Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors

Exclusion Criteria

• •Bowel obstruction within the past 60 days
• •Subjects who are currently pregnant, planning to become pregnant, or breast-feeding.
• •* Females participants of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 5 months following the last dose
• •* Males participants with partners of child-bearing potential are required to use an effective contraception method or abstain from intercourse during treatment and for at least 7 months following the last dose
• •Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation
• •Subjects with contraindications to immune checkpoint therapy, as follows:
• •* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
• •* Prior organ allograft or allogeneic bone marrow transplantation
• •* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
• •* Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
• •* Condition requiring systemic treatment with corticosteroids
• •* Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted.
• •* Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted.
• •Established non-peritoneal metastatic disease, including but not limited to metastases to the liver, lung, brain, extra-abdominal lymph nodes, and bone
• •A second primary malignancy that, in the judgment of the investigator, may affect interpretation of results
• •Prior treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody
• •Toxicities attributed to prior anti-cancer therapy other than alopecia, fatigue, and peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug. In addition, a washout period will be required for prior therapies as specified:
• •* No chemotherapy within 14 days prior to first dose
• •* No investigational product(s) (IPs) and/or biologic therapy within 28 days or 5 half-lives, whichever is longer, prior to first dose
• •* No major surgery within 28 days prior to first dose. Any surgery-related AE(s) must have resolved at least 14 days prior to first dose.
• •* No radiation therapy with curative intent within 28 days prior to first dose. Prior focal palliative radiotherapy must have been completed at least 14 days prior to first dose.
• •Active hepatitis B or hepatitis C, defined as the following:
• •* Hepatitis B surface antigen positive or HBV DNA PCR \>100 IU/mL
• •* Hepatitis C antibody positive unless HCV RNA PCR is negative (i.e. undetectable viral load)
• •Prisoners or participants who are involuntarily incarcerated. (Note: under specific circumstances a person who has been imprisoned may be included as a participant. Strict conditions apply and BMS approval is required.)
• •Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness