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
1 other identifier
interventional
168
4 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2011
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedStudy Start
First participant enrolled
May 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2013
CompletedResults Posted
Study results publicly available
October 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2021
CompletedMay 12, 2022
May 1, 2022
2 years
May 10, 2011
September 8, 2015
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is defined as the time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator). Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.
From randomization to disease progression or death (up to approximately 2 years)
Secondary Outcomes (3)
Best Overall Response Rate (BORR)
From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Overall Survival (OS)
From randomization to to date of death (up to approximately 8 years)
Number of Participants Experiencing Adverse Events
From first dose to 30 days following last dose (up to approximately 6 years)
Study Arms (3)
Arm 1: nivolumab - 0.3 mg/kg
EXPERIMENTALArm 2: nivolumab - 2.0 mg/kg
EXPERIMENTALArm 3: nivolumab - 10.0 mg/kg
EXPERIMENTALInterventions
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subjects with any active autoimmune disease or a history of known autoimmune disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharma USA Inccollaborator
Study Sites (41)
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Ucla
Los Angeles, California, 90024, United States
Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, 90048, United States
Stanford Cancer Center
Stanford, California, 94305, United States
University Of Colorado
Aurora, Colorado, 80045, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University Of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University Of Maryland
Baltimore, Maryland, 21201, United States
The Bunting-Blaustein Cancer Research Building
Baltimore, Maryland, 21287, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Beth Israel Deaconess Medical Ctr.
Boston, Massachusetts, 02215, United States
University Of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Masonic Cancer Ctr, University Of Minnesota
Minneapolis, Minnesota, 55455, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, 38801, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
St. Luke'S Roosevelt Hospital Center
New York, New York, 10019, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan Kettering Nassau
New York, New York, 10065, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, 37232, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Wheaton Franciscan Health Care
Wauwatosa, Wisconsin, 53226, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Centre D'Oncologie Dr-Leon-Richard
Moncton, New Brunswick, E1C 8X3, Canada
Local Institution
Halifax, Nova Scotia, B3H 2Y9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
Montreal, Quebec, H2L 4M1, Canada
Local Institution
Helsinki, 00029, Finland
Local Institution
Siena, 53100, Italy
Related Publications (3)
George 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: 27243803DERIVEDMotzer 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: 25452452DERIVEDGeorge 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: 21917625DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 16, 2011
Study Start
May 31, 2011
Primary Completion
May 15, 2013
Study Completion
April 15, 2021
Last Updated
May 12, 2022
Results First Posted
October 20, 2015
Record last verified: 2022-05