A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer

Exclusion Criteria

• •Previous treatment with PD1/PDL1 inhibitors.
• •* Untreated symptomatic brain or leptomeningeal metastatic disease.
• •* Medical or psychiatric conditions compromising informed consent.
• •* Any medical condition which, in the opinion of the Investigator, would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
• •* Administration of chemotherapy, radioactive or biological cancer therapy within 4 weeks prior to the first dose of trial therapy Patient has not recovered to CTCAE grade 1 or better from the Adverse Event (AE) due to cancer therapeutics administered more than 4 weeks earlier.
• •* Active autoimmune disease that has required systemic treatment in past 2 years (i.e.
• •with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• •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.
• •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 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. Patient has risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess and abdominal carcinomatosis).
• •Patient has a known history of other malignancy, unless the patient has undergone potentially curative therapy with no evidence of that disease for 3 years.
• •Has a history of non-infectious pneumonitis requiring steroids or has active pneumonitis.
• •Female patients that are either pregnant or breast feeding.
• •Male and female patients (of childbearing age) not willing to use adequate contraception.
• •Patient previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
• •Patient is positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected); patients with negative Hepatitis C antibody testing may not need RNA testing.
• •Known history of tuberculosis.
• •Patient has an active infection requiring therapy.
• •Has received a live vaccine within 30 days prior to the first dose of trial treatment.
• •Patient is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).