA(2)IL(1)US(4)