Adequate laboratory values must be obtained within 21 days prior to starting arm therapy.
 Fasting total glucose ≤ 126 mg/dL
 HbA1C ≤ 5.7%
 Cholesterol < 300 mg/dL; 10.34 mmol/L
 Triglycerides < 300 mg/dL; 3.42 mmol/L

Clinically significant infections as judged by the treating physician. NOTE: For participants who
are exhibiting symptoms consistent with COVID-19 or have tested positive using a test consistent
with the institutional standard of care, enrollment and protocol treatment should not be initiated
until resolution of symptoms as per investigator discretion.
2. Stage IV (metastatic) disease, however no specific staging studies are required in the absence of
symptoms or physical exam findings that would suggest distant disease.
3. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6
months of registration are eligible for this trial. NOTE: Patients without a known history of being
HIV positive do not require testing at screening. Patients who are known to be HIV positive will
require testing as described to be eligible for this trial. Testing should be considered standard of
care.
4. Patients with evidence of chronic hepatitis B virus (HBV) infection, with undetectable HBV viral
load within 6 months of registration are eligible for this trial. They should be on suppressive
therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been
treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral
load must be undetectable within 6 months of registration to be eligible for this trial. . NOTE:
Patients without a known history of being hepatitis positive do not require testing at screening.
Patients who are known to be hepatitis positive will require testing as described to be eligible for
this trial. Testing should be considered standard of care.
5. Participants with unstable angina or a myocardial infarction within 12 months of study
registration.
6. Active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer
found on cystectomy): Active second malignancy is defined as a current need for cancer therapy
or a high possibility (> 30%) of recurrence during the study. Previous contralateral breast cancer
is allowable unless it meets “active” criteria as stated above.
7. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis,
organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or
evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of
radiation pneumonitis in the radiation field (fibrosis) is permitted.
8. History of interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis,
active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or
cytomegalovirus pneumonia).

History of or active inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis) or
active bowel inflammation (e.g., diverticulitis).
10. History of autoimmune disease, including but not limited to myasthenia gravis, myositis,
autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis, inflammatory
bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s
granulomatosis, Sjogren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or
glomerulonephritis. Patients with the following are eligible:
● history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement
hormone
● controlled Type 1 diabetes mellitus on a stable insulin dosing regimen
● eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations
only (e.g. patients with psoriatic arthritis would be excluded) are permitted provided that
they meet the following conditions:
o rash must cover less than 10% of body surface area
o disease is well controlled prior to arm assignment and only requires low potency
topical steroids
o no acute exacerbations of underlying condition within the previous 12 months
(not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral
steroids).
11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications
(including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine,
methotrexate, thalidomide, mycophenolate and anti-tumor necrosis factor [TNF] agents) within 2
weeks prior to arm assignment, or anticipated requirement for systemic immunosuppressive
medications during the trial. Patients who have received acute, low dose, systemic
immunosuppressant medications (e.g. one-time dose of dexamethasone) may be enrolled in the
study. The use of inhaled corticosteroids for chronic obstructive pulmonary disease,
mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic hypotension, and low dose
supplemental corticosteroids (<10 mg prednisone or equivalent) for adrenocortical insufficiency
are allowed. Patients with a history of allergic reaction to IV contrast requiring steroid pretreatment
should have screening and subsequent tumor assessments performed using magnetic
resonance imaging (MRI).
12. Inability to swallow pills.
13. Evidence of significant uncontrolled concomitant disease that could affect compliance with the
protocol, safety of participation, or interpretation of results. This includes significant liver disease
(such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome) or any
other serious medical condition or abnormality in clinical laboratory tests that meet these criteria
in the investigator’s opinion.
14. Prior history of stem cell or solid organ transplantation.
15. History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study
medications being used in this study.
16. Treatment with any investigational agent within 30 days prior to study registration.