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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

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma

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Trial Information

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

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation.

Inclusion Criteria:

- Histologic confirmation of Renal cell carcinoma (RCC) with a clear cell component

- Previous treatment with at least one anti-angiogenic agent

- Progressed within 6 months of study enrollment

- Subjects should not have had more than 3 prior treatments for locally advanced or
metastatic disease

- Must have available tumor tissue for submission

- Subjects must also meet various laboratory parameters for inclusion

Exclusion Criteria:

- Subjects with any active autoimmune disease or a history of known autoimmune disease

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival as measured by tumor assessments (radiographic scans) and the collection of death data. It will be compared to the doses given across the 3 treatment arms to see if a dose response exists.

Outcome Time Frame:

Tumor assessments (radiographic scans) will be done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression is documented. Subjects will be assessed for survival every 3 months.

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Renal Cell Carcinoma
  • Advanced/Metastatic
  • clear cell component
  • Carcinoma
  • Carcinoma, Renal Cell



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