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Phase 2 N=20 Treatment

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 · Recurrent Grade 1 Follicular Lymphoma · Recurrent Grade 2 Follicular Lymphoma

Enrolled (actual)
20
Serious AEs
50.0%
Results posted
Nov 2025
Primary outcome: Primary: Best Overall Response Rate (ORR) — 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Nivolumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Sep 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Best Overall Response Rate (ORR)
2
SECONDARY
Overall Survival
8
SECONDARY
Progression-free Survival
SECONDARY
Duration of Response
SECONDARY
Incidence of Adverse Events
20

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.

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%
  • Age 18 years and older, and have the capacity to give informed consent
  • Anticipated survival of > 3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Post CAR T cell receipt of intervening palliative radiation therapy is allowed
  • Estimated glomerular filtration rate (eGFR) >= 20 ml/min
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04205409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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