Toripalimab for Controlling Disease after Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Unknown Primary	NCT ID:	NCT07140679
Trial Phases:	Phase II	Protocol IDs:	WINSHIP6483-24 (primary) NCI-2025-05423 STUDY00008833
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT07140679

Summary

This phase II trial tests how well toripalimab works for controlling disease after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer who have undergone a surgical resection. Immunotherapy with monoclonal antibodies, such as toripalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. Evaluate the efficacy of adjuvant toripalimab in patients with resected stage IIB, IIC, and III mismatch repair deficient (dMMR) colon cancer by measuring 3-year disease-free survival.

SECONDARY OBJECTIVES:
I. Define the immune related toxicity profile of toripalimab in the adjuvant setting.
II. Further evaluate the efficacy of adjuvant toripalimab specifically by measuring 3-year relapse free survival (RFS), 5-year disease free survival (DFS), and overall survival.

TERTIARY/EXPLORATORY OBJECTIVES:
I. To explore immune and omic markers associated with clinical efficacy (DFS, overall survival [OS]).
II. To assess patient reported outcomes (PRO) and health related quality of life (QOL).

OUTLINE:
Patients receive toripalimab IV every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Patients also undergo computed tomography (CT) and collection of blood samples throughout the trial, undergo colonoscopy during follow up, and undergo biopsy at the time of disease progression.

After completion of study treatment, patients are followed up 21-30 days after day 1 of cycle 8, at 1 year post-resection, and then every 6 months until 5 years post-resection.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.