Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    20
  • sponsor
    University of Washington
Updated on 4 October 2022
ct scan
cancer
lymphoid leukemia
hematologic malignancy
chronic lymphocytic leukemia
lymphoma
multiple myeloma
hodgkin's disease
absolute neutrophil count
monoclonal antibodies
measurable disease
cell therapy
leukemia
lymphocytic leukemia
glomerular filtration rate
neutrophil count
tumor cells
monoclonal antibody therapy
nivolumab
follicular lymphoma
monoclonal protein
diffuse large b-cell lymphoma
b-cell lymphoma
cellular therapy
marginal zone lymphoma
large b-cell lymphoma
proteasome inhibitor
plasmacytoma
immunomodulatory imide drug
bone marrow plasma cells
light chain level
light chain measurement

Summary

This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Description

OUTLINE

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then for up to 5 years.

Details
Condition Recurrent Chronic Lymphocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Follicular Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Grade 3a Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Refractory Chronic Lymphocytic Leukemia, Refractory Diffuse Large B-Cell Lymphoma, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Treatment Nivolumab
Clinical Study IdentifierNCT04205409
SponsorUniversity of Washington
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of the following tumor types
Non Hodgkin-lymphoma, including
Diffuse large B-cell lymphoma: Histopathologic confirmation
Follicular lymphoma, all grades: Histopathologic confirmation
Mantle cell lymphoma: Histopathologic confirmation
Marginal zone lymphoma: Histopathologic confirmation
Chronic lymphocytic leukemia: Histopathologic or flow cytometric confirmation
Multiple myeloma: Histopathologic or flow confirmation
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)
Relapsed, refractory, or detectable disease after treatment with chimeric antigen
receptor T-cells
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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