Stage III or IV Melanoma
Conditions
Brief 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.
Interventions
BIOLOGICALBMS-936559 (Anti-PD-L1)
Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Outcome results
None listed