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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 1 (PD-1) Antibody (BMS-936558) in Subjects With Relapsed or Refractory Hematologic Malignancy

Phase 1
18 Years
Open (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 1 (PD-1) Antibody (BMS-936558) in Subjects With Relapsed or Refractory Hematologic Malignancy

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email Please visit for more information on clinical trial participation

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 > 1.5 cm 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 3 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:

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

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

- Platelet count ≥ 50 X 1000/ 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:

- Aspartate aminotransferase (AST) ≤ 3 x Upper limit of normal (ULN)

- Alanine aminotransferase (ALT) ≤ 3 x ULN

- 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) must use highly effective methods of birth
control for up to 18 weeks after the last dose of investigational product

- Men and women ≥ 18 years of age

Exclusion Criteria:

- Subjects with myelodysplasia, polycythemia vera, idiopathic thrombocythemia,
myelofibrosis, acute leukemias, blast phase CML, T cell lymphoblastic or Burkitt
lymphoma acute leukemias

- 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, resolved childhood
asthma/atopy or autoimmune thyroid disorders

- 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 human
papilloma virus (HPV) vaccine) within 4 weeks of study drug administration. The
inactivated seasonal influenza vaccine can be given to subjects before treatment and
while on therapy without restriction. Influenza vaccines containing live virus or
other clinically indicated vaccinations for infectious diseases (ie, pneumovax,
varicella, etc.] may be permitted; but must be discussed with the Sponsor's Medical
Monitor and may require a study drug washout period prior to and after administration
of 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 Antigen 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

- WOCBP who are unwilling or unable to use an acceptable method to minimize the risk of
pregnancy for the entire study period and for at least 18 weeks after the last dose
of investigational product

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-936558 as measured by the occurrence of AEs, SAEs, deaths, hematologic laboratory abnormalities, serum chemistry laboratory abnormalities, and changes in blood pressure and heart rate measurements

Outcome Description:

AEs = adverse events SAEs = serious adverse events

Outcome Time Frame:

Up to 100 days after the last treatment (expected to be no more than 225 weeks)

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:

August 2012

Completion Date:

March 2015

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



Mayo Clinic Rochester, Minnesota  55905
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Dana Farber Cancer Institute Boston, Massachusetts  02115
Memorial Sloan Kettering Cancer Ctr New York, New York  10021
Yale University School Of Medicine New Haven, Connecticut  06520
The Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland  21231
University of Michigan Health System Ann Arbor, Michigan  
Huntsman Cancer Institute At The Univ. Of Utah Salt Lake City, Utah  84112
John Theurer Cancer Center Hackensack, New Jersey  07601
Division Of Hematology & Oncology Ctr. For Health Sciences Los Angeles, California  90095-1678
Holy Cross Hospital-Bienes Cancer Center Fort Lauderdale, Florida  33308
OR HSU CtrforHema Malignancies Portland, Oregon  97239