Clinical Trial Details
Braintumor Website

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NCT03458455 : Improved Therapy Response Assessment in Metastatic Brain Tumors
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Participants must have histologically - or - radiographically confirmed metastatic
disease from a primary non-small-cell lung cancer - or - metastatic melanoma.

- Participants must have measurable disease in the central nervous system (CNS), defined
as at least one lesion that can be accurately measured in at least one dimension as ?5
mm with MRI - or - compromise more than 30 image voxels on perfusion MRI to ensure
adequate parametric statistical assessments. For a perfusion MRI resolution of
1.2x1.2x5mm, this equals a tumor volume of 0.2cubic centimeters (cc).

- Eastern Cooperative Oncology Group (ECOG) performance status ?1 (Karnofsky ?60%)

- Life expectancy of greater than 6 weeks

- Eligible for stereotactic radiosurgery

- Have normal organ functions per clinical guidelines

- Ability to understand and the willingness to sign a written informed consent document.

- Previously untreated asymptomatic brain metastases - or - progressive brain metastases
after systemic therapy or prior local therapy such as radiation or surgery as defined

1. Untreated measurable lesions in patients that have received surgery and/or SRS to
one or more other lesions

2. Residual or progressive lesions after surgery if asymptomatic

3. Patients who have had prior whole-brain radiation therapy (WBRT) and/or SRS and
then whose lesions have progressed are eligible. Lesions treated with SRS may be
eligible if there is unequivocal evidence of progression

4. Progression after prior systemic therapy.

Exclusion Criteria:

- Participants who received major surgery must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting therapy.

- Has a diagnosis of immunodeficiency or hypersensitivity to ipilimumab or any of its
excipients (Cohorts C and D).

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the pre-screening or screening visit
through 120 days after the last dose of trial treatment.

- Has a known additional malignancy that is progressing or requires active treatment.

- Has active autoimmune disease that has required systemic treatment in the past 2 years
(i.e. with use of disease modifying agents, corticosteroids or immunosuppressive
drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.

- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

- Unable to undergo brain MRI
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