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Completed

NCT Number: NCT00656734

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beth Israel Deaconness Medical Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDX 1411

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

Primary outcomes

  1. Determine the safety profile of MDX 1411

    Time frame: duration of study

  2. Determine the maximum tolerated dose of MDX 1411

    Time frame: duration of study

Secondary outcomes

  1. Determine the best overall response rate (BORR)

    Time frame: Day 38-42 of each cycle

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: MDX1411-01

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 11, 2008
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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