The following criteria is provided for health care professionals.

Inclusion Criteria:

• Diagnosis of the following tumor types:
  • Non Hodgkin-lymphoma, including:
    • Diffuse large B-cell lymphoma: Histopathologic confirmation
    • Mantle cell lymphoma: Histopathologic confirmation
    • Follicular lymphoma, all grades: Histopathologic confirmation
    • Marginal zone lymphoma: Histopathologic confirmation
  • Chronic lymphocytic leukemia: Histopathologic or flow cytometric confirmation
  • Multiple myeloma: Histopathologic or flow confirmation
• Relapsed, refractory, or detectable disease after treatment with chimeric antigen receptor T-cells
  • Multiple Myeloma: patients must have exhausted all treatment options known to provide clinical benefit, and are refractory to a minimum of 3 prior lines of therapy (including an immunomodulatory imide drug [IMiD], proteasome inhibitor [PI], or anti-CD38 monoclonal antibody)
• Have measurable disease, defined by histology:
  • Non-Hodgkin's lymphoma, based on presence of lesions >= 1.5 cm that can be accurately measured in 2 dimensions by computed tomography (CT) (preferred) or magnetic resonance imaging (MRI), and are not included in any prior field of radiation therapy
  • Chronic lymphocytic leukemia: circulating lymphocytes >= 5,000 / mm^3
  • Multiple myeloma, based on the International Myeloma Working Group (IMWG) criteria of having one or more of the following findings:
    • Serum M protein >= 1.0 g/dL
    • Urine M protein >= 200 mg/24 hours
    • Involved serum free light chain level >= 10 mg/dL with abnormal kappa/lambda ratio
    • Measurable biopsy-proven plasmacytomas (>= 1 lesion has a single diameter >= 2 cm)
    • Bone marrow plasma cells >= 30%
• Have the capacity to give informed consent
• Anticipated survival of > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Estimated glomerular filtration rate (eGFR) >= 20 ml/min
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x upper limit of normal (ULN)
• Total bilirubin =< 2 x ULN
• Absolute neutrophil count (ANC) >= 1,000/uL
• Platelets >= 50,000/uL
• Hemoglobin >= 8 g/dL

Exclusion Criteria:

 

• Receipt of intervening therapy after CAR T-cell infusion
• History of another primary malignancy that has not been in remission for at least 1 year (with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer, curatively treated superficial bladder cancer and cervical carcinoma in site on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)
• Active hepatitis B, hepatitis C at time of screening
• Known (human immunodeficiency virus [HIV]) seropositivity
• Subjects with uncontrolled infection
• Concurrent use of other anticancer agents or experimental treatments
• Active autoimmune disease requiring immunosuppressive therapy with the exception of vitiligo and autoimmune alopecia
• Known active central nervous system (CNS) involvement
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses are permitted in absence of active autoimmune disease
• Known history of any active infectious pneumonitis
• Receipt of prior anti PD-1 or PD-L1 therapy
• Presence of acute or chronic graft-versus-host disease (GVHD) requiring active treatment unless limited to skin involvement and managed with topical steroid therapy alone
• Has active cytokine release syndrome
• Pregnancy or breastfeeding: Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine pregnancy test: minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 14 days of the first dose of study drug. Women must not be breastfeeding. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 8 months following the last dose of nivolumab