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

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Updated on 19 February 2024

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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 Identifier	NCT04401774
Sponsor	Memorial Sloan Kettering Cancer Center
Last Modified on	19 February 2024

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