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

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

Detailed Description
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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.

Official Title
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A Phase 1, Open-Label, Multicenter Dose-escalation, Multidose Study of MDX1411 Administered Every 14 Days in Subjects With Advanced or Recurrent Clear Cell Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: MDX 1411


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDX 1411<br>Dose Escalation Cohorts | Biological: MDX 1411<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety profile of MDX 1411 |  | duration of study | 
| Determine the maximum tolerated dose of MDX 1411 |  | duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the best overall response rate (BORR) |  | Day 38-42 of each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medarex Inc.