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|NCT02669914 : MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors|
|Ages||Min: 18 Years Max: N/A|
- Cohort A: Histologically confirmed metastatic non-small cell lung cancer (all
histologic subtypes allowed) with radiographic evidence by MRI of at least one
measurable brain lesion as defined by RANO criteria that does not require
corticosteroids for symptomatic control.
- Cohort B: Histologically confirmed metastatic solid tumor of epithelial origin,
excluding NSCLC, including but not limited to ovarian cancer, colorectal cancer,
pancreatic cancer, gastric cancer, renal cancer, bladder cancer, or breast cancer with
radiographic evidence by MRI of at least one measurable brain lesion as defined by
RANO criteria that does not require corticosteroids for symptomatic control.
- Cohort C: Histologically confirmed metastatic solid tumor of epithelial origin,
including both NSCLC and non-NSCLC, with radiographic evidence by MRI of at least one
measurable brain lesion as defined by RANO criteria that requires corticosteroids for
- At least one prior treatment to a CNS-based lesion is required. Prior therapy must be
completed > 2 weeks prior to enrollment. A previously treated lesion must be
demonstrated by MRI to have progressed following treatment in order to be eligible.
The subsequent development of a new CNS lesion that was not previously treated will be
permitted and dose not require treatment followed by progression prior to enrollment.
Treatment of a single CNS lesion with local therapy in the context of multifocal
disease is permitted as long as at least one untreated lesions meets criteria for
measurable disease. Patients should have received minimum of one line of systemic
- At least 18 years of age.
- ECOG performance status of 0 to 2
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ? 1,500/mcL
- Platelets ? 100,000/mcL
- Hemoglobin ? 8.0 g/dL
- Serum bilirubin ? 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ? 2.5 x IULN
- Creatinine clearance ? 40 mL/min/1.73 m2 by the Cockcroft-Gault formula or by
24-hour urine collection for determination of creatinine clearance
- Negative antiviral serology:
- Negative human immunodeficiency virus (HIV) antibody.
- Negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core (HBc)
antibody or undetectable hepatitis B (HBV) DNA by quantitative polymerase chain
reaction (PCR) testing.
- Negative hepatitis C virus (HCV) antibody or negative HCV ribonucleic acid (RNA)
by quantitative PCR.
- Mean QT interval corrected for heart rate (QTc) < 470 msec calculated from 3 ECGs
performed at least 2 minutes apart using Frediricia's Correction.
- Female subjects must either be of non-reproductive potential (i.e., post-menopausal by
history: ?60 years old and no menses for 1 year without an alternative medical cause;
OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of
bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
- Diagnosis of leptomeningeal carcinomatosis.
- Diagnosis of melanoma or other non-epithelial based malignancy such as sarcoma,
neuroendocrine tumor, small cell lung cancer.
- Presence of unstable systemic disease (e.g., visceral crisis or rapid progression) in
the judgment of the investigator.
- A history of other malignancy ? 5 years previous with the exception of basal cell or
squamous cell carcinoma of the skin which were treated with local resection only or
carcinoma in situ of the cervix.
- Currently receiving any other investigational agents.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to MEDI4736 or other agents used in the study.
- Previous treatment with a PD-1 or PD-L1 inhibitor, including MEDI4736, or a CTLA-4
- Current or prior use of immunosuppressive medication within 28 days before the first
dose of MEDI4736 with the exceptions of intranasal and inhaled corticosteroids, or
systemic corticosteroids in Cohort C.
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy,
endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal
antibodies, other investigational agent) 21 days prior to the first dose of study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension (>180/110),
unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or
gastritis, active bleeding diatheses, or psychiatric illness/social situations that
would limit compliance with study requirements.
- Active or prior documented autoimmune disease within the past 2 years (Note: subjects
with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within
the past 2 years) are not excluded).
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,
- History of prior immunodeficiency.
- History of allogeneic organ transplant.
- Known history of previous clinical diagnosis of tuberculosis.
- Receipt of live attenuated vaccination within 30 days prior to first dose of MEDI4736.
- Pregnant and/or breastfeeding or female patients of reproductive potential who are not
employing an effective method of birth control.
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results
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