Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer

Exclusion Criteria

• •Anticancer therapy, monoclonal antibody or major surgery within 4 weeks prior to the first dose of MEDI4736.
• •Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable.
• •Any prior Grade ≥ 3 irAE while receiving immunotherapy (including anti-CTLA-4 or anti-CD137 MAb) or any unresolved irAE of any grade (controlled irAE endocrinopathies are allowed).
• •Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
• •Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
• •Any unresolved toxicity CTCAE \>Grade 2 from previous anti-cancer therapy.
• •Active autoimmune disease within the past 2 years, except for mild conditions not requiring systemic treatment, such as vitiligo.
• •Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. NOTE: Local treatment of isolated lesions, excluding target lesions, for palliative intent is acceptable (e.g., by local ablation, surgery or radiotherapy).
• •Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, irritable bowel syndrome, ulcerative colitis).
• •Receipt of radiation therapy within 4 weeks prior to starting investigational product, or limited field of radiation for palliation within 2 weeks of the first dose of investigational product.
• •Known allergy or reaction to any component of the MEDI4736 formulation or its excipients.
• •Known central nervous system (CNS) metastases requiring treatment, such as surgery, radiation or steroids.
• •Known history of confirmed primary immunodeficiency.
• •History of organ transplant requiring therapeutic immunosuppression.
• •Other malignancy within 3 years, except for noninvasive malignancies such as cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that has/have been surgically cured, or prior malignancy considered by the investigator to be of low likelihood for recurrence.
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have active hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.
• •Women who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
• •Any other condition(s) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
• •Subjects who are known to be HIV positive.
• •Receipt of live attenuated vaccination within 30 days prior to receiving MEDI4736