Phase 2
Completed N=168
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Source: ClinicalTrials.gov NCT01354431 ↗Enrolled (actual)
168
Serious AEs
53.3%
Results posted
Oct 2015
Primary outcomePrimary: Progression Free Survival (PFS) — 2.63; 4.11; 4.17 Months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
2.63; 4.11; 4.17 | — |
| SECONDARY Best Overall Response Rate (BORR) |
20.0; 24.1; 20.4 | — |
| SECONDARY Overall Survival (OS) |
18.45; 25.46; 24.82 | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
58; 54; 53; 44; 36; 41 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01354431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.