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

NCT04205409 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: RG1005491NCI-2019-0819210388
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (ORR)

  Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided.

  Up to 1 year 8 months

Secondary Outcomes (4)

• Overall Survival

  From the first study drug administration to death from any cause, up to 5 years

• Progression-free Survival

  From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years

• Duration of Response

  Up to 5 years

• Incidence of Adverse Events

  Up to 30 days after the last dose of study drug, up to a maximum of 1 year 9 months

Study Arms (1)

Treatment (nivolumab)

EXPERIMENTAL

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

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Given IV

Also known as: 946414-94-4, BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo, CMAB819, Nivolumab Biosimilar CMAB819

Treatment (nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Non-Hodgkin; Multiple Myeloma; Lymphoma, Mantle-Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Andrew Cowan
• Organization: University of Washington

ajcowan@fredhutch.org

2066067348

Study Officials

• Rahul Banerjee, MD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: June 5, 2020
• Primary Completion: September 20, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: November 3, 2025
• Results First Posted: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)