Phase II, 2nd Line Melanoma - RAND Monotherapy

September 23, 2015 updated by: Bristol-Myers Squibb

A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects With Previously Treated Unresectable Stage III or IV Melanoma

The main purpose of this study is to estimate the proportion of patients with a type of skin cancer called melanoma who are progression free, (that is, the cancer has not gotten substantially worse), when treated with Anti-CD137 (4-1BB) (BMS-663513) at 0.1 mg/kg, 1 mg/kg or 5 mg/kg every 3 weeks or 1 mg/kg every 6 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

158

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Local Institution
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Local Institution
  • Denmark
      • Aarhus C, Denmark, 8000
        • Local Institution
      • Odense C, Denmark, DK-5000
        • Local Institution
  • France
      • Lille, France, 59037
        • Local Institution
      • Paris, France, 75010
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Homburg / Saar, Germany, 66421
        • Local Institution
      • Jena, Germany, 07740
        • Local Institution
      • Kiel, Germany, 24105
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Mannheim, Germany, 68167
        • Local Institution
      • Tubingen, Germany, 72076
        • Local Institution
      • Wuerzburg, Germany, 97080
        • Local Institution
  • Italy
      • Genove, Italy, 16132
        • Local Institution
      • Milano, Italy, 20141
        • Local Institution
      • Napoli, Italy, 80131
        • Local Institution
      • Padova, Italy, 35128
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinic & Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Melvin and Bren Simon Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Harry & Jeanette Weinberg Cancer Inst At Franklin Square
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Inst
    • New York
      • New York, New York, United States, 10021
        • Mem Sloan-Ket Can Ctr
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Blumenthal Cancer Center, Carolinas Medical Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas

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:

  • Subjects must have been previously treated with one line of systemic anti-cancer therapy (non-experimental or experimental) for metastatic disease, and relapsed, failed to respond (CR or PR) or did not tolerate that regimen. If the treatment has been administered as an adjuvant and/or neoadjuvant therapy, the subject must have documented disease progression from the last treatment and also received one additional line of systemic therapy for metastatic disease.
  • Men and women, who are at least 18 years of age

Exclusion Criteria:

  • Ocular or mucosal melanoma
  • Complete surgical resection of all identifiable sites of disease
  • Symptomatic brain metastasis. Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by computerized axial tomography (CT) scan or magnetic resonance imaging (MRI). Subjects with stable brain metastasis and those who were previously treated with radiotherapy or surgery must have no current evidence of symptomatic brain metastasis and are off steroid therapy for at least 4 weeks prior to randomization

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
0.1 mg/kg every 3 weeks
Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Active Comparator: Arm 2
1 mg/kg every 3 weeks
Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Active Comparator: Arm 3
1 mg/kg every 6 weeks
Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity
Active Comparator: Arm 4
5 mg/kg every 3 weeks
Drug: Anti-CD137 (4-1BB) (BMS-663513)
IV solution, IV, until PD or toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic imaging, photographic and clinical evaluation will be used for tumor assessment to determine 6-month progression-free survival rate
Time Frame: every 6 weeks starting at week 12 after randomization
every 6 weeks starting at week 12 after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety profiles
Time Frame: throughout the study
throughout the study
Disease response rate
Time Frame: end of study
end of study
Disease control rate
Time Frame: end of study
end of study
1-year survival
Time Frame: end of study
end of study
Pharmacokinetics
Time Frame: throughout the study
throughout the study
Pharmacodynamics
Time Frame: throughout the study
throughout the study
Biomarkers
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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

March 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

January 30, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA186-006

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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