[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06948448":3,"trial-entities:NCT06948448":399,"trial-summary:NCT06948448":403},{"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":55,"secondary_outcomes":67,"sex":108,"minimum_age":109,"maximum_age":110,"healthy_volunteers":111,"eligibility_criteria":112,"std_ages":126,"locations":129,"central_contacts":384,"overall_officials":393,"references":397,"see_also_links":398},"NCT06948448","ONO-4578-10","A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H\u002FdMMR, PD-L1 Positive Advanced Colorectal Cancer","A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H\u002FdMMR, PD-L1 Positive Advanced Colorectal Cancer","RECRUITING","2028-10-01","2026-07","2026-07-16","2025-11-18","Ono Pharmaceutical Co., Ltd.","INDUSTRY",true,"The purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.","Potential participants will be consented and screened for study eligibility. Eligible participants will be randomized in a 1:1:1 ratio to one of the three study intervention arms. Study intervention will be administered in 28-day treatment cycles and continued until disease progression, intolerable toxicity, Investigator decision or withdrawal of consent by the participant, or termination of the study by the Sponsor.",[19],"Colorectal Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},144,"ESTIMATED",[29,36,42,46,49,52],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","ONO-4578","ONO-4578 tablets once a day",[34,35],"Arm A ONO-4578 dose 1 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)","Arm B ONO-4578 dose 2 + Opdivo® + SOC (mFOLFOX6 + bevacizumab)",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Opdivo®","Specified dose on specified days",[34,35],[41],"Nivolumab",{"type":30,"name":43,"description":38,"armGroupLabels":44},"Oxaliplatin",[34,35,45],"Arm C SOC (mFOLFOX6+bevacizumab)",{"type":30,"name":47,"description":38,"armGroupLabels":48},"5-Fluorouracil",[34,35,45],{"type":30,"name":50,"description":38,"armGroupLabels":51},"Bevacizumab",[34,35,45],{"type":30,"name":53,"description":38,"armGroupLabels":54},"Leucovorin",[34,35,45],[56,60,64],{"measure":57,"description":58,"timeFrame":59},"Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)","ORR (assessed by BICR per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by BICR per RECIST v1.1 divided by the total number of participants.","From randomization to the end of treatment (Up to 39 months)",{"measure":61,"description":62,"timeFrame":63},"Number of participants with Adverse Events (AEs)","An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.","From first dose to 28 days post last dose",{"measure":65,"description":66,"timeFrame":63},"Number of participants with Serious Adverse Events (SAEs)","SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in significant disability\u002Fincapacity.",[68,71,74,77,80,83,85,88,90,93,95,98,100,103,105],{"measure":69,"description":70,"timeFrame":59},"Overall Response Rate (ORR) per Investigator assessment","ORR (assessed by site Investigator per RECIST v1.1) is defined as the proportion of participants with a BOR of confirmed CR or PR. The ORR will be estimated as the number of participants achieving BOR of CR or PR assessed by site Investigator per RECIST v1.1 divided by the total number of participants.",{"measure":72,"description":73,"timeFrame":59},"Overall Survival (OS)","OS is defined as the time between the date of randomization and the date of death due to any cause.",{"measure":75,"description":76,"timeFrame":59},"Progression-Free Survival (PFS) by BICR","PFS by BICR is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by BICR per RECIST version 1.1, or the date of death due to any cause, whichever occurs first.",{"measure":78,"description":79,"timeFrame":59},"Progression-Free Survival (PFS) by Investigator assessment","PFS by Investigator assessment is defined as the time from date of randomization to the date of the first documented progressive disease (PD) as determined by site Investigator per RECIST version 1.1, or the date of death due to any cause, whichever occurs first.",{"measure":81,"description":82,"timeFrame":59},"Best overall response (BOR) by BICR","BOR is defined as the best response designation, recorded between the start of the study intervention and the date of the initial objectively documented PD per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.",{"measure":84,"description":82,"timeFrame":59},"Best overall response (BOR) by Investigator assessment",{"measure":86,"description":87,"timeFrame":59},"Duration of response (DOR) by BICR","DOR is defined as the time between the date of first confirmed CR or PR to the date of the first documented PD per RECIST v1.1 or death due to any cause, whichever occurs first.",{"measure":89,"description":87,"timeFrame":59},"Duration of response (DOR) by Investigator assessment",{"measure":91,"description":92,"timeFrame":59},"Disease Control Rate (DCR) by BICR","DCR is defined as the percentage of participants whose BOR is determined to be CR, PR, or stable disease (SD).",{"measure":94,"description":92,"timeFrame":59},"Disease Control Rate (DCR) by Investigator assessment",{"measure":96,"description":97,"timeFrame":59},"Time to Response (TTR) by BICR","TTR is defined as the time from the date of randomization to the date of first confirmed CR or PR.",{"measure":99,"description":97,"timeFrame":59},"Time to Response (TTR) by Investigator assessment",{"measure":101,"description":102,"timeFrame":59},"Maximum percent change in the sum of the diameters of the target lesions by BICR","In participants who have target lesions at baseline and at least 1 post-baseline imaging evaluation, the maximum percent change in the sum of diameters of target lesions is the percent change at the point of the minimum sum of diameters of the target lesions.",{"measure":104,"description":102,"timeFrame":59},"Maximum percent change in the sum of the diameters of the target lesions by Investigator assessment",{"measure":106,"description":107,"timeFrame":59},"Progression-Free Survival of second line therapy (PFS2) by Investigator assessment","PFS2 is defined as the time from date of randomization to the date of an overall response of PD after subsequent anti-cancer therapy, initiating date of a second subsequent anti-cancer therapy, or date of death from any cause, whichever occurs first.","ALL","18 Years",null,false,{"inclusion":113,"exclusion":118,"raw_text":125},[114,115,116,117],"Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection","ECOG Performance Status of 0-1","No prior systemic treatment for advanced local or mCRC","Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory",[119,120,121,122,123,124],"Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor","Participants with BRAF V600E mutation","Unable to swallow tablets.","Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis","Participants with an active, known or suspected autoimmune disease.","Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.","Inclusion Criteria:\n\n* Histologically confirmed advanced (locally advanced or metastatic) colorectal cancer not amenable to curative resection\n* ECOG Performance Status of 0-1\n* No prior systemic treatment for advanced local or mCRC\n* Participants whose tumor is positive for PD-L1 expression as determined at a central laboratory\n\nExclusion Criteria:\n\n* Participants with high microsatellite instability (MSI-High), or mismatch repair deficient (dMMR) tumor\n* Participants with BRAF V600E mutation\n* Unable to swallow tablets.\n* Participants with complication or history of interstitial lung disease, pneumonitis or pulmonary fibrosis\n* Participants with an active, known or suspected autoimmune disease.\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply",[127,128],"ADULT","OLDER_ADULT",[130,139,147,155,163,170,178,186,194,202,210,217,225,232,239,247,254,261,267,273,276,283,290,297,300,303,310,313,319,327,334,337,340,348,353,359,365,372,378],{"facility":131,"status":8,"city":132,"state":133,"zip":134,"country":135,"geoPoint":136},"Mayo Clinic Arizona","Phoenix","Arizona","85054","United States",{"lat":137,"lon":138},33.44838,-112.07404,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":135,"geoPoint":144},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90033",{"lat":145,"lon":146},34.05223,-118.24368,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":135,"geoPoint":152},"Rocky Mountain Cancer Centers, LLP","Lone Tree","Colorado","80124",{"lat":153,"lon":154},39.55171,-104.8863,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":135,"geoPoint":160},"Mayo Clinic Florida","Jacksonville","Florida","32224",{"lat":161,"lon":162},30.33218,-81.65565,{"facility":164,"status":8,"city":165,"state":158,"zip":166,"country":135,"geoPoint":167},"Advent Health","Orlando","32803",{"lat":168,"lon":169},28.53834,-81.37924,{"facility":171,"status":8,"city":172,"state":173,"zip":174,"country":135,"geoPoint":175},"May Clinic Rochester","Rochester","Minnesota","55905",{"lat":176,"lon":177},44.02163,-92.4699,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":135,"geoPoint":183},"The Ohio State University Comprehensive Cancer Center","Columbus","Ohio","43221",{"lat":184,"lon":185},39.96118,-82.99879,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":135,"geoPoint":191},"Thomas Jefferson University, Sidney Kimmel Cancer Center","Philadelphia","Pennsylvania","19107",{"lat":192,"lon":193},39.95238,-75.16362,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":135,"geoPoint":199},"Baylor Scott & White Medical Center","Temple","Texas","76508",{"lat":200,"lon":201},31.09823,-97.34278,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":135,"geoPoint":207},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"lat":208,"lon":209},36.84681,-76.28522,{"facility":211,"status":8,"city":212,"state":205,"zip":213,"country":135,"geoPoint":214},"Blue Ridge Cancer Care","Salem","24153",{"lat":215,"lon":216},37.29347,-80.05476,{"facility":218,"status":8,"city":219,"state":220,"country":221,"geoPoint":222},"The Ottawa Hospital Cancer Centre","Ottawa","Ontario","Canada",{"lat":223,"lon":224},45.41117,-75.69812,{"facility":226,"status":8,"city":227,"state":220,"zip":228,"country":221,"geoPoint":229},"Princess Margaret Cancer Centre- University Health Network","Toronto","M5G 2M9",{"lat":230,"lon":231},43.70643,-79.39864,{"facility":233,"status":8,"city":234,"state":235,"country":221,"geoPoint":236},"Jewish General Hospital","Montreal","Quebec",{"lat":237,"lon":238},45.50884,-73.58781,{"facility":240,"status":8,"city":241,"state":242,"country":243,"geoPoint":244},"CHU Besançon - Hôpital Jean Minjoz","Besançon","Doubs","France",{"lat":245,"lon":246},47.24878,6.01815,{"facility":248,"status":8,"city":249,"state":250,"country":243,"geoPoint":251},"CHU Bordeaux - Hôpital Haut-Lévêque","Pessac","Gironde",{"lat":252,"lon":253},44.80565,-0.6324,{"facility":255,"status":8,"city":256,"state":257,"country":243,"geoPoint":258},"Chru De Nantes Hotel-Dieu","Nantes","Loire Atlantique",{"lat":259,"lon":260},47.21725,-1.55336,{"facility":262,"status":8,"city":263,"state":263,"country":243,"geoPoint":264},"Hôpital de la Timone","Marseille",{"lat":265,"lon":266},43.29695,5.38107,{"facility":268,"status":8,"city":269,"state":269,"country":243,"geoPoint":270},"Hôpital Européen Georges Pompidou","Paris",{"lat":271,"lon":272},48.85341,2.3488,{"facility":274,"status":8,"city":269,"state":269,"country":243,"geoPoint":275},"Hôpital Saint-Antoine",{"lat":271,"lon":272},{"facility":277,"status":8,"city":278,"state":279,"country":243,"geoPoint":280},"Centre Leon Berard","Lyon","Rhone",{"lat":281,"lon":282},45.74906,4.84789,{"facility":284,"status":8,"city":285,"state":286,"country":243,"geoPoint":287},"CHU Poitiers - Hôpital la Milétrie","Poitiers","Vienne",{"lat":288,"lon":289},46.58261,0.34348,{"facility":291,"status":8,"city":292,"state":293,"country":293,"geoPoint":294},"Azienda Socio Sanitaria Territoriale Niguarda","Milan","Italy",{"lat":295,"lon":296},42.78235,12.59836,{"facility":298,"status":8,"city":292,"state":293,"country":293,"geoPoint":299},"Istituto Clinico Humanitas",{"lat":295,"lon":296},{"facility":301,"status":8,"city":292,"state":293,"country":293,"geoPoint":302},"Istituto Europeo di Oncologia",{"lat":295,"lon":296},{"facility":304,"status":8,"city":305,"state":306,"country":293,"geoPoint":307},"AOU Uni degli Studi Della Campania Lugi Vanvitelli","Naples","Napoli",{"lat":308,"lon":309},40.85216,14.26811,{"facility":311,"status":8,"city":305,"state":306,"country":293,"geoPoint":312},"Istituto Nazionale Tumori Fondazione G. Pascale",{"lat":308,"lon":309},{"facility":314,"status":8,"city":315,"state":315,"country":293,"geoPoint":316},"IOV-Istituto Oncologico","Padova",{"lat":317,"lon":318},44.38225,11.14261,{"facility":320,"status":8,"city":321,"state":322,"country":323,"geoPoint":324},"Kobe City Medical Center General Hospital","Hyōgo","Kobe-shi","Japan",{"lat":325,"lon":326},43.36667,144.43333,{"facility":328,"status":8,"city":329,"state":330,"country":323,"geoPoint":331},"National Hospital Organization Osaka National Hospital","Osaka","Osaka-shi",{"lat":332,"lon":333},34.69379,135.50107,{"facility":335,"status":8,"city":329,"state":330,"country":323,"geoPoint":336},"Osaka General Medical Center",{"lat":332,"lon":333},{"facility":338,"status":8,"city":329,"state":330,"country":323,"geoPoint":339},"Osaka International Cancer Institute",{"lat":332,"lon":333},{"facility":341,"status":8,"city":342,"state":343,"country":344,"geoPoint":345},"Institut Catala d'Oncologia (H. Germans Trias I Pujol, ICO-Barcelona)","Badalona","Barcelona","Spain",{"lat":346,"lon":347},41.45004,2.24741,{"facility":349,"status":8,"city":343,"state":343,"country":344,"geoPoint":350},"Hosptial Universitari Vall d'Hebron",{"lat":351,"lon":352},41.38879,2.15899,{"facility":354,"status":8,"city":355,"state":355,"country":344,"geoPoint":356},"Hospital Universitario Reina Sofia","Córdoba",{"lat":357,"lon":358},37.89155,-4.77275,{"facility":360,"status":8,"city":361,"state":361,"country":344,"geoPoint":362},"Hospital Universitario 12 de Octubre","Madrid",{"lat":363,"lon":364},40.4165,-3.70256,{"facility":366,"status":8,"city":367,"state":368,"country":344,"geoPoint":369},"Hospital Universitario Virgen del Rocio","Seville","Sevilla",{"lat":370,"lon":371},37.38283,-5.97317,{"facility":373,"status":8,"city":374,"state":344,"country":344,"geoPoint":375},"Hospital Regional Universitario de Malaga","Málaga",{"lat":376,"lon":377},36.72016,-4.42034,{"facility":379,"status":8,"city":380,"state":380,"country":344,"geoPoint":381},"Hospital General Universitario de Valencia","Valencia",{"lat":382,"lon":383},39.47391,-0.37966,[385,390],{"name":386,"role":387,"phone":388,"email":389},"North America Clinical Trial Support Desk","CONTACT","+18665877745(Toll-Free)","clinical_trial@ono-pharma.com",{"name":391,"role":387,"phone":392,"email":389},"International Clinical Trial Support Desk","+17162141777(Standard)",[394],{"name":395,"affiliation":13,"role":396},"Project Leader","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":400,"biomarkers":402},[401],"Colorectal Carcinoma",[],{"nct_id":4,"found":15,"summary":404,"prompt_version":414},{"design":405,"status":406,"heading":407,"summary":408,"follow_up":409,"word_count":410,"commitments":411,"compensation":412,"drugs_mentioned":413},"This is an interventional study with an unclear phase, planning to enroll 144 participants. Participants will be randomly assigned to one of three treatment groups.","completed","A Study of ONO-4578 with Opdivo® for Advanced Colorectal Cancer","This study is looking at two different doses of ONO-4578, given along with Opdivo®, mFOLFOX6 (a chemotherapy combination of Oxaliplatin, 5-Fluorouracil, and Leucovorin), and Bevacizumab. This combination is compared to the standard treatment for advanced colorectal cancer. You may be able to join if you have advanced colorectal cancer that has not spread to other parts of your body, or has spread (metastatic), and your tumor shows a specific biomarker called PD-L1. The study aims to see how well the treatment shrinks tumors (Overall Response Rate) and to track any side effects. The current status of this study is unclear.","The study will track how well the treatment works until the end of treatment (up to 39 months). Side effects will be monitored from the first dose until 28 days after the last dose.",100,"Eligible participants will receive treatment in 28-day cycles. Treatment continues until the disease gets worse, side effects are too severe, or you decide to stop.","Not stated in the trial record.",[31,37,43,47,50],"v2"]