Clinical Trial Details
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NCT02311920 : Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histopathologically proven diagnosis of glioblastoma or gliosarcoma prior to
registration by pathology report

- The tumor must be unifocal, confined to the supratentorial compartment and have
undergone a gross total or near gross total resection; this will increase the
likelihood that the patient will not require corticosteroids or develop

- The formalin-fixed, paraffin-embedded (FFPE) tumor tissue block must be available to
be sent for retrospective central pathology review after registration

- Patients must be registered within 35 days of completion of chemoradiation

- History/physical examination within 7 days prior to registration

- Patients must have undergone an evaluation by magnetic resonance imaging (MRI) within
35 days of completing radiation and must also be within 7 days prior to registration;
MRI must NOT demonstrate tumor progression, but patients with imaging changes
consistent with pseudo-progression, stable neurologic function and not needing
corticosteroid treatment are eligible

- Karnofsky performance status >= 70 within 7 days prior to registration

- Absolute neutrophil count >= 1,500 cells/mm^3

- Platelet count >= 100,000 cells/mm^3

- Hemoglobin (Hgb) > 9 g/dL (can be achieved with transfusion)

- Blood urea nitrogen (BUN) =< 30 mg/dl

- Serum creatinine =< 1.7 mg/dl

- Total bilirubin (except patients with Gilbert's syndrome, who are eligible for the
study but exempt from the total bilirubin eligibility criterion) =< 2.0 mg/dl

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper
limit of normal (ULN)

- The patient must have completed chemoradiation (all cohorts) within standards of care
established by prior Radiation Therapy Oncology Group (RTOG)/Network Radiotherapy
Group (NRG) Oncology studies as follows:

- Radiation therapy

- Modality: either 3-dimensional (3D) or intensity-modulated radiation
therapy (IMRT), or proton therapy is allowed

- Time to initiation: radiotherapy must be initiated within or equal to 42
days after surgery

- Target volumes: target volume definition will be based upon
postoperative-enhanced MRI; preoperative imaging should be used for
correlation and improved identification, as necessary

- Dose guidelines: the initial target volume will be treated to 46 Gray (Gy)
in 23 fractions; after 46 Gy, the cone-down or boost volume will be treated
to a total of 60 Gy, with seven additional fractions of 2 Gy each (14 Gy
boost dose)

- Temozolomide during concomitant radiation therapy

- Temozolomide must have been administered continuously from day 1 of
radiotherapy to the last day of radiation (+/- 3 days to take into
consideration holidays) at a daily oral dose of 75 mg/m^2 for a maximum of
49 days (except missed doses due to toxicity)

- The patient must not be on a corticosteroid dose greater than physiologic replacement
dosing defined as 30 mg of cortisone per day or its equivalent

- The patient must provide study-specific informed consent prior to study entry

- Echocardiogram (ECHO) cardiogram and cardiology consultation required within 7 days
prior to registration for patients with a history of congestive heart failure or
cardiovascular disease or history of exposure to cardiotoxic agents who are not
already excluded

Exclusion Criteria:

- Definitive clinical or radiologic evidence of progressive disease

- Prior placement of Gliadel wafer or local brachytherapy

- Use of an immunotherapy such as a vaccine therapy, dendritic cell vaccine or
intracavitary or convectional enhanced delivery of therapy

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years

- Unstable angina within the last 6 months prior to registration

- Transmural myocardial infarction within the last 6 months prior to registration

- Evidence of recent myocardial infarction or ischemia by the findings of S-T
elevations of >= 2 mm using the analysis of an electrocardiogram (EKG) performed
within 7 days prior to registration

- New York Heart Association grade II or greater congestive heart failure requiring
hospitalization within 12 months prior to registration

- History of stroke, cerebral vascular accident (CVA) or transient ischemic attack
within 6 months prior to registration

- Serious and inadequately controlled cardiac arrhythmia

- Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or
clinically significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Serious or non-healing wound, ulcer, or bone fracture or history of abdominal
fistula, gastrointestinal perforation, intra-abdominal abscess major surgical
procedure, open biopsy, or significant traumatic injury within 28 days prior to
registration, with the exception of the craniotomy for tumor resection

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for additional liver function tests and
coagulation parameters are not required for entry into this protocol

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human immunodeficiency
virus (HIV) testing is not required for entry into this protocol

- Active connective tissue disorders, such as lupus or scleroderma, which in the
opinion of the treating physician may put the patient at high risk for immunologic

- Patients with active autoimmune disease or history of autoimmune disease that might
recur, which may affect vital organ function or require immune suppressive treatment
including systemic corticosteroids, should be excluded; these include but are not
limited to patients with a history of immune related neurologic disease, multiple
sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic
inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic
autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue
diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis,
hepatitis; and patients with a history of toxic epidermal necrolysis (TEN),
Stevens-Johnson syndrome, or phospholipid syndrome should be excluded

- Of note, patients with vitiligo, endocrine deficiencies including thyroiditis
managed with replacement hormones including physiologic corticosteroids are
eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren's
syndrome and psoriasis controlled with topical medication and patients with
positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies
should be evaluated for the presence of target organ involvement and potential
need for systemic treatment but should otherwise be eligible

- Any other major medical illnesses or psychiatric impairments that in the
investigator's opinion will prevent administration or completion of protocol therapy

- Pregnancy or lactating females; women of childbearing potential must have a negative
serum pregnancy test within 7 days prior to registration

- History of severe hypersensitivity reaction to any monoclonal antibody
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