Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 19 February 2024
blood transfusion
ct scan
direct bilirubin
gilbert's syndrome
neutrophil count
nivolumab
anticoagulants
international normalized ratio
lymphoma
aptt
platelet transfusion
serum bilirubin level
ffpe
primary cns lymphoma

Summary

The purpose of this additional part of the study is to test whether the study drug, nivolumab, is a safe treatment that will prevent participants' primary central nervous system lymphoma (PCNSL) from growing again (recurrence). Participants will be people with PCNSL who continue to have cell free tumor DNA (cfDNA) in their CSF despite completion of their first treatment (first-line treatment).

Details
Condition Primary Central Nervous System Lymphoma (PCNSL)
Age 18years - 100years
Treatment Nivolumab
Clinical Study IdentifierNCT04401774
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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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