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Phase I Biomarker Study (BMS-936558)

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ClinicalTrials.gov Identifier: NCT01358721
Recruitment Status : Active, not recruiting
First Posted : May 24, 2011
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE May 24, 2011
Last Update Posted Date January 23, 2018
Actual Study Start Date  ICMJE August 11, 2011
Actual Primary Completion Date December 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Immunomodulatory activity as measured by the functional and phenotypic characterization of peripheral immune cells, modulation/changes in soluble factors, and the characterization of tumor immune infiltrates and the expression of tumor markers [ Time Frame: Biomarker samples will be collected prior to the first study treatment through up to 24 weeks following initiation of study treatment ]
Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01358721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
  • Safety and tolerability of BMS-936558 as measured by the incidence and severity of adverse events [ Time Frame: Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (at progression of disease, toxicities requiring discontinuation, withdrawal of consent or study closure) ]
  • 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
  • Overall response rate for BMS-936558 as assessed by the number of subjects which demonstrate an objective response divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: response rate will be assessed by tumor assessments every 6 weeks ]
  • Disease control rate for BMS-936558 as measured by the number of subjects with an objective response + the number of subjects with stable disease divided by the total number of treated subjects with measurable disease at baseline [ Time Frame: disease control will be assessed by tumor assessments every 6 weeks ]
  • Duration of objective response for BMS-936558 as measured by the time when the criteria for an objective response are first met until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ]
  • Duration of stable disease for BMS-936558 as measured in subjects whose best overall response is stable disease as the time from baseline until the date of documented disease progression or death [ Time Frame: Duration of response will be assessed by tumor assessments every 6 weeks ]
  • Immunogenicity of BMS-936558 as measured by the detection of human antibodies against BMS-936558 [ Time Frame: Serum sample collected at baseline, 12 weeks following initiation of study treatment; and during the first 2 follow-up visits in the follow-up phase ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Biomarker Study (BMS-936558)
Official Title  ICMJE An Exploratory Study to Investigate the Immunomodulatory Activity of Various Dose Levels of Anti Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Subjects With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Brief Summary The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.
Detailed Description Intervention Model: Parallel Dose Comparison
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: BMS-936558 (Anti-PD-1)
    Solution, Intravenous infusion, 0.3 mg/kg, Every 3 weeks, Indefinitely depending on response
  • Drug: BMS-936558 (Anti-PD-1)
    Solution, Intravenous infusion, 2 mg/kg, Every 3 weeks, Indefinitely depending on response
  • Drug: BMS-936558 (Anti-PD-1)
    Solution, Intravenous infusion, 10 mg/kg, Every 3 weeks, Indefinitely depending on response
Study Arms
  • Experimental: Arm 1: BMS-936558
    Intervention: Drug: BMS-936558 (Anti-PD-1)
  • Experimental: Arm 2: BMS-936558
    Intervention: Drug: BMS-936558 (Anti-PD-1)
  • Experimental: Arm 3: BMS-936558
    Intervention: Drug: BMS-936558 (Anti-PD-1)
  • Experimental: Arm 4: BMS-936558
    (treatment naive)
    Intervention: Drug: BMS-936558 (Anti-PD-1)
Publications * Not Provided

*   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: June 1, 2017)
119
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
80
Estimated Study Completion Date November 16, 2018
Actual Primary Completion Date December 1, 2014   (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:

  • Women and men ≥ 18 years of age.
  • Histologic confirmation of renal cell carcinoma with a clear cell component.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST).
  • Tumor sites that can be accessed for repeat biopsies at acceptable clinical risk.
  • Previously treated subjects must have failed at least 1 prior anti-angiogenic agent and can have a maximum of 3 prior systemic treatments for renal cell cancer.
  • Subjects in the treatment naive arm cannot have received prior systemic therapy for their renal cell carcinoma.

Exclusion Criteria:

  • Active or progressing brain metastases.
  • Active concomitant.
  • Active or history of autoimmune disease.
  • Active use of systemic corticosteroids.
  • Prior therapy with Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4), anti Programmed death-1 (anti-PD1), anti Programmed death ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137, anti-CD40, anti-OX40 antibodies.
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 France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01358721
Other Study ID Numbers  ICMJE CA209-009
2011-005379-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 January 2018

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