Can nivolumab rescue patients when CAR T-Cell therapy fails?
NCT ID NCT04205409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested nivolumab, an immunotherapy drug, in 20 people with blood cancers like lymphoma, leukemia, or myeloma that came back or didn't respond after CAR T-cell therapy. The goal was to see if nivolumab could help the immune system attack the cancer again. The study measured how many patients responded and how long they lived without the cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (Opdivo)
- What this could lead to
- If it works, this could offer a new treatment option for people whose blood cancer returns after CAR T-cell therapy.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. Nivolumab can cause immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
-
Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) =\< 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Multi-Drug combo outsmart resistant lymphoma?
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- Radiation boost may supercharge CAR T-Cell therapy against tough lymphoma
- Combination therapy aims to outsmart tough lymphoma
- Targeted drug combo aims to tackle Hard-to-Treat lymphoma