Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for MMR-D or MSI-H Stage IIB - III Colon Cancer

https://www.facingourrisk.org/research-clinical-trials/study/358/post-surgery-immunotherapy-toripalimab-for-mmr-d-msi-h-stage-iib-iii-colon-cancer

Clinicaltrials.gov identifier:
NCT07140679 (https://clinicaltrials.gov/show/NCT07140679)

Treatment
Study for people who have had surgery to remove the Stage IIB-III MMR-D / MSI-H colon cancer

Study Contact Information:

PI: Oluwadunni E. Emiloju, MD, MS. oemiloj@emory.edu

Co-I: Olatunji B. Alese, MD, FASCO olatunji.alese@emory.edu

Mismatch repair deficiency (dMMR) is a biomarker that predicts excellent response to immunotherapy such as toripalimab. Immunotherapy is more effective than chemotherapy in stage IV dMMR colon cancer. This clinical trial will study the effectiveness of immunotherapy after surgery for dMMR 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 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 dMMR colon cancer who have undergone surgery to have their colon cancer removed.

The purpose of this study is to see if giving immunotherapy (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 Lynch syndrome.

This Study is Open To:

This study is open to:

Adult participants (18 years or older) diagnosed with Stage IIB-III MMR-D / MSI-H colon cancer
(adenocarcinoma) who:

provide written informed consent
have had surgery to remove the Stage IIB-III MMR-D / 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 immunotherapy or chemotherapy for your colon cancer
active prior or ongoing cancer (there are some exceptions)

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.