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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04401774
Phase
PHASE2
Status
Completed

Conditions

  • Primary Central Nervous System Lymphoma (PCNSL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given every 4 weeks at 480mg flat dose intravenously for one year (total of 13 nivolumab doses).

Study Details

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).

Key Dates

Start date
May 22, 2020
Status verified
Jan 2026
Primary completion
Jan 22, 2026
Completion
Jan 22, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab Maintenance
    All patients will undergo cerebrospinal fluid (CSF) and blood collection as well as MRI imaging as standard of care prior to (- 21 days) first-line treatment initiation, during first-line therapy (before initiation of the 5th methotrexate dose (+/- 7 days)), at completion of first-line chemotherapy therapy (+/- 7 days) as well as 60, 180, and 360 days after enrollment into maintenance or observation (+/- 7 days). Those patients with persistent cfDNA in the CSF after completion of first-line chemotherapy and either complete or partial response on imaging will be enrolled into the nivolumab maintenance treatment arm. All other patients (no persistent cfDNA in the CSF and either complete or partial response on imaging) are followed with observation. Patients who do not respond to first-line therapy are not eligible for nivolumab maintenance and will no longer be followed in the biospecimen and clinical data collection cohort.

Primary Outcome Measure

Frequencies of toxicities [ Time Frame: within 60 days of therapy ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited protocol activities)UniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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