Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies
Recurrent Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Chronic Lymphocytic Leukemia
Eligibility Criteria
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
- 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
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment (nivolumab)
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.