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Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

Primary Purpose

Unresectable Stage III or IV Malignant Melanoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Stage III or IV Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.

Sites / Locations

  • Comprehensive Cancer Center
  • The Angeles Clinic And Research Institution
  • Beth Israel Deaconess Medical Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A1

A2

Arm Description

Outcomes

Primary Outcome Measures

Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)

Secondary Outcome Measures

Safety & tumor response are important secondary objectives. Safety evaluated
Tumor response measured

Full Information

First Posted
December 1, 2005
Last Updated
September 27, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00261365
Brief Title
Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)
Official Title
An Exploratory Study to Determine Potential Predictive Markers of Response and/or Toxicity in Patients With Unresectable Stage III or IV Malignant Melanoma Randomized and Treated With Ipilimumab (MDX-010/BMS-734016) at Two Dose Levels
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to identify candidate markers predictive of response and/or serious toxicity to BMS-734016 (MDX-010).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Stage III or IV Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Active Comparator
Arm Title
A2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, (MDX-010)
Intervention Description
Solution, Intravenous, 3 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, (MDX-010)
Intervention Description
Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
Primary Outcome Measure Information:
Title
Purpose - to identify candidate markers predictive of response and/or serious toxicity to MDX-101 (BMS-734016)
Time Frame
on a continuous & ongoing basis
Secondary Outcome Measure Information:
Title
Safety & tumor response are important secondary objectives. Safety evaluated
Time Frame
on a continuous & ongoing basis
Title
Tumor response measured
Time Frame
starting @ wk 12 through wk 24. Those continuing on therapy after wk 24 have tumor responses evaluated every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic diagnosis of unresectable State III or IV malignant melanoma (excluding ocular melanoma); A pre- and post-treatment fresh core or excision tumor biopsy must be provided.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
The Angeles Clinic And Research Institution
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
72080
Country
Israel
Facility Name
Local Institution
City
Bari
ZIP/Postal Code
70126
Country
Italy
Facility Name
Local Institution
City
Forli'
ZIP/Postal Code
47100
Country
Italy
Facility Name
Local Institution
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Local Institution
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
43
Country
Peru
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Local Institution
City
Gothenberg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25667295
Citation
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.
Results Reference
derived
PubMed Identifier
22123319
Citation
Hamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204.
Results Reference
derived

Learn more about this trial

Phase II Study to Determine Predictive Markers of Response to BMS-734016 (MDX-010)

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