[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colo-rectal-cancer-dmmrmsi-h-crc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colo-rectal-cancer-dmmrmsi-h-crc":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100610118",false,"NCT07223424","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy","Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)","PSI-Immune","Inclusion Criteria:\n\n* Able to understand and willing to sign a written informed consent document.\n* Able to read and write in English.\n* Must be eligible to receive nivolumab (Cohorts A-1, B-1) or pembrolizumab (Cohorts A-2, B-2) singly or in combination with other FDA-approved agents (TKIs or chemotherapy) according to standard of care practices, as determined by the clinical judgment of the investigator.\n* Prior and concurrent therapy criteria\n\n  o Patients should either be ICI-naïve (Cohorts A-1, A-2) or be currently receiving adjuvant or front-line PD-(L)1 based therapy singly or in combination with FDA-approved agents (TKIs or chemotherapy) (Cohorts B-1, B-2).\n* Locally advanced or advanced\u002Fmetastatic solid tumor for which nivolumab OR pembrolizumab is on-label.\n\n  * NOTE: IV nivolumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma (gastric\u002FGEJ).\n  * NOTE: IV pembrolizumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR\u002FMSI-H CRC, HCC, esophageal cancer, gastric\u002FGEJ, cervical cancer, cutaneous squamous cell carcinoma (cSCC), Merkel cell carcinoma (MCC), endometrial carcinoma, tumor mutational burden-high (TMB-H) cancers, triple negative breast cancer (TNBC).\n* Cohort-specific criteria.\n\n  * Cohort A-1: Patients who are treatment-naive (i.e. for whom nivolumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-1: Patients who are already receiving treatment with nivolumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to nivolumab monotherapy or nivolumab based combinations may eligible to enroll if nivolumab is on-label for their cancer.\n  * Cohort A-2: Patients who are treatment-naive (i.e. for whom pembrolizumab is planned but has not yet been initiated) are eligible to enroll.\n  * Cohort B-2: Patients who are already receiving treatment with pembrolizumab (singly or in combination with TKI or chemotherapy) OR a different ICI-therapy but are willing to switch to pembrolizumab monotherapy or pembrolizumab based combinations may eligible to enroll if pembrolizumab is on-label for their cancer.\n  * NOTE: Patients who are currently receiving nivolumab + ipilimumab combination as induction may be eligible to enroll in Cohort B-1 following induction (i.e. during planned maintenance) in indications including but not limited to advanced\u002Fmetastatic melanoma, ccRCC, MSI-H\u002FdMMR mCRC.\n  * NOTE: Patients for whom nivolumab + ipilimumab combination is planned as maintenance are not eligible (i.e. NSCLC patients being treated per CheckMate-227 or CheckMate-9LA).\n  * NOTE: Patients for whom anti-PD-1 based immunotherapy is planned as neoadjuvant therapy are not appropriate. Such patients may be considered for enrollment at the time of commencing adjuvant therapy in cohorts A-2 or B-2 as appropriate.\n\nExclusion Criteria:\n\n* Participant unable to receive nivolumab (or pembrolizumab) due to prior allergic reactions to nivolumab (or pembrolizumab) or any of its ingredients.\n* Has severe hypersensitivity (≥Grade 3) to nivolumab (or pembrolizumab) and\u002For any of its excipients.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":19,"type":20},880,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The study will evaluate patient and Health Care Professional- reported preference for Subcutaneous (SC) compared with IV nivolumab administration or similarly for SC compared with IV pembrolizumab.",[26,27,28,29,30,31,32,33,34,35,36,37],"Renal Cell Carcinoma","Non Small Cell Lung Cancer","Melanoma","Colo-rectal Cancer (dMMR\u002FMSI-H CRC)","Hepatocellular Carcinoma","Ulcerative Colitis","Esophageal Cancer","Squamous Cell Carcinoma","Gastric\u002FGEJ","Cervical Cancer","Gastro-Esophageal Adenocarcinoma","Esophageal Adenocarcinoma","RECRUITING","2026-04-13",{"date":41,"type":42},"2026-04-16","ACTUAL",{"date":44,"type":42},"2025-11-04",{"date":46,"type":20},"2030-11-30",{"name":48,"class":49},"Diwakar Davar","OTHER",1,{"id":52,"slug":4,"hasResults":10,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":50},"100620027","NCT07352280","Neoadjuvant Therapy With Tislelizumab for dMMR\u002FMSI-H Stage II-III Colorectal Cancer","An Observational, Prospective, Real-World Study of Tislelizumab as Neoadjuvant Therapy for dMMR\u002FMSI-H Stage II-III Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, ECOG performance status score 0-2.\n2. Pathologically confirmed stage II-III colorectal adenocarcinoma (according to AJCC 8th edition).\n3. Histologically confirmed mismatch repair deficient or genetic testing confirmed microsatellite instability high tumor.\n4. Signed written informed consent.\n\nExclusion Criteria:\n\n1. The patient has a history of other serious conditions rendering them unsuitable for surgery.\n2. Subjects with the following conditions: active autoimmune diseases, active infectious diseases, inflammatory bowel diseases; requiring long-term glucocorticoid or immunosuppressive therapy during treatment; history of immunodeficiency; history of organ transplantation or haematopoietic stem cell transplantation; severe interstitial pneumonia or pulmonary fibrosis.\n3. Known hypersensitivity to any component or excipient of tislelizumab or other PD-1\u002FPD-L1 agents.\n4. Other conditions deemed unsuitable for inclusion by the investigator.",{"count":58,"type":20},30,"OBSERVATIONAL","This study is a prospective, observational, real-world investigation. This study will evaluate the efficacy and safety of tislelizumab monotherapy before surgery in patients with mismatch repair deficient or microsatellite instability high (dMMR\u002FMSI-H) locally advanced colorectal cancer.\n\nAll patients will receive three cycles of tislelizumab neoadjuvant therapy followed by curative surgery. Postoperatively, based on surgical pathology, patients will receive adjuvant therapy with a regimen selected by the investigator or adopt a watch-and-wait strategy. The investigators will conduct a 5-year prospective follow-up.\n\nThe investigators plan to enroll approximately 30 subjects.",[29],[63,64,65],"tislelizumab","dMMR\u002FMSI-H stage II-III colorectal cancer","neoadjuvant therapy","2026-02-18",{"date":68,"type":42},"2026-02-19",{"date":70,"type":42},"2026-02-01",{"date":72,"type":20},"2032-12-31",{"name":74,"class":49},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",""]