[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dmmr-colorectal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dmmr-colorectal-cancer":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,61,97,129],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":40,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":60},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120",false,"NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[26,41,42,25,43,44,45,46,47,48],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","RECRUITING","2026-06-25",{"date":52,"type":53},"2026-06-29","ACTUAL",{"date":55,"type":53},"2025-04-14",{"date":57,"type":21},"2038-04",{"name":42,"class":59},"INDUSTRY",8,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100457664","phase-2-single-arm-study-of-neoadjuvant-dostarlimab-in-stage-ii-and-iii-deficient-mismatch-repair-colon-cancers-100457664","NCT05239546","Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers","Phase II, Single Arm Study of Neoadjuvant Dostarlimab (TSR-042) in Stage II and III Deficient Mismatch Repair Colon Cancers","NAIO","Inclusion Criteria:\n\n* Capable of understanding and complying with the protocol requirements and have signed the informed consent document. Patients with mild cognitive impairment may be considered for enrollment in the study if their legally authorized representative provides written informed consent for the patient.\n* 18 years or older in age\n* Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, 2017, amendable to en block surgical resection as determined by colorectal surgeon.\n* Biopsy specimen for diagnosis of dMMR Colon cancer should have enough tissue for minimum 4 and max 6 adjacent unstained FFPE slides (4µm each) as determined by Protocol Pathologist Dr. Anthony Snow for CD3+ and CD8+ analysis. If there is not enough tissue present in original sample, a repeat colonoscopy and biopsy may be performed; otherwise patient is not eligible.\n* Potentially surgically resectable Stage II or III patients who are willing to forgo surgical resection if study endpoints are met. Patient with easily manageable bowel changes amenable to laxatives or stool softeners as outpatient per assessment by colorectal surgery are allowed. (See exclusion criteria #2)\n* ECOG performance status less than or equal to 1\n* Absence of metastatic disease on CT CAP with Contrast within 28 days from treatment start\n* Absolute neutrophil count greater than or equal to 1,500\u002FµL\n* Platelets greater than or equal to 100,000\u002FµL\n* Hemoglobin greater than or equal to 9 g\u002FdL\n* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 60mL\u002Fmin using the Cockcroft-Gault equation\n* Total bilirubin less than or equal to 1.5 x ULN (less than or equal to 2.0 in patients with known Gilberts syndrome) OR direct bilirubin less than or equal to 1 x ULN\n* Aspartate aminotransferase and alanine aminotransferase less than or equal to 3.0 x ULN\n* International normalized ratio (INR) or prothrombin time (PT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) less than or equal to 1.5× ULN unless patient is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulants\n* Participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to taking study treatment and agree to use an adequate method of contraception from screening through 180 days after the last dose of study treatment. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner starting with first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n\nExclusion Criteria:\n\n* Synchronous primary tumor (i.e. more than 1)\n* Obstruction or perforation requiring diverting ostomy or immediate resection, or bright red blood per rectum requiring urgent blood transfusion, from their primary tumor.\n* Clinical T4b tumors\n* Known hypersensitivity to dostarlimab components or excipients.\n* Major surgery less than or equal to 3 weeks prior to initiating protocol therapy\n* Received investigational therapy less than or equal to 3 months, or within a time interval less than at least 5 half- lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.\n* Heavy bleeding from the colon cancer tumors requiring PRBC transfusions that would require palliative surgical resection\n* Concurrent, clinically significant, active malignancies within two years of study enrollment.\n* 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* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, glucocorticoids, or immunosuppressive drugs). Other than Replacement hormone therapy with thyroxine for hypothyroidism , insulin for T1 diabetes mellitus , or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.)\n* Diagnosis of immunodeficiency or has received any systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.\n* History of greater than or equal to Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.\n* Patients with known HIV (Human Immunodeficiency Virus) infection on effective retroviral therapy regardless of CD4 count who have had an opportunistic infection within the past 12 months.\n* Organ transplant recipients on immunosuppressive medications\n* Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy but not on suppressive antiviral therapy prior to initiation of treatment of this protocol are excluded. Also, patients with history of HCV infection that have not completed curative antiviral treatment and the HCV viral load is not below the limit of quantification areexcluded.(e.g. a patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution is eligible.)\n* Prior history of interstitial lung disease.\n* Received a live vaccine within 30 days of initiating protocol therapy.\n* Not enough tissue for confirming dMMR status and CD3+ \u002FCD8+ testing\n* 19\\. Patients with severe cognitive impairment.",{"count":70,"type":21},25,"INTERVENTIONAL",[73],"PHASE2","This is a Phase II, single arm study looking at the rate of major clinical response and non-operative management in Stage II and III colon cancer after 18 weeks (up to 6 cycles) of neoadjuvant dostarlimab.",[76,77],"Colon Cancer","dMMR Colorectal Cancer",[79,80,81,82,83,84,85],"Colon cancer","dMMR","Deficient mismatch repair colon cancer","MSI-High","MSI-H","Non-operative management","No surgery","2026-06-10",{"date":88,"type":53},"2026-06-12",{"date":90,"type":53},"2023-03-24",{"date":92,"type":21},"2029-06-30",{"name":94,"class":95},"University of Iowa","OTHER",2,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":71,"phases":107,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100624454","phase-2-neoadjuvant-immunotherapy-and-organ-sparing-treatment-in-patients-with-stage-i-iii-dmmr-colon-cancer-100624454","NCT07409844","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer","Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)","RESET C2","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Written informed consent\n3. Clinical UICC stage I-III dMMR colon carcinoma\n4. Indication for elective curative-intent surgery\n5. ECOG status 0-2\n\nExclusion Criteria:\n\n1. Patients deemed to be non-surgical candidates by MDT\n2. Patients with a need for emergent surgery due to tumour obstruction\n3. Contraindications to pembrolizumab, including allergy and hypersensitivity reactions, assessed by the study investigator(s)\n4. Any serious or uncontrolled medical disorder, including other malignant disease, that may increase the risk associated with participation or drug administration.\n5. Patients with colonic stents\n\nAdditional Circumstances:\n\nIn the following circumstances, eligibility will be individually verified:\n\n* Synchronous colonic tumours (may be included if other lesions are biopsy-verified with dMMR status)\n* Concurrent tumours (e.g., patients with prostate cancer may be included if this does not hinder their other cancer treatment or assessments of efficacy)\n\nIn the following circumstance patients may be excluded from the PROMs outcomes:\n\n* Danish language skills insufficient to answer PROMs\n* Unable to use eBoks",{"count":106,"type":21},152,[73],"The RESET C2 trial aims to introduce organ sparing treatment or watch-and-wait (WW) to patients with localized deficient mismatch repair (dMMR) colon cancer through use of neoadjuvant pembrolizumab. Patients will be divided into four treatment arms based on their surgical and oncologic risks. Each arm provides different intensity neoadjuvant immunotherapy regimens. Patients with complete response at disease restaging procedures will be offered non-operative management, whereas those with non-complete response will proceed to surgery ± adjuvant chemotherapy as standard of care. A WW protocol with regular disease surveillance continues over survivorship. If there is recurrence, surgery and\u002For appropriate oncologic therapy will be offered determined by multi-disciplinary teams. This is a national, non-randomised, investigator-initiated trial including patients from 13 hospitals across Denmark. The rationale, design, and clinical response metrics are derived from the RESET C study (NCT05662527) showing efficacy, safety and feasibility of neoadjuvant pembrolizumab in this cohort.",[31,110,111,112,26],"Colon Cancer Stage I","Colon Cancer Stage II\u002FIII","Pembrolizumab",[112,80,114,115,116,117],"colon cancer","watch-and-wait","organ sparing","neoadjuvant immunotherapy","NOT_YET_RECRUITING","2026-02-17",{"date":121,"type":53},"2026-02-20",{"date":123,"type":21},"2026-03-01",{"date":125,"type":21},"2031-01-01",{"name":127,"class":95},"Ismail Gögenur",1,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":128},"100563207","exploring-the-treatment-duration-of-pd-1-neoadjuvant-therapy-in-stage-ii-iii-dmmr-rectal-cancer-100563207","NCT06613165","Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer","Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer: a Prospective，Multicentre, Single-arm Study","Inclusion Criteria:\n\n* 1.Age: 18 to 80 years old, male or female;\n* 2.Patients with histologically or cytologically confirmed dMMR\u002FMSI-H rectal adenocarcinoma, clinical stage II-III;\n* 3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;\n* 4.ECOG Performance Status (PS) score of 0-1;\n* 5.Estimated life expectancy of ≥ 3 months;\n* 6.Normal function of major organs, with no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency. Laboratory tests must meet the following criteria: Hemoglobin (Hb) ≥ 90 g\u002FL; White blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL; Neutrophil count (NEUT) ≥ 1.5 × 10\\^9\u002FL; Platelet count (PLT) ≥ 90 × 10\\^9\u002FL; Liver function (Aspartate Aminotransferase AST or Alanine Aminotransferase ALT) ≤ 2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) ≤ 1.5 times ULN; Total bilirubin (TBIL) ≤ 1.5 times ULN; Urine protein and occult blood \\\u003C 2+; Fecal occult blood \\\u003C 2+;\n* 7.Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits;\n* 8.The investigator believes that the patient can benefit from the treatment. Physical status score PS ≤ 2;\n* 9.Patients and their families must understand and be willing to participate in this study, providing written informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with a confirmed allergy to the investigational drug and\u002For its excipients;\n* 2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;\n* 3.Patients with any active autoimmune disease or a history of autoimmune disease;\n* 4.Patients with Lynch syndrome;\n* 5.Patients with poorly controlled cardiac symptoms or diseases, such as New York Heart Association (NYHA) Class II or higher heart failure, unstable angina pectoris, or myocardial infarction within the past year;\n* 6.Pregnant or lactating women;\n* 7.Patients with acute infections requiring antibiotic treatment;\n* 8.Patients with positive hepatitis B or hepatitis C antibodies;\n* 9.Patients with positive HIV antibodies;\n* 10.Patients with other diseases that the investigating physician considers may affect prognosis and survival;\n* 11.Any other conditions deemed inappropriate for participation in this study by the investigating physician.","80 Years",{"count":138,"type":21},100,"This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR\u002FMSI-H rectal cancer.\n\nParticipants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved.\n\nResearchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.",[141,142,77],"Immune-related Adverse Event","Neoadjuvant Therapy",[30,144,145,146],"deficient Mismatch Repair","locally advanced","immune checkpoint","2024-12-22",{"date":149,"type":53},"2024-12-27",{"date":151,"type":21},"2025-01-01",{"date":153,"type":21},"2028-09-20",{"name":155,"class":95},"Xijing Hospital"]