[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633528":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":55,"centralContacts":59,"locations":65,"responsibleParty":148,"collaborators":29,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":29,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":29,"enrollmentInfo":159,"targetDuration":29,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":29,"overallStatus":68,"whyStopped":29,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"DEN monotherapy (Arm A)","EXPERIMENTAL","Participants will receive DEN via intravenous (IV) infusion.",[13],"Drug: Denikitug",{"label":15,"type":10,"description":16,"interventionNames":17},"DEN in combination with NIVO (Arm B)","Participants will receive DEN as an IV infusion in combination with NIVO as an IV infusion.",[13,18],"Drug: Nivolumab",{"label":20,"type":10,"description":21,"interventionNames":22},"DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)","Participants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally.\n\nIncludes a Safety Run-in cohort (non-randomized cohort) prior to randomization.",[13,23,24],"Drug: Bevacizumab","Drug: Trifluridine-Tipiracil",{"label":26,"type":27,"description":28,"interventionNames":29},"Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)","ACTIVE_COMPARATOR","Participants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC.",null,[31,39,44,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Denikitug","Administered Intravenously",[15,20,9],[37,38],"GS-1811","DEN",{"type":32,"name":40,"description":34,"armGroupLabels":41,"otherNames":42},"Nivolumab",[15],[43],"NIVO",{"type":32,"name":45,"description":34,"armGroupLabels":46,"otherNames":47},"Bevacizumab",[20],[48],"BVZ",{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Trifluridine-Tipiracil","Administered orally",[20],[54],"FTD-TPI",[56],{"name":57,"affiliation":5,"role":58},"Gilead Study Director","STUDY_DIRECTOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":29,"email":64},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[66,80,90,96,106,116,128,138],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":29},"Yale-New Haven Hospital - Yale Cancer Center","RECRUITING","North Haven","Connecticut","06473 2195","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-72.85954,41.39093,{"lat":78,"lon":77},{"facility":81,"status":68,"city":82,"state":83,"zip":84,"country":72,"countryCode":73,"cosmosGeoPoint":85,"geoPoint":89,"contacts":29},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":75,"coordinates":86},[87,88],-71.05977,42.35843,{"lat":88,"lon":87},{"facility":91,"status":92,"city":82,"state":83,"zip":84,"country":72,"countryCode":73,"cosmosGeoPoint":93,"geoPoint":95,"contacts":29},"Dana-Farber Cancer Institute","ACTIVE_NOT_RECRUITING",{"type":75,"coordinates":94},[87,88],{"lat":88,"lon":87},{"facility":97,"status":68,"city":98,"state":99,"zip":100,"country":72,"countryCode":73,"cosmosGeoPoint":101,"geoPoint":105,"contacts":29},"Avera Cancer Institute","Sioux Falls","South Dakota","57105",{"type":75,"coordinates":102},[103,104],-96.72796,43.54369,{"lat":104,"lon":103},{"facility":107,"status":68,"city":108,"state":109,"zip":110,"country":72,"countryCode":73,"cosmosGeoPoint":111,"geoPoint":115,"contacts":29},"University of Virginia,","Charlottesville","Virginia","22908",{"type":75,"coordinates":112},[113,114],-78.47668,38.02931,{"lat":114,"lon":113},{"facility":117,"status":68,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":29},"Chris O'Brien Lifehouse","Camperdown","CA","2050","Australia","AU",{"type":75,"coordinates":124},[125,126],151.17642,-33.88965,{"lat":126,"lon":125},{"facility":129,"status":68,"city":130,"state":131,"zip":132,"country":121,"countryCode":122,"cosmosGeoPoint":133,"geoPoint":137,"contacts":29},"Royal Brisbane and Women's Hospital","Herston","Queensland","4029",{"type":75,"coordinates":134},[135,136],153.01852,-27.44453,{"lat":136,"lon":135},{"facility":139,"status":68,"city":140,"state":141,"zip":142,"country":121,"countryCode":122,"cosmosGeoPoint":143,"geoPoint":147,"contacts":29},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"type":75,"coordinates":144},[145,146],144.96332,-37.814,{"lat":146,"lon":145},{"type":149,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100633528","phase-2-study-of-denikitug-gs-1811-given-alone-or-with-nivolumab-or-with-chemotherapy-in-adults-with-advanced-colorectal-cancer-100633528",false,"NCT07527858","Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer","A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)","Key Inclusion Criteria:\n\nMedical History\u002FPhysical Characteristics\n\n* Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).\n* Documented MSS or proficient mismatch repair (pMMR) disease by local assessment using a validated polymerase chain reaction (PCR) (microsatellite status) and\u002For immunohistochemistry (IHC) mismatch repair (MMR) assay is required.\n* Has received up to 2 prior lines of systemic therapy for advanced or metastatic CRC, which must have included at least fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapies if indicated; and if applicable: anti-vascular endothelial growth factor (VEGF) therapy, anti epidermal growth factor receptor (EGFR) therapy, encorafenib or adagrasib\u002Fsotorasib.\n* Documented progressive disease (PD) by computed tomography (CT) or magnetic resonance imaging (MRI) during or after the most recent therapy per RECIST Version 1.1 criteria by investigator assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\nLaboratory Assessments\n\n* Have adequate organ function.\n\nKey Exclusion Criteria with:\n\nMedical Conditions\u002FHistory:\n\n* Significant cardiovascular disease.\n* History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease or current pneumonitis\u002F interstitial lung disease.\n* History of gastrointestinal (GI) perforation, permanent ileostomy, abdominal abscess or fistula within 6 months, active or uncontrolled GI bleeding within 4 weeks, or any condition associated with significant risk of bleeding or perforation (eg, untreated varices, tumor erosion, recent GI surgery).\n\nPrior\u002FConcurrent Therapy or Clinical Study Experience\n\nPrior treatment with:\n\n* Trifluridine-tipiracil, regorafenib, or fruquitinib.\n* Any immuno-oncology therapy.\n* Anticancer biologic agent within 4 weeks prior to randomization or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to randomization and have not recovered (ie, Grade 2 or less) from AEs from prior anticancer therapy at the time of randomization. Individuals in observational studies are eligible.\n* Allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":160,"type":161},170,"ESTIMATED","INTERVENTIONAL",[164],"PHASE2","The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based Combinations in participants with advanced microsatellite stable (MSS) colorectal cancer (CRC).\n\nThe primary objective of this study is to assess the effect of DEN as monotherapy and in combination with nivolumab (NIVO) or trifluridine-tipiracil (FTD-TPI) and bevacizumab (BVZ) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1).",[167],"Advanced Microsatellite Stable Colorectal Cancer","2026-06-30",{"date":170,"type":171},"2026-07-01","ACTUAL",{"date":173,"type":171},"2026-05-19",{"date":175,"type":161},"2028-12",{"name":5,"class":6},8]