A Randomized, Blinded, Phase 2 Dose-Ranging Study of BMS-936558 (MDX-1106) in Subjects with Progressive Advanced/Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Study Status

Closed to Enrollment

Study Description

The purpose of this study is to test the effectiveness, safety and tolerability of the experimental drug BMS-936558 in patients with advanced/metastatic renal cell cancer (kidney cancer). The study drug will be given at different dose levels to determine the most effective dose for further study.

BMS-936558 is also called MDX-1106. MDX-1106 is an antibody that binds to PD-1, a molecule present in T-cells. It is believed that PD-1 controls part of the immune system by shutting it down. Researchers believe that one way cancers can escape the immune system could be through taking advantage of the immune system shutting down. MDX-1106 may stop PD-1 from turning off the immune system and allow an immune reaction against the cancer.

All patients enrolled in the study will receive BMS-936558 via infusion. Patients will be randomly assigned to receive one of three different dose levels.

Treatment Phase:

Patients will be infused every 3 weeks until disease progression or if unable to tolerate the study drug

Follow-up Phase:

The follow-up phase begins when the decision to discontinue therapy is made and the patient stops receiving the study drug. Patients will be in the follow-up phase for a maximum of 4 years after study entry. 

Disease Status and/or Stage

Advanced/Metastatic Renal Cell Carcinoma (RCC)

Sponsor

Bristol-Myers Squibb

Key Eligibility

  • Men and women age 18 and older
  • Advanced/metastatic Renal Cell Carcinoma (RCC)
  • Must have received treatment with at least 1 angiogenic therapy (for example, sunitinib, sorafenib, pazopanib, axitinib, tivozanib, bevacizumab) in advanced/metastatic setting
  • Must have received not more than 3 prior treatment regimens in the advanced/metastatic setting and should have progressed from the most recent therapy within 6 months of enrolling in the study
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Scott Tagawa, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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