[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100372233":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":11,"locations":26,"responsibleParty":177,"collaborators":179,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":11,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":190,"minAge":191,"maxAge":11,"enrollmentInfo":192,"targetDuration":11,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":11,"overallStatus":201,"whyStopped":11,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Regorafenib + Nivolumab","EXPERIMENTAL",null,[13,14],"Drug: Regorafenib (Stivarga, BAY73-4506)","Biological: Nivolumab (Opdivo)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Regorafenib (Stivarga, BAY73-4506)","Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)",[9],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BIOLOGICAL","Nivolumab (Opdivo)","Administered on day 1 of every treatment cycle.",[9],[27,40,50,60,70,80,90,100,110,120,130,139,148,157,167],{"facility":28,"status":11,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":11},"City of Hope National Medical Center","Duarte","California","91010","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-117.97729,34.13945,{"lat":38,"lon":37},{"facility":41,"status":11,"city":42,"state":43,"zip":44,"country":32,"countryCode":33,"cosmosGeoPoint":45,"geoPoint":49,"contacts":11},"Rocky Mountain Cancer Centers","Denver","Colorado","80218",{"type":35,"coordinates":46},[47,48],-104.9847,39.73915,{"lat":48,"lon":47},{"facility":51,"status":11,"city":52,"state":53,"zip":54,"country":32,"countryCode":33,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"Miami Cancer Institute at Baptist Health South Florida","Miami","Florida","33176",{"type":35,"coordinates":56},[57,58],-80.19366,25.77427,{"lat":58,"lon":57},{"facility":61,"status":11,"city":62,"state":63,"zip":64,"country":32,"countryCode":33,"cosmosGeoPoint":65,"geoPoint":69,"contacts":11},"Illinois Cancer Specialists","Arlington Heights","Illinois","60005",{"type":35,"coordinates":66},[67,68],-87.98063,42.08836,{"lat":68,"lon":67},{"facility":71,"status":11,"city":72,"state":73,"zip":74,"country":32,"countryCode":33,"cosmosGeoPoint":75,"geoPoint":79,"contacts":11},"Minnesota Oncology Hematology, PA","Minneapolis","Minnesota","55404",{"type":35,"coordinates":76},[77,78],-93.26384,44.97997,{"lat":78,"lon":77},{"facility":81,"status":11,"city":82,"state":83,"zip":84,"country":32,"countryCode":33,"cosmosGeoPoint":85,"geoPoint":89,"contacts":11},"Nebraska Cancer Specialists","Papillion","Nebraska","68046",{"type":35,"coordinates":86},[87,88],-96.04224,41.15444,{"lat":88,"lon":87},{"facility":91,"status":11,"city":92,"state":93,"zip":94,"country":32,"countryCode":33,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"New York Oncology Hematology. P.C.","Albany","New York","12206",{"type":35,"coordinates":96},[97,98],-73.75623,42.65258,{"lat":98,"lon":97},{"facility":101,"status":11,"city":102,"state":103,"zip":104,"country":32,"countryCode":33,"cosmosGeoPoint":105,"geoPoint":109,"contacts":11},"Willamette Valley Cancer Institute and Research Center","Eugene","Oregon","97401",{"type":35,"coordinates":106},[107,108],-123.08675,44.05207,{"lat":108,"lon":107},{"facility":111,"status":11,"city":112,"state":113,"zip":114,"country":32,"countryCode":33,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"Sarah Cannon Cancer Center","Nashville","Tennessee","37203",{"type":35,"coordinates":116},[117,118],-86.78444,36.16589,{"lat":118,"lon":117},{"facility":121,"status":11,"city":122,"state":123,"zip":124,"country":32,"countryCode":33,"cosmosGeoPoint":125,"geoPoint":129,"contacts":11},"Texas Oncology-Arlington North","Arlington","Texas","76012",{"type":35,"coordinates":126},[127,128],-97.10807,32.73569,{"lat":128,"lon":127},{"facility":131,"status":11,"city":132,"state":123,"zip":133,"country":32,"countryCode":33,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Baylor Charles A. Sammons Cancer Center at Dallas","Dallas","75246",{"type":35,"coordinates":135},[136,137],-96.80667,32.78306,{"lat":137,"lon":136},{"facility":140,"status":11,"city":141,"state":123,"zip":142,"country":32,"countryCode":33,"cosmosGeoPoint":143,"geoPoint":147,"contacts":11},"University of Texas MD Anderson Cancer Center","Houston","77030",{"type":35,"coordinates":144},[145,146],-95.36327,29.76328,{"lat":146,"lon":145},{"facility":149,"status":11,"city":150,"state":123,"zip":151,"country":32,"countryCode":33,"cosmosGeoPoint":152,"geoPoint":156,"contacts":11},"Texas Oncology-Sherman","Sherman","75090",{"type":35,"coordinates":153},[154,155],-96.60888,33.63566,{"lat":155,"lon":154},{"facility":158,"status":11,"city":159,"state":160,"zip":161,"country":32,"countryCode":33,"cosmosGeoPoint":162,"geoPoint":166,"contacts":11},"Virginia Oncology Associates","Newport News","Virginia","23606",{"type":35,"coordinates":163},[164,165],-76.42975,36.98038,{"lat":165,"lon":164},{"facility":168,"status":11,"city":169,"state":170,"zip":171,"country":32,"countryCode":33,"cosmosGeoPoint":172,"geoPoint":176,"contacts":11},"Northwest Cancer Specialists, PC","Vancouver","Washington","98684",{"type":35,"coordinates":173},[174,175],-122.66149,45.63873,{"lat":175,"lon":174},{"type":178,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[180],{"name":181,"class":6},"Bristol-Myers Squibb","100372233","phase-2-study-on-the-effectiveness-and-safety-of-the-combination-of-the-two-drugs-regorafenib-and-nivolumab-in-patients-with-colorectal-cancer-cancer-of-the-colon-or-rectum-classified-as-proficient-mismatch-repair-and-microsatellite-stable-100372233",true,"NCT04126733","Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)","An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)\u002FMicrosatellite Stable (MSS) Colorectal Cancer (CRC)","Inclusion Criteria:\n\n* Histological or cytological confirmed advanced, metastatic, or progressive pMMR\u002FMSS adenocarcinoma of colon or rectum\n* Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply\n* Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n* Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1\n* Provision of recently obtained tumor tissue as per protocol specified requirement\n* Anticipated life expectancy greater than 3 months\n* Be able to swallow and absorb oral tablets\n\nExclusion Criteria:\n\n* Participants with Mismatch repair deficient (dMMR) \u002F microsatellite instable-high (MSI-H) colorectal cancer\n* Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer\n* Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry\n* Poorly controlled hypertension, defined as a blood pressure consistently above 150\u002F90 mmHg despite optimal medical management\n* Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen\n* Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication\n* Participants with an active, known or suspected autoimmune disease\n* History of interstitial lung disease or pneumonitis\n* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection\n* Other protocol defined inclusion\u002Fexclusion criteria could apply",false,"ALL","18 Years",{"count":193,"type":194},70,"ACTUAL","INTERVENTIONAL",[197],"PHASE2","The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells.\n\nBoth drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.",[200],"Colorectal Cancer","COMPLETED","2023-06-25",{"date":204,"type":194},"2023-07-18",{"date":206,"type":194},"2019-10-14",{"date":208,"type":194},"2022-03-28",{"name":5,"class":6},15]