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Localized Colon CarcinomaPhase 2NCT07140679

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

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Colonoscopy in people with Localized Colon Carcinoma and Stage IIB Colon Cancer AJCC v8, run by Emory University at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Colonoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesUnited States
Study dates
19 Sep 2025to 31 Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) ≥ 1,000 /mcL
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  • Platelets ≥ 75,000 / 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]) ≤ 3 x ULN
  • Alkaline phosphatase ≤ 3 x ULN
  • Signed informed consent
  • Patients at least 18 years of age
  • Colonoscopy should be performed before surgery and if synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible. If colonoscopy was not done pre-operatively, the patient may still be eligible if all other inclusion criteria are met. It should however be performed within 6 months after initial colon resection surgery
  • 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

Who cannot join

  • 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 prior malignancy other than the cancer under study, that is progressing or has required active treatment within the past 3 years. Exceptions include adequately treated basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured.
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  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oluwadunni E. Emiloju, MBBS, MS contact

404-778-1900

oluwadunni.eunice.emiloju@emory.edu

Olatunji B. Alese, MD, FASCO contact

olatunji.alese@emory.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • Emory Decatur Hospital

    Atlanta, Georgia, 30033

    Kathleen Coleman, 404-778-1900, kmcole5@emory.edu

    Oluwadunni Emiloju

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Jalpa Patel, jalpa.r.patel@emory.edu

    Oluwadunni E. Emiloju, MBBS, MS

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Tyler Whitfield, 404-778-1900, tyler.stephen.whitfield@emory.edu

    Oluwadunni E. Emiloju, MBBS, MS

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

    Ainsley Hymel, ainsley.hymel@emory.edu

    Oluwadunni E. Emiloju, MBBS, MS

    Recruiting

  • Emory Johns Creek Hospital

    Johns Creek, Georgia, 30097

    Hafsa Ahmed, hafsa.maheen.ahmed@emory.edu

    Oluwadunni E. Emiloju, MBBS, MS

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biopsy Procedure, Biospecimen Collection, Colonoscopy, Computed Tomography, Questionnaire Administration
Keywords
immunotherapy, deficient mismatch repair, colon adenocarcinoma, colon cancer, adjuvant therapy, MSI-H colon adenocarcinoma, dMMR colon cancer
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Specimen Collection

    Undergo collection of blood samples

  • ColonoscopyProcedure or surgery

    Undergo colonoscopy

  • Computed TomographyProcedure or surgery

    Also called Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan

    Undergo CT

  • Questionnaire AdministrationOther

    Ancillary studies

  • ToripalimabDrug

    Also called Anti-PD-1 Monoclonal Antibody JS001, JS-001, Loqtorzi, Toripalimab-tpzi

    Given IV

Study groups in NCT07140679
Study groupRoleWhat they receive
Treatment (toripalimab)ExperimentalEligible 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.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Colonoscopy; Procedure: Computed Tomography; Other: Questionnaire Administration; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. Incidence of treatment-related adverse events

    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.

    Measured: Up to 5 years

  2. 3-year Relapse free survival (RFS)

    Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years

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

  3. 5-year 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 5 years.

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

  4. Colon cancer specific survival (CCSC)

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

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

  5. Overall survival (OS)

    Time between the date of registration and the date of death due to any cause.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2025
  2. Study start19 Sep 2025
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07140679
Sponsor's protocol ID
STUDY00008833
Other IDs
P30CA138292, NCI-2025-05423, STUDY00008833, WINSHIP6483-24
Status last verified
Sep 2026
First submitted
22 Aug 2025
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Colonoscopy in people with Localized Colon Carcinoma and Stage IIB Colon Cancer AJCC v8, run by Emory University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oluwadunni E. Emiloju, MBBS, MS (404-778-1900, oluwadunni.eunice.emiloju@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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