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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Biological: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01354431

CA209-010

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 3 patient groups

Arm 1: nivolumab - 0.3 mg/kg

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Biological: nivolumab

Arm 2: nivolumab - 2.0 mg/kg

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Biological: nivolumab

Arm 3: nivolumab - 10.0 mg/kg

Experimental group

Treatment:

Biological: nivolumab

Biological: nivolumab

Biological: nivolumab