[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05775159":3,"trial-entities:NCT05775159":394,"trial-summary:NCT05775159":111},{"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":21,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":69,"secondary_outcomes":80,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":15,"eligibility_criteria":112,"std_ages":131,"locations":134,"central_contacts":390,"overall_officials":391,"references":392,"see_also_links":393},"NCT05775159","D7987C00001","Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer","A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)","ACTIVE_NOT_RECRUITING","2027-10-28","2026-08","2026-08-24","2023-04-24","AstraZeneca","INDUSTRY",false,"GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.","This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and\u002For in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).\n\nThis study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and\u002For in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.\n\nIn Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced\u002Fmetastatic disease.",[19,20],"Hepatocellular Carcinoma","Biliary Tract Cancer",[22,23,24,25,26,27,28,29,30],"Hepatobiliary cancer","Hepatocellular carcinoma","Biliary tract cancer","GEMINI-Hepatobiliary","MEDI5752","AZD2936","Bispecific antibody","Volrustomig","Rilvegostomig","INTERVENTIONAL","TREATMENT",[34],"PHASE2",{"count":36,"type":37},294,"ESTIMATED",[39,48,53,57,61,65],{"type":40,"name":29,"description":41,"armGroupLabels":42},"DRUG","CTLA-4\u002FAnti-PD-1 Bispecific Antibody",[43,44,45,46,47],"Cohort 1A","Cohort 1B","Cohort 1C","Cohort 1D","Cohort 2B",{"type":40,"name":49,"description":50,"armGroupLabels":51},"Bevacizumab","15 mg\u002Fkg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.",[44,46,52],"Cohort 1E",{"type":40,"name":54,"description":55,"armGroupLabels":56},"Lenvatinib","Daily use per oral (8 mg capsules\u002Fday for participants \\\u003C 60 kg or 12 mg\u002Fday for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.",[45],{"type":40,"name":30,"description":58,"armGroupLabels":59},"anti- PD-1 and TIGIT bispecific antibody",[46,52,60],"Cohort 2A",{"type":40,"name":62,"description":63,"armGroupLabels":64},"Gemcitabine","1000 mg\u002Fm2, IV infusion",[60,47],{"type":40,"name":66,"description":67,"armGroupLabels":68},"Cisplatin","25 mg\u002Fm2, IV infusion",[60,47],[70,74,77],{"measure":71,"description":72,"timeFrame":73},"Objective response rate (ORR)","ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)","Through study completion, an average of 2 years",{"measure":75,"description":76,"timeFrame":73},"The number of participants with adverse events\u002Fserious adverse events","Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.",{"measure":78,"description":79,"timeFrame":73},"Progression free survival (PFS)","PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)",[81,84,88,90,93,96,100,103,107],{"measure":82,"description":83,"timeFrame":73},"Duration Of Response (DOR)","DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 by the Investigator at local site or death due to any cause in the absence of disease progression, whichever occurs first.",{"measure":85,"description":86,"timeFrame":87},"Disease Control Rate (DCR)","DCR at 12 and 24 weeks is defined as the percentage of participants who have a Complete response (CR) or Partial response (PR) in the first 13 and 25 weeks or who have Stable disease (SD) for at least 11 and 23 weeks after the date of first dose respectively, per RECIST 1.1 as assessed by the investigator at local site and derived from the raw tumour data.","At 12 and 24 weeks",{"measure":78,"description":89,"timeFrame":73},"PFS is defined as the time from the start of study intervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first.",{"measure":91,"description":92,"timeFrame":73},"Overall Survival (OS)","OS is defined as the time from the start of study intervention until the date of death due to any cause, whichever occurs first.",{"measure":94,"description":95,"timeFrame":73},"Anti Drug Antibody (ADA)","Incidences of ADAs against novel immunomodulators in serum.",{"measure":97,"description":98,"timeFrame":99},"Pharmacokinetics of novel immunomodulators: Maximum plasma concentration of the study drug (Cmax)","Maximum observed plasma concentration of the study drug","From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years )",{"measure":101,"description":102,"timeFrame":99},"Pharmacokinetics of novel immunomodulators: Time to maximum plasma concentration of the study drug (T-max)","Time to maximum observed plasma concentration of the study drug",{"measure":104,"description":105,"timeFrame":106},"lmmunogenicity of novel immunomodulators","The number and percentage of participants who develop ADAs.","From the first dose of study intervention, at predefined intervals throughout the administration of novel immunomodulators ( approx 2 years)",{"measure":71,"description":108,"timeFrame":73},"ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1","ALL","18 Years",null,{"inclusion":113,"exclusion":121,"raw_text":130},[114,115,116,117,118,119,120],"Age ≥18 years at the time of signing the ICF.","Provision of a signed and dated written ICF.","Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.","Adequate organ and bone marrow function.","At least 1 measurable not previously irradiated lesion per RECIST 1.1","Life expectancy of at least 12 weeks at the time of screening.","Willing and able to provide an adequate tumor sample.",[122,123,124,125,126,127,128,129],"History of allogeneic organ transplantation.","Active or prior documented autoimmune or inflammatory disorders.","Uncontrolled intercurrent illness.","History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.","Active infection, brain metastases or spinal cord compression.","Participants co-infected with HBV and hepatitis D virus (HDV).","Previous treatment in the present study.","For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the ICF.\n* Provision of a signed and dated written ICF.\n* Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.\n* Adequate organ and bone marrow function.\n* At least 1 measurable not previously irradiated lesion per RECIST 1.1\n* Life expectancy of at least 12 weeks at the time of screening.\n* Willing and able to provide an adequate tumor sample.\n\nExclusion Criteria:\n\n* History of allogeneic organ transplantation.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Uncontrolled intercurrent illness.\n* History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.\n* Active infection, brain metastases or spinal cord compression.\n* Participants co-infected with HBV and hepatitis D virus (HDV).\n* Previous treatment in the present study.\n* For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.",[132,133],"ADULT","OLDER_ADULT",[135,144,151,157,164,170,177,180,183,189,192,198,204,210,213,219,225,231,237,243,250,256,262,268,275,281,287,294,300,303,306,309,316,319,325,328,334,341,344,350,356,359,365,371,378,384],{"facility":136,"city":137,"state":138,"zip":139,"country":140,"geoPoint":141},"Research Site","Birmingham","Alabama","35233","United States",{"lat":142,"lon":143},33.52066,-86.80249,{"facility":136,"city":145,"state":146,"zip":147,"country":140,"geoPoint":148},"Los Angeles","California","90089",{"lat":149,"lon":150},34.05223,-118.24368,{"facility":136,"city":152,"state":146,"zip":153,"country":140,"geoPoint":154},"Orange","92868",{"lat":155,"lon":156},33.78779,-117.85311,{"facility":136,"city":158,"state":159,"zip":160,"country":140,"geoPoint":161},"Kansas City","Kansas","66103",{"lat":162,"lon":163},39.11417,-94.62746,{"facility":136,"city":165,"state":165,"zip":166,"country":140,"geoPoint":167},"New York","10065",{"lat":168,"lon":169},40.71427,-74.00597,{"facility":136,"city":171,"zip":172,"country":173,"geoPoint":174},"Beijing","100050","China",{"lat":175,"lon":176},39.9075,116.39723,{"facility":136,"city":171,"zip":178,"country":173,"geoPoint":179},"100142",{"lat":175,"lon":176},{"facility":136,"city":171,"zip":181,"country":173,"geoPoint":182},"101100",{"lat":175,"lon":176},{"facility":136,"city":184,"zip":185,"country":173,"geoPoint":186},"Chengdu","610000",{"lat":187,"lon":188},30.66667,104.06667,{"facility":136,"city":184,"zip":190,"country":173,"geoPoint":191},"610041",{"lat":187,"lon":188},{"facility":136,"city":193,"zip":194,"country":173,"geoPoint":195},"Chongqing","400030",{"lat":196,"lon":197},29.56026,106.55771,{"facility":136,"city":199,"zip":200,"country":173,"geoPoint":201},"Fuzhou","350007",{"lat":202,"lon":203},26.06139,119.30611,{"facility":136,"city":205,"zip":206,"country":173,"geoPoint":207},"Guangzhou","510060",{"lat":208,"lon":209},23.11667,113.25,{"facility":136,"city":205,"zip":211,"country":173,"geoPoint":212},"510515",{"lat":208,"lon":209},{"facility":136,"city":214,"zip":215,"country":173,"geoPoint":216},"Harbin","150081",{"lat":217,"lon":218},45.75,126.65,{"facility":136,"city":220,"zip":221,"country":173,"geoPoint":222},"Nanning","530021",{"lat":223,"lon":224},22.81667,108.31667,{"facility":136,"city":226,"zip":227,"country":173,"geoPoint":228},"Shanghai","200032",{"lat":229,"lon":230},31.22222,121.45806,{"facility":136,"city":232,"zip":233,"country":232,"geoPoint":234},"Hong Kong","999077",{"lat":235,"lon":236},22.27832,114.17469,{"facility":136,"city":238,"zip":239,"country":232,"geoPoint":240},"Shatin","00000",{"lat":241,"lon":242},22.38333,114.18333,{"facility":136,"city":244,"zip":245,"country":246,"geoPoint":247},"Florence","50134","Italy",{"lat":248,"lon":249},43.77925,11.24626,{"facility":136,"city":251,"zip":252,"country":246,"geoPoint":253},"Milan","20132",{"lat":254,"lon":255},42.78235,12.59836,{"facility":136,"city":257,"zip":258,"country":246,"geoPoint":259},"Naples","80131",{"lat":260,"lon":261},40.85216,14.26811,{"facility":136,"city":263,"zip":264,"country":246,"geoPoint":265},"Rozzano","20089",{"lat":266,"lon":267},45.38193,9.1559,{"facility":136,"city":269,"zip":270,"country":271,"geoPoint":272},"Chūōku","104-0045","Japan",{"lat":273,"lon":274},33.63867,130.67068,{"facility":136,"city":276,"zip":277,"country":271,"geoPoint":278},"Kashiwa","277-8577",{"lat":279,"lon":280},35.86224,139.97732,{"facility":136,"city":282,"zip":283,"country":271,"geoPoint":284},"Yokohama","241-8515",{"lat":285,"lon":286},35.43333,139.65,{"facility":136,"city":288,"zip":289,"country":290,"geoPoint":291},"Seongnam-si","463-712","South Korea",{"lat":292,"lon":293},37.43861,127.13778,{"facility":136,"city":295,"zip":296,"country":290,"geoPoint":297},"Seoul","03080",{"lat":298,"lon":299},37.566,126.9784,{"facility":136,"city":295,"zip":301,"country":290,"geoPoint":302},"03722",{"lat":298,"lon":299},{"facility":136,"city":295,"zip":304,"country":290,"geoPoint":305},"05505",{"lat":298,"lon":299},{"facility":136,"city":295,"zip":307,"country":290,"geoPoint":308},"06351",{"lat":298,"lon":299},{"facility":136,"city":310,"zip":311,"country":312,"geoPoint":313},"Barcelona","08036","Spain",{"lat":314,"lon":315},41.38879,2.15899,{"facility":136,"city":310,"zip":317,"country":312,"geoPoint":318},"8035",{"lat":314,"lon":315},{"facility":136,"city":320,"zip":321,"country":312,"geoPoint":322},"Madrid","28007",{"lat":323,"lon":324},40.4165,-3.70256,{"facility":136,"city":320,"zip":326,"country":312,"geoPoint":327},"28040",{"lat":323,"lon":324},{"facility":136,"city":329,"zip":330,"country":312,"geoPoint":331},"Pamplona","31008",{"lat":332,"lon":333},42.81687,-1.64323,{"facility":136,"city":335,"zip":336,"country":337,"geoPoint":338},"Kaohsiung City","80756","Taiwan",{"lat":339,"lon":340},22.61626,120.31333,{"facility":136,"city":335,"zip":342,"country":337,"geoPoint":343},"833",{"lat":339,"lon":340},{"facility":136,"city":345,"zip":346,"country":337,"geoPoint":347},"Taichung","407219",{"lat":348,"lon":349},24.1469,120.6839,{"facility":136,"city":351,"zip":352,"country":337,"geoPoint":353},"Tainan","70403",{"lat":354,"lon":355},22.99083,120.21333,{"facility":136,"city":351,"zip":357,"country":337,"geoPoint":358},"710",{"lat":354,"lon":355},{"facility":136,"city":360,"zip":361,"country":337,"geoPoint":362},"Taipei","10002",{"lat":363,"lon":364},25.05306,121.52639,{"facility":136,"city":366,"zip":367,"country":337,"geoPoint":368},"Taoyuan","333",{"lat":369,"lon":370},24.99368,121.29696,{"facility":136,"city":372,"zip":373,"country":374,"geoPoint":375},"Cambridge","CB2 0QQ","United Kingdom",{"lat":376,"lon":377},52.2,0.11667,{"facility":136,"city":379,"zip":380,"country":374,"geoPoint":381},"London","NW3 2QG",{"lat":382,"lon":383},51.50853,-0.12574,{"facility":136,"city":385,"zip":386,"country":374,"geoPoint":387},"Manchester","M20 4BX",{"lat":388,"lon":389},53.48095,-2.23743,[],[],[],[],{"nct_id":4,"conditions":395,"biomarkers":397},[19,396],"Malignant neoplasm of biliary tract",[]]