Colorectal Cancer Clinical Trials

• Age ≥18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.

• Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.

• Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.

• Must not have received any prior systemic treatment or radiation.

• Candidate for sphincter-sparing surgical resection after neoadjuvant therapy according to the primary surgeon.

• Patients have the following clinical staging:

‣ cT2 node-positive:

⁃ T: Tumor is invading the muscularis propria but has not grown through it to the serosa

⁃ N: At least 1 perirectal lymph node ≥5 mm and no more than 4 perirectal lymph nodes \>10 mm in short axis

⁃ M: No evidence of metastasis

⁃ cT3 node-negative

⁃ T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs

⁃ N: No perirectal lymph nodes ≥ 5 mm in size that suggest tumor involvement

⁃ M: No evidence of metastasis

⁃ cT3 node-positive

⁃ T: Tumor has grown through the muscularis propria into the serosa but has not invaded nearby organs

⁃ N: At least 1 perirectal lymph node ≥ 5 mm and no more than 4 perirectal lymph nodes \> 10 mm in size in short axis

⁃ M: No evidence of metastasis

• Absence of distant metastases on CT or MRI imaging

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

• LVEF assessment with documented LVEF ≥ 50% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.

• For both Women and Men, must use acceptable form of birth control while on study.

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