Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02716948 : SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have histologically confirmed diagnosis of melanoma; the pathologic
confirmation may be from another metastatic site or from metastatic brain or spine
lesions

- Patients must have stage IV melanoma, with newly identified brain or spine metastases

- Patients must have measurable lesion in the brain or spine that is >= 3 mm seen on
magnetic resonance imaging (MRI) with contrast; NOTE: contrasted pre-treatment MRI
scan must be obtained =< 21 days prior to stereotactic radiosurgery treatment

- Karnofsky performance scale >= 70%

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 2 x institutional upper limit of normal

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
institutional upper limit of normal

- Creatinine within normal institutional limits OR according to Johns Hopkins MRI policy

- Women of child bearing potential (WOCBP) must use a reliable form of contraception
during the study treatment period and for up to 12 weeks following the last dose of
study drug

- Men must agree to the use of male contraception during the study treatment period and
for at least 12 weeks after the last dose of study drug

- Ability to understand and the willingness to sign written informed consent document(s)

Exclusion Criteria:

- Prior whole brain radiation or conventional radiation to the spine at the site of new
lesion

- Prior chemotherapy within 28 days of starting treatment

- Prior therapy with investigational drugs within 28 days or at least 5 half-lives
(whichever is longer) before study administration

- Prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell
death-ligand 1 (PD-L1), or anti-PDL-2 antibody

- Neurologic dysfunction that would confound the evaluation of neurologic and other
adverse events

- Known allergy to compounds of similar chemical or biologic composition to nivolumab

- Pregnant or breastfeeding women

- Known history of human immunodeficiency virus

- Active infection requiring therapy, positive tests for hepatitis B surface antigen or
hepatitis C ribonucleic acid (RNA)

- Active autoimmune disease, history of autoimmune disease or history of syndrome that
required systemic steroids or immunosuppressive medications; exceptions include those
with vitiligo or resolved childhood asthma/atopy; subjects with asthma who require
intermittent use of bronchodilators (such as albuterol) will not be excluded from this
study

- Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up
to 4 weeks (28 days) before receiving nivolumab

- Prisoners or subjects who are compulsorily detained for treatment of either a
psychiatric or physical (e.g. infectious disease) illness

- Patients with both brain and spine metastases will be excluded from the trial

- Patients who are allergic to MRI contrast agent or have contraindication for MRI
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02716948      |      Link to official Clinicaltrials.gov listing
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