Clinical Trial Details
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NCT02834013 : Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients must have histologically confirmed rare cancer and/or cancer of unknown
primary, that did not have a match to a molecularly-guided therapy on EAY131
"National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)"
protocol or who progressed on molecularly-matched therapy and have no further
molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"

- All baseline assessments must have been completed within 28 days prior to

- Patients that do not qualify for one of the histologic cohorts may be considered for
registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation
of the study chairs via email

- Patients that are determined to have a rare cancer with unknown primary site are
eligible provided that there is histologic documentation of metastatic malignancy
with no discernible primary site identified from histopathologic review, physical
exam and associated cross-sectional imaging of the chest, abdomen, and pelvis

- Patients must have a diagnostic quality computed tomography (CT) scan or magnetic
resonance imaging (MRI), performed within 28 days prior to registration, which
demonstrates measurable disease, as defined in RECIST v. 1.1; additionally, CT scans
or MRIs used to assess non-measurable disease must have been completed within 42 days
prior to registration; all disease must be assessed and documented on the S1609
Baseline Tumor Assessment Form

- No other prior malignancy is allowed except for the following:

- Adequately managed stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease free for five years

- Adequately managed stage I or II follicular thyroid or prostate cancer is also
eligible, wherein patient is not required to be in complete remission

- Patients who have received prior anti-programmed death-1(PD-1) or anti-programmed
death-ligand 1(PD-L1) therapy are not eligible; other immunotherapy is permitted:
including ipilimumab, other anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4), and
cancer vaccine therapy provided that it is completed >= 7 days prior to registration

- Patients who had prior immune-related adverse event (grade 3 or higher immune-related
pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g.
cancer vaccine, cytokine, etc.) are not eligible

- Patients with brain metastases or primary brain tumors must have completed treatment,
surgery or radiation therapy >= 28 days prior to registration and have stable disease
at time of registration; metastatic brain parenchymal disease must have been treated
and patient must be off steroids for 7 days prior to registration

- Patients must not currently be receiving any other investigational agents or any
other systemic anti-cancer therapy (including radiation); in event patient recently
received any other systemic anti-cancer therapy, patient must be off therapy at least
7 days prior to registration and any therapy-induced toxicity must have recovered to
=< grade 1

- Patients must have a Zubrod performance status of 0-2

- ANC >= 1,000/mcL

- Platelets >= 75,000/mcL

- Hemoglobin >= 8 g/dL

- Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for
documented/suspected Gilbert's disease

- Total bilirubin =< 3.0 x IULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN

- Serum creatinine =< 2.0 IULN

- Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault
formula; estimated creatinine clearance is based on actual body weight

- Patients must have adequate thyroid function, as evidenced by thyroid-stimulating
hormone (TSH), free thyroxine (T4) serum tests demonstrating values within the normal
range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable
if per institutional standard; otherwise, both TSH and free-T4 must be obtained

- Patients must have adequate adrenal axis function, as evidenced by
Adrenocorticotropic Hormone (ACTH) values within the normal ranges, within 28 days
prior to registration

- Females of childbearing potential must have negative serum pregnancy test 14 days
prior to registration and agree to use birth control throughout study and for 23
weeks after completion of protocol therapy; patients must not be pregnant or nursing;
women/men of reproductive potential must have agreed to use an effective
contraceptive method; a woman is considered to be of "reproductive potential" if she
has had menses at any time in the preceding 12 consecutive months; in addition to
routine contraceptive methods, "effective contraception" also includes heterosexual
celibacy and surgery intended to prevent pregnancy (or with a side-effect of
pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral
tubal ligation; however, if at any point a previously celibate patient chooses to
become heterosexually active during the time period for use of contraceptive measures
outlined in the protocol, he/she is responsible for beginning contraceptive measures

- Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV)
infection at time of registration; patients with HBV or HCV that have an undetectable
viral load, or in the opinion of the treating investigator is well-controlled, are

- Patients who are known to be human immunodeficiency virus (HIV)-positive at
registration are eligible at the time of registration:

1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3

2. If patient is on antiretroviral therapy, there must be minimal interactions or
overlapping toxicity of the antiretroviral therapy with the experimental cancer
treatment; once daily combinations that use pharmacologic boosters may not be

3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining
conditions other than historical low CD4+ cell counts

4. Probable long-term survival with HIV if cancer were not present

- Patients must not have active autoimmune disease that has required systemic treatment
in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs,
or corticosteroids with doses higher than prednisone 10mg or equivalent). 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. Autoimmune diseases include but are not limited to autoimmune hepatitis,
inflammatory bowel disease, multiple sclerosis, vasculitis, or glomerulonephritis;
patients with well-controlled systemic lupus erythematous or rheumatoid arthritis may
be eligible after communication with the study chairs at; vitiligo,
alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis
not requiring systemic therapy within the past 3 years is permitted; short-term
steroid premedication for contrast allergy is permitted

- Patients must not have any uncontrolled intercurrent illness including (not limited
to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA]
III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24
weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac
dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version
[v] 4 grade >= 2), known psychiatric illness that would limit study compliance,
intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve
morphology (>= grade 3)
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