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Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

Primary Purpose

Melanoma

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AntiCD137

Ipilimumab

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

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

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

Sites / Locations

Local Institution
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

0.1 mg/kg

0.3 mg/kg

1.0 mg/kg

3.0 mg/kg

10 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evidence of clinical improvement in tumor burden confirmed by CT or MRI

Full Information

NCT ID

NCT00803374

First Posted

December 4, 2008

Last Updated

November 18, 2011

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00803374

Brief Title

Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Withdrawn

Study Start Date

November 2010 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.1 mg/kg

Arm Type

Experimental

Arm Title

0.3 mg/kg

Arm Type

Experimental

Arm Title

1.0 mg/kg

Arm Type

Experimental

Arm Title

3.0 mg/kg

Arm Type

Experimental

Arm Title

10 mg/kg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AntiCD137

Other Intervention Name(s)

BMS-663513

Intervention Description

Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response

Intervention Type

Drug

Intervention Name(s)

AntiCD137

Other Intervention Name(s)

BMS-663513

Intervention Description

Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response

Intervention Type

Drug

Intervention Name(s)

AntiCD137

Other Intervention Name(s)

BMS-663513

Intervention Description

Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response

Intervention Type

Drug

Intervention Name(s)

AntiCD137

Other Intervention Name(s)

BMS-663513

Intervention Description

Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response

Intervention Type

Drug

Intervention Name(s)

AntiCD137

Other Intervention Name(s)

BMS-663513

Intervention Description

Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

BMS-734016, MDX-010

Intervention Description

Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

Local Institution

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Local Institution

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Local Institution

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Local Institution

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

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Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

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