New anti-PD1 trial

[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

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

[Anonymous]

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.

Jeff

[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.

[Author]

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