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A Phase I Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Immunoregulatory Activity, and Preliminary Antitumor Activity of Anti-Programmed-Death-Ligand 1 (PD-L1) Antibody (BMS-936559) in Subjects With Relapsed or Refractory Hematologic Malignancy

Phase 1
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma, Chronic Myelogenous Leukemia

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Trial Information

A Phase I Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Immunoregulatory Activity, and Preliminary Antitumor Activity of Anti-Programmed-Death-Ligand 1 (PD-L1) Antibody (BMS-936559) in Subjects With Relapsed or Refractory Hematologic Malignancy

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) Performance of 0 or 1

- Subjects must have histological confirmation of relapsed or refractory hematologic

- Subjects with non-Hodgkin's lymphoma or Hodgkin lymphoma must have at least one
measureable lesion as defined by lymphoma response criteria. Tumor sites that are
considered measureable must not have received prior radiation therapy

- Subjects with multiple myeloma (MM) must have detectable disease as measured by
presence of monoclonal immunoglobulin protein in a serum electrophoresis: IgG, IgA,
IgM, (M-protein ≥ 0.5 g/dl or serum IgD M-protein ≥ 0.05 g/dl) or serum free-light
chain or 24 hour urine with free light chain. Excluded are subjects with only
plasmacytomas, plasma cell leukemia, or non-secretory myeloma

- Subjects with chronic myelogenous leukemia (CML) must have evidence of the
Philadelphia chromosome by polymerase chain reaction (PCR) or chromosome analysis

- Life expectancy of at least 3 months

- For subjects with lymphoma, either a formalin fixed tissue block or 7 to 15 slides of
tumor sample (archival or fresh) must be available for performance of correlative

- Subjects must have received at least one prior chemotherapy regimen. Subjects must be
off therapy for at least 4 weeks ( 2 weeks for oral agents) prior to Day 1

- Prior palliative radiation must have been completed at least 2 weeks prior to study
Day 1

- Toxicities related to prior therapy must have returned to Grade 1 or less, except for
alopecia. Peripheral neuropathy must be Grade 2 or less

- Adequate bone marrow function defined as:

1. Absolute neutrophil count ≥ 1000/μl (stable off any growth factor within 1 week
of study drug administration)

2. Hemoglobin ≥ 9 g/dL (transfusion to achieve this level is permitted)

3. Platelet count ≥ 50 X 103/ μl (transfusion to achieve this level is not

- Adequate renal parameters defined as Creatinine clearance (CrCl) > 40 ml/min
(Cockcroft-Gault formula)

- Adequate hepatic parameters defined as:

1. Aspartate aminotransferase (AST) ≤ 3 x ULN

2. Alanine aminotransferase (ALT) ≤ 3 x ULN

3. Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert's Syndrome, who must have
total bilirubin < 3.0 mg/dL and direct bilirubin < 0.5 mg/dL)

- Women of child bearing potential (WOCBP) and for at least 70 days after the last dose
of investigational product

- Men and women ≥ 18 years of age

Exclusion Criteria:

- Subjects with acute leukemias, blast phase CML, T cell lymphoblastic or Burkitt

- Subjects with a history of central nervous system involvement by hematologic
malignancy or symptoms suggestive of central nervous system involvement

- Subjects with concomitant second malignancies (except adequately treated
nonmelanomatous skin cancers, ductal carcinoma in situ, treated superficial bladder
cancer or prostate cancer or in situ cervical cancers) are excluded unless a complete
remission was achieved at least 3 years prior to study entry and no additional
therapy is required or anticipated to be required during the study period

- Subjects with any active autoimmune disease or a history of known or suspected
autoimmune disease, or history of syndrome that requires systemic corticosteroids or
immunosuppressive medications, except for subjects with vitiligo or resolved
childhood asthma/atopy

- A serious uncontrolled medical disorder or active infection which would impair the
ability of the subject to receive protocol therapy or whose control may be
jeopardized by the complications of this therapy

- Prior therapy with an anti programmed death-1 (anti-PD-1), anti Programmed death
ligand 1 (anti-PD-L1), anti Programmed death ligand 2 (anti-PD-L2), anti-CD137 or
anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (or any other
antibody or drug specifically targeting T-cell costimulation or checkpoint pathways)

- Non-oncology vaccine therapies for prevention of infectious diseases (eg seasonal flu
vaccine, Human Papilloma Virus (HPV) vaccine) within 4 weeks of study drug
administration Vaccination while on study is also prohibited except for
administration of the inactivated influenza vaccine

- Prior organ allograft or allogeneic bone marrow transplantation

- Positive for human immunodeficiency virus (HIV 1/2) or known acquired
immunodeficiency syndrome (AIDS)

- Positive tests for hepatitis B virus surface antigen (HBsAg), or antibody to
hepatitis B core Ag or hepatitis C virus antibody (confirmed by Western Blot) or
hepatitis C ribonucleic acid (RNA) in serum

- Ejection fraction less than 45% in subjects with prior anthracycline exposure

- History of Grade 4 anaphylactic reaction to monoclonal antibody therapy

- Women who are pregnant or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of BMS-936559 as measured by the incidence of adverse events (AEs), serious AEs, dose-limiting toxicities, laboratory test abnormalities, and changes in vital signs

Outcome Time Frame:

Weeks 1

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

November 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin Lymphoma
  • Multiple Myeloma
  • Chronic Myelogenous Leukemia
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms