Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.

NCT ID: NCT00656734

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-06-30

Brief Summary

To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).

Detailed Description

Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MDX 1411

Dose Escalation Cohorts

Group Type: EXPERIMENTAL

MDX 1411

Intervention Type: BIOLOGICAL

MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total

Interventions

MDX 1411

MDX-1411 (fully human monoclonal antibody) administered as an i.v. infusion for up to 5 doses per cycle, with a maximum of 17 cycles total

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed diagnosis of RCC with clear cell component
• Measurable disease
• Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
• Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
• At least 28 days since the last chemotherapy
• At least 28 days before the first dose of MDX 1411 since any major surgery
• ECOG performance status 0-2
• No known positivity for human immunodeficiency virus (HIV), Hep B or C

Exclusion Criteria

• Previous treatment with any other anti-CD70 antibody
• Active infection requiring i.v systemic therapy within 28 days before first dose
• Evidence of bleeding diathesis or coagulopathy
• Active autoimmune disease requiring immunosuppressive therapy
• Known current drug or alcohol abuse
• Any underlying medical condition which will make the administration of MDX 1411 hazardous
• Psychiatric illness or social situation that would preclude study compliance

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Beth Israel Deaconness Medical Center

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

CA214-001

Identifier Type: OTHER

Identifier Source: secondary_id

MDX1411-01

Identifier Type: -

Identifier Source: org_study_id