Phase 1 Biomarker Study of Anti-PD-1 in Advanced Melanoma

This study is currently recruiting participants.
Verified February 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01621490
First received: June 14, 2012
Last updated: February 25, 2014
Last verified: February 2014

June 14, 2012
February 25, 2014
October 2012
August 2017   (final data collection date for primary outcome measure)
  • Immunomodulatory effects of BMS-936558 as measured by changes from baseline in activated and memory T cells, interferon, interferon inducible factors, and CD4 and CD8 T cell infiltration [ Time Frame: Pre-dose day 1 ] [ Designated as safety issue: No ]
  • Immunomodulatory effects of BMS-936558 as measured by changes from baseline in activated and memory T cells, interferon, interferon inducible factors, and CD4 and CD8 T cell infiltration [ Time Frame: Up to day 57 (Cycle 2 Day 1) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01621490 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of BMS-936558 as measured by the incidence of adverse events (AEs), serious AEs, death, and changes in vital signs [ Time Frame: Up to 14 weeks after last dose of study drug ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of BMS-936558 as measured by laboratory test abnormalities [ Time Frame: Every 2 weeks up to 14 weeks after last treatment ] [ Designated as safety issue: Yes ]
  • Antitumor Activity of BMS-936558 as measured by the objective response rate (ORR), duration of response, and progression free survival (PFS) [ Time Frame: Every 8 weeks until confirmed disease progression and in follow-up if no progression ] [ Designated as safety issue: No ]
  • Immunogenicity of BMS-936558 as measured by the frequency of subjects with at least one positive ADA assessment and the frequency of subjects who develop anti-drug antibodies (ADA) after a negative baseline assessment [ Time Frame: Day 1, Day 15, Day 43 of cycle 1, Day 1 of cycle 2, Day 15 of cycle 3, every 16 weeks after cycle 3 Up to 2 years, and at Follow-up visits 1 (49±3 days after last treatment) and Follow-up visit 2 (90-120 days since last treatment) ] [ Designated as safety issue: Yes ]
  • Association between Programmed cell death ligand 1 (PD-L1) and clinical efficacy will be measured by PDL1 expression levels clinical activity (ORR, PFS) [ Time Frame: Pre-dose Up to Day 1 (screening) and Day 29 of cycle 1 ] [ Designated as safety issue: No ]
    Screening (day -7 to day 1 predose)
Same as current
Not Provided
Not Provided
 
Phase 1 Biomarker Study of Anti-PD-1 in Advanced Melanoma
An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects With Advanced Melanoma (Unresectable or Metastatic)

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936558 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced).

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Advanced Melanoma
  • Metastatic Melanoma
Biological: BMS-936558 (Anti-PD-1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years depending on response
Experimental: Arm 1: BMS-936558 (3 mg/kg)
Intervention: Biological: 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.
 
Recruiting
160
August 2017
August 2017   (final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Men and women > 18 years
  • Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
  • Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma
  • Subject must have histologic or cytologic confirmation of advanced melanoma
  • Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies

Exclusion Criteria:

  • Active or progressing brain metastases
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active or history of autoimmune disease
  • Positive test for human immunodeficiency virus (HIV) 1&2 or known acquired immunodeficiency syndrome (AIDS)
  • History of any hepatitis
  • Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40,and anti-CD40 antibodies. However, half the patients must have progressed on anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) monoclonal antibody therapy
Both
18 Years and older
No
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
United States,   Spain
 
NCT01621490
CA209-038, 2012-001840-23
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2014

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