A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

September 27, 2016 updated by: Bristol-Myers Squibb

A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Local Institution
      • Wels, Austria
        • Local Institution
      • Wien, Austria
        • Local Institution
  • Finland
      • Turku, Finland
        • Local Institution
  • Italy
      • Genova, Italy
        • Local Institution
      • Meldola, Italy
        • Local Institution
      • Milano, Italy
        • Local Institution
      • Napoli, Italy
        • Local Institution
      • Padova, Italy
        • Local Institution
      • Siena, Italy
        • Local Institution
      • Torino, Italy
        • Local Institution
  • Norway
      • Oslo, Norway
        • Local Institution
  • Poland
      • Lodz, Poland
        • Local Institution
      • Poznan, Poland
        • Local Institution
      • Wroclaw, Poland
        • Local Institution
  • Russian Federation
      • Barnaul, Russian Federation
        • Local Institution
      • Moscow, Russian Federation
        • Local Institution
      • Murmansk, Russian Federation
        • Local Institution
      • Ryazan, Russian Federation
        • Local Institution
      • Samara, Russian Federation
        • Local Institution
      • St Petersburg, Russian Federation
        • Local Institution
      • St. Petersburg, Russian Federation
        • Local Institution
      • Stavropol, Russian Federation
        • Local Institution
      • Velikiy Novgorod, Russian Federation
        • Local Institution
      • Voronezh, Russian Federation
        • Local Institution
  • Spain
      • Barcelona, Spain
        • Local Institution
      • Madrid, Spain
        • Local Institution
      • Malaga, Spain
        • Local Institution
      • Tenerife, Spain
        • Local Institution
      • Valencia, Spain
        • Local Institution
  • Sweden
      • Goteborg, Sweden
        • Local Institution
      • Lund, Sweden
        • Local Institution
      • Stockholm, Sweden
        • Local Institution
      • Uppsala, Sweden
        • Local Institution
  • Ukraine
      • Cherkassy, Ukraine
        • Local Institution
      • Dnipropetrovsk, Ukraine
        • Local Institution
      • Kiev, Ukraine
        • Local Institution
      • Lvov, Ukraine
        • Local Institution
      • Sumy, Ukraine
        • Local Institution
      • Uzhgorod, Ukraine
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • San Francisco, California, United States
      • Santa Monica, California, United States
    • Illinois
      • Chicago, Illinois, United States
      • Park Ridge, Illinois, United States
    • Indiana
      • Goshen, Indiana, United States
    • Kentucky
      • Hazard, Kentucky, United States
    • New Mexico
      • Alburquerque, New Mexico, United States
    • New York
      • New York, New York, United States
    • Oregon
      • Portland, Oregon, United States
    • South Carolina
      • Greenville, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
    • Virginia
      • Charlottesvillle, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ipilimumab (MDX-010, BMS-734016)
Drug: ipilimumab (MDX-010, BMS-734016)
IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.

Secondary Outcome Measures

Outcome Measure
estimate disease control rate
estimate progression free survival rate at Week 12
estimate PFS
estimate overall survival
estimate survival rate at one year
estimate duration of BOR
evaluate proportion of patients whose duration of response is >=24 weeks
estimate time to BOR
evaluate safety profile of ipilimumab during the induction and maintenance phases
evaluate health-related quality of life
obtain PK sample for population PK analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Medarex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA184-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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