NCT01354431
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
PHASE2
COMPLETED
NCT01354431
INTERVENTIONAL
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
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.
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
Other protocol-defined inclusion/exclusion criteria apply
Renal Cell Carcinoma
- TREATMENT
-
- Type: BIOLOGICAL
- Name: nivolumab
- Description: Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
- Arm Group Labels: Arm 1: nivolumab - 0.3 mg/kg
-
- Type: BIOLOGICAL
- Name: nivolumab
- Description: Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
- Arm Group Labels: Arm 2: nivolumab - 2.0 mg/kg
-
- Type: BIOLOGICAL
- Name: nivolumab
- Description: Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
- Arm Group Labels: Arm 3: nivolumab - 10.0 mg/kg
- Bristol-Myers Squibb