Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lā¦ (NCT03770416) | Clinical Trial Compass
CompletedPhase 2
Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma
United States18 participantsStarted 2019-02-15
Plain-language summary
This phase II trial studies the side effects and how well nivolumab and ibrutinib works in treating patients with central nervous system lymphoma that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and ibrutinib may work better in treating patients with central nervous system lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Relapsed refractory central nervous system lymphoma, pathology confirmed B cell lymphoma either by biopsy or by CSF review. Patient must previously have had at least one line of systemic therapy for CNS lymphoma.
ā. Age 18 years or older
ā. Eastern Cooperative Oncology Group (ECOG) Performance Status ā¤2
ā. Patients must have adequate renal and hepatic function
ā. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (Ī²-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use a highly effective contraception method during the study and for 23 weeks following the last dose of the study drugs. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 31 weeks following the last dose of study drugs. Men must agree not to donate sperm during and for 3 months after the last dose of study drug. Women who are pregnant or breastfeeding are ineligible for this study.
ā. Patients or their legally authorized representative must provide written informed consent.
ā. Hematology values must be within the following limits:
ā. Absolute neutrophil count (ANC) 1000/mm3 independent of growth factor support
Exclusion criteria
ā. History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses). If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center and after consultation with the Principal Investigator
ā. Any major surgery or wound that has not healed, radiotherapy, cytotoxic chemotherapy, biologic therapy, immunotherapy, immunomodulatory drugs, experimental therapy within 4 weeks prior to the first dose of the study drugs.
ā. Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
ā. History of stroke or cerebral hemorrhage within 6 months of enrollment.
ā. Patients who have uncontrolled hypertension (defined as sustained systolic blood pressure ā„ 160 mmHg or diastolic ā„ 100 mmHg)
ā. Prior history of BTK inhibitor or PD1 inhibitor prior to start of trial.
ā. Patients with autoimmune diseases are excluded: Patients with a history of Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener's granulomatosis).