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

September 23, 2025 updated by: Oluwadunni Emiloju, Emory University

A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 5-year overall survival.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To explore immune, ctDNA, and omic markers associated with clinical efficacy (DFS).

II. To assess patient reported outcomes (PRO) and health related quality of life (QoL).

OUTLINE:

Eligible consenting participants will receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months until 5 years post-resection. After completion of study medication, participants undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life will also be assessed with questionnaires.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Principal Investigator:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Oluwadunni E. Emiloju, MBBS, MS
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Principal Investigator:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:
      • Atlanta, Georgia, United States, 30033
        • Recruiting
        • Emory Decatur Hospital
        • Principal Investigator:
          • Oluwadunni Emiloju
        • Contact:
      • Johns Creek, Georgia, United States, 30097
        • Recruiting
        • Emory Johns Creek Hospital
        • Principal Investigator:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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
  • Signed informed consent
  • Patients at least 18 years of age
  • Must have had a full colonoscopy prior to enrollment. If synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible
  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP are women younger than 55 years (yrs) of age excluding those who are surgically unable to get pregnant due to prior hysterectomy and or bilateral salpingo-oophorectomy
  • Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 90 days after the last dose of study drug. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard
  • Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of study drug

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (toripalimab)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Specimen Collection
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • Computerized Tomography
  • CT Scan
  • Computerized Tomography (CT) scan
Procedure: Colonoscopy
Undergo colonoscopy
Procedure: Biopsy Procedure
Undergo biopsy
Other Names:
  • BIOPSY_TYPE
  • Biopsy
Drug: Toripalimab
Given IV
Other Names:
  • JS-001
  • Loqtorzi
  • Toripalimab-tpzi
  • Anti-PD-1 Monoclonal Antibody JS001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: Up to 5 years
Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Treatment-related adverse events (defined as potentially, probably and definitely) will be summarized in preferred term by system organ class and listed on an individual subject basis at patient level. Immune-related adverse events will also be tabulated.
Up to 5 years
3-year Relapse free survival (RFS)
Time Frame: Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.
Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years
Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.
5-year 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 5 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 5 years.
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 Frame: Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
CCSC is the time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
Overall survival (OS)
Time Frame: Time between the date of registration and the date of death due to any cause, assessed up to 5 years
Time between the date of registration and the date of death due to any cause.
Time between the date of registration and the date of death due to any cause, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)
Coherus Oncology, Inc.

Investigators

  • Principal Investigator: Oluwadunni E. Emiloju, MBBS, MS, Emory University Hospital/Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2025

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

August 22, 2025

First Submitted That Met QC Criteria

August 22, 2025

First Posted (Estimated)

August 25, 2025

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008833 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (U.S. NIH Grant/Contract)
  • NCI-2025-05423 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • WINSHIP6483-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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