Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for MMR-D or MSI-H Stage IIB - III Colon Cancer
Treatment
Study for people who have had surgery to remove the Stage IIB-III MMR-D / MSI-H colon cancer
Clinicaltrials.gov identifier:NCT07140679
Study Contact Information:
PI: Oluwadunni E. Emiloju, MD, MS. oemiloj@emory.edu
Co-I: Olatunji B. Alese, MD, FASCO olatunji.alese@emory.edu
() is a that predicts excellent response to such as toripalimab. is more effective than chemotherapy in IV colon cancer. This clinical trial will study the effectiveness of after surgery for stage IIB - III colon cancer. This clinical trial will be done at Winship Cancer Institute (Emory). Participants will receive toripalimab every 3 weeks for 6 months, followed by 6 monthly follow up.
This Study is Open To:
This study is open to:
Adult participants (18 years or older) diagnosed with IIB-III / MSI-H colon cancer
() who:
-
provide written informed consent
-
have had surgery to remove the IIB-III / MSI-H colon cancer
-
have recovered from surgery (4- 12 weeks after colon cancer surgery)
This Study is NOT Open To:
Some exclusions from this trial include the following:
-
severe or active autoimmune disease
-
severe liver, kidney, or bone marrow dysfunction
-
prior or chemotherapy for your colon cancer
-
active prior or ongoing cancer (there are some exceptions)
This is a single-arm study, which means all patients will receive the same treatment with toripalimab. All patients will know which intervention or medication they are receiving during the study (open label). This research study is enrolling participants with stages IIB- III colon cancer who have undergone surgery to have their colon cancer removed.
The purpose of this study is to see if giving (toripalimab) after surgery will be effective in reducing the risk of the cancer coming back. Participation in this study is voluntary.
Treatment:
- Participants will receive toripalimab intravenously every 3 weeks for 6 months
Follow up:
- Participants will be followed up every 6 months with CT scans, blood tests, and physical examination for 4.5 years.
- Participants will also have the opportunity to complete a patient-reported outcome (PRO) questionnaire during treatment and annually thereafter.
- Similar to the standard of care, routine colonoscopy will also be performed at 1 year and at 4 years. An annual colonoscopy will be performed for participants with .
Study Contact Information:
PI: Oluwadunni E. Emiloju, MD, MS. oemiloj@emory.edu
Co-I: Olatunji B. Alese, MD, FASCO olatunji.alese@emory.edu
Locations:
Georgia
City: Atlanta RECRUITING
Facility: Emory Decatur Hospital
Contact Info:
ariana.satcher@emoryhealthcare.org
404-778-1900
Oluwadunni Emiloju
City: Atlanta RECRUITING
Facility: Emory University Hospital Midtown
Contact Info:
jalpa.r.patel@emory.edu
Oluwadunni E. Emiloju, MBBS, MS
City: Atlanta RECRUITING
Facility: Emory University Hospital/Winship Cancer Institute
Contact Info:
tyler.stephen.whitfield@emory.edu
404-778-1900
Oluwadunni E. Emiloju, MBBS, MS
City: Atlanta RECRUITING
Facility: Emory Saint Joseph's Hospital
Contact Info:
ainsley.hymel@emory.edu
Oluwadunni E. Emiloju, MBBS, MS
City: Johns Creek RECRUITING
Facility: Emory Johns Creek Hospital
Contact Info:
hafsa.maheen.ahmed@emory.edu
Oluwadunni E. Emiloju, MBBS, MS
Treatment
Study for people who have had surgery to remove the Stage IIB-III MMR-D / MSI-H colon cancer
Clinicaltrials.gov identifier:NCT07140679
Study Contact Information:
PI: Oluwadunni E. Emiloju, MD, MS. oemiloj@emory.edu
Co-I: Olatunji B. Alese, MD, FASCO olatunji.alese@emory.edu