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
- Time Frame: Pre-dose day 1
- 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
- Time Frame: Up to day 57 (Cycle 2 Day 1)
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
- Time Frame: Up to 14 weeks after last dose of study drug
- 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
- Time Frame: Every 2 weeks up to 14 weeks after last treatment
- 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
- Time Frame: Every 8 weeks until confirmed disease progression and in follow-up if no progression
- 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
- 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)
- 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
- Time Frame: Pre-dose Up to Day 1 (screening) and Day 29 of cycle 1
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
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 IndustryOverall Clinical Trial Officials and Contacts
Bristol-Myers Squibb, Study Director, Bristol-Myers SquibbAdditional Information on this Clinical Trial
Information obtained from ClinicalTrials.gov on June 27, 2012Link to the current ClinicalTrials.gov record. – http://clinicaltrials.gov/show/NCT01621490
Study ID Number: CA209-038
ClinicalTrials.gov Identifier: NCT01621490
Health Authority: United States: Food and Drug Administration
Source
Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01621490
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