[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-colon-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-colon-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,84,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100452642","phase-2-colon-adjuvant-chemotherapy-based-on-evaluation-of-residual-disease-100452642",false,"NCT05174169","Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease","CIRCULATE-US","Inclusion Criteria:\n\nThe patient must have an ECOG performance status of 0 or 1.\n\nPatients must have histologically\u002Fpathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.\n\nNo radiographic evidence of overt metastatic disease within 45 days prior to Step 1\u002FStudy entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis).\n\nThe distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation).\n\nThe patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible.\n\nThe resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1\u002FStudy entry and before Step2\u002FRandomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery).\n\nTumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded.\n\nThe treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan).\n\nThe interval between surgery (post-operative Day 7) and Step 1\u002FStudy entry must be no more than 60 days. NOTE: Step 1\u002FStudy Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery.\n\nAvailability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.\n\nAdequate hematologic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before Step 1\u002FStudy entry defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before Step 1\u002FStudy entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW).\n\nHIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1\u002FStudy entry must be negative (for women of childbearing potential only).\n\nPatients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.\n\nEligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPatient must have developed a ctDNA +ve assay during serial monitoring.\n\nPatient's willingness to be re-randomized affirmed.\n\nThe patient must continue to have an ECOG performance status of 0 or 1.\n\nNo radiographic evidence of overt metastatic disease.\n\nPregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only).\n\nAdequate hematologic function within 28 days before second randomization defined as follows:\n\n* Absolute neutrophil count (ANC) must be greater than or equal to 1500\u002Fmm3;\n* Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.\n* BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n* Platelet count must be greater than or equal to 100,000\u002Fmm3; and\n* Hemoglobin must be greater than or equal to 9 g\u002FdL.\n\nAdequate hepatic function within 28 days before second randomization defined as follows:\n\n* total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and\n* alkaline phosphatase must be less than 2.5 x ULN for the lab; and\n* AST and ALT must be less than 2.5 x ULN for the lab.\n\nAdequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL\u002Fmin using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab.\n\nFor Women Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg\u002FdL) For Men Creatinine Clearance (mL\u002Fmin) = (140 - age) x weight (kg) 72 x serum creatinine (mg\u002FdL)\n\nExclusion Criteria:\n\nColon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).\n\nPathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected.\n\nTumor-related bowel perforation.\n\nHistory of prior invasive colon malignancy, regardless of disease-free interval.\n\nHistory of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ\u002Ftissue donation are not exclusionary.\n\nAny prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and\u002For radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization.\n\nOther invasive malignancy within 5 years before Step 1\u002FStudy entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ.\n\nSynchronous primary rectal and\u002F or colon cancers.\n\nPatients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\nSensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0.\n\nBlood transfusion within two weeks before collection of blood for central ctDNA testing.\n\nActive seizure disorder uncontrolled by medication.\n\nActive or chronic infection requiring systemic therapy.\n\nKnown homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.\n\nPatients known to have Gilbert's Syndrome or homozygosity for UGT1A1\\*28 polymorphism.\n\nPregnancy or lactation at the time of Step 1\u002FStudy entry.\n\nCo-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up).\n\nIneligibility Criteria for Cohort A Arm-2 patients on Second Randomization\n\nPregnancy or lactation at the time of randomization.\n\nNo longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.","ALL","18 Years",{"count":19,"type":20},1912,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This Phase II\u002FIII trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.",[27],"Stage III Colon Cancer",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"ctDNA positive","ctDNA negative","Adjuvant Chemotherapy","Natera","Signatera","mFOLFOX6","Stage III","CAPOX","mFOLFIRINOX","Oxaliplatin","5-Fluorouracil (5-FU)","Capecitabine","Leucovorin","Irinotecan","Stage II","RECRUITING","2026-07-01",{"date":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2022-07-08",{"date":52,"type":20},"2030-03-10",{"name":54,"class":55},"NRG Oncology","OTHER",1063,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100538206","french-assessment-of-mrd-by-liquid-biopsies-in-stage-iii-crc-patients-frenchmrdcrc-100538206","NCT06287814","French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC)","French Assessment of Minimal Residual Disease by Liquid Biopsies in Stage III Colorectal Patients","FRENCH.MRD.CRC PART I Inclusion criteria\n\n* Colon or rectal cancer, clinical tumor stage I-III.\n* Patient 18 years or older.\n* Scheduled for curative intent resection surgery (including \"compromised\" curative resections).\n\nExclusion criteria\n\n* Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome.\n* Verified distant metastases.\n* Malignant colorectal polyps diagnosed after polypectomy.\n* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study.\n* Pregnant or nursing woman, or in childbearing age and not willing to use contraception\n* Protected and vulnerable adult\n* Not covered by Health insurance\n* Patient unable to understand and sign written informed consent.\n\nFRENCH.MRD.CRC PART II Inclusion criteria\n\n* Participation in FRENCH.MRD.CRC part 1 - SURGERY\n* Colorectal cancer, UICC stage III\n* Has received curative-intent resection and is a candidate for adjuvant chemotherapy (3- or 6-months regime) Exclusion criteria\n* Inflammatory bowel disease (Crohn's disease or ulcerative colitis) related colon cancer\n* Not treated with adjuvant chemotherapy despite indication (incomplete treatment not included)\n* Treated with neoadjuvant chemo-radiation therapy\n* Synchronous colorectal and non-colorectal cancer diagnosed per operative (except skin cancer other than melanoma)\n* Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from eligibility screening\n* Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and\u002For otherwise considered by the Investigator to be unlikely to complete the study",{"count":65,"type":20},70,"OBSERVATIONAL","Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.\n\nThere is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.\n\nThe GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.\n\nFRENCH-MRD-CRC is the French study of the european GUIDE.MRD project.",[69,27,70,71],"Colorectal Cancer","Minimal Residual Disease","Liquid Biopsy",[73,70,71],"Stage III colorectal cancer","2026-06-17",{"date":76,"type":48},"2026-06-22",{"date":78,"type":48},"2024-04-11",{"date":80,"type":20},"2033-10-31",{"name":82,"class":55},"University Hospital, Montpellier",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100347423","phase-3-identification-and-treatment-of-micrometastatic-disease-in-stage-iii-colon-cancer-100347423","NCT03803553","Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer","Early Identification and Treatment of Occult Metastatic Disease in Stage III Colon Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed resected Stage III adenocarcinoma of the colon. Any T \\[Tx, T1, T2, T3, or T4-\\], N1-2M0.\n* Participants must have completely resected disease. In patients with tumor adherent to adjacent structures, en block RO resection must be documented.\n* Entire tumor must be in the colon (rectal involvement is excluded).\n* Participants must have completed standard adjuvant chemotherapy per the discretion of the treating physician. Standard therapy includes FOLFOX, CAPOX, or therapy with 5FU analog alone will be permitted if it constitutes appropriate standard therapy in the opinion of the treating physician.\n* Participants must not have received prior neoadjuvant chemotherapy.\n* Age ≥18 years.\n* ECOG performance status ≤1.\n* Life expectancy of greater than 3 months.\n* Participants must have normal organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002F mcL\n  * total bilirubin within normal institutional limits. For patients with Gilbert's syndrome, total bilirubin must be ≤ 2 and documented as elevated indirect bilirubin.\n  * AST(SGOT)\u002FALT(SGPT) ≤3 (AST) or ≤ 3 (ALT) × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n  * creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal by Cockroft-Gault formula.\n* In order to be eligible for the ctDNA positive cohort, women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG).\n* The effects on the developing human fetus are unknown. For this reason and because 5FU, Capecitabine, Oxaliplatin, Irinotecan, Leucovorin, Nivolumab, and Cetuximab are known to be teratogenic, in order to be eligible for the ctDNA positive cohort, females of child-bearing potential (FOCBP) and males must be willing to abstain from heterosexual activity or use 2 forms of effective contraception (fail rate of less than 1% per year, hormonal or barrier method of birth control) from time of informed consent until 5 months (FOCBP) and 7 months (males) after the last dose of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women who are not of childbearing potential, ie, who are postmenopausal or surgically sterile as well as azoospermic men, do not require contraception.\n* Participants must have documentation of microsatellite instability status. Testing by NGS, PCR based assessment and Immunohistochemistry (IHC) are acceptable. Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicated dMMR. This may be done locally.\n* Participant's circulating tumor DNA (ctDNA) assay (Guardant Reveal-Guardant Health) must satisfy assay specific quality control metrics to generate a result.\n* In order to be eligible for the ctDNA positive cohort, patient must be ctDNA positive following adjuvant therapy using the CLIA certified Guardant Reveal assay. ctDNA positive will be defined as positive based on having a tumor derived signal in the cfDNA that passes calling threshold (\"ctDNA detected\").\n* Ability to understand and the willingness to sign a written informed consent document.\n\nTrastuzumab and Pertuzumab Specific Inclusion Criteria for HER2 cohort\n\n* HER2 overexpression\u002Famplification as shown by NGS sequencing, IHC\u002FFISH or Tumor with 3+ by IHC or 2+ by IHC and HER2\u002Fcep17 ratio \\>2 by FISH.\n* AST(SGOT) ≤ 1.25 and ALT(SGPT) ≤ 1.25 × institutional upper limit of normal\n* Participants of childbearing potential must use effective contraceptive methods during and for 7 months after the last dose of HER2-targeted therapy\n* History of other malignancies within the 5 years prior to study registration, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin (\\*malignancies occurring more than 5 years prior to study entry are permitted if curatively treated with surgery alone).\n* LVEF ≥ 55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) within 12 weeks of treatment start.\n\nExclusion Criteria:\n\n* Patients who are receiving additional investigational therapy or on another investigational protocol\n* Patients who have confirmed metastatic disease per CT.\n* Patients who are unable to get any standard adjuvant therapy\n* Patients who have received more than 6 months of standard adjuvant therapy at the time of study entry.\n* With the exception of standard of care adjuvant therapy, patient received anticancer therapy including chemotherapy, immunotherapy, or antineoplastic biologic therapy (e.g., cetuximab, bevacizumab etc.), within 30 days prior to start of study treatment.\n* Patients who are MSI-high or have a BRAF V600E mutation are excluded from Arm 1 (FOLFIRI) and Arm 2 (Active Surveillance).\n* Patients with a BRAFV600E mutation and who are MSI-high are excluded from Arm 5 (ENCO\u002FBINI\u002FCETUX).\n* Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* (ctDNA positive cohort only). Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 6 months for woman and 6 months for men, after the last dose of trial treatment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Has an active infection requiring systemic therapy.\n\nNivolumab Specific Inclusion Criteria for MSI-H Cohort:\n\n* Must have documentation of microsatellite instability status. NGS, PCR based assessment and Immunohistochemistry (IHC) are acceptable. Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicated dMMR. This may be done locally.\n* Patients must have detectable ctDNA (Guardant Reveal assay) post standard adjuvant therapy in order to be in this cohort.\n\nNivolumab Specific Exclusion Criteria for MSI-H Cohort:\n\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other forms of immunosuppressive therapy within 7 days prior to the first dose of nivolumab treatment. Subject requiring systemic steroids are excluded from the trial. The use of physiologic doses of corticosteroids may be approved after discussion with the sponsor.\n* Has a known history of active TB (Bacillus tuberculosis)\n* Hypersensitivity to nivolumab or any of is excipients\n* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.\n* Has active autoimmune disease that has required systemic treatment in the 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.\n* Patients that require supplemental oxygen are excluded.\n* Patients who are known HIV+ positive are eligible if their CD4+ count is ≥ 350\u002FμL for at least 3 months and they have an undetectable viral load. In addition, patient must be currently receiving Highly Active Antiretroviral Therapy (HAART) and have been on therapy for at least 3 months prior to study entry, under the care of an Infectious Diseases specialist. Patients should have no history of an AIDS-defining opportunistic infection.\n* Patients known hepatitis B and hepatitis C must be under the care of viral hepatitis expert consultant. Patients with hepatitis B are required to be treated with anti-HBV treatment (e.g., entecavir) and have an HBV viral load \\\u003C100 IU\u002FmL. Patients with hepatitis C need to have received prior and\u002For ongoing hepatitis C treatment.\n* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n\nEncorafenib, binimetinib, and cetuximab Specific Inclusion Criteria for BRAF mutant Cohort\n\n* Presence of BRAFV600E in tumor tissue previously determined by IMPACT at any time prior to Screening.\n* Patients must have detectable ctDNA (Guardant Health LUNAR assay) post standard adjuvant therapy in order to be in this cohort.\n* Participants must have normal organ, marrow, and hematologic function as defined below:\n\n  * Hemoglobin ≥9 g\u002FdL (5.58 mmol\u002FL)\n  * Total bilirubin ≤ 1.5 (25.65 μmol\u002FL)\n  * Platelets ≥100,000\u002FμL\n\nEncorafenib, binimetinib, and cetuximab Specific Exclusion Criteria for BRAF V600E mutant Cohort:\n\n* Patients with a BRAFV600E mutation and who are MSI-H are excluded from Arm 5 (ENCO\u002FBINI\u002FCETUX)\n* Prior therapy with a BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) and\u002For a MEK inhibitor (e.g., binimetinib, trametinib, cobimetinib).\n* Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients.\n* The patient has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, or has red meat allergy or tick bit history.\n* Inability to swallow and retain study drug.\n* Participants who have undergone major surgery (e.g., in-patient procedures) ≤ 6 weeks prior to start of study treatment or who have not recovered from side effects of such procedure.\n* Participants who have had radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure. Note: Palliative radiation therapy must be complete 7 days prior to the first dose of study treatment.\n* Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment.\n\nNote: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and may enroll.\n\n* Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, any of the following:\n\n  * History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) \\\u003C 6 months prior to Screening;\n  * Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);\n  * Left ventricular ejection fraction (LVEF) \\\u003C 50% as determined by MUGA or ECHO;\n  * Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;\n  * History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);\n  * Triplicate average baseline QTc interval ≥ 480 ms.\n* Impairment of gastrointestinal function or disease which may significantly alter the absorption of study drug (e.g., active ulcerative disease, uncontrolled vomiting or diarrhea, malabsorption syndrome, small bowel resection with decreased intestinal absorption), or recent (≤ 3 months) history of a partial or complete bowel obstruction, or other conditions that will interfere significantly with the absorption of oral drugs.\n* Known history of acute or chronic pancreatitis.\n* Concurrent neuromuscular disorder that is associated with elevated CK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* History or current evidence of RVO or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease.\n* Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in Section 5.5, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.\n* History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment. Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (i.e. massive or sub-massive) deep vein thrombosis or pulmonary emboli.\n\nNote: Patients with either deep vein thrombosis or pulmonary emboli that does not result in hemodynamic instability are allowed to enroll as long as they are on a stable dose of anticoagulants for at least 4 weeks.\n\nNote: Patients with thromboembolic events related to indwelling catheters or other procedures may be enrolled.\n\n* Concurrent or previous other malignancy within 2 years of study entry, except adequately treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease and Gleason 6 prostate cancer.\n* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n* Evidence of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. Note: Patients with laboratory evidence of cleared HBV or HCV infection may be enrolled.\n\nNote: Patients with no prior history of HBV infection who have been vaccinated against HBV and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may be enrolled.\n\nTrastuzumab and Pertuzumab Specific Exclusion Criteria for HER2 cohort\n\n* Serious cardiac illness or medical conditions including but not confined to:\n\n  * History of NCI CTCAE v5.0 Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II\n  * High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate ≥ 100\u002Fmin at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 \\[Mobitz 2\\] or third degree AV-block)\n  * Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication\n  * Angina pectoris requiring anti-anginal medication.\n  * Evidence of myocardial infarction within 12 months prior to enrollment\n  * Clinically significant valvular heart disease\n  * Evidence of transmural infarction on electrocardiogram (ECG)\n  * Poorly controlled hypertension (eg, systolic \\> 180 mm Hg or diastolic \\> 100 mm Hg).\n  * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction \\[LVSD\\], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome\n* High risk patients who have received chemoprevention drugs in the past are not allowed to enroll in the study.\n* Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy and immunotherapy.\n* Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions\u002Fillness (e.g., infections or poorly controlled diabetes).",{"count":92,"type":20},400,[24],"This research study is comparing two standard of care treatment options based on blood test results for participants who have metastatic colon cancer.\n\nThe names of the potential treatments involved in this study are:\n\n* Active surveillance\n* FOLFIRI treatment\n* Nivolumab treatment\n* Encorafenib\u002FBinimetinib\u002FCetuximab treatment\n* Trastuzumab + Pertuzumab",[96,27],"Metastatic Colon Cancer",[98,27],"Metastatic colon Cancer","2026-04-27",{"date":101,"type":48},"2026-05-01",{"date":103,"type":48},"2020-04-16",{"date":105,"type":20},"2027-12",{"name":107,"class":55},"Massachusetts General Hospital",3,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":83},"100506162","phase-2-phase-ii-open-label-trial-of-neoadjuvant-immunochemotherapy-for-resectable-non-metastatic-colon-cancer-nicer-100506162","NCT05870800","Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER","Phase II Open-label Trial of Neoadjuvant Immunotherapy (Atezolizumab) in Combination With CAPOX for Resectable Non-metastatic Proficient Mismatch Repair (pMMR) Colon CancER: NICER Study","NICER","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Age ≥18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol\n* MSS or pMMR tumor determined by local CLIA-certified PCR or IHC testing respectively.\n* Histologically or cytologically confirmed resectable non-metastatic adenocarcinoma of the colon.\n* The distal extent of the tumor must be ≥12 cm from the anal verge on pre-surgical endoscopy and\u002For imaging (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be ≥12 cm from the anal verge as determined by surgical examination or pre-operative imaging.\n* One or more of the following high-risk features:\n\n  * High CEA levels (\\>5 ng\u002Fml in non-smoker patients , \\>10ng\u002Fml in smoker patients)\n  * Low Lymphocyte-to-monocyte Ratio (\\\u003C2.38)\n  * Poor grade of tumor differentiation\n  * Evidence of Lymphovascular Invasion\n  * Evidence of Perineural Invasion\n  * CT evidence of T3 orT4 disease w\u002F ≥4 cm tumor longitudinal diameter\n  * CT evidence of regional lymphadenopathy\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:\n\n  * ANC ≥ 1.5 x 10\\*9\u002FL (1500\u002FmL) without granulocyte colony-stimulating factor support\n  * Lymphocyte count ≥ 0.5 x 10\\*9\u002FL (500\u002FµL)\n  * Platelet count ≥100 x 10\\*9\u002FL (100,000\u002FµL) without transfusion\n  * Hemoglobin ≥ 9 g\u002FL (9 g\u002FdL) Patients may be transfused to meet this criterion.\n  * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)\n  * Serum bilirubin ≤ 1.5 x ULN with the following exception:\n\nPatients with known Gilbert disease: serum bilirubin ≤ 3 x ULN\n\n* Serum creatinine ≤1.5 x ULN or Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n* Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n* For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN\n\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n  * Negative hepatitis B surface antigen (HBsAg) test at screening\n  * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening The HCV RNA test must be performed for patients who have a positive HCV antibody test.\n  * Negative HIV test at screening\n  * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:\n\nWomen must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 6 months following any of the adjuvant chemotherapy regimens (if applicable) after the final dose of mFOLFOX6 or CAPEOX.Women must refrain from donating eggs during this same period.\n\nA woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\n• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of any chemotherapy regimen. Men must refrain from donating sperm during this same period.\n\nWith a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 5 months after any of the chemotherapy regimens to avoid exposing the embryo.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or any site actively progressing metastatic disease.\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain Patients requiring pain medication must be on a stable regimen at study entry. Presence of any metastatic effusion (pleural, pericardial, ascites)\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 11 for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\nPatients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\nPatients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\nPatients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n* Rash must cover \\\u003C 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\n  * Active tuberculosis\n  * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n  * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n  * History of malignancy other than colon adenocarcinoma within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer or colonic polyps\n  * Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n  * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n  * Prior allogeneic stem cell or solid organ transplantation\n  * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n  * Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n  * Current treatment with anti-viral therapy for HBV\n  * Synchronous primary rectal and\u002F or colon cancers or history of prior invasive colon malignancy, regardless of disease-free interval.\n  * Treatment with investigational therapy within 28 days prior to initiation of study treatment\n  * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n  * Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n  * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\nPatients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n\nPatients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the CAPOX or mFOLFOX6 chemotherapy formulations\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months for Atezolizumab and 6 months for any chemotherapy regimen after the final dose of study treatment Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.","80 Years",{"count":119,"type":20},28,[23],"This is a Phase II open-label trial of neoadjuvant immunochemotherapy with Atezolizumab and CAPOX followed by surgery and potentially adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 28 patients. The investigators will explore if appropriately timed neoadjuvant CAPOX with anti-PD-L1 mAb (Atezolizumab) can be administered safely and feasibly, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors. Patients will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPOX (atezolizumab will be administered prior to chemotherapy) before standard of care surgical resection. Following surgery, patients still considered to be at high-risk of recurrence (per SOC guidelines) will receive further adjuvant chemotherapy (mFOLFOX6 or CAPOX), based on the discretion of the treating oncologist\u002Finvestigator. Circulating tumor DNA (ctDNA) dynamic change status will be analyzed through collection of blood samples throughout different stages of the patient's neoadjuvant treatment regimen (baseline, pre-neoadjuvant therapy, mid-neoadjuvant, post-neoadjuvant therapy, and during postoperative period) as a marker of early read on efficacy.\n\nThe end of the study for each patient enrolled will be at the 6 month postoperative visit.\n\nOn Study Protocol: Patients will be followed up for an efficacy follow-up phase during the first 6 months after surgery (week 2 \\& months 3, 6 visits). All assessments beyond the 6 month visit will be performed under standard of care surveillance office visits.\n\nOff Study Protocol: Thereafter they will enter a survival follow-up phase per standard of care protocols. Patients will be seen every 6 months starting at month 12 until month 36. All collection of research-specific assessments including whole blood, stool collection and quality of life questionnaires will be optional beyond the 6 month postop visit (months 12-36).",[123,124,27],"Stage I Colon Cancer","Stage II Colon Cancer",[126],"Non-metastatic resectable colon cancer","2025-05-20",{"date":129,"type":48},"2025-05-25",{"date":131,"type":20},"2025-06-15",{"date":133,"type":20},"2028-01-01",{"name":135,"class":55},"Baylor College of Medicine"]