Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

NCT00803374 | Withdrawn Phase 1

• 1 other identifier: CA186-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (1)

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

  Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter

Study Arms (5)

0.1 mg/kg

EXPERIMENTAL

Drug: AntiCD137; Drug: Ipilimumab

0.3 mg/kg

EXPERIMENTAL

Drug: AntiCD137; Drug: Ipilimumab

1.0 mg/kg

EXPERIMENTAL

Drug: AntiCD137; Drug: Ipilimumab

3.0 mg/kg

EXPERIMENTAL

Drug: AntiCD137; Drug: Ipilimumab

10 mg/kg

EXPERIMENTAL

Drug: AntiCD137; Drug: Ipilimumab

Interventions

AntiCD137 DRUG

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

Also known as: BMS-663513

0.1 mg/kg

Ipilimumab DRUG

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

Also known as: BMS-734016, MDX-010

0.1 mg/kg; 0.3 mg/kg; 1.0 mg/kg; 10 mg/kg; 3.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (7)

Local Institution

Los Angeles, California, 90025, United States

Location

Local Institution

New Haven, Connecticut, 06520, United States

Location

Local Institution

Tampa, Florida, 33612, United States

Location

Local Institution

Boston, Massachusetts, 02114, United States

Location

Local Institution

Boston, Massachusetts, 02115, United States

Location

Local Institution

Boston, Massachusetts, 02215, United States

Location

Local Institution

New York, New York, 10021, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Melanoma

Interventions

urelumab; Ipilimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 21, 2011

Record last verified: 2011-11

Locations

US (7)