Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell T… (NCT04205409) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab for Relapsed, Refractory, or Detectable Disease Post Chimeric Antigen Receptor T-cell Treatment in Patients With Hematologic Malignancies
United States20 participantsStarted 2020-06-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 li…