Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer. (MDX1411-01)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Kidney Cancer

Treatments

Biological: MDX 1411

Study type

Interventional

Funder types

Industry

Identifiers

NCT00656734

MDX1411-01

CA214-001 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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