[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07527858":3,"trial-entities:NCT07527858":229,"trial-summary:NCT07527858":234},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":57,"secondary_outcomes":62,"sex":88,"minimum_age":89,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":90,"std_ages":108,"locations":111,"central_contacts":214,"overall_officials":220,"references":224,"see_also_links":225},"NCT07527858","GS-US-741-7756","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)","RECRUITING","2028-12","2026-07","2026-07-28","2026-05-19","Gilead Sciences","INDUSTRY",false,"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).",null,[19],"Advanced Microsatellite Stable Colorectal Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},170,"ESTIMATED",[29,40,45,51],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":37},"DRUG","Denikitug","Administered Intravenously",[34,35,36],"DEN in combination with NIVO (Arm B)","DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C)","DEN monotherapy (Arm A)",[38,39],"GS-1811","DEN",{"type":30,"name":41,"description":32,"armGroupLabels":42,"otherNames":43},"Nivolumab",[34],[44],"NIVO",{"type":30,"name":46,"description":32,"armGroupLabels":47,"otherNames":49},"Bevacizumab",[35,48],"Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D)",[50],"BVZ",{"type":30,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Trifluridine-Tipiracil","Administered orally",[35,48],[56],"FTD-TPI",[58],{"measure":59,"description":60,"timeFrame":61},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.","Up to 60 months",[63,66,69,72,75,77,80,83,86],{"measure":64,"description":65,"timeFrame":61},"Duration of response (DOR)","DOR is defined as the time from first response (CR or PR) as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first.",{"measure":67,"description":68,"timeFrame":61},"Progression-Free Survival (PFS)","PFS is defined as the time from date of randomization until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.",{"measure":70,"description":71,"timeFrame":61},"Overall Survival (OS)","OS is defined as the length of time from randomization until the date of death from any cause.",{"measure":73,"timeFrame":74},"Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0","First dose date up to 120 days post last dose, up to 60 months",{"measure":76,"timeFrame":74},"Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0",{"measure":78,"timeFrame":79},"Pharmacokinetic (PK) Parameter: Serum concentration of Denikitug","Up to 36 months",{"measure":81,"description":82,"timeFrame":79},"PK Parameter: Cmax for Denikitug","Cmax is defined as the maximum observed concentration.",{"measure":84,"description":85,"timeFrame":79},"PK Parameter: AUCall for Denikitug","AUCall is defined as the cumulative areas under the curve for all time points.",{"measure":87,"timeFrame":79},"Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug","ALL","18 Years",{"inclusion":91,"exclusion":98,"raw_text":107},[92,93,94,95,96,97],"Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer).","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.","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.","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.","Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.","Have adequate organ function.",[99,100,101,102,103,104,105,106],"Significant cardiovascular disease.","History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years.","History of (noninfectious) pneumonitis\u002Finterstitial lung disease or current pneumonitis\u002F interstitial lung disease.","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).","Trifluridine-tipiracil, regorafenib, or fruquitinib.","Any immuno-oncology therapy.","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.","Allogeneic tissue\u002Fsolid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.","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.",[109,110],"ADULT","OLDER_ADULT",[112,121,129,133,142,150,158,167,175,183,191,198,202,206],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"Yale-New Haven Hospital - Yale Cancer Center","North Haven","Connecticut","06473 2195","United States",{"lat":119,"lon":120},41.39093,-72.85954,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":117,"geoPoint":126},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"lat":127,"lon":128},42.35843,-71.05977,{"facility":130,"status":131,"city":123,"state":124,"zip":125,"country":117,"geoPoint":132},"Dana-Farber Cancer Institute","ACTIVE_NOT_RECRUITING",{"lat":127,"lon":128},{"facility":134,"status":135,"city":136,"state":137,"zip":138,"country":117,"geoPoint":139},"Washington University School of Medicine","NOT_YET_RECRUITING","St Louis","Missouri","63110",{"lat":140,"lon":141},38.62727,-90.19789,{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":117,"geoPoint":147},"Avera Cancer Institute","Sioux Falls","South Dakota","57105",{"lat":148,"lon":149},43.54369,-96.72796,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":117,"geoPoint":155},"University of Virginia,","Charlottesville","Virginia","22908",{"lat":156,"lon":157},38.02931,-78.47668,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":163,"geoPoint":164},"Chris O'Brien Lifehouse","Camperdown","CA","2050","Australia",{"lat":165,"lon":166},-33.88965,151.17642,{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":163,"geoPoint":172},"Royal Brisbane and Women's Hospital","Herston","Queensland","4029",{"lat":173,"lon":174},-27.44453,153.01852,{"facility":176,"status":8,"city":177,"state":178,"zip":179,"country":163,"geoPoint":180},"Peter MacCallum Cancer Centre","Melbourne","Victoria","3000",{"lat":181,"lon":182},-37.814,144.96332,{"facility":184,"status":135,"city":185,"zip":186,"country":187,"geoPoint":188},"Samsung Medical Center","Busan","48775","South Korea",{"lat":189,"lon":190},35.10168,129.03004,{"facility":192,"status":135,"city":193,"zip":194,"country":187,"geoPoint":195},"Seoul National University Hospital","Seoul","03080",{"lat":196,"lon":197},37.566,126.9784,{"facility":199,"status":135,"city":193,"zip":200,"country":187,"geoPoint":201},"Yonsei University Severance Hospital ( aka Yonsei Cancer Center)","03722",{"lat":196,"lon":197},{"facility":203,"status":135,"city":193,"zip":204,"country":187,"geoPoint":205},"Asan Medical Center","138-736",{"lat":196,"lon":197},{"facility":207,"status":135,"city":208,"zip":209,"country":210,"geoPoint":211},"Hospital General Universitario Gregorio Maranon","Madrid","28050","Spain",{"lat":212,"lon":213},40.4165,-3.70256,[215],{"name":216,"role":217,"phone":218,"email":219},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[221],{"name":222,"affiliation":13,"role":223},"Gilead Study Director","STUDY_DIRECTOR",[],[226],{"label":227,"url":228},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07527858",{"nct_id":4,"conditions":230,"biomarkers":232},[231],"Colorectal Carcinoma",[233],"MRC1 wt Allele",{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]