BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)

Trial ID or NCT#

NCT01354431

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to measure how active BMS-936558 (nivolumab) is against Renal Cell Carcinoma (RCC) as measured by the disease not progressing and whether a dose response relationship exists.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Subjects with any active autoimmune disease or a history of known autoimmune disease Other protocol-defined inclusion/exclusion criteria apply

Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Cancer Clinical Trials Office
650-498-7061