This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and
how well it works in combination with intravenous nivolumab in treating patients with
leptomeningeal disease. 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.
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Locations near you
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Full eligibility criteria for NCT03025256
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients must have radiographic and/or CSF cytological evidence of LMD. For patient with melanoma: Must have a confirmed diagnosis of primary CNS melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted. For patients with lung cancer: non small cell lung cancer, based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted
Must have a confirmed diagnosis of primary central nervous system (CNS) melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
(PS) of =< 2
Patients may receive steroids to control symptoms related to CNS involvement, but the dose must be =< 4 mg per 24 hours of dexamethasone (or the equivalent). Patient's symptoms should experience stability of neurological symptoms for at least 7 days, or on tapering dose of steroids. Physiologic replacement doses for adrenal insufficiency is allowed on this protocol
Patients who have received radiation to brain and/or spine, including whole brain radiation, stereotactic radiosurgery, or stereotactic body radiation therapy (SBRT), are eligible, but must have completed radiation treatment at least 7 days prior to the start of treatment
Concurrent treatment with other anti-cancer systemic therapies is not allowed. No other concomitant intrathecal therapy with another agent will be allowed. For patients that have received other systemic therapies, the minimum wash out period is as follows:
Patients that received previous IT therapy must have received their last treatment >= 7 days prior to the start of treatment
Patients who have received systemic chemotherapy must have received their last treatment >= 21 days prior to the start of treatment
Patients who have received an approved systemic biologic therapy (e.g. anti-PD-1, anti-CTLA4, IL2, interferon) must have received their last treatment >= 4 weeks prior to the start of treatment
Patients who have been treated with an approved targeted therapy (BRAF inhibitor and/or MEK inhibitor) must have received their last treatment >= 7 days or 5 half-lives (whichever is shorter) prior to the start of treatment
Patients who have received any other investigational agents must have received their last treatment >= 14 days prior to the start of treatment
Age >= 18 years
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Hemoglobin >= 9.0 g/dL
Platelets >= 75 X 10^9/L
Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)
Total bilirubin: =< 1.5 X ULN (isolated bilirubin > 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X ULN
Albumin >= 2.5 g/dL
Creatinine OR =< 2 x ULN; calculated creatinine clearance OR >= 50 mL/min; 24-hour urine creatinine clearance >= 50 mL/min
Absence of contraindication for Ommaya reservoir
Patients must not have active autoimmune disease that has required systemic treatment in 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
Subjects with a condition requiring systemic treatment with either corticosteroids (> 4 mg daily dexamethasone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
Patients who have previously received a-PD-1 and/or anti-CTLA-4 will be eligible, unless they have ongoing > grade 2 adverse event (AE) side effects of such therapy. Ongoing physiologic replacement doses for adrenal and thyroid insufficiency are allowed on protocol
Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug
Pregnant or lactating female
Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled
Patients with a history of pneumonitis
Evidence of active infections =< 7 days prior to initiation of study drug therapy
(does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry)
Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 12 weeks prior to study drug
Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on antiretroviral therapy (ART)—due to the unknown effects of HIV on the immune response to combined nivolumab plus ipilimumab or the unique toxicity spectrum of these drugs in patients with HIV
History of allergy to study drug components
History of severe hypersensitivity reaction to any monoclonal antibody
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
All locations for NCT03025256
United States (1)
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Put me in touch!
View full eligibility
Tris trial is registered with FDA with number: NCT03025256. The sponsor of the trial is M.D. Anderson Cancer Center and it is looking for 30 volunteers for the current phase.
Official trial title: A Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Patients With Leptomeningeal Disease (LMD)
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