Friday, June 29, 2012

New trial for anti-PD1

 All I've done is copy and paste.  Hope it helps. - c


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

Brief Summary

Official Title: “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).
  • Study Type: Interventional
  • Study Design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • Study Primary Completion Date: December 2015

Interventions Used in this Clinical Trial

  • Biological: BMS-936558 (Anti-PD-1)
    • Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years depending on response

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1: BMS-936558 (3 mg/kg)

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      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)
      Safety Issue?: No

Secondary Measures

  • 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
      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
      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
      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)
      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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

Lead Investigator: Bristol-Myers Squibb Industry

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb


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