Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

NCT07140679 | Recruiting Phase 2 FDA Drug

• 4 other identifiers: STUDY00008833P30CA138292NCI-2025-05423WINSHIP6483-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Localized Colon Carcinoma; Stage IIB Colon Cancer AJCC v8; Stage IIC Colon Cancer AJCC v8; Stage III Colon Cancer AJCC v8

Keywords

immunotherapy; deficient mismatch repair; colon adenocarcinoma; colon cancer; adjuvant therapy; MSI-H colon adenocarcinoma; dMMR colon cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years

Secondary Outcomes (5)

• Incidence of treatment-related adverse events

  Up to 5 years

• 3-year Relapse free survival (RFS)

  Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.

• 5-year DFS

  Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years

• Colon cancer specific survival (CCSC)

  Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years

• Overall survival (OS)

  Time between the date of registration and the date of death due to any cause, assessed up to 5 years

Study Arms (1)

Treatment (toripalimab)

EXPERIMENTAL

Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence.

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Colonoscopy; Procedure: Computed Tomography; Other: Questionnaire Administration; Drug: Toripalimab

Interventions

Biopsy Procedure PROCEDURE

Undergo biopsy

Also known as: Biopsy, BIOPSY_TYPE

Treatment (toripalimab)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Specimen Collection

Treatment (toripalimab)

Colonoscopy PROCEDURE

Undergo colonoscopy

Treatment (toripalimab)

Computed Tomography PROCEDURE

Undergo CT

Also known as: Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan

Treatment (toripalimab)

Questionnaire Administration OTHER

Ancillary studies

Treatment (toripalimab)

Toripalimab DRUG

Given IV

Also known as: Anti-PD-1 Monoclonal Antibody JS001, JS-001, Loqtorzi, Toripalimab-tpzi

Treatment (toripalimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 creatinine clearance \[CrCl\])
• Creatinine clearance should be calculated per institutional standard
• Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 x ULN
• Patients with previously diagnosed Gilbert syndrome can have total bilirubin \< 3.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
• Alkaline phosphatase ≤ 2.5 x ULN

You may not qualify if:

• 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
• History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease
• History of a hematologic or primary solid tumor malignancy within the last 5 years
• Autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, diabetes mellitus type 1, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, controlled psoriasis or resolved childhood asthma/atopy not requiring systemic treatment can be enrolled
• Active hepatitis B or hepatitis C
• Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
• Treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, nasal seasonal flu, H1N1 flu, rabies, Bacille Calmette Guerin (BCG) and typhoid vaccine
• Prior treatment with any immune checkpoint inhibitor
• Current pregnancy or breastfeeding

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator
• Coherus Oncology, Inc.: collaborator

Study Sites (5)

Emory Decatur Hospital

Atlanta, Georgia, 30033, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Biopsy; Specimen Handling; Colonoscopy; toripalimab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures

Study Officials

• Oluwadunni E. Emiloju, MBBS, MS

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwadunni E. Emiloju, MBBS, MS

CONTACT

404-778-1900; oluwadunni.eunice.emiloju@emory.edu

Olatunji B. Alese, MD, FASCO

CONTACT

olatunji.alese@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 25, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (5)