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

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ClinicalTrials.gov Identifier: NCT01354431
Recruitment Status : Active, not recruiting
First Posted : May 16, 2011
Results First Posted : October 20, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 10, 2011
First Posted Date  ICMJE May 16, 2011
Results First Submitted Date September 8, 2015
Results First Posted Date October 20, 2015
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE May 17, 2011
Actual Primary Completion Date May 15, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
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. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
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. ]
Change History Complete list of historical versions of study NCT01354431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • 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. ]
    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. ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2011)
  • 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 ]
  • 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 ]
    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 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE BMS-936558 (MDX-1106) In Subjects With Advanced/Metastatic Clear-Cell Renal Cell Carcinoma (RCC)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 21, 2015)
198
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2011)
150
Estimated Study Completion Date July 1, 2019
Actual Primary Completion Date May 15, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Finland,   Italy,   United States
Removed Location Countries Belgium,   Spain
 
Administrative Information
NCT Number  ICMJE NCT01354431
Other Study ID Numbers  ICMJE CA209-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharma USA Inc
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2018

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