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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
  Purpose
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.

Condition Intervention Phase
Renal Cell Carcinoma
Biological: nivolumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 198
Study Start Date: May 2011
Estimated Study Completion Date: July 2016
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: nivolumab - 0.3 mg/kg 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
Experimental: Arm 2: nivolumab - 2.0 mg/kg 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
Experimental: Arm 3: nivolumab - 10.0 mg/kg 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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354431

  Show 41 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharma USA Inc
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01354431     History of Changes
Other Study ID Numbers: CA209-010 
Study First Received: May 10, 2011
Results First Received: September 8, 2015
Last Updated: December 9, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Advanced/Metastatic
clear cell component

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016