Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

November 18, 2011 updated by: Bristol-Myers Squibb

A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma

The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Local Institution
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution
    • Florida
      • Tampa, Florida, United States, 33612
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution
      • Boston, Massachusetts, United States, 02114
        • Local Institution
      • Boston, Massachusetts, United States, 02115
        • Local Institution
    • New York
      • New York, New York, United States, 10021
        • Local Institution

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:

  • Histologically or cytologically confirmed malignant melanoma
  • Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
  • Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

  • Active/symptomatic brain metastases
  • Primary ocular melanoma or primary tumor of unknown origin
  • Concurrent autoimmune disease
  • Previous treatment with a CD137 agonist or CTLA-4 inhibitor

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 0.1 mg/kg
Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
EXPERIMENTAL: 0.3 mg/kg
Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
EXPERIMENTAL: 1.0 mg/kg
Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
EXPERIMENTAL: 3.0 mg/kg
Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010
EXPERIMENTAL: 10 mg/kg
Drug: AntiCD137
Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: AntiCD137
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response
Other Names:
  • BMS-663513
Drug: Ipilimumab
Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
Other Names:
  • BMS-734016
  • MDX-010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
Time Frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinical improvement in tumor burden confirmed by CT or MRI
Time Frame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter

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

November 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

January 1, 2013

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (ESTIMATE)

December 5, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA186-007

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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