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About
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).
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Inclusion criteria
Biospecimen and Data Collection:
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:
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:
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:
Primary purpose
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Interventional model
Masking
14 participants in 1 patient group
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Central trial contact
Christian Grommes, MD; Lauren Schaff, MD
Data sourced from clinicaltrials.gov
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