Home Forums Melanoma Diagnosis: Stage IV New anti-PD1 trial

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    Celeste Morris

    All I’ve done is copy and paste. Hope it helps. – c

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

    Verified by: Bristol-Myers Squibb, June 2012

    First Received: June 14, 2012 | Last Updated: June 15, 2012

    Phase: Phase 1 | Start Date: September 2012

    Overall Status: Not yet recruiting | Estimated Enrollment: 80

    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

    Additional Information on this Clinical Trial

    Information obtained from ClinicalTrials.gov on June 27, 2012

    Link 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


    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.

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    Actually Catherine, this looks like a brand new one but not recruiting yet.

    Interesting to note they want half of the participants to have failed IPI.


    Catherine Poole

    You are correct Jeff, but I’m finding wait lists on this expected trial even! There are very few slots available and their is a long line of folks hoping to get in. It is worth it though to contact the leading sites and get on the list as far as I can tell.

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