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.
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
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
Single group
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Colonoscopy
Procedure/SurgeryUndergo colonoscopy
Computed Tomography
Procedure/SurgeryUndergo CT
Questionnaire Administration
Other interventionAncillary studies
Toripalimab
DrugGiven IV
3-year Disease free survival (DFS)
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 3 years
Incidence of treatment-related adverse events
Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Treatment-related adverse events (defined as potentially, probably and definitely) will be summarized in preferred term by system organ class and listed on an individual subject basis at patient level. Immune-related adverse events will also be tabulated.
3-year Relapse free survival (RFS)
Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years
5-year DFS
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 5 years.
Colon cancer specific survival (CCSC)
CCSC is the time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Coherus Oncology, Inc.
Collaborator
