Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer

Inclusion Criteria:

- Age ≥18 years.

- ECOG performance status 0 or 1

- Have metastatic or locally advanced microsatellite stable (MSS) colorectal
adenocarcinoma.

- Must have received at least one chemotherapy regimen.

- Patients with the presence of at least one measurable lesion using RECIST 1.1.

- Patients must have available archival tissue from the surgical resection of their
primary tumor.

- Patient's acceptance of tumor biopsies.

- Life expectancy of greater than 3 months.

- Patients must have adequate organ and marrow function defined by study - specified
laboratory tests.

- Documented LVEF ≥ 50% - 6 month prior to drug administration.

- Must use acceptable form of birth control while on study.

- Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- Known history or evidence of brain metastases.

- Require any antineoplastic therapy.

- History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or
anti-Lag-3 antibodies.

- Had chemotherapy, radiation, or steroids within 14 days prior to study treatment.

- Hypersensitivity reaction to any monoclonal antibody.

- Has uncontrolled intercurrent acute or chronic medical illness.

- Has an active known or suspected autoimmune disease.

- Has a diagnosis of immunodeficiency.

- Prior tissue or organ allograft or allogeneic bone marrow transplantation.

- Requires daily supplemental oxygen

- History of interstitial lung disease.

- Significant heart disease

- History of encephalitis, meningitis, or uncontrolled seizures in the year prior to
informed consent.

- Infection with HIV or hepatitis B or C at screening.

- Has an active infection.

- Unable to have blood drawn.

- Patient with uncontrolled intercurrent illness including, but not limited to,
uncontrolled infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.

- Woman who are pregnant or breastfeeding.