No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
This trial is looking for patients who have recently had surgery for specific types of colon cancer. Participants will receive immunotherapy to help lower the chance of cancer returning.
Are You a Good Fit for This Trial?
Rules you outMetastatic colon cancerActive hepatitis BActive hepatitis C
You may be able to join if
I have been diagnosed with stage IIB, IIC, or III colon cancer.
I have had surgery to remove my colon cancer recently.
I can provide a tissue sample from my surgery.
I am at least 18 years old.
I have a good performance status (ECOG 0, 1, or 2).
My blood counts meet the required levels.
I have had a full colonoscopy before enrolling.
You may not be able to join if
I have had treatment for my colon cancer before surgery.
I have cancer that has spread to other parts of my body.
I have uncontrolled health issues that could complicate treatment.
I have a history of serious lung conditions.
I have had another cancer in the last 5 years.
I have an autoimmune disease that required treatment in the last 2 years.
I am currently pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 sequ…
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
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