Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

NCT00729950 | Completed Phase 1

• 2 other identifiers: MDX010-15CA184-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase I, open-label, multicenter, pharmacokinetic study of MDX-010 in up to 90 evaluable subjects with surgically unresectable malignant melanoma.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• To determine the safety and pharmacokinetic profile of single and multiple doses of MDX-010.

  up to approximately 1 year

Secondary Outcomes (1)

• Determine the clinical activity profile of single and multiple doses of MDX-010

  up to aproximately one year.

Interventions

MDX-010 BIOLOGICAL

Subjects will be treated with transfectoma-derived MDX-010 at 2.8 or 5 mg/kg/dose, or with hybridoma-derived MDX-010 at 3 mg/kg/dose administered on Days 1, 57, and 85. The 2.8, 3, and 5 mg/kg dosage cohorts may be initiated concurrently. Additionally, 6 subjects per cohort will receive single doses of transfectoma-derived MDX-010 at 7.5, 10, 15, and 20 mg/kg.

Eligibility Criteria

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

You may qualify if:

• Subject must have read, understood, and provided written informed consent and authorization in compliance with the Health Insurance Portability and Accountability Act (HIPAA) afer the nature of the study has been fully explained.
• Subject must be at least 18 years of age with a histologic diagnosis of unresectable Stage III or IV malignant melanoma (may include mucosal melanoma). Subjects with either stable or progressive malignancy will be permitted in the study. Classification of stable or progressive disease, to be recorded for all subjects, will be defined by the Response Evaluation Criteria in Solid Tumors (RECIST), as detailed in Appendix 3 and determined since last melanoma treatment. Subjects must have at least 1 site of measurable disease.
• At least 4 weeks since treatment (surgery, chemotherapy, radiation, or immuno- therapy) for melanoma and recovered from any serious toxicity experienced during treatment.
• Life expectancy of at least 18 weeks.
• Karnofsky Performance Status of at least 70%
• Screening laboratory values must meet the following criteria:
• WBC ≥2500/μL
• ANC ≥1500/μL
• Platelets ≥100 x 10'/μL
• Hematocrit ≥30%
• Hemoglobin ≥10 g/dL
• Creatinine ≤2 mg/dL
• AST ≤2 x ULN\*
• Bilirubin ≤1.0 x ULN\*, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
• HIV negative

You may not qualify if:

• Any prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the subject has been disease-free for at least 5 years
• History of autoimmune disease (including uveitis and autoimmune inflammatory eye disease) prior to entrance into the study.
• Active infection requiring therapy, chronic active HBV or HCV, or confirmed reactivity with HIV tests.
• Tetanus booster immunization within 2 months of initial screening procedures, or a history of anaphylaxis or severe local reaction to the tetanus vaccine.
• Pregnant or nursing: it is not known what effect MDX-010 could have on the developing immune system of the fetus or infant, therefore, exposure in utero or via breast milk will not be allowed.
• Any underlying medical condition which, in the opinion of the principal investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events.
• Any concurrent medical condition requiring the use of systemic or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporine and its analog, or chemotherapy agents). All corticosteroid use must have been discontinued at least 4 weeks prior to trial entry.
• Prior treatment with MDX-010 or any other anti-CTLA-4 monoclonal antibody.
• Evidence or history of significant cardiac, pulmonary, hepatic, renal, psychiatric or gastrointestinal disease that would make the administration of MDX-010 unsafe.
• Concurrent treatment with chemotherapy or other immunotherapy regimens (must be completed at least 4 weeks before Screening).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Piedmont Oncology Specialists

Charlotte, North Carolina, 28207, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

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: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 8, 2008
• Study Start: July 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: June 1, 2007
• Last Updated: April 26, 2010

Record last verified: 2010-04

Locations

US (4)