New anti-PD1 trial
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June 29, 2012 at 3:24 pm #20420
Celeste Morris
ParticipantAll I’ve done is copy and paste. Hope it helps. – cPhase 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
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 June 29, 2012 at 6:32 pm #55124Anonymous
GuestActually 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.
Jeff
June 29, 2012 at 6:41 pm #55125Catherine Poole
KeymasterYou 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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