[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07284849":3,"trial-entities:NCT07284849":1783,"trial-summary:NCT07284849":1788},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":48,"secondary_outcomes":53,"sex":79,"minimum_age":80,"maximum_age":17,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":99,"locations":102,"central_contacts":1765,"overall_officials":1775,"references":1779,"see_also_links":1780},"NCT07284849","INCA033890-303","A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer","RECRUITING","2029-09-28","2026-08","2026-08-06","2026-03-05","Incyte Corporation","INDUSTRY",true,"The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.",null,[19],"CRC (Colorectal Cancer)",[21,22,23],"Metastatic Colorectal Cancer","Colon Cancer","INCA33890","INTERVENTIONAL","TREATMENT",[27],"PHASE3",{"count":29,"type":30},700,"ESTIMATED",[32,36,40,44],{"type":33,"name":23,"description":34,"armGroupLabels":35},"DRUG","INCA33890 will be administered at protocol defined dose.",[23],{"type":33,"name":37,"description":38,"armGroupLabels":39},"Placebo","Placebo will be administered at protocol defined dose.",[37],{"type":33,"name":41,"description":42,"armGroupLabels":43},"Bevacizumab","Bevacizumab will be administered at protocol defined dose.",[23,37],{"type":33,"name":45,"description":46,"armGroupLabels":47},"FOLFOX","FOLFOX will be administered at protocol defined dose.",[23,37],[49],{"measure":50,"description":51,"timeFrame":52},"Progression-Free Survival (PFS)","Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.","Up to 3 years",[54,58,61,64,67,70,73,76],{"measure":55,"description":56,"timeFrame":57},"Overall Survival (OS)","Defined as the time from the date of randomization to the date of death due to any cause.","Up to 4 years",{"measure":59,"description":60,"timeFrame":52},"Objective response","Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.",{"measure":62,"description":63,"timeFrame":52},"Duration of Response (DOR)","Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.",{"measure":65,"description":66,"timeFrame":57},"Treatment Emergent Adverse Events (TEAEs)","Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment, up to 90 days after the last dose INCA33890\u002Fplacebo (or 30 days after the last dose of any FOLFOX component or bevacizumab if later) or the start of new anticancer therapy, whichever comes first.",{"measure":68,"description":69,"timeFrame":57},"TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen","TEAEs leading to dose interruption or study drug discontinuation.",{"measure":71,"description":72,"timeFrame":57},"Change from baseline in EQ-5D-5L score at protocol-defined visits","The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).",{"measure":74,"description":75,"timeFrame":57},"Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at protocol-defined visits","The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status\u002FQoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.",{"measure":77,"description":78,"timeFrame":57},"Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits","The FCSI-9 is a 9-item questionnaire derived from the FACT-C questionnaire to be a briefer, more targeted symptom-specific measure for patients with CRC. The FCSI-9 assesses common symptoms of CRC, including energy, pain, weight loss, nausea, diarrhea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. 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City","64111",{"lat":359,"lon":360},39.09973,-94.57857,{"facility":362,"status":8,"city":356,"state":349,"zip":363,"country":109,"geoPoint":364},"Midamerica Cancer Care","64121",{"lat":359,"lon":360},{"facility":366,"status":8,"city":273,"state":349,"zip":367,"country":109,"geoPoint":368},"Oncology Hematology Associates","65807",{"lat":369,"lon":370},37.21533,-93.29824,{"facility":372,"status":8,"city":373,"state":349,"zip":374,"country":109,"geoPoint":375},"Washington University School of Medicine","St Louis","63110",{"lat":376,"lon":377},38.62727,-90.19789,{"facility":379,"status":105,"city":380,"state":381,"zip":382,"country":109,"geoPoint":383},"Morristown Medical Center","Morristown","New Jersey","07960",{"lat":384,"lon":385},40.79677,-74.48154,{"facility":387,"status":8,"city":388,"state":389,"zip":390,"country":109,"geoPoint":391},"Presbyterian Rust Medical Center","Rio Rancho","New 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Center","Columbus","43210",{"lat":461,"lon":462},39.96118,-82.99879,{"facility":464,"status":105,"city":458,"state":444,"zip":465,"country":109,"geoPoint":466},"Ohio Health","43214",{"lat":461,"lon":462},{"facility":468,"status":8,"city":469,"state":470,"zip":471,"country":109,"geoPoint":472},"Alliance Cancer Specialists","Doylestown","Pennsylvania","18901",{"lat":473,"lon":474},40.31011,-75.12989,{"facility":476,"status":105,"city":477,"state":470,"zip":478,"country":109,"geoPoint":479},"Penn State Milton S. Hershey Medical Center","Hershey","17033",{"lat":480,"lon":481},40.28592,-76.65025,{"facility":483,"status":105,"city":484,"state":470,"zip":485,"country":109,"geoPoint":486},"Hillman Cancer Center","Monroeville","15146",{"lat":487,"lon":488},40.42118,-79.7881,{"facility":490,"status":105,"city":491,"state":470,"zip":492,"country":109,"geoPoint":493},"University of Pennsylvania","Philadelphia","19104",{"lat":494,"lon":495},39.95238,-75.16362,{"facility":497,"status":8,"city":498,"state":470,"zip":499,"country":109,"geoPoint":500},"Allegheny General Hospital Cancer Institute","Pittsburgh","15212",{"lat":501,"lon":502},40.44062,-79.99589,{"facility":504,"status":8,"city":505,"state":470,"zip":506,"country":109,"geoPoint":507},"Cancer Care Associates of York","York","17403",{"lat":508,"lon":509},39.9626,-76.72774,{"facility":511,"status":8,"city":512,"state":513,"zip":514,"country":109,"geoPoint":515},"Avera Cancer Institute","Sioux Falls","South Dakota","57105",{"lat":516,"lon":517},43.54369,-96.72796,{"facility":519,"status":8,"city":520,"state":521,"zip":522,"country":109,"geoPoint":523},"Provision Center For Biomedical Research","Knoxville","Tennessee","37909",{"lat":524,"lon":525},35.96064,-83.92074,{"facility":527,"status":105,"city":528,"state":529,"zip":530,"country":109,"geoPoint":531},"Ascension Seton Spclty Care Ctr","Austin","Texas","78712",{"lat":532,"lon":533},30.26715,-97.74306,{"facility":535,"status":8,"city":528,"state":529,"zip":536,"country":109,"geoPoint":537},"Texas Oncology","78745",{"lat":532,"lon":533},{"facility":539,"status":105,"city":540,"state":529,"zip":541,"country":109,"geoPoint":542},"University of Texas Southwestern Medical Center","Dallas","75235",{"lat":543,"lon":544},32.78306,-96.80667,{"facility":546,"status":8,"city":547,"state":529,"zip":548,"country":109,"geoPoint":549},"Md Anderson Cancer 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Casa Sollievo Della Sofferenza","San Giovanni Rotondo","71013",{"lat":1330,"lon":1331},41.70643,15.7277,{"facility":1333,"status":105,"city":1334,"zip":1335,"country":1226,"geoPoint":1336},"Centro Ricerche Cliniche Di Verona","Verona","37134",{"lat":1337,"lon":1338},45.43854,10.9938,{"facility":1340,"status":105,"city":1341,"zip":1342,"country":1343},"Hyogo Cancer Center","Akashi-shi","673-8558","Japan",{"facility":1345,"status":105,"city":1346,"zip":1347,"country":1343,"geoPoint":1348},"Chiba Cancer Center","Chiba","260-8717",{"lat":1349,"lon":1350},35.6,140.11667,{"facility":1352,"status":105,"city":1353,"zip":1354,"country":1343,"geoPoint":1355},"National Cancer Center Hospital","Chūōku","104-0045",{"lat":1356,"lon":1357},33.63867,130.67068,{"facility":1359,"status":8,"city":1360,"zip":1361,"country":1343,"geoPoint":1362},"Nho Kyushu Cancer Center","Fukuoka","811-1395",{"lat":1363,"lon":1364},33.6,130.41667,{"facility":1366,"status":8,"city":1367,"zip":1368,"country":1343},"Saitama Medical University International Medical Center","Hidaka-shi","350-1298",{"facility":1370,"status":105,"city":1371,"zip":1372,"country":1343},"National Cancer Center Hospital East","Kashiwa-shi","277-8577",{"facility":1374,"status":105,"city":1375,"zip":1376,"country":1343},"St. Marianna University Hospital","Kawasaki-shi","216-8511",{"facility":1378,"status":8,"city":1379,"zip":1380,"country":1343},"Kagawa University Hospital","Kita-gun","761-0793",{"facility":1382,"status":105,"city":1383,"zip":1384,"country":1343,"geoPoint":1385},"Kobe City Hospital Organization Kobe City Medical Center General Hospital","Kobe","650-0047",{"lat":1386,"lon":1387},34.6913,135.183,{"facility":1389,"status":8,"city":1390,"zip":1391,"country":1343,"geoPoint":1392},"Cancer Institute Hospital of Jfcr","Kōtoku","135-8550",{"lat":1393,"lon":1394},42.50417,143.14297,{"facility":1396,"status":105,"city":1397,"zip":1398,"country":1343},"Kochi Medical School Hospital","Nankoku-shi","783-8505",{"facility":1400,"status":8,"city":1401,"zip":1402,"country":1343,"geoPoint":1403},"Osaka International Cancer Institute","Osaka","541-8567",{"lat":1404,"lon":1405},34.69379,135.50107,{"facility":1407,"status":8,"city":1408,"zip":1409,"country":1343,"geoPoint":1410},"Shizuoka Cancer Center","Shizuoka","411-8777",{"lat":1411,"lon":1412},34.98333,138.38333,{"facility":1414,"status":8,"city":1415,"zip":1416,"country":1343},"The University of Osaka Hospital","Suita-shi","565-0871",{"facility":1418,"status":105,"city":1419,"zip":1420,"country":1343,"geoPoint":1421},"Kanagawa Cancer Center","Yokohama","241-8515",{"lat":1422,"lon":1423},35.43333,139.65,{"facility":1425,"status":8,"city":1426,"zip":1427,"country":1428,"geoPoint":1429},"Meander Medisch Centrum","Amersfoort","3818 TZ","Netherlands",{"lat":1430,"lon":1431},52.155,5.3875,{"facility":1433,"status":105,"city":1434,"zip":1435,"country":1428,"geoPoint":1436},"Martini Ziekenhuis","Groningen","9728 NT",{"lat":1437,"lon":1438},53.21917,6.56667,{"facility":1440,"status":8,"city":1441,"zip":1442,"country":1428,"geoPoint":1443},"Maastricht Umc+","Maastricht","6229 HX",{"lat":1444,"lon":1445},50.84833,5.68889,{"facility":1447,"status":105,"city":1448,"zip":1449,"country":1428,"geoPoint":1450},"Erasmus Medical Center","Rotterdam","3015 GD",{"lat":1451,"lon":1452},51.9225,4.47917,{"facility":1454,"status":105,"city":1455,"zip":1456,"country":1457,"geoPoint":1458},"Haukeland Universitetssjukehus","Bergen","05021","Norway",{"lat":1459,"lon":1460},60.39299,5.32415,{"facility":1462,"status":105,"city":1463,"zip":1464,"country":1457},"Akershus Universitetssykehus Hf","Lørenskog","01478",{"facility":1466,"status":8,"city":1467,"zip":1468,"country":1457,"geoPoint":1469},"Utprovingsenheten, Oslo University Hospital Radiumhospitalet","Oslo","00379",{"lat":1470,"lon":1471},59.91273,10.74609,{"facility":1473,"status":105,"city":1474,"zip":1475,"country":1457,"geoPoint":1476},"Universitetssykehuset I Trondheim - St. Olavs Hospital","Trondheim","07030",{"lat":1477,"lon":1478},63.43049,10.39506,{"facility":1480,"status":105,"city":1481,"zip":1482,"country":1483,"geoPoint":1484},"Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej","Jelenia Góra","58-506","Poland",{"lat":1485,"lon":1486},50.89973,15.72899,{"facility":1488,"status":105,"city":1489,"zip":1490,"country":1483,"geoPoint":1491},"Mazowiecki Szpital Wojewodzki Im. SW. Jana Pawla Ii W Siedlcach Sp Z O O","Siedlce","08-110",{"lat":1492,"lon":1493},52.16772,22.29006,{"facility":1495,"status":105,"city":1496,"zip":1497,"country":1483,"geoPoint":1498},"Luxmed Onkologia Sp. Z O.O.","Warsaw","01-748",{"lat":1499,"lon":1500},52.22977,21.01178,{"facility":1502,"status":105,"city":1496,"zip":1503,"country":1483,"geoPoint":1504},"Narodowy Instytut Onkologii Im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy","02-034",{"lat":1499,"lon":1500},{"facility":1506,"status":8,"city":1507,"zip":1508,"country":1509,"geoPoint":1510},"Pan American Center For Oncology Trials Llc Dorado Office","Dorado","00646","Puerto Rico",{"lat":1511,"lon":1512},18.45883,-66.26767,{"facility":1514,"status":8,"city":1515,"zip":1516,"country":1517},"Samsung Changwon Hospital","Changwon-si","51353","South Korea",{"facility":1519,"status":8,"city":1520,"zip":1521,"country":1517,"geoPoint":1522},"National Cancer Center","Goyang-si","10408",{"lat":1523,"lon":1524},37.65639,126.835,{"facility":1526,"status":105,"city":1527,"zip":1528,"country":1517,"geoPoint":1529},"Seoul National University Bundang Hospital","Seongnam","13620",{"lat":1530,"lon":1531},35.48474,129.30505,{"facility":1533,"status":8,"city":1534,"zip":1535,"country":1517,"geoPoint":1536},"Cha Bundang Medical 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2TL",{"lat":1720,"lon":1721},51.48,-3.18,{"facility":1723,"status":105,"city":1724,"zip":1725,"country":1711,"geoPoint":1726},"St James University Hospital","Leeds","LS9 7TF",{"lat":1727,"lon":1728},53.79648,-1.54785,{"facility":1730,"status":105,"city":1731,"zip":1732,"country":1711,"geoPoint":1733},"Barts Hospital","London","EC1A 7BE",{"lat":1734,"lon":1735},51.50853,-0.12574,{"facility":1737,"status":105,"city":1731,"zip":1738,"country":1711,"geoPoint":1739},"Guys Hospital","SE1 9RT",{"lat":1734,"lon":1735},{"facility":1741,"status":8,"city":1731,"zip":1742,"country":1711,"geoPoint":1743},"Royal Marsden Hospital - Fulham","SW3 6JJ",{"lat":1734,"lon":1735},{"facility":1745,"status":105,"city":1746,"zip":1747,"country":1711,"geoPoint":1748},"Kent Oncology Centre - Maidstone Hospital","Maidstone","ME16 9QQ",{"lat":1749,"lon":1750},51.26667,0.51667,{"facility":1752,"status":8,"city":1753,"zip":1754,"country":1711,"geoPoint":1755},"The Christie Nhs Foundation Trust Uk","Manchester","M20 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Gene",{"nct_id":4,"found":15,"summary":1789,"prompt_version":1799},{"design":1790,"status":1791,"heading":1792,"summary":1793,"follow_up":1794,"word_count":1795,"commitments":1796,"compensation":1797,"drugs_mentioned":1798},"This is an interventional study involving approximately 700 participants. It compares standard chemotherapy and bevacizumab with or without INCA33890 or a placebo.","completed","Study for Metastatic Colorectal Cancer with INCA33890","This study is looking at a new treatment for metastatic colorectal cancer (cancer that has spread to other parts of the body) that is microsatellite stable (a specific genetic feature of the cancer). It combines standard chemotherapy (FOLFOX) and bevacizumab with or without an investigational drug called INCA33890. The main goal is to see if adding INCA33890 helps people live longer without their cancer getting worse (progression-free survival). You might be able to join if you are 18 or older, have stage IV colorectal cancer that can't be removed by surgery, and haven't had prior treatment for metastatic disease. The study aims to enroll about 700 participants. The current status of the study is unclear.","The study will measure how long participants live without their cancer progressing for up to 3 years.",115,"Not specified in the trial record.","Not stated in the trial record.",[23,41,45],"v2"]