Clinical trial · Interventional
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
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
NCT01354431CI-TRIAL-00058450completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: nivolumab - 0.3 mg/kg
- interventionNames
- Biological: nivolumab
- type
- EXPERIMENTAL
- label
- Arm 2: nivolumab - 2.0 mg/kg
- interventionNames
- Biological: nivolumab
- type
- EXPERIMENTAL
- label
- Arm 3: nivolumab - 10.0 mg/kg
- interventionNames
- Biological: nivolumab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDGeorge S, Motzer RJ, Hammers HJ, Redman BG, Kuzel TM, Tykodi SS, Plimack ER, Jiang J, Waxman IM, Rini BI. Safety and Efficacy of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Treated Beyond Progression: A Subgroup Analysis of a Randomized Clinical Trial. JAMA Oncol. 2016 Sep 1;2(9):1179-86. doi: 10.1001/jamaoncol.2016.0775. PMID 27243803
- DERIVEDMotzer RJ, Rini BI, McDermott DF, Redman BG, Kuzel TM, Harrison MR, Vaishampayan UN, Drabkin HA, George S, Logan TF, Margolin KA, Plimack ER, Lambert AM, Waxman IM, Hammers HJ. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol. 2015 May 1;33(13):1430-7. doi: 10.1200/JCO.2014.59.0703. Epub 2014 Dec 1. PMID 25452452
- DERIVEDGeorge S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Compr Canc Netw. 2011 Sep 1;9(9):1011-8. doi: 10.6004/jnccn.2011.0085. PMID 21917625