New hope for brain cancer patients: drug may stop relapse

NCT ID NCT04401774

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether the drug nivolumab can safely prevent primary central nervous system lymphoma (PCNSL) from coming back. It included 14 people who still had signs of tumor DNA in their spinal fluid after finishing their first chemotherapy. The goal was to see if nivolumab could clear that DNA and keep the cancer under control.

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

14 people

The number who actually took part.

Started

May 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

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

Inclusion Criteria: Biospecimen and Data Collection: * Histologically documented PCNSL with the ability to submit up to 20 unstained formalinfixed, paraffin embedded (FFPE) slides from the initial tissue diagnosis prior to study registration or histologically confirmed lymphomatous involvement of the CSF and/or eye/vitreous * Patients must be able to tolerate MRI/CT scans with \[18F FDG\] * Patients must be able to tolerate lumbar punctures and/or Ommaya taps Additional Criteria for Nivolumab Maintenance Arm: All criteria in the above "Biospecimen and Data Collection" section must be satisfied as well as: * Persistent cfDNA in the CSF * Participants must be able to understand and be willing to sign a written informed consent document * Women and men who are at least 18 years of age on the day of consenting to the study * KPS ≥60 * Life expectancy of \> 3 months (in the opinion of the investigator) * Participants must have adequate bone marrow and organ function shown by: * Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9/L * Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 21 days prior to study registration * Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study registration * International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal. Patients on anticoagulants should be managed according to MSK SOPs as outlined in: 'Therapeutic Anticoagulation Guidelines in Adults' regarding management of anticoagulants prior to each CSF collection. Please discuss any complicated patient with the PI for consideration. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal * Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome * Serum creatinine ≤ 2 times the upper limit of normal * Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 5 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 7 months after the last dose * Women of childbearing potential must have a negative plasma pregnancy test upon study entry. See section on Pregnancy and Reproduction Exclusion Criteria: Biospecimen and Data Collection: * Patients with recurrent/refractory PCNSL. Patients with stable disease as their best response to first-line chemotherapy will also come off study. * Patient with systemic, non-CNS lymphoma metastatic to the CNS * Patient is known to have human immunodeficiency virus (HIV) infection * Patient is known to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests * Patient's who are planned to undergo consolidation with autologous HSCT Additional Criteria for Nivolumab Maintenance Arm: None of the criteria in the above "Biospecimen and Data Collection" section can be present. The following criteria must also not be present: * Patient has undergone prior allogenic stem cell transplant * Patient's who are planned to undergo consolidation with autologous HSCT * Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 14 days of the first dose of study drug * Patient is allergic to components of the study drug * Patient is concurrently using other approved or investigational antineoplastic agents * Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent * Patient has an active concurrent malignancy requiring active therapy * Patient is requiring escalating or chronic supraphysiologic doses of corticosteroids (\> 8 mg dexamethasone daily) for control of disease at the time of registration * Patient is using systemic immunosuppressant therapy including: cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \> 5 mg/day of prednisone or the equivalent. Participants must be off immunosuppressant therapy for at least 28 days prior to the first dose of the study drug * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Known history of, or any evidence of active, non-infectious pneumonitis * Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening * Peptic ulcer, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within past 6 months * Patient is known to have an uncontrolled active systemic infection * Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk * Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma hCG laboratory test of \> 5 mIU/mL (See section on Pregnancy and Reproduction) * The patient is unwell or unable to participate in all required study evaluations and procedures * Participants who have received a live / attenuated vaccine within 30 days of first treatment.

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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

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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