A Phase 2 Clinical Trial of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Microsatellite High (MSI-H)and non-MSI-H Colon Cancer

The purpose of this study is to examine if Nivolumab alone or in combination with Ipilimumab will demonstrate a meaningful objective response rate in patients with recurrent and metastatic colon cancer who also have a specific biomarker in their tumors.

Inclusion Criteria:
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
• Histologically confirmed recurrent or metastatic colorectal cancer
• Measurable disease by CT or MRI
• Testing for MSI Status (by an accredited lab)
-Subjects with microsatellite instability high (MSI-H) tumors will enroll in the MSI-H Cohort (mStage and cStage groups), the C3 Cohort, and the C5 Cohort.
-Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C6, C4 Cohorts.
• Adequate organ function as defined by study-specific laboratory tests
• Subjects enrolled into the C3 Cohort must have not had treatment for their metastatic disease

Exclusion Criteria:
• Active brain metastases or leptomeningeal metastases are not allowed.
• Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
• Prior malignancy active within the previous 3 years except for locally curable cancers
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Other protocol defined inclusion/exclusion criteria could apply
Phase II
Todd Crocenzi, M.D.
BMS (Bristol-Myers Squibb)
Mary Mccormick
  • Oncology and Hematology Care Eastside