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New cocktail aims to tame rare brain cancer

NCT ID NCT04609046

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 13 times

Summary

This early-stage trial tests a combination of four drugs—lenalidomide, nivolumab, rituximab, and methotrexate—in people with primary CNS lymphoma, a rare cancer of the brain or spinal cord. The goal is to find the safest dose and see if adding lenalidomide and nivolumab to standard therapy can improve control of the disease. After initial treatment, participants may continue on a maintenance regimen of lenalidomide and nivolumab to try to keep the cancer from coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lenalidomide, nivolumab, rituximab, methotrexate
What this could lead to
If this works, it could lead to a more effective and longer-lasting treatment for primary CNS lymphoma, potentially extending remission with a maintenance therapy.
What could go wrong
This is an early Phase I trial with only 47 participants, focused on safety and dosing. The combination may cause significant side effects, and it is too early to know if it will improve outcomes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 47 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically proven primary CNS diffuse large b-cell lymphoma confirmed by one of the following: * Brain biopsy or resection * Cerebrospinal fluid * Vitreous fluid * No prior organ transplantation to exclude post-transplant lymphoproliferative disorders * No prior chemotherapy or radiation therapy for lymphoma * No prior allogeneic stem cell transplantation * Use of systemic corticosteroids (dexamethasone up to 24 mg/day or equivalent) for disease control or improvement of performance status to be tapered as fast as clinically safe after initiation of therapy is permissible * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, female of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) =\< 7 days prior to registration * Age \>= 18 years * Karnofsky performance scale (KPS) \>= 40 (\>= 50 for patients older than 60 unless related to lymphoma on investigator's opinion) * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault formula * Total Bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * No evidence of non-Hodgkin's lymphoma (NHL) outside CNS * No prior history of NHL * No history of autoimmune disorder. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as Systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible * Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event) * Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (except short course of systemic corticosteroids for disease control or improvement of performance status) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted * Patients who have had evidence of active or acute diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study * No prior or concurrent malignancies with exception of surgically cured carcinoma in situ (CIS) of the uterus, carcinoma of the skin without evidence of disease for \>= 5 years * No concurrent malignancy requiring active therapy * No untreated hepatitis C virus (HCV) infection with detectable HCV viral load * No untreated chronic hepatitis B virus (HBV) infection with detectable HBV viral load * No untreated human immunodeficiency virus (HIV) infection or with detectable viral load or with CD4+T-cell count of less than 500/mm\^3 * No history of HIV infection and evidence of Epstein Barr virus (EBV)-related primary central nervous system lymphoma (PCNSL) * Inability to tolerate anticoagulation with acetylsalicylic acid, warfarin, or direct oral anticoagulants * No other investigational agent * No history of severe hypersensitivity reaction to any monoclonal antibody * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to or other agents used in study * Sulfonamide drugs, trimethoprim, salicylates, nonsteroidal anti-inflammatory drugs, penicillin, vitamin C, ciprofloxacin, and proton pump inhibitors should be held at least 48 hours prior to methotrexate administration

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma of the central nervous system

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary diffuse large B-cell lymphoma of the central nervous system

Contacts and locations

Locations

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601, United States

  • Hickman Cancer Center

    Adrian, Michigan, 49221, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316, United States

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309, United States

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805, United States

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106, United States

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102, United States

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074, United States

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548, United States

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476, United States

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868, United States

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314, United States

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • North Shore University Hospital

    Manhasset, New York, 11030, United States

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808, United States

  • Overlook Hospital

    Summit, New Jersey, 07902, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401, United States

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136, United States

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162, United States

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623, United States

  • UCSF Medical Center-Parnassus

    San Francisco, California, 94143, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263, United States

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325, United States

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    North Miami, Florida, 33181, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.