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

Phase 1

Completed

• Conditions: Kidney Cancer
• Interventions: Biological: MDX 1411

• Registration Number: NCT00656734
• Lead Sponsor: Bristol-Myers Squibb

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDX 1411	MDX 1411	Dose Escalation Cohorts

Primary Outcome Measures

Name	Time	Method
Determine the safety profile of MDX 1411	duration of study
Determine the maximum tolerated dose of MDX 1411	duration of study

Secondary Outcome Measures

Name	Time	Method
Determine the best overall response rate (BORR)	Day 38-42 of each cycle

Trial Locations

Locations (7)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Beth Israel Deaconness Medical Center; 🇺🇸 Boston, Massachusetts, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States