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

Stage III or IV Melanoma Clinical Trial

— PD-L1  

Official title:

A Phase I Study of the Biologic Effects of BMS-936559 Treatment in Subjects With Unresectable Stage III or IV Melanoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01455103
• Other study ID #: CA210-002
• Status: Withdrawn
• Phase: Phase 1
• First received: October 18, 2011
• Last updated: December 12, 2011
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: October 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate pharmacodynamic changes of BMS-936559 treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with unresectable Stage III or IV Melanoma.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Programmed cell death 1 (PD-1), anti Programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Melanoma
• Stage III or IV Melanoma

Intervention

Biological:
• BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
• BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
• BMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of immunomodulatory effects of BMS-936559 as measured by changes from baseline in biomarkers assessed 1) peripheral blood assays including flow cytometry and soluble factors and 2) tumor based assays including immunohistochemistry		Baseline and within the first 24 weeks of study participation	No
Secondary	Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, laboratory test abnormalities, and changes in vital signs		Every 2 weeks until 70 days after last treatment	Yes
Secondary	Antitumor Activity of BMS-936559 as measured by the objective response rate, disease control rate, duration of response, and progression free survival		Every 6 weeks for 1 year, every 12 weeks thereafter until confirmed disease progression	No
Secondary	Immunogenicity of BMS-936559 as measured by the frequency of subjects with an increase in anti-drug antibody levels from baseline		Baseline, Week 6, Week 12, and then every 12 weeks until follow-up	Yes
Secondary	Pharmacodynamic activity of BMS-936559 as measured by changes from baseline of the tetramer assay in HLA-A*0210 positive subject only		Predose (screening) and Cycle 3 Day 1	No