Patients 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 eligible
Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) or who are receiving systemic therapy for an autoimmune disease; exceptions include vitiligo, hypothyroidism controlled on hormone replacement, type I diabetes, Grave’s disease,\r\nadrenal insufficiency on stable replacement doses of steroids (prednisone =< 10 mg/day or equivalent), or with principal investigator approval
Active 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 treatment
Active 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:
Hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
Active 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 treatment
Active 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 excluded
Active 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 treatment
Active or prior documented autoimmune or inflammatory disorders requiring therapy within the past 3 years prior to the start of treatment; 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 \r\n* Psoriasis not requiring systemic treatment
Active 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)
Active 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 excluded
Subject 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 treatment
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, 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 treatment
DOSE 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 approval
DOSE 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 approval
Patients 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 eligible
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, 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:
Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or
Subject 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:
Active 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 treatment
Active 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 treatment
Active 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 treatment
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, 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 hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement for ? 3 months; or
Active 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 treatment
Active 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 treatment
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 alone
EXCLUSION - 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 alone
Has an active autoimmune disease (or inflammatory disorders) requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with 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 or resolved childhood asthma/atopy\r\n* Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study\r\n* Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study\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 alone.
Active or prior documented autoimmune disease within the past 2 years (NOTE: The following are exceptions to this criterion: Participants with vitiligo or alopecia; Participants with hypothyroidism (e.g. following Hashimoto syndrome) who are stable on hormone replacement; Participants with celiac disease controlled by diet alone: Participants with Grave’s disease, or any chronic skin condition not requiring systemic treatment. Participants without active disease in the last 5 years may be included but only after consultation with the study physician.
Active 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 alone
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* 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 alone
Active or prior documented autoimmune or inflammatory disorders are NOT permitted; the following are EXCEPTIONS to this criterion and are allowed\r\n* Patients with vitiligo or alopecia, type I diabetes mellitus\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome)\r\n* Any chronic autoimmune or inflammatory skin condition that does not require systemic therapy\r\n* Patients without active disease requiring treatment in the last 3 years may be included but only after consultation with principal investigator\r\n* Patients with celiac disease controlled by diet alone may be included but only after consultation with principal investigator
History 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 diarrhea
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: 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.
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* 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 alone
Active 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 alone
Active 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 alone
Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement • Any chronic skin condition that does not require systemic therapy • Patients without active disease in the last 3 years may be included but only after consultation with AstraZeneca • Patients with celiac disease controlled by diet alone may be included but only after consultation with AstraZeneca.
Active 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 alone
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* 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 alone
Active 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 alone
Active 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.
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.])\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 alone
Active 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 alone
Active 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 alone
Active 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 alone
Active 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 alone