NCT07140679 · Emory University
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Biopsy Procedure
Undergo biopsy
PROCEDURE
Biospecimen Collection
Undergo collection of blood samples
PROCEDURE
Colonoscopy
Undergo colonoscopy
PROCEDURE
Computed Tomography
Undergo CT
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Toripalimab
Given IV
Primary outcome measures
3-year Disease free survival (DFS)
Time frame: Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Absolute neutrophil count (ANC) ≥ 1,500 /mcL
- Platelets ≥ 100,000 / mcL
- Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L
- Transfusion is allowed to obtain an adequate hemoglobin level
- Creatinine ≤ 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 40 mL/min for patient with creatinine levels \> 1.5 x institutional ULN (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creati
Where
- Atlanta, Georgia
- Johns Creek, Georgia
Collaborators
National Cancer Institute (NCI), Coherus Oncology, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2025 · Source of record for eligibility and locations