Colorectal Cancer Clinical Trials

• The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated appropriate Institutional Review Board (IRB) -approved consent forms that conform to federal and institutional guidelines for study treatment.

• Patients must be greater than or equal to18 years old.

• The ECOG performance status must be 0-1.

• Patients must have confirmed histologic and pathologic stage II/III colon, stage II/III rectal, or oligometastatic stage IV colorectal adenocarcinoma (per AJCC 8th edition).

• There must be documentation by CT scan with contrast that the patient has no definitive evidence of (non-resected or non-ablated) metastatic disease including assessment of chest, abdomen, and pelvis at the time of study enrollment

• All patients must have had a complete (R0) resection of their primary tumor and resected or ablated (radiofrequency ablation, stereotactic body radiation therapy \[SBRT\], microwave ablation, etc.\]) oligometastatic disease if present AND at least 3 months of a standard systemic chemotherapy regimen (e.g., FOLFOX or CAPOX or fluoropyrimidine monotherapy). This includes either adjuvant chemotherapy for colon cancer or perioperative (adjuvant or neoadjuvant) chemotherapy for rectal cancer or oligometastatic colon or rectal cancer. Chemoradiotherapy for rectal cancer (as a component of curative treatment) is acceptable. NOTE: Patients who achieve a clinical complete response and opt for a non-operative approach to their primary tumor management are not eligible.

‣ Patients must be ctDNA-positive by an assay run in any CLIA-certified lab obtained within 2 weeks to 12 months following completion of definitive all curative therapy for colorectal cancer.

⁃ Tumor status of microsatellite stability (MSS) or Proficient mismatch repair (pMMR) is confirmed through a standard of care assay through a CLIA-certified lab.

• At the time of study entry, blood counts performed within 28 days prior to study entry must meet the following criteria:

‣ ANC must be greater than or equal to (≥) 1000/mm3,

⁃ Platelet count must be ≥ to 80,000/mm3; and

⁃ Hemoglobin must be ≥ 8 g/dL. (Note: transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.)

⁃ Albumin greater than (\>) 3.0 g/dL.

• The following criteria for evidence of adequate hepatic function performed within 28 days prior to study entry must be met:

‣ Total bilirubin less than or equal to (≤) 1.5 x ULN

⁃ AST and ALT must be ≤ 3.0 x ULN for the lab. (Note: In patients with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction on imaging.)

• Creatinine must be ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 40mL/min.

• All prior chemotherapy toxicities (excluding alopecia, amenorrhea, and peripheral neuropathy) must be less than (\<) Grade 2 at the time study therapy is to begin unless AE(s) are clinically stable on supportive therapy.

• Patients must have no evidence of opportunistic infections.

• Patients of childbearing potential must have a negative pregnancy per institutional policies prior to receiving the first dose of study therapy.

• Male and female patients with reproductive potential must agree to use accepted effective methods of contraception while receiving study therapy and for at least 180 days (6 months) after the completion of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.