Toripalimab for Controlling Disease after Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer
Colon/Rectal Cancer
Unknown Primary
18 Years and older, Male and Female
WINSHIP6483-24 (primary)
NCI-2025-05423
STUDY00008833
Summary
This phase II trial tests how well toripalimab works for controlling disease after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer who have undergone a surgical resection. Immunotherapy with monoclonal antibodies, such as toripalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Objectives
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 overall survival.
TERTIARY/EXPLORATORY OBJECTIVES:
I. To explore immune and omic markers associated with clinical efficacy (DFS, overall survival [OS]).
II. To assess patient reported outcomes (PRO) and health related quality of life (QOL).
OUTLINE:
Patients receive toripalimab IV every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Patients also undergo computed tomography (CT) and collection of blood samples throughout the trial, undergo colonoscopy during follow up, and undergo biopsy at the time of disease progression.
After completion of study treatment, patients are followed up 21-30 days after day 1 of cycle 8, at 1 year post-resection, and then every 6 months until 5 years post-resection.
Eligibility
- 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 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
Treatment Sites in Georgia
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