Phase I Biomarker Study (BMS-936558)

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:
NCT01358721
First received: May 20, 2011
Last updated: March 26, 2014
Last verified: March 2014

May 20, 2011
March 26, 2014
June 2012
August 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Immunomodulation across the 4 treatment arms will be evaluated to explore these measures at multiple doses
Same as current
Complete list of historical versions of study NCT01358721 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: Yes ]
  • 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
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase I Biomarker Study (BMS-936558)
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).

The purpose of this study is to evaluate the pharmacodynamic and biologic properties of BMS-936558 in subjects with metastatic renal cell carcinoma.

Intervention Model: Parallel Dose Comparison

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Renal Cell Carcinoma
  • 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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2015
August 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Spain
 
NCT01358721
CA209-009, 2011-005379-18
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Ono Pharma USA Inc
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2014

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