Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
A Phase II Trial of Adjuvant Toripalimab in High Risk Localized Colon Cancer With Mismatch Repair Deficiency
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
- Procedures mentioned: Blood draws, CT scans, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase II study tests whether toripalimab, an immune system treatment, lowers the chance of colon cancer coming back after surgery. It is for adults with stage IIB, IIC, or III colon cancer that has trouble fixing errors in its DNA, called deficient mismatch repair (dMMR).
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and sign a form agreeing to join the study.
- Have stage IIB, IIC, or III colon cancer with lab tests showing dMMR or high microsatellite instability (MSI-H), signs of problems fixing DNA.
- Have all cancer removed by surgery 4 to 12 weeks before the first study dose. A tumor tissue sample from surgery must be available.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- Meet the study’s blood cell count, kidney, and liver test limits. A blood transfusion may be used to raise your red blood cell level.
- Have a colonoscopy, a test that looks inside the colon, before surgery or within 6 months after surgery. If two colon cancers are found, both must have dMMR and be fully removed.
- If you can become pregnant, have a negative pregnancy test within 72 hours before treatment. If you can have children, use study-approved birth control during treatment and for 90 days afterward.
- If breastfeeding, stop before the first dose and do not restart until 90 days after the last dose.
Who can't join
- Had treatment for this colon cancer before surgery, or have colon cancer that has spread to distant parts of the body.
- Have a health condition that could make treatment unsafe or side effects hard to judge, or an uncontrolled mental health condition that could prevent study follow-up.
- Have had lung inflammation needing steroids, or interstitial lung disease, which can scar the lungs.
- Have another cancer that is growing or needed treatment in the past 3 years. Some treated, cured, or low-risk cancers are allowed.
- Have an autoimmune disease, where the immune system attacks the body, that needed whole-body treatment in the past 2 years. Some conditions and hormone replacement treatments are allowed.
- Have active hepatitis B or C, infections that affect the liver, or used whole-body steroids or other drugs that weaken the immune system within 7 days before treatment.
- Received a live vaccine within 30 days before treatment, or ever received an immune checkpoint inhibitor, a type of immune system cancer treatment.
- Are pregnant or currently breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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) ≥ 1,000 /mcL * 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 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 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. * 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 sites (5)
GA
- Emory Decatur Hospital · Atlanta, GA 30033Kathleen Coleman · Study contact · 404-778-1900 · kmcole5@emory.eduOluwadunni Emiloju · Principal investigatorMore trials in Atlanta
- Emory University Hospital Midtown · Atlanta, GA 30308Jalpa Patel · Study contact · jalpa.r.patel@emory.eduOluwadunni E. Emiloju, MBBS, MS · Principal investigatorMore trials in Atlanta
- Emory University Hospital/Winship Cancer Institute · Atlanta, GA 30322Tyler Whitfield · Study contact · 404-778-1900 · tyler.stephen.whitfield@emory.eduOluwadunni E. Emiloju, MBBS, MS · Principal investigatorMore trials in Atlanta
- Emory Saint Joseph's Hospital · Atlanta, GA 30342Ainsley Hymel · Study contact · ainsley.hymel@emory.eduOluwadunni E. Emiloju, MBBS, MS · Principal investigatorMore trials in Atlanta
- Emory Johns Creek Hospital · Johns Creek, GA 30097Hafsa Ahmed · Study contact · hafsa.maheen.ahmed@emory.eduOluwadunni E. Emiloju, MBBS, MS · Principal investigatorMore trials in Johns Creek