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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01354431
First received: May 10, 2011
Last updated: December 9, 2015
Last verified: December 2015

May 10, 2011
December 9, 2015
May 2011
May 2013   (final data collection date for primary outcome measure)
Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ] [ Designated as safety issue: No ]
PFS: time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) and measured in Months. 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.
Progression free survival as measured by tumor assessments (radiographic scans) and the collection of death data. It will be compared to the doses given across the 3 treatment arms to see if a dose response exists. [ Time Frame: Tumor assessments (radiographic scans) will be done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression is documented. Subjects will be assessed for survival every 3 months. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01354431 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) at Primary Endpoint- Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ] [ Designated as safety issue: No ]
    Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate (ORR) was defined as the number of responders divided by the number of randomized participants; Responders=complete response (CR) or partial response (PR). 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. ORR was estimated along with exact 80% Confidence Interval (CI) using the Clopper and Pearson method.
  • Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population [ Time Frame: From randomization until after approximately 116 events (disease progression or death), approximately 2 years. ] [ Designated as safety issue: No ]
    Best response defined as the best response across all time points. Primary endpoint=116 events, approximately 2 years. Tumor response was evaluated by investigator according to RECIST version 1.1. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; partial response (PR): at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease Progression (PD) 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; Stable disease: neither shrinkage to qualify for PR or increase to qualify for PD.
  • Median Overall Survival in Months at Interim Data Cut-off - Randomized Population [ Time Frame: From Randomization to approximately 4 years post randomization ] [ Designated as safety issue: No ]
    Median Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.
  • Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population [ Time Frame: From Randomization to approximately 4 years post randomization ] [ Designated as safety issue: No ]
    PFS: the time from randomization to the date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) was measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. 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. Participants were censored if they had not experienced disease progression (they were still on treatment or in follow-up) or had received subsequent cancer therapy. Disease 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.
  • Progression free survival in the BMS-936558 arms [ Time Frame: Progression free survival will be assessed in each individual treatment arm by tumor assessments every 6 weeks ] [ Designated as safety issue: No ]
  • The tumor response rate in the BMS-936558 arms as assessed by the Investigator assessment of best overall response [ Time Frame: Up to 22 months after study start ] [ Designated as safety issue: No ]
    The tumor response rate will be assessed on all subjects at the time they discontinue study treatment by the Investigators assessment of best overall response for a subject
  • The overall survival in the BMS-936558 arms as collected by death data [ Time Frame: The survival in each treatment arm will be assessed by the collection of death data every 3 months following the discontinuation of study therapy until a subjects death ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Biological: nivolumab
    Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
    Other Name: BMS-936558
  • Biological: nivolumab
    Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
    Other Name: BMS-936558
  • Biological: nivolumab
    Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
    Other Name: BMS-936558
  • Experimental: Arm 1: nivolumab - 0.3 mg/kg
    Intervention: Biological: nivolumab
  • Experimental: Arm 2: nivolumab - 2.0 mg/kg
    Intervention: Biological: nivolumab
  • Experimental: Arm 3: nivolumab - 10.0 mg/kg
    Intervention: Biological: nivolumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
198
July 2016
May 2013   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   Italy
Belgium,   Spain
 
NCT01354431
CA209-010
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharma USA Inc
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP