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

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nivolumab
nivolumab
nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Advanced/Metastatic, clear cell component

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCSD Moores Cancer Center
  • Ucla
  • Samuel Oschin Comprehensive Cancer Inst.
  • Stanford Cancer Center
  • University Of Colorado
  • Georgetown University Medical Center
  • Northwestern University Feinberg School Of Medicine
  • Loyola University Medical Center
  • Indiana University Health Melvin And Bren Simon Cancer Center
  • University Of Kansas Medical Center
  • University Of Maryland
  • The Bunting-Blaustein Cancer Research Building
  • Beth Israel Deaconess Medical Center
  • Beth Israel Deaconess Medical Ctr.
  • University Of Michigan Medical Center
  • Wayne State University
  • Masonic Cancer Ctr, University Of Minnesota
  • North Mississippi Hematology And Oncology Associates, Ltd
  • Dartmouth-Hitchcock Medical Center
  • Roswell Park Cancer Institute
  • St. Luke'S Roosevelt Hospital Center
  • Mount Sinai Medical Center
  • Memorial Sloan Kettering Nassau
  • Weill Cornell Medical College
  • Blumenthal Cancer Center
  • Duke University Medical Center
  • Cleveland Clinic
  • University Of Pennsylvania
  • Fox Chase Cancer Center
  • Medical University Of South Carolina
  • Tennessee Oncology, PLLC
  • Vanderbilt-Ingram Cancer Ctr
  • University of Washington - Seattle Cancer Care Alliance
  • Wheaton Franciscan Health Care
  • Tom Baker Cancer Centre
  • Centre D'Oncologie Dr-Leon-Richard
  • Local Institution
  • London Regional Cancer Program
  • Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1: nivolumab - 0.3 mg/kg

Arm 2: nivolumab - 2.0 mg/kg

Arm 3: nivolumab - 10.0 mg/kg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Best Overall Response Rate (BORR)
BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method
Overall Survival (OS)
OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up. OS is based on Kaplan-Meier estimates.
Number of Participants Experiencing Adverse Events
Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs. Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0

Full Information

First Posted
May 10, 2011
Last Updated
May 10, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01354431
Brief Title
BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2011 (Actual)
Primary Completion Date
May 15, 2013 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharma USA Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Advanced/Metastatic, clear cell component

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: nivolumab - 0.3 mg/kg
Arm Type
Experimental
Arm Title
Arm 2: nivolumab - 2.0 mg/kg
Arm Type
Experimental
Arm Title
Arm 3: nivolumab - 10.0 mg/kg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From randomization to disease progression or death (up to approximately 2 years)
Secondary Outcome Measure Information:
Title
Best Overall Response Rate (BORR)
Description
BORR is defined as the percentage of participants whose best response is either partial response (PR) or complete response (CR). Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 80% confidence interval is based on the Clopper and Pearson method
Time Frame
From randomization until disease progression or discontinuation of study therapy (up to approximately 2 years)
Title
Overall Survival (OS)
Description
OS is defined as the time from date of randomization until date of death. If the participant did not die, overall survival will be censored on the last date the participant was known to be alive. Survival status is collected at each visit during treatment and every 3 months during follow-up. OS is based on Kaplan-Meier estimates.
Time Frame
From randomization to to date of death (up to approximately 8 years)
Title
Number of Participants Experiencing Adverse Events
Description
Number of participants experiencing different types of events, including Adverse Events (AEs), Drug-related AEs, AEs leading to discontinuation, Drug-related AEs leading to discontinuation, Serious Adverse Events (SAEs), Drug-related SAEs. Events are classified based on the NCI Common Terminology Criteria (CTC) version 4.0
Time Frame
From first dose to 30 days following last dose (up to approximately 6 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Ucla
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Samuel Oschin Comprehensive Cancer Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern University Feinberg School Of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Health Melvin And Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University Of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Bunting-Blaustein Cancer Research Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Medical Ctr.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Masonic Cancer Ctr, University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
North Mississippi Hematology And Oncology Associates, Ltd
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
St. Luke'S Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Wheaton Franciscan Health Care
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Centre D'Oncologie Dr-Leon-Richard
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Centre Hospitalier Universitaire De Montreal-Notre-Dame Hosp
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27243803
Citation
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.
Results Reference
derived
PubMed Identifier
25452452
Citation
Motzer 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.
Results Reference
derived
PubMed Identifier
21917625
Citation
George 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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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