RECRUITING

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

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Conditions

Localized Colon CarcinomaStage IIB Colon Cancer AJCC v8Stage IIC Colon Cancer AJCC v8Stage III Colon Cancer AJCC v8immunotherapydeficient mismatch repaircolon adenocarcinomacolon canceradjuvant therapyMSI-H colon adenocarcinomadMMR colon cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09-19
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07140679

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \[AJCC\] 8)
  2. * Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)
  3. * Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug
  4. * Available tissue sample from surgical specimen
  5. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  6. * Absolute neutrophil count (ANC) ≥ 1,500 /mcL
  7. * Platelets ≥ 100,000 / mcL
  8. * Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L
  9. * Transfusion is allowed to obtain an adequate hemoglobin level
  10. * 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 \[CrCl\])
  11. * Creatinine clearance should be calculated per institutional standard
  12. * Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 x ULN
  13. * Patients with previously diagnosed Gilbert syndrome can have total bilirubin \< 3.0 mg/dL
  14. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
  15. * Alkaline phosphatase ≤ 2.5 x ULN
  16. * Signed informed consent
  17. * Patients at least 18 years of age
  18. * 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
  19. * 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
  20. * 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
  21. * 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
  1. * Neoadjuvant treatment for dMMR colon cancer
  2. * Presence of metastatic dMMR colon cancer
  3. * 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
  4. * Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule
  5. * History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease
  6. * History of a hematologic or primary solid tumor malignancy within the last 5 years
  7. * 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
  8. * Active hepatitis B or hepatitis C
  9. * Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  10. * 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
  11. * Prior treatment with any immune checkpoint inhibitor
  12. * Current pregnancy or breastfeeding

Contacts and Locations

Study Contact

Oluwadunni E. Emiloju, MBBS, MS
CONTACT
404-778-1900
oluwadunni.eunice.emiloju@emory.edu
Olatunji B. Alese, MD, FASCO
CONTACT
olatunji.alese@emory.edu

Principal Investigator

Oluwadunni E. Emiloju, MBBS, MS
PRINCIPAL_INVESTIGATOR
Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory Decatur Hospital
Atlanta, Georgia, 30033
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
United States
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
United States

Collaborators and Investigators

Sponsor: Emory University

  • Oluwadunni E. Emiloju, MBBS, MS, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-09-19
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2025-09-19
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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