About this trial
This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.
Eligibility criteria
Qualifiers
Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer [AJCC] 8)
Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)
Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug
Available tissue sample from surgical specimen
Disqualifiers
Neoadjuvant treatment for dMMR colon cancer
Presence of metastatic dMMR colon cancer
Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule
Trial design
Treatments tested in this trial
- Biopsy Procedure
- Biospecimen Collection
- Colonoscopy
- Computed Tomography
- Questionnaire Administration
- Toripalimab
Treatment groups
Sponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Coherus Oncology, Inc.
Collaborator