Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis [with the exception of diverticulosis]; sarcoidosis syndrome, or other serious gastrointestinal [GI] chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves disease; rheumatoid arthritis; hypophysitis; uveitis, sarcoidosis syndrome, etc.) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: \r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur 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, 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; 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 eligibleXx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ?12 months prior to randomizationXx_NEWLINE_xXChronic inflammatory bowel disease (Crohn's disease or ulcerative colitis)Xx_NEWLINE_xXNo history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study dietXx_NEWLINE_xXPatients must not have any prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, immune-mediated alopecia, Grave’s disease, or psoriasis requiring systemic treatment within the past 2 years are not eligible; patients with hypothyroidism (e.g. post Hashimoto syndrome) who are stable on hormone replacement therapy are eligibleXx_NEWLINE_xXNo 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; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, 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 because of the risk of recurrence or exacerbation of disease; human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4 > 200, undetectable viral load and on highly active antiretroviral therapy (HAART) therapyXx_NEWLINE_xXPatients 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, 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; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligibleXx_NEWLINE_xXNo gastrointestinal disorders associated with a high risk of perforation or fistula formation within 3 months prior to registration:\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n* Known malabsorption syndrome\r\n* Bowel obstruction or gastric outlet obstruction\r\n* Percutaneous endoscopic gastrostomy (PEG) tube placementXx_NEWLINE_xXNo active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn’s disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiencyXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen, or type 2 diabetes mellitus are eligible\r\n* Patients with 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:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however,\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with 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:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, lichen sclerosis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatient has any concurrent autoimmune disease or has a history of chronic or recurrent autoimmune disease; these include but are not limited to: multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpuraXx_NEWLINE_xXActive small or large intestine inflammation such as Crohn’s disease or ulcerative colitisXx_NEWLINE_xXInflammatory bowel disease that is uncontrolled or on active treatment (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory of chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc) with symptomatic disease within the last 3 years; Note: active vitiligo or alopecia or a history of vitiligo or alopecia will not be a basis for exclusionXx_NEWLINE_xXActive or history of inflammatory bowel disease (eg, colitis, Crohn’s), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosisXx_NEWLINE_xXGastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXPatients with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding are NOT eligible for participation; these may include (but are not limited to):\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding \r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)\r\n* Other gastrointestinal conditions with increased risk of perforationXx_NEWLINE_xXHistory of inflammatory bowel disease (Crohn's or ulcerative colitis)Xx_NEWLINE_xX13. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);Xx_NEWLINE_xXKnown history of colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.Xx_NEWLINE_xXPresence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea;Xx_NEWLINE_xXActive or history of any autoimmune disease including colitis and inflammatory bowel disease (subjects with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.Xx_NEWLINE_xXActive immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis, (non-infectious) pneumonitis.Xx_NEWLINE_xXHave inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years.Xx_NEWLINE_xXActive diarrhea or inflammatory bowel diseaseXx_NEWLINE_xXActive or documented inflammatory disease.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).Xx_NEWLINE_xXPatients with history of and/or active inflammatory bowel disease.Xx_NEWLINE_xXSubject with a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Subjects with vitiligo, endocrinopathies, and alopecia are allowed. Subjects with psoriasis not requiring systemic treatment within the past 6 months are allowed;Xx_NEWLINE_xXHistory or risk of autoimmune disease that threatens vital organ function, including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis\r\n* Patients with a prior history of immune related events to anti-CTLA-4 may be eligible after discussion with the sponsor; however, patients with a history of grade 3 and 4 pulmonary, CNS and renal events attributed to anti-CTLA-4 agents will be excluded\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn’s disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatmentXx_NEWLINE_xXHave current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.Xx_NEWLINE_xXParticipants with inflammatory bowel diseaseXx_NEWLINE_xXActive inflammatory or other gastrointestinal disease,Xx_NEWLINE_xXHistory of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.Xx_NEWLINE_xXActive rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders including but not limited to inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatmentXx_NEWLINE_xXKnown history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.Xx_NEWLINE_xXBowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrheaXx_NEWLINE_xXBowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), or any other chronic, serious GI condition associated with diarrhea; NOTE: Subjects with known diverticulosis are permitted to enrollXx_NEWLINE_xXBilateral hip prostheses, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus (radiotherapy contraindications)Xx_NEWLINE_xXInflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or constipationXx_NEWLINE_xXHistory of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)Xx_NEWLINE_xXCurrent acute or chronic colitis, inflammatory bowel disease, pneumonitis or pulmonary fibrosis.Xx_NEWLINE_xXAny history of active or severe autoimmune disease: inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, rheumatoid arthritis, systemic progressive scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), CNS or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis); patients with hypothyroidism with stable hormone replacement therapy dosing are allowed on studyXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematous, Wegner's syndrome, myasthenia gravis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune pneumonitis, autoimmune nephritis or nephropathy, etc.) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:Xx_NEWLINE_xXActive autoimmune disease including active diverticulitis, symptomatic peptic ulcer disease, colitis, or inflammatory bowel disease that has required systemic treatment in past 2 yearsXx_NEWLINE_xXUnresolved diarrhea ? CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)Xx_NEWLINE_xXUncontrolled medical conditions including diabetes, heart failure, chronic obstructive pulmonary disease (COPD), ulcerative colitis, or Crohn’s diseaseXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vacuities, or glomerulonephritis\r\n* Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen are eligible for this studyXx_NEWLINE_xXPatients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus (SLE), and Sjogren’s syndrome, sarcoidosis; asthma or chronic obstructive pulmonary disease (COPD) that does not require systemic corticosteroids or routine use of inhaled steroids is acceptableXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritisXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis, etc.) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Requirement for intermittent use of bronchodilators or local steroid injections\r\n* Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatmentXx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosisXx_NEWLINE_xXPatients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis)Xx_NEWLINE_xXHistory of autoimmune disease including, but not limited to:\r\n* Systemic lupus erythematosus (SLE), scleroderma, calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome, rheumatoid arthritis\r\n* Inflammatory bowel disease, celiac disease, primary biliary cirrhosis, autoimmune hepatitis\r\n* Dermatomyositis, polymyositis, giant cell arteritis\r\n* Autoimmune hemolytic anemia (AIHA), cryoglobulinemia, antiphospholipid antibody syndrome (APLS)\r\n* Diabetes mellitus type I, myasthenia gravis, Grave’s disease\r\n* Wegener’s granulomatosis or other vasculitis\r\n* A history of Hashimoto’s thyroiditis, psoriasis, or eczema, any of which has been inactive for at least one year, or isolated Raynaud’s phenomenon is acceptableXx_NEWLINE_xXHistory of inflammatory bowel disease or other serious autoimmune disease; (not including thyroiditis and rheumatoid arthritis); patients already on hydroxychloroquine for such disorders are not eligibleXx_NEWLINE_xXActive rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).Xx_NEWLINE_xXHistory of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXUncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.Xx_NEWLINE_xXActive rectal diverticulitis, Crohn’s disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn’s disease not affecting the rectum are allowed)Xx_NEWLINE_xXEXCLUSION - DURVALUMAB DRUG-SPECIFIC: Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:\r\n* Participants with vitiligo or alopecia\r\n* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement \r\n* Any chronic skin condition that does not require systemic therapy\r\n* Participants without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Participants with celiac disease controlled by diet aloneXx_NEWLINE_xXSubject has any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the subject at risk for such interference (for example, short bowel syndrome or inflammatory bowel disease).Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis).Xx_NEWLINE_xXAuto-immune disease including inflammatory bowel disease, lupus, rheumatoid arthritis, but not including hypothyroidism or psoriasis if condition has been stable for 2 months or greaterXx_NEWLINE_xXHas active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXHistory of active autoimmune diseases such as but not limited to Crohn’s disease, ulcerative colitis, Sjogren’s syndrome, requiring active immune suppression; patient may have hay fever or controlled asthmaXx_NEWLINE_xXGENERAL: History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).Xx_NEWLINE_xXKnown contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (ataxia telangiectasia or Fanconi’s anemia)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXHistory of inflammatory bowel disease, autoimmune disease, or other connective tissue diseasesXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjoogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\r\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study\r\n* Patients with controlled type 1 diabetes mellitus who are on a stable insulin regimen are eligible for the studyXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone, controlled type 1 diabetes mellitus on a stable insulin regimen are eligible.\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations.\r\n** Rash must cover less than 10% of body surface area (BSA).\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).Xx_NEWLINE_xXPatients with history or current diagnosis of inflammatory bowel disease are not eligibleXx_NEWLINE_xXAny condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;Xx_NEWLINE_xXOther severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, severe Chronic obstructive pulmonary disease (COPD) requiring > 3 hospitalization in the past yearXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, systemic vasculitis, or glomerulonephritisXx_NEWLINE_xXPatients 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\r\n* 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, Sjogren’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 eligibleXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia,\r\n* Grave’s disease,\r\n* Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement,\r\n* Psoriasis not requiring systemic treatment (within the past 2 years),\r\n* Any chronic skin condition that does not require systemic therapy, patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXActive inflammatory bowel disease, other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day), or bowel obstructionXx_NEWLINE_xXPatients with a history of autoimmune disease (e.g., rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Patients with vitiligo or alopecia are allowed. Patients with Graves disease or psoriasis not requiring systemic treatment within the past 2 years are allowed.Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormonal replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Subjects without active disease in the last 5 years may be included but only after consultation with the principal investigator\r\n* Subjects with celiac disease controlled by diet aloneXx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXPatients 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, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren'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 eligibleXx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXHistory of chronic autoimmune disease (e.g. systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, hypophysitis, etc.) with symptomatic disease within the 3 years before enrollment; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity e.g. rheumatoid arthritis or thyroiditis may be allowed per principal investigator (PI) discretion provided it has been quiescent for a minimum of three years; the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included\r\n* Patients with celiac disease controlled by diet alone\r\n* Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrheaXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: 1) Patients with vitiligo or alopecia; 2) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; 3) Any chronic skin condition that does not require systemic therapy; 4) Patients without active disease in the last 5 years may be included but only after consultation with the study physician; 5) Patients with celiac disease controlled by diet alone. Subjects with history of diverticulitis may be included only after consultation and approval of the study physician.Xx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exception: a. patients with a history of autoimmune hypothyroidism who are on thyroid replacement hormone are eligible for the study; b. patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; c. patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: i. rash must cover < 10% of body surface area.; ii. disease is well controlled at baseline and requires only low-potency topical corticosteroids; iii. no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 monthsXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Subjects without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Subjects with celiac disease controlled by diet aloneXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis a) Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. b) Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible. c) Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations; rash must cover less than 10% of body surface area (BSA)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 2 years prior to the start of treatment\r\nNOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excludedXx_NEWLINE_xXPatients 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\r\n* 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, Sjogren’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; however, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolledXx_NEWLINE_xXPatients with inflammatory bowel diseaseXx_NEWLINE_xXHave an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatmentXx_NEWLINE_xXCurrent severe acute or chronic colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosisXx_NEWLINE_xXSubjects with bowel obstructionXx_NEWLINE_xXHistory of automimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), vascular thrombosis associated with antiphospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis\r\n* Note: Patients with type 1 diabetes mellitus, vitiligo, alopecia, hypothyroidism requiring hormone replacement, Graves disease, or skin disorders not requiring systemic treatment are permitted to enrollXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) or pneumonitisXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\r\n* Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study\r\n* Subjects with controlled type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study\r\n* Subjects with a history of celiac disease may be eligible if controlled with dietXx_NEWLINE_xXPatients with inflammatory bowel diseaseXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive or prior documented inflammatory bowel diseaseXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosisXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis a. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. b. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. c. Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n* Rash must cover less than 10% of body surface area (BSA)\r\n* Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n* No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory of active or known autoimmune disease that can cause diarrhea like (but not limited to) Addison's disease, celiac disease/gluten intolerance/irritable bowel syndrome, sclerodermaXx_NEWLINE_xXActive/uncontrolled autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.Xx_NEWLINE_xXHistory of or active autoimmune disorders (including but not limited to: Crohn’s disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave’s disease) and other conditions that compromise or impair the immune systemXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory of inflammatory bowel disease;Xx_NEWLINE_xXSevere (requiring active treatment) acute or chronic medical conditions including: colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosisXx_NEWLINE_xXPatients with active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)Xx_NEWLINE_xXActive auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapyXx_NEWLINE_xXPatients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia Gravis, multiple sclerosis); history of Grave’s disease on stable thyroid hormone replacement for at least 1 year is allowedXx_NEWLINE_xXAll other significant diseases (for example, colitis, pneumonitis, pulmonary fibrosis, inflammatory bowel disease, uncontrolled asthma)Xx_NEWLINE_xXPatients 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, 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 because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’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 eligibleXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXAny of the following within 28 days before the first dose of study treatment\r\n* Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n* Malabsorption syndromeXx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis); patients with Hashimoto’s thyroiditis are eligible to go on studyXx_NEWLINE_xXHistory of autoimmune disease, such as, but not restricted to: rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years; patients with vitiligo or diabetes are not excluded; 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; patients with recent history of thyroiditis; subjects with remote history (greater than 5 years) of thyroiditis are not excludedXx_NEWLINE_xXmalabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndromeXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXAny symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) that requires administration of >10mg of prednisone equivalent. Lower dose steroids for conditions such as hypophysitis are allowed.Xx_NEWLINE_xXPatients 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, 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; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren'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 eligibleXx_NEWLINE_xXHas active or prior documented inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjogren syndrome, and sarcoidosis)Xx_NEWLINE_xXPatients are excluded if they have a history of autoimmune disease, as follows: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Patients with a history of Guillain-Barre Syndrome are excluded but myasthenia gravis or psoriasis is acceptable.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXPatient with other co-morbidities that in the opinion of the treating physician would be a contra-indication to protocol participation (e.g. inflammatory bowel disease)Xx_NEWLINE_xXHistory of Crohn’s disease or ulcerative colitisXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis) or a history of primary immunodeficiencyXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXSerious autoimmune disease: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) or autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic Lupus Erythematosus or autoimmune vasculitis [e.g. Wegener's Granulomatosis] are excluded from this study.Xx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener's granulomatosisXx_NEWLINE_xXHistory of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease; (concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable); history of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotilityXx_NEWLINE_xXPatients with risk factors for bowel obstruction or bowel perforation (e.g., acute diverticulitis) will be excludedXx_NEWLINE_xXPatients with active autoimmune diseases are excluded: Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as well as patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis; currently receiving immunosuppressive doses of steroids or other immunosuppressive medications (inhaled and topical steroids are permitted)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHave active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapyXx_NEWLINE_xXHave a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea.Xx_NEWLINE_xXInflammatory bowel disease that is uncontrolled or on active treatment (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusionXx_NEWLINE_xXHistory of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any originXx_NEWLINE_xXActive autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigatorsXx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXSmall bowel obstructionXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion: a) patients with vitiligo or alopecia; b) patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; c) any chronic skin condition that does not require systemic therapy; d) patients without active disease in the last 5 years may be included but only after consultation with the study physician; d) patients with celiac disease controlled by diet aloneXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea; autoimmune vasculitis; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis, etc.) within 3 years prior to the planned start of treatment; the following are exceptions to this criterion:\r\n* Vitiligo\r\n* Alopecia\r\n* Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Psoriasis not requiring systemic treatment\r\n* Other conditions considered to be low risk of serious deterioration by the principal investigator (PI)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXPatients with complete bowel obstruction or who are at high risk for gastrointestinal (GI) perforation or severe hemorrhage and patients with inflammatory bowel diseaseXx_NEWLINE_xXSevere autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic Lupus Erythematosus or autoimmune vasculitis (e.g. Wegener’s Granulomatosis) are excluded from this study; patients with history of mild autoimmune disorders, including but not limited to mild psoriasis or Hashimoto’s hyperthyroidism may be included at the discretion of the principle investigatorXx_NEWLINE_xXHistory of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any originXx_NEWLINE_xXHistory of any autoimmune disease, including any history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as history of symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the principal investigatorXx_NEWLINE_xXActive or prior documented autoimmune disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease, Wegner syndrome, Hashimoto syndrome) within the past 3 years; subjects with vitiligo, alopecia, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded; patients with hypothyroidism stable on thyroid replacement therapy for the previous 3 months are not excludedXx_NEWLINE_xXClinical contraindication to stereotactic body radiotherapy as determined by the investigator (e.g., active systemic sclerosis, active inflammatory bowel disease if bowel is within radiation field)Xx_NEWLINE_xXPoorly controlled inflammatory bowel diseaseXx_NEWLINE_xXPatients 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, 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; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligibleXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) whose possible progression during treatment would be considered unacceptable by the investigatorsXx_NEWLINE_xXSubjects must not have active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapyXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician and/or PI\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXPatients with a history of inflammatory bowel disease such as Crohn’s disease and ulcerative colitisXx_NEWLINE_xXUncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible; patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations, rash must cover less than 10% of body surface area (BSA), disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%), no acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients with a history of inflammatory bowel disease such as Crohn’s disease and ulcerative colitisXx_NEWLINE_xXClinically significant ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are to be excludedXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXActive autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen); such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn’s disease and temporal arteritisXx_NEWLINE_xXNo prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease including Addison’s disease, Grave’s disease, Hashimoto’s thyroiditis, hypophysitis, uveitis); asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; active vitiligo or alopecia, or a history of vitiligo or alopecia is acceptableXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn`s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXPHASE II STUDY NON-SMALL CELL LUNG CANCER (COHORT 2; MEDI+O AND MEDI+C) AND SMALL CELL LUNG CANCER (COHORT 3; MEDI+O ONLY) ELIGIBILITY CRITERIA:\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basisXx_NEWLINE_xXAny kind of malabsorption syndrome significantly affecting gastrointestinal function, including history of Crohn’s disease or inflammatory bowel diseaseXx_NEWLINE_xXHistory or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn’s disease) or other symptomatic autoimmune disease including, inflammatory bowel disease, or history of any poorly controlled or severe systemic autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, type I diabetes, or autoimmune vasculitis)Xx_NEWLINE_xXHave a history of any autoimmune disease; patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, or autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the protocol chairXx_NEWLINE_xXHistory of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowedXx_NEWLINE_xXADDITIONAL CRITERIA FOR STUDY CONTINUATION: History of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowedXx_NEWLINE_xXHistory of inflammatory colitis or other active severe comorbiditiesXx_NEWLINE_xXPatients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's disease, multiple sclerosis (MS), ankylosing spondylitis)Xx_NEWLINE_xXPrior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjorgen’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligibleXx_NEWLINE_xXPatients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)Xx_NEWLINE_xXHistory of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligibleXx_NEWLINE_xXPatients with a known history of any of the following autoimmune diseases are excluded: \r\n* Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) \r\n* Patients with a history of rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis)Xx_NEWLINE_xXSerious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitisXx_NEWLINE_xXPrior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the PI to determine if eligibleXx_NEWLINE_xXUncontrolled inflammatory bowel diseaseXx_NEWLINE_xXAutoimmune disease such as scleroderma, lupus, or inflammatory bowel diseaseXx_NEWLINE_xXHistory of collagen vascular disease or inflammatory bowel disease (Crohn’s or ulcerative colitis)Xx_NEWLINE_xXHistory of Crohn’s disease or Ulcerative colitisXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded.Xx_NEWLINE_xXSerious autoimmune disease at the discretion of the treating attending: patients with a history of active serious inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this studyXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, irritable bowel syndrome, ulcerative colitis)Xx_NEWLINE_xXPrior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligibleXx_NEWLINE_xXHistory of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritisXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and myasthenia gravis)Xx_NEWLINE_xXHistory of autoimmune disease such as scleroderma, lupus, and inflammatory bowel diseaseXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis); history of Grave’s disease on stable thyroid hormone replacement for at least 1 year is allowedXx_NEWLINE_xXPatients with active inflammatory bowel diseaseXx_NEWLINE_xXPatients with inflammatory bowel diseaseXx_NEWLINE_xXHistory of (H/o) Crohn’s disease/ulcerative colitis/sclerodermaXx_NEWLINE_xXPatients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosisXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXPresence of other known significant autoimmune or inflammatory disease; examples include major chronic infectious/inflammatory/immunologic diseases such as systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome and periodic fever syndromesXx_NEWLINE_xXKnown autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves’ disease, or Hashimoto’s thyroiditisXx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.Xx_NEWLINE_xXHistory of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (example [e.x.]: fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusionXx_NEWLINE_xXHistory of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any originXx_NEWLINE_xXPrior diagnosis of Crohn's disease or ulcerative colitisXx_NEWLINE_xXActive autoimmune disease including but not limited to: rheumatoid arthritis (RA), inflammatory bowel disease (IBD), celiac disease, systemic lupus erythematosus (SLE), scleroderma or multiple sclerosis; patients with autoimmune hypothyroidism or type I diabetes mellitus will be eligible; patients who are seropositive only without clinical symptoms will not be excludedXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with a history of autoimmune disease (specifically including: diabetes mellitus, vitiligo, Hashimoto’s thyroiditis) who are asymptomatic, do not require immune suppression or steroids, and do not have threatened vital organ function from these conditions may be considered after discussion with the principal investigator (PI)Xx_NEWLINE_xXA documented history of inflammatory bowel disease (ulcerative colitis or Crohn's disease, within three years)Xx_NEWLINE_xXHas active or prior inflammatory bowel disease or primary immunodeficiencyXx_NEWLINE_xXThere are no exclusions due to co-morbid disease or illnesses except for patients who carry a diagnosis of Inflammatory Bowel Disease that has been active within the last yearXx_NEWLINE_xXActive rectal diverticulitis, Crohn’s disease, or ulcerative colitisXx_NEWLINE_xXPatients with history of prior bowel resection, malabsorption syndrome, inflammatory bowel disease, prior bowel obstruction (partial or complete), Crohn disease, or any other disease significantly affecting the gastrointestinal tractXx_NEWLINE_xXPatients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptableXx_NEWLINE_xXNo prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptableXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXAny patient with active Crohn’s disease or active ulcerative colitisXx_NEWLINE_xXHistory of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders; patients without active disease in the last 5 years may be included after consultation with the study physician; this includes: inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, and diverticulitis with the exception of diverticulosis; sarcoidosis syndrome, or other serious GI chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome (granulomatosis with polyangiitis); myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis; or uveitis; the following are exceptions to this criterion:\r\n* Vitiligo or alopecia\r\n* Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Celiac disease controlled by diet aloneXx_NEWLINE_xXOngoing acute or chronic inflammatory skin disease.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).Xx_NEWLINE_xXGastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXHistory of or ongoing inflammatory bowel diseaseXx_NEWLINE_xXActive autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).Xx_NEWLINE_xXPrior autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis); note: patients with other immune disorders should not be enrolled without discussion with the principal investigatorXx_NEWLINE_xXGastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitisXx_NEWLINE_xXPre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitisXx_NEWLINE_xXKnown history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;Xx_NEWLINE_xXKnown history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.Xx_NEWLINE_xXPatient who have a history or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients 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, 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 because of the risk of recurrence or exacerbation of disease; 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 eligibleXx_NEWLINE_xXHas a known clinically significant GI disorder(s) including, but not limited to, inflammatory bowel disease or a history of extensive gastric resection and/or small intestinal resection.Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA) \r\n** Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) \r\n** No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXSubject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., Crohns disease], diverticulitis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome; myasthenia gravis; Grave's disease; rheumatoid arthritis; hypophysitis, uveitis, etc) within the past 3 years prior to the start of treatment; the following are exceptions:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement\r\n* Psoriasis not requiring systemic treatmentXx_NEWLINE_xXInclusion Criteria:\n\n          -  Scheduled to undergo an elective (non-emergent) bowel resection with or without a\n             planned stoma via laparotomy or minimally invasive technique. This includes any\n             subject in which a resection of the small intestine, colon, or rectum is performed for\n             any elected indication.\n\n          -  Has been informed of the nature of the study (either the subject or their legal\n             representative), agrees to its provisions, and has provided written informed consent.\n\n        Exclusion Criteria:\n\n        Subjects will not be eligible for participation in the study if they meet ANY of the\n        following exclusion criteria:\n\n          -  <18 or >80 years of age.\n\n          -  Requires emergency bowel surgery.\n\n          -  Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel\n             disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's\n             Disease, or ulcerative colitis. Note: This does not apply to previous surgery such as\n             hernia repair unrelated to IBD.\n\n          -  American Society of Anesthesiologists (ASA) Class 4 or 5.\n\n          -  Insulin dependent diabetes mellitus.\n\n          -  Known inability to take the study drug orally (i.e. complete small bowel obstruction).\n\n          -  Has contraindications or potential risk factors to taking TXA. These include subjects\n             with:\n\n               1. Known sensitivity to TXA;\n\n               2. Recent craniotomy (past 30 days);\n\n               3. Active cerebrovascular bleed;\n\n               4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism,\n                  cerebral thrombosis, ischemic stroke, or acute coronary syndrome);\n\n               5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission\n                  induction, or\n\n               6. Continuing use of a combined hormonal contraceptive and or combined hormonal\n                  replacement therapy (including combined hormonal pill, patch, or vaginal ring).\n\n          -  Has the following risk factors for thromboembolic disease:\n\n               1. Known medical history of congenital or acquired thrombophilia such as, but not\n                  limited to patients with:\n\n                    -  Sickle cell disease;\n\n                    -  Nephrotic syndrome;\n\n                    -  Factor V Leiden;\n\n                    -  Prothrombin gene mutation;\n\n                    -  Protein C or S deficiency;\n\n                    -  Antithrombin III deficiency;\n\n                    -  Antiphospholipid syndrome.\n\n               2. Stage IV malignant neoplasm;\n\n               3. Neurologic paresis, partial paralysis, or paralysis;\n\n               4. Pacemaker;\n\n               5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or\n                  rental venous/arterial occlusion;\n\n          -  History of or current seizure disorder.\n\n          -  Patients with myeloproliferative disorders.\n\n          -  Body Mass Index (BMI) >40.\n\n          -  Any other condition that, in the opinion of the Investigator, would preclude the\n             subject from being an appropriate candidate for the study, including severe renal or\n             hepatic impairment.\n\n          -  Planned treatment with alvimopan (Entereg®) during study participation period.\n\n          -  Received any other investigational therapy within 4 weeks prior to Randomization\n\n          -  Chronic opioid usage, defined by the American Pain Society as daily or near-daily use\n             of opioids for at least 90 days.\n\n          -  Female subjects of childbearing potential with a positive urine or serum pregnancy\n             test or who are not taking (or not willing to take) acceptable birth control measures\n             (abstinence, intrauterine devices, contraceptive implants or barrier methods) through\n             Day 30. Additionally, those women who are lactating and insist on breast feeding\n             within 5 days of the last dose of study drug.\n\n          -  Known history of radiation enteritis.Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.Xx_NEWLINE_xXHistory of Crohn’s disease, ulcerative colitis, or ataxia telangiectasiaXx_NEWLINE_xXPatients with active autoimmune diseases or active immune suppressive therapy or inflammatory bowel disease; a low dose steroid daily administration (equivalent dexamethasone < 10mg/day) is acceptableXx_NEWLINE_xXHistory of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), or any other known autoimmune diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, and autoimmune vasculitisXx_NEWLINE_xXAny medical condition that would be a contra-indication to radiation therapy, such as inflammatory bowel diseaseXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included, but only after consultation with the PI\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Note:\r\n** Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\r\n** Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible\r\n** Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n*** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n*** Rash must cover less than 10% of body surface area (BSA)\r\n*** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n*** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia;\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; \r\n* Any chronic skin condition that does not require systemic therapy; \r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician; \r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable.Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis, ulcerative colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: patients with vitiligo or alopecia, patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, patients without active disease in the last 5 years may be included but only after consultation with the study physician, and patients with celiac disease controlled by diet alone.Xx_NEWLINE_xXHistory of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease\r\nor any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXChronic diarrhea > grade 1, or a diagnosis of Crohn’s or ulcerative colitisXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the Investigator to be unacceptable.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptableXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatmentXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (i.e. not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients with Crohn's disease or ulcerative colitisXx_NEWLINE_xXPatients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.])\r\n* The following are exceptions to this criterion:\r\n** Patients with vitiligo or alopecia;\r\n** Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement;\r\n** Any chronic skin condition that does not require systemic therapy;\r\n** Patients without active disease in the last 5 years may be included but only after consultation with the medical oncology study chair;\r\n** Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXPatients with active autoimmune disease or documented autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritisXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXDOSE ESCALATION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease\r\n* Exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approvalXx_NEWLINE_xXDOSE EXPANSION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease; exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approvalXx_NEWLINE_xXHistory of diverticulitis, diverticulosis requiring antibiotic treatment or chronic ulcerative lower gastrointestinal (GI) disease such as Crohn’s disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforationsXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXNo standard contraindications to radiation therapy including prior significant radiation therapy, inflammatory bowel disease, irritable bowel syndrome or collagen vascular diseaseXx_NEWLINE_xXPatients 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, are 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, 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; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’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 eligibleXx_NEWLINE_xXPatients with significantly diseased or obstructed gastrointestinal tract that could interfere with absorption of oral medication, including inflammatory or chronic functional bowel disorder, such as Crohn disease, inflammatory bowel disease, chronic diarrhea, or constipationXx_NEWLINE_xXActive autoimmune process (eg rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who have been receiving therapy for an autoimmune or inflammatory disease; vitiligo, thyroiditis, or eczema is permitted if patient is otherwise eligibleXx_NEWLINE_xXHistory of inflammatory bowel disease requiring ongoing therapyXx_NEWLINE_xXDONOR: History of or symptoms consistent with inflammatory bowel disease or a serious autoimmune disorderXx_NEWLINE_xXPatients must not have active or a history of small or large intestine inflammation such as Crohn’s disease or ulcerative colitisXx_NEWLINE_xXPatients must not have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease) or diverticulitis (history of diverticulosis is allowed)Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the protocol chair, following discussion with the study sponsor and Cancer Therapy Evaluation Program (CTEP)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis \r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)Xx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic non-gastrointestinal autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)Xx_NEWLINE_xXActive inflammatory bowel diseaseXx_NEWLINE_xXPatients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular diseaseXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)Xx_NEWLINE_xXPatients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)Xx_NEWLINE_xXPatients with active inflammatory bowel diseaseXx_NEWLINE_xXHistory of gastrointestinal disease causing malabsorption or obstruction such as, but not limited to Crohn’s disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resectionXx_NEWLINE_xXAny condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, ulcerative colitis, inflammatory bowel disease, a partial or complete small bowel obstruction, or active peptic ulcer disease) that impairs their ability to swallow and retain MK-2206 or hydroxychloroquine tabletsXx_NEWLINE_xXThe participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.Xx_NEWLINE_xXPatient must not have a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention within the 12 months prior to randomizationXx_NEWLINE_xXActive peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), diverticulitis or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleedingXx_NEWLINE_xXPrior diagnosis of Crohn's disease or ulcerative colitisXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritisXx_NEWLINE_xXPatient must have no active inflammatory bowel diseaseXx_NEWLINE_xXSevere gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.Xx_NEWLINE_xXActive inflammatory disease requiring immunosuppressants, including small or large intestinal inflammation such as Crohn's disease or ulcerative colitisXx_NEWLINE_xXActive inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.Xx_NEWLINE_xXPatients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligibleXx_NEWLINE_xXSubjects who have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or Wegener's granulomatosis;Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:Xx_NEWLINE_xXActive bowel obstruction, or hospitalization for bowel obstruction within 2 months prior to screeningXx_NEWLINE_xXHave current or recent gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.Xx_NEWLINE_xXPatients must be able to tolerate oral medication and not have evidence of active bowel obstruction\r\n* Note: patients can have a history of prior bowel obstruction, provided the patient is not having symptoms of bowel obstruction at the time of enrolment and the bowel obstruction is not anticipated to recur during the participation in the studyXx_NEWLINE_xXOngoing inflammatory bowel diseaseXx_NEWLINE_xXHistory of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defectXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXIntraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforationXx_NEWLINE_xXSubject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease [exclude only if active within the last 6 months prior to signing the ICF], or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:Xx_NEWLINE_xXActive inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resectionXx_NEWLINE_xXHistory or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitisXx_NEWLINE_xXHistory of inflammatory bowel disease (e.g., Crohnis disease, ulcerative colitis),celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption, distribution, metabolism, or excretion of the IP and/or predispose the subject to an increased risk of gastrointestinal toxicity.Xx_NEWLINE_xXHistory of inflammatory bowel disease or active bowel inflammationXx_NEWLINE_xXHistory of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.Xx_NEWLINE_xXHistory of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reasonXx_NEWLINE_xXActive or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study; patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\r\n* Rash must cover < 10% of body surface area\r\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\r\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 monthsXx_NEWLINE_xXHistory of or active autoimmune disease including, but not limited to, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, and vasculitis or glomerulonephritis; patients with autoimmune thyroid disease on a stable thyroid replacement regimen; controlled vitiligo, eczema, psoriasis, or seborrhoic dermatitis with only dermatologic manifestations; or controlled type I diabetes on a stable insulin regimen may be eligible for the study with approval by the medical monitorXx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn's), celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this studyXx_NEWLINE_xXHistory of Crohn's Disease or Ulcerative ColitisXx_NEWLINE_xXHistory of pre-existing immunodeficiency disorder, autoimmune condition requiring immunosuppressive therapy, or chronic infection (i.e. hepatitis B, hepatitis C, human immunodeficiency syndrome virus [HIV]); this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccinesXx_NEWLINE_xXPatients 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, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’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 eligibleXx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXRheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitisXx_NEWLINE_xXPatients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis)Xx_NEWLINE_xXPatients with a known history of any of the following autoimmune diseases are excluded: (a) patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) (b) patients with a history of rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])Xx_NEWLINE_xXInflammatory bowel disease (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHave a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ?12 months prior to randomization.Xx_NEWLINE_xXPatients 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 \r\n* 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, Sjogren’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 eligibleXx_NEWLINE_xXUncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXActive autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogren’s syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within 4 weeks prior to the screening visit, with the exception of thyroid replacementXx_NEWLINE_xXHave active metabolic or digestive illnesses such as malabsorptive disorders (Crohn’s, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndromeXx_NEWLINE_xXActive peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleedingXx_NEWLINE_xXHistory of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves' disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusionXx_NEWLINE_xXHistory of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any originXx_NEWLINE_xXInflammatory bowel disease including Crohn's disease and colitis ulcerosa.Xx_NEWLINE_xXInflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.Xx_NEWLINE_xXOngoing acute or chronic inflammatory skin disease.Xx_NEWLINE_xXClinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)Xx_NEWLINE_xXAutoimmune- or antibody (Ab)-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditisXx_NEWLINE_xXHistory of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.g. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusionXx_NEWLINE_xXHistory of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any originXx_NEWLINE_xXHistory of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritisXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, systemic vasculitis, or glomerulonephritis\r\n* Patients with history of autoimmune related hypothyroidism on stable dose of thyroid replacement hormone may be eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin may be eligible for this studyXx_NEWLINE_xXHistory of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) =< 12 months prior to randomizationXx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable. Acceptable exclusions include: Hashimoto’s thyroiditis, type 1 diabetes mellitus, and other localized or inactive conditions with approval of the PI.Xx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis\r\n* Patients with history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen for more than a month may be eligible for this study\r\n* Patients with auto immune disease that does not recur unless patient is exposed to an external trigger (i.e. gluten and celiac disease) may also be eligibleXx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune pneumonitis, autoimmune vasculitis [eg, Wegener’s granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia, Gravis); patients with Hashimoto’s thyroiditis are eligible to go on studyXx_NEWLINE_xXActive inflammatory bowel diseaseXx_NEWLINE_xXHistory of diverticulitis, chronic ulcerative lower GI disease such as Crohn’s disease or ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforationsXx_NEWLINE_xXHistory of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; Note: patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this studyXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 3 years prior to the start of treatment\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatmentXx_NEWLINE_xXActive or history of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, polymyositis, sarcoidosis, etc.) with symptomatic disease within the 2 years before randomization; Note: subjects with vitiligo, Graves' disease or psoriasis not requiring systemic treatment within the past 2 years will not be excludedXx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s disease), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrheaXx_NEWLINE_xXHave a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive autoimmune disease, defined as any autoimmune condition currently requiring therapy (e.g., systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis)Xx_NEWLINE_xXPatients with a history of Inflammatory bowel disease such as Crohn’s disease and ulcerative colitisXx_NEWLINE_xXActive or history of autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis, Crohn’s), diverticulitis (with the exception of diverticulosis), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis, Sarcoidosis syndrome, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc; patients without active disease in the last 5 years may be included but only after consultation with the study physician; Note: the following are exceptions to this criterion: vitiligo or alopecia; patients with hypothyroidism (i.e. following Hashimoto syndrome) stable on hormone replacement; any chronic skin condition that does not require systemic therapy; patients with celiac disease controlled by diet aloneXx_NEWLINE_xXParticipant has a history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the IP and/or predispose the participant to an increased risk of gastrointestinal toxicity.Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible; patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n* Rash must cover less than 10% of body surface area (BSA)\r\n* Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n* No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)Xx_NEWLINE_xXPatients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)Xx_NEWLINE_xXPatients receiving treatment for active autoimmune disease. \Active\ refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.Xx_NEWLINE_xXActive autoimmune disease (e.g., systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigatorsXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXActive autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, 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; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’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 eligibleXx_NEWLINE_xXPatients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), 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, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome should be excludedXx_NEWLINE_xXOther nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as: Active infection or chronic infection requiring chronic suppressive antibiotics; Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function; Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids); Seizure disorders requiring medication.Xx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXMedical history of autoimmune disease (e.g., Crohn's disease, ulcerative colitis) or other diseases requiring systemic glucocorticoid or immunosuppressive therapy.Xx_NEWLINE_xXHistory of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowedXx_NEWLINE_xXHistory of inflammatory bowel disease (e.g., Crohn’s, ulcerative colitis) - note patients with irritable bowel syndrome are eligibleXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this studyXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)Xx_NEWLINE_xXActive or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXGastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXUncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXPatients with active inflammatory bowel disease or collagen vascular disease –systemic lupus erythematosus (SLE), sclerodermaXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptableXx_NEWLINE_xXCOHORT A: Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)Xx_NEWLINE_xXCOHORT B: Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)Xx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.Xx_NEWLINE_xXPatients with active duodenal ulcer or bleeding or history of a gastrointestinal fistula or perforation or other significant bowel problems (severe nausea, vomiting, inflammatory bowel disease and significant bowel resection)Xx_NEWLINE_xXPatients with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing spondylitis)Xx_NEWLINE_xXInflammatory bowel disease or connective tissue disease requiring medical managementXx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with inactive inflammatory bowel disease, not currently receiving therapy, may be eligibleXx_NEWLINE_xXKnown history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.Xx_NEWLINE_xXHistory of bowel obstruction, refractory ascites, or bowel perforation due to advanced disease within the past 3 months from start of study treatmentXx_NEWLINE_xXActive immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.Xx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosisXx_NEWLINE_xXAutoimmune disease; patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis)Xx_NEWLINE_xXPatients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study. Any patient with an allo-transplant of any kind would be excluded as well. This would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration. Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded.Xx_NEWLINE_xXHistory of autoimmune disease, including inflammatory bowel diseaseXx_NEWLINE_xXKnown active autoimmune disease will be excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).Xx_NEWLINE_xXThe patient has uncontrolled or significant medical condition other than cancer, that would prevent the participation in the study or make this protocol unreasonably hazardous, in the opinion of the investigator, including but not limited to:\r\n* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g. Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)\r\n* Known or suspected brain metastasis, or untreated leptomeningeal disease\r\n* Active infection or other medical condition that would make prednisone use contraindicated\r\n* Active or symptomatic viral hepatitis or chronic liver diseaseXx_NEWLINE_xXHave a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)Xx_NEWLINE_xXInflammatory bowel disease (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXPrior history of scleroderma or inflammatory bowel diseaseXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome)Xx_NEWLINE_xXHistory of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; prior history of autoimmune thyroiditis or vitiligo is permittedXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. myasthenia gravis, Guillain-Barre syndrome); those with immune-mediated skin toxicity (i.e. toxic epidermal necrolysis, Stevens-Johnson syndrome) will also be excludedXx_NEWLINE_xXClinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)Xx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)Xx_NEWLINE_xXFor abdominal or pelvic irradiation: active inflammatory bowel diseaseXx_NEWLINE_xXAt the time of screening, active peptic ulcer disease or active inflammatory bowel disease (including ulcerative colitis or Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis, or appendicitisXx_NEWLINE_xXAutoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded from this studyXx_NEWLINE_xXE 11. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.Xx_NEWLINE_xXAny chronic inflammatory bowel disease and/or chronic bowl obstructionXx_NEWLINE_xXAny patient currently requiring or anticipated to require tumor necrosis factor (TNF) blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with diverticulosis\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXKnown history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosisXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's Palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritisXx_NEWLINE_xXDiagnosis of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis).Xx_NEWLINE_xXPatients with Crohn’s disease or ulcerative colitisXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves‘ disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatmentXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXActive inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)Xx_NEWLINE_xXPatients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; patients receiving replacement thyroid hormone would be eligibleXx_NEWLINE_xXActive autoimmune disease requiring active therapy with any form of steroid or immunosuppressive therapy or a documented history of any of the following: inflammatory bowel disease; regional enteritis systemic lupus erythematosus; Sjogren's syndrome; inflammatory neurologic disorder such as multiple sclerosis; or any immune mediated disease that can cause life-threatening symptoms or severe organ/tissue damage in the opinion of the principle investigatorXx_NEWLINE_xXAcute pelvic inflammatory diseaseXx_NEWLINE_xXhistory of inflammatory bowel disease of the rectum;Xx_NEWLINE_xXPre-existing autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring anti-inflammatory therapyXx_NEWLINE_xXOngoing inflammatory bowel diseaseXx_NEWLINE_xXHistory of autoimmune disease or known inflammatory bowel disease.Xx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXPatients with a history of inflammatory bowel diseaseXx_NEWLINE_xXUncontrolled inflammatory bowel disease, peptic ulcer disease or history of significant gastro intestinal bleeding within 6 months of enrollment.Xx_NEWLINE_xXOngoing inflammatory bowel diseaseXx_NEWLINE_xXHistory of Crohn’s disease or ulcerative colitisXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritisXx_NEWLINE_xXHave a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrheaXx_NEWLINE_xXGastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXPatients with history of inflammatory bowel disease or major bowel surgeryXx_NEWLINE_xXHistory of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any originXx_NEWLINE_xXActive peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.Xx_NEWLINE_xXOngoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipationXx_NEWLINE_xXOngoing inflammatory bowel diseaseXx_NEWLINE_xXCurrent or recent (within 3 months of study drug administration) gastrointestinal disease such as chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease. Non-chronic conditions (e.g. infectious diarrhea) that are completely resolved for at least 2 weeks prior to starting study treatment are not exclusionaryXx_NEWLINE_xXActive autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) whose possible progression during treatment would be considered unacceptable by the investigatorsXx_NEWLINE_xXAutoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)Xx_NEWLINE_xXActive autoimmune disease such as Crohn’s disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditionsXx_NEWLINE_xXAutoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)Xx_NEWLINE_xXHistory or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)Xx_NEWLINE_xXPatients 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, 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; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’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 eligibleXx_NEWLINE_xXAutoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)Xx_NEWLINE_xXKnown clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel diseaseXx_NEWLINE_xXActive or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.;Xx_NEWLINE_xXKnown history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;Xx_NEWLINE_xXCurrent bowel obstructionXx_NEWLINE_xXKnown clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel diseaseXx_NEWLINE_xXPatient has an autoimmune condition, including, but not limited to, multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura.Xx_NEWLINE_xXInflammatory bowel disease including Crohn's disease and colitis ulcerosa.Xx_NEWLINE_xXInflammatory lung disease including moderate and severe asthma and chronic obstructive pulmonary disease (COPD) requiring chronic medical therapy.Xx_NEWLINE_xXOngoing acute or chronic inflammatory skin disease.Xx_NEWLINE_xXOngoing inflammatory bowel diseaseXx_NEWLINE_xXActive inflammatory bowel diseaseXx_NEWLINE_xXHistory of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity eg rheumatoid arthritis or thyroiditis may be allowed per Principal Investigator (PI) discretion provided it has been quiescent for a minimum of three yearsXx_NEWLINE_xXActive or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrheaXx_NEWLINE_xXSubjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel diseaseXx_NEWLINE_xXPatients with active autoimmune disease; “active” refers to any condition currently requiring therapy; examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritisXx_NEWLINE_xXAny of the following within 3 months prior to study entry: grade 3-4 gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic eventXx_NEWLINE_xXKnown clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel diseaseXx_NEWLINE_xXPatients with active inflammatory bowel diseaseXx_NEWLINE_xXKnown history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosaXx_NEWLINE_xXKnown clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel diseaseXx_NEWLINE_xXGastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXPre-existing diarrhea uncontrolled with supportive care; prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause; active, uncontrolled peptic ulcer disease even in the setting of proton-pump inhibitor or histamine2-blocker useXx_NEWLINE_xXPrior history of inflammatory bowel disease.Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis)Xx_NEWLINE_xXPatients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectumXx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)Xx_NEWLINE_xXGastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)Xx_NEWLINE_xXHave any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting or diarrhea.Xx_NEWLINE_xXGastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.Xx_NEWLINE_xXHistory of or active inflammatory bowel disease or active bowel inflammationXx_NEWLINE_xXParticipants with active gastrointestinal conditions (Crohn's disease, ulcerative colitis, diverticulosis associated colitis, and Behçet's disease)Xx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXGastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)Xx_NEWLINE_xXAutoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome)Xx_NEWLINE_xXGastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]Xx_NEWLINE_xXThe patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease. Patients with vitiligo are not excluded.Xx_NEWLINE_xXActive small or large intestine inflammation (such as Crohn's disease or ulcerative colitis)Xx_NEWLINE_xXThe patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease.Xx_NEWLINE_xXActive inflammatory bowel disease or other bowel disease causing chronic diarrhea.Xx_NEWLINE_xXHistory of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis (RA), inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritisXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXActive or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXPatients with inflammatory or chronic functional bowel disorder, such as Crohn disease, inflammatory bowel disease, or gastrointestinal graft versus host disease that in the opinion of the investigator may interfere with absorption of ponatinib or increase the risk of serious complicationsXx_NEWLINE_xXPatients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)Xx_NEWLINE_xXHave a history (within 3 years) of inflammatory bowel disease,Xx_NEWLINE_xXInflammatory arthritis that requires disease modifying drugs (e.g. rheumatoid arthritis)Xx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXHistory of or active inflammatory disease or active bowel inflammationXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatmentXx_NEWLINE_xXSevere gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel diseaseXx_NEWLINE_xXPatients with gastrointestinal disease or disorder that could interfere with absorption of CUDC-907, such as bowel obstruction or inflammatory bowel diseaseXx_NEWLINE_xXSubjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).Xx_NEWLINE_xXPatients with a confirmed history of calcium oxalate nephrolithiasis are excluded; patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, inflammatory bowel disease [IBD] or other, as determined by the treating physician) are excluded; patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (> 1000 IU)Xx_NEWLINE_xXRheumatoid arthritis and other types of autoimmune and inflammatory joint diseaseXx_NEWLINE_xXBowel obstructionXx_NEWLINE_xXA prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)Xx_NEWLINE_xXHistory of clinically significant Crohn’s disease or inflammatory bowel disease (IBD)Xx_NEWLINE_xXPatients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligibleXx_NEWLINE_xXChronic inflammatory conditionsXx_NEWLINE_xXInflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXAny history of inflammatory bowel diseaseXx_NEWLINE_xXParticipants with inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s)Xx_NEWLINE_xXPatients with a diagnosis of inflammatory bowel disease, i.e. Crohn’s disease or ulcerative colitisXx_NEWLINE_xXBowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.Xx_NEWLINE_xXPrior history of inflammatory bowel disease or other chronic diarrheal illnessXx_NEWLINE_xXPatients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn’s disease, bowel surgery such as gastric bypass, and celiac diseaseXx_NEWLINE_xXClinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.Xx_NEWLINE_xXHistory of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), Parkinson’s disease and cancer involving the boneXx_NEWLINE_xXInflammatory bowel disease (IBD)/Crohn'sXx_NEWLINE_xXPatients with a history of gastric bypass surgery or inflammatory bowel diseaseXx_NEWLINE_xXPatients with a history of or current bowel obstructionXx_NEWLINE_xXPrior colorectal surgery or history of inflammatory bowel diseaseXx_NEWLINE_xXHistory of diverticulitis, Crohn’s disease or ulcerative colitisXx_NEWLINE_xXAny history of inflammatory bowel diseaseXx_NEWLINE_xXPatient with Crohn's colitis or ulcerative colitisXx_NEWLINE_xXHave a personal history of inflammatory bowel disease (Crohn’s disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancerXx_NEWLINE_xXPrior diagnosis of cancer (except non-melanoma skin cancer), Crohn’s disease, inflammatory bowel disease or colitisXx_NEWLINE_xXPrevious medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.Xx_NEWLINE_xXPatients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel diseaseXx_NEWLINE_xXCONTROL (HEALTHY) GROUP: Inflammatory conditions, such as rheumatoid arthritis, systemic lupus or inflammatory bowel diseaseXx_NEWLINE_xXOngoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn’s disease, microscopic colitis, etc.)Xx_NEWLINE_xXPatients with inflammatory bowel diseaseXx_NEWLINE_xXDiagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesisXx_NEWLINE_xXHas a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, human immunodeficiency virus [HIV])Xx_NEWLINE_xXPatient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn’s disease, ulcerative colitis) or history of bowel resectionXx_NEWLINE_xXThose with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancerXx_NEWLINE_xXNo history of Inflammatory bowel diseaseXx_NEWLINE_xXIndividuals with inflammatory bowel diseaseXx_NEWLINE_xXParticipants with dysplasia-associated mass or lesion (DALM) due to longstanding idiopathic inflammatory bowel disease will be excludedXx_NEWLINE_xXInflammatory bowel diseaseXx_NEWLINE_xXKnown diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXHas severe colitis of any etiology or a history of inflammatory bowel disease (IBD)Xx_NEWLINE_xXNo previous diagnoses of ulcerative colitis, Crohn’s disease or irritable bowel diseaseXx_NEWLINE_xXHistory of auto?immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto’s thyroiditis, or Grave’s diseaseXx_NEWLINE_xXHistory of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the IP (INVESTIGATIONAL PRODUCT) and/or predispose the subject to an increased risk of gastrointestinal toxicityXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:Xx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with diverticulosis\r\n* Patients with celiac disease controlled by diet aloneXx_NEWLINE_xXDiagnosis of inflammatory bowel diseaseXx_NEWLINE_xXSerious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.Xx_NEWLINE_xXPersonal history of inflammatory bowel diseaseXx_NEWLINE_xXHistory of CRC, bowel resection, polyposis syndrome, or inflammatory bowel diseaseXx_NEWLINE_xXInflammatory bowel disease (Crohn’s disease, ulcerative colitis)Xx_NEWLINE_xXContraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiation therapy [XRT])Xx_NEWLINE_xXContraindications to radiotherapy (including active inflammatory bowel disease).Xx_NEWLINE_xXActive inflammatory bowel disease within the last 6 monthsXx_NEWLINE_xXPatients with active inflammatory bowel diseaseXx_NEWLINE_xXHistory of Meniere’s diseaseXx_NEWLINE_xXActive inflammatory bowel disease within the last 6 monthsXx_NEWLINE_xXHistory of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study; patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible for this studyXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders including but not limited to the following:\r\n* Gastrointestinal (GI) disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea\r\n* Systemic lupus erythematosus\r\n* Wegener’s syndrome (granulomatosis with polyangiitis)\r\n* Myasthenia gravis\r\n* Graves’ disease\r\n* Rheumatoid arthritis\r\n* Hypophysitis\r\n* Uveitis\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatmentXx_NEWLINE_xXActive or prior documented autoimmune or inflammatory disorders including but not limited to the following:\r\n* GI disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea\r\n* Systemic lupus erythematosus\r\n* Wegener’s syndrome (granulomatosis with polyangiitis)\r\n* Myasthenia gravis\r\n* Graves’ disease\r\n* Rheumatoid arthritis\r\n* Hypophysitis\r\n* Uveitis\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatmentXx_NEWLINE_xXUnable to swallow capsules or malabsorption syndrome, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction at time of screeningXx_NEWLINE_xXPatients with various autoimmune disorders (including rheumatoid arthritis?RA, Crohn’s disease, systemic lupus erythematosus–SLE, Takayasu arthritis)Xx_NEWLINE_xXAny active cancer, history of gastrointestinal cancer, or chronic disease such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, intestinal malabsorption syndrome or other gastrointestinal disorderXx_NEWLINE_xXSelf-reported inflammatory bowel diseaseXx_NEWLINE_xXPatient must have malignant bowel obstruction (MBO) as evidenced by all of the following:\r\n* Clinical evidence of a small bowel obstruction (via history, physical, and radiographic examination)\r\n* Bowel obstruction below (distal to) ligament of Treitz\r\n* Intra-abdominal primary cancer with incurable diseaseXx_NEWLINE_xXNo history of inflammatory bowel diseaseXx_NEWLINE_xXHistory of inflammatory bowel diseaseXx_NEWLINE_xXPatients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.Xx_NEWLINE_xXInflammatory bowel disease, active rectal diverticulitis, Crohn's disease affecting the rectum, anal stenosis or ulcerative colitis. (Nonactive diverticulitis and Crohn's disease not affecting the rectum are allowed)Xx_NEWLINE_xXHas a history of inflammatory bowel disease or history of sclerodermaXx_NEWLINE_xXHistory of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.Xx_NEWLINE_xXHistory of inflammatory bowel disease.Xx_NEWLINE_xX