[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07227012":3,"trial-entities:NCT07227012":453,"trial-summary:NCT07227012":456},{"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":26,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":33,"interventions":36,"primary_outcomes":49,"secondary_outcomes":65,"sex":89,"minimum_age":90,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":116,"locations":119,"central_contacts":439,"overall_officials":445,"references":448,"see_also_links":449},"NCT07227012","C6461013","Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatment in Adult Participants With a Liver Cancer Called Hepatocellular Carcinoma, That is Too Advanced to be Removed by Surgery and May Have Spread to Other Parts of the Body.","AN INTERVENTIONAL OPEN-LABEL PHASE 1B\u002F2 STUDY TO EVALUATE SAFETY, PHARMACOKINETICS, AND PRELIMINARY EFFICACY OF PF-08634404 AS MONOTHERAPY AND COMBINATION THERAPY IN ADULT PARTICIPANTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA","RECRUITING","2028-10-17","2026-08","2026-08-17","2025-12-01","Pfizer","INDUSTRY",false,"The purpose of this study is to learn about the effects of study medicine (PF-08634404) when given alone or with another antibody (ipilimumab) for the treatment of a type of liver cancer called hepatocellular carcinoma (HCC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced or metastatic HCC.\n* Is not a candidate for complete surgical or loco-regional therapies.\n* Have not received any whole-body treatment for HCC.\n\nParticipants will receive PF-08634404 either alone or in combination with ipilimumab. The medicine will be given through intravenous (IV) infusions, which means it will be administered directly into a vein. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.",null,[19,20,21,22,23,24,25],"Carcinoma, Hepatocellular","Hepatocellular Cancer","Hepatocellular Carcinoma","Unresectable Hepatocellular Carcinoma","Liver Neoplasms","Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma",[21,27,23],"Liver cancer","INTERVENTIONAL","TREATMENT",[31,32],"PHASE1","PHASE2",{"count":34,"type":35},138,"ESTIMATED",[37,44],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BIOLOGICAL","PF-08634404","Solution for infusion",[42,43],"Phase 1b","Phase 2",{"type":38,"name":45,"description":40,"armGroupLabels":46,"otherNames":47},"Ipilimumab",[42,43],[48],"YERVOY",[50,54,58,62],{"measure":51,"description":52,"timeFrame":53},"Number of Participants With Adverse Events","Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.","Through end of study and up to approximately 24 months",{"measure":55,"description":56,"timeFrame":57},"Phase 1b: Number of participants with Dose limiting toxicities (DLT)","DLTs are a predefined set of adverse events that are at least possibly related to any or all of the study interventions. The number of participants who experienced DLTs during the DLT observation period.","Through 90 days after the last dose of study intervention; Approximately 24 months",{"measure":59,"description":60,"timeFrame":61},"Phase 2: Confirmed Overall Response Rate (ORR) using RECIST 1.1 as assessed by investigator","ORR is the proportion of participants with a best overall response (BOR) of confirmed CR or confirmed PR per RECIST 1.1 by investigator.","Approximately 24 months",{"measure":63,"description":64,"timeFrame":61},"Phase 2: Recommended dose of PF-08634404 in combination with ipilimumab","The doses of PF-08634404 and ipilimumab selected to be used in combination based on safety, tolerability, pharmacokinetics, and initial anti-tumor efficacy from Phase 2.",[66,69,72,75,78,82,86],{"measure":67,"description":68,"timeFrame":61},"Phase 1b: Confirmed Objective Response Rate (ORR) using RECIST 1.1 as assessed by investigator","ORR is the proportion of participants with a best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST 1.1 by investigator.",{"measure":70,"description":71,"timeFrame":61},"Duration of Response (DOR) per RECIST 1.1 by investigator","DOR is the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.",{"measure":73,"description":74,"timeFrame":61},"Progression Free Survival (PFS) per RECIST 1.1 by investigator","PFS is defined as the time from the date of first dose to the date of first documented disease progression per RECIST 1.1 as assessed by investigator, or death due to any cause, whichever occurs first.",{"measure":76,"description":77,"timeFrame":61},"Overall Survival (OS)","OS is defined as the time from the date of first dose to the date of death due to any cause.",{"measure":79,"description":80,"timeFrame":81},"Number of Participants With Clinical Laboratory Abnormalities","Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing","Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (assessed up to approximately 24 months)",{"measure":83,"description":84,"timeFrame":85},"Pharmacokinetics (PK): Serum concentrations of PF-08634404","Predose and\u002For postdose concentrations of PF-08634404 in combination with ipilimumab.","Up to 24 months",{"measure":87,"description":88,"timeFrame":85},"Incidence of antidrug antibody against PF-08634404","To evaluate immunogenicity of PF-08634404 in combination with ipilimumab.","ALL","18 Years",{"inclusion":92,"exclusion":101,"raw_text":115},[93,94,95,96,97,98,99,100],"18 years of age or older at screening.","Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.","Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.","At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.","Adequate hepatic, liver, and renal function","No prior systemic therapy for HCC.","ECOG performance status 0 or 1","Child-Pugh Class A",[102,103,104,105,106,107,108,109,110,111,112,113,114],"Moderate or severe ascites.","History of hepatic encephalopathy.","Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.","Clinically significant risk of hemorrhage or fistula.","Participants with any history of another malignancy within 3 years.","History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.","Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.","Clinically significant cardiovascular disease within 6 months prior to the first dose.","Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.","History of severe bleeding tendency or coagulation dysfunction.","History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.","Participants with acute, chronic or symptomatic infections.","Participants with history of immunodeficiency.","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Locally advanced or metastatic HCC with diagnosis confirmed by histology\u002Fcytology or clinically by AASLD criteria (for patients with cirrhosis). Participants without cirrhosis require histological confirmation of diagnosis.\n* Disease that is not amenable to curative surgical and\u002For locoregional therapies, or progressive disease after surgical and\u002For locoregional therapies.\n* At least 1 measurable (as defined by RECIST 1.1 per investigator) and untreated lesion.\n* Adequate hepatic, liver, and renal function\n* No prior systemic therapy for HCC.\n* ECOG performance status 0 or 1\n* Child-Pugh Class A\n\nKey Exclusion Criteria:\n\n* Moderate or severe ascites.\n* History of hepatic encephalopathy.\n* Participants with known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Clinically significant risk of hemorrhage or fistula.\n* Participants with any history of another malignancy within 3 years.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years.\n* Clinically significant cardiovascular disease within 6 months prior to the first dose.\n* Major surgery or severe trauma within 4 weeks prior to the first dose or planned major surgery during the study.\n* History of severe bleeding tendency or coagulation dysfunction.\n* History of severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, including bleeding event due to esophageal and\u002For gastric varices, within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections.\n* Participants with history of immunodeficiency.",[117,118],"ADULT","OLDER_ADULT",[120,129,132,135,142,145,148,151,158,165,173,180,187,191,194,197,204,212,215,223,230,237,245,252,259,266,269,276,280,283,287,295,298,301,309,316,319,322,329,338,342,346,355,363,371,376,383,392,399,406,413,421,428,435],{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":125,"geoPoint":126},"Chao Family Comprehensive Cancer Center and Ambulatory Care","Irvine","California","92612","United States",{"lat":127,"lon":128},33.66946,-117.82311,{"facility":130,"status":8,"city":122,"state":123,"zip":124,"country":125,"geoPoint":131},"UCI Health - Irvine Infusion Pharmacy ACC",{"lat":127,"lon":128},{"facility":133,"status":8,"city":122,"state":123,"zip":124,"country":125,"geoPoint":134},"UCI Health - Irvine",{"lat":127,"lon":128},{"facility":136,"status":8,"city":137,"state":123,"zip":138,"country":125,"geoPoint":139},"Keck Hospital of USC","Los Angeles","90033",{"lat":140,"lon":141},34.05223,-118.24368,{"facility":143,"status":8,"city":137,"state":123,"zip":138,"country":125,"geoPoint":144},"Los Angeles General Medical Center",{"lat":140,"lon":141},{"facility":146,"status":8,"city":137,"state":123,"zip":138,"country":125,"geoPoint":147},"USC\u002FNorris Comprehensive Cancer Center \u002F Investigational Drug Services",{"lat":140,"lon":141},{"facility":149,"status":8,"city":137,"state":123,"zip":138,"country":125,"geoPoint":150},"USC\u002FNorris Comprehensive Cancer Center",{"lat":140,"lon":141},{"facility":152,"status":8,"city":153,"state":123,"zip":154,"country":125,"geoPoint":155},"UC Irvine Health - Chao Family Comprehensive Cancer Center","Orange","92868",{"lat":156,"lon":157},33.78779,-117.85311,{"facility":159,"status":8,"city":160,"state":123,"zip":161,"country":125,"geoPoint":162},"Keck Medical Center of USC Pasadena","Pasadena","91105",{"lat":163,"lon":164},34.14778,-118.14452,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":125,"geoPoint":170},"Moffitt Cancer Center at Speros","Land O' Lakes","Florida","34638",{"lat":171,"lon":172},28.2189,-82.45759,{"facility":174,"status":8,"city":175,"state":168,"zip":176,"country":125,"geoPoint":177},"Moffitt Cancer Center at SouthShore","Ruskin","33570",{"lat":178,"lon":179},27.72086,-82.43315,{"facility":181,"status":8,"city":182,"state":168,"zip":183,"country":125,"geoPoint":184},"Moffitt Cancer Center - International Plaza","Tampa","33607",{"lat":185,"lon":186},27.94752,-82.45843,{"facility":188,"status":8,"city":182,"state":168,"zip":189,"country":125,"geoPoint":190},"Moffitt Cancer Center - McKinley Campus","33612",{"lat":185,"lon":186},{"facility":192,"status":8,"city":182,"state":168,"zip":189,"country":125,"geoPoint":193},"Moffitt Cancer Center",{"lat":185,"lon":186},{"facility":195,"status":8,"city":182,"state":168,"zip":189,"country":125,"geoPoint":196},"Moffitt McKinley Hospital",{"lat":185,"lon":186},{"facility":198,"status":8,"city":199,"state":168,"zip":200,"country":125,"geoPoint":201},"Moffitt Cancer Center at Wesley Chapel","Wesley Chapel","33544",{"lat":202,"lon":203},28.23973,-82.32787,{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":125,"geoPoint":209},"Memorial Hospital","Shiloh","Illinois","62269",{"lat":210,"lon":211},38.56144,-89.89732,{"facility":213,"status":8,"city":206,"state":207,"zip":208,"country":125,"geoPoint":214},"Siteman Cancer Center - Shiloh",{"lat":210,"lon":211},{"facility":216,"status":8,"city":217,"state":218,"zip":219,"country":125,"geoPoint":220},"Allina Health Cancer Institute - Mercy Hospital","Coon Rapids","Minnesota","55433",{"lat":221,"lon":222},45.11997,-93.28773,{"facility":224,"status":8,"city":225,"state":218,"zip":226,"country":125,"geoPoint":227},"Allina Health Cancer Institute - Abbott Northwestern Hospital","Minneapolis","55407",{"lat":228,"lon":229},44.97997,-93.26384,{"facility":231,"status":8,"city":232,"state":218,"zip":233,"country":125,"geoPoint":234},"Allina Health Cancer Institute - United Hospital","Saint Paul","55102",{"lat":235,"lon":236},44.94441,-93.09327,{"facility":238,"status":8,"city":239,"state":240,"zip":241,"country":125,"geoPoint":242},"Siteman Cancer Center - St. Peters","City of Saint Peters","Missouri","63376",{"lat":243,"lon":244},38.80033,-90.62651,{"facility":246,"status":8,"city":247,"state":240,"zip":248,"country":125,"geoPoint":249},"Siteman Cancer Center - West County","Creve Coeur","63141",{"lat":250,"lon":251},38.66089,-90.42262,{"facility":253,"status":8,"city":254,"state":240,"zip":255,"country":125,"geoPoint":256},"Siteman Cancer Center - North County","Florissant","63031",{"lat":257,"lon":258},38.78922,-90.32261,{"facility":260,"status":8,"city":261,"state":240,"zip":262,"country":125,"geoPoint":263},"Saint Luke's Cancer Institute","Kansas City","64111",{"lat":264,"lon":265},39.09973,-94.57857,{"facility":267,"status":8,"city":261,"state":240,"zip":262,"country":125,"geoPoint":268},"Saint Luke's Hospital of Kansas City",{"lat":264,"lon":265},{"facility":270,"status":8,"city":271,"state":240,"zip":272,"country":125,"geoPoint":273},"Siteman Cancer Center","St Louis","63108",{"lat":274,"lon":275},38.62727,-90.19789,{"facility":277,"status":8,"city":271,"state":240,"zip":278,"country":125,"geoPoint":279},"Barnes-Jewish Hospital","63110",{"lat":274,"lon":275},{"facility":281,"status":8,"city":271,"state":240,"zip":278,"country":125,"geoPoint":282},"Washington University School of Medicine - Siteman Cancer Center",{"lat":274,"lon":275},{"facility":284,"status":8,"city":271,"state":240,"zip":285,"country":125,"geoPoint":286},"Siteman Cancer Center - South County","63129",{"lat":274,"lon":275},{"facility":288,"status":8,"city":289,"state":290,"zip":291,"country":125,"geoPoint":292},"Renown Health Medical Oncology","Reno","Nevada","89502",{"lat":293,"lon":294},39.52963,-119.8138,{"facility":296,"status":8,"city":289,"state":290,"zip":291,"country":125,"geoPoint":297},"Renown Office of Clinical Research",{"lat":293,"lon":294},{"facility":299,"status":8,"city":289,"state":290,"zip":291,"country":125,"geoPoint":300},"Renown Regional Medical Center",{"lat":293,"lon":294},{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":125,"geoPoint":306},"Duke Cancer Center Cary","Cary","North Carolina","27518",{"lat":307,"lon":308},35.79154,-78.78112,{"facility":310,"status":8,"city":311,"state":304,"zip":312,"country":125,"geoPoint":313},"Duke Cancer Center - Investigational Chemotherapy Service","Durham","27710",{"lat":314,"lon":315},35.99403,-78.89862,{"facility":317,"status":8,"city":311,"state":304,"zip":312,"country":125,"geoPoint":318},"Duke Cancer Center",{"lat":314,"lon":315},{"facility":320,"status":8,"city":311,"state":304,"zip":312,"country":125,"geoPoint":321},"Duke University - Main Hospital and Clinics",{"lat":314,"lon":315},{"facility":323,"status":8,"city":324,"state":304,"zip":325,"country":125,"geoPoint":326},"Duke Cancer Center Raleigh","Raleigh","27609",{"lat":327,"lon":328},35.7721,-78.63861,{"facility":330,"status":331,"city":332,"state":333,"zip":334,"country":125,"geoPoint":335},"Virginia Mason Medical Center","NOT_YET_RECRUITING","Seattle","Washington","98101",{"lat":336,"lon":337},47.60621,-122.33207,{"facility":339,"status":8,"city":332,"state":333,"zip":340,"country":125,"geoPoint":341},"Fred Hutchinson Cancer Center","98109",{"lat":336,"lon":337},{"facility":343,"status":8,"city":332,"state":333,"zip":344,"country":125,"geoPoint":345},"University of Washington Medical Center- Montlake","98195",{"lat":336,"lon":337},{"facility":347,"status":8,"city":348,"state":349,"zip":350,"country":351,"geoPoint":352},"Aichi Cancer Center","Nagoya","Aichi-ken","464-8681","Japan",{"lat":353,"lon":354},35.18147,136.90641,{"facility":356,"status":8,"city":357,"state":358,"zip":359,"country":351,"geoPoint":360},"National Cancer Center Hospital East","Kashiwa","Chiba","277-8577",{"lat":361,"lon":362},35.86224,139.97732,{"facility":364,"status":8,"city":365,"state":366,"zip":367,"country":351,"geoPoint":368},"Kindai University Hospital- Osaka Medical Campus","Sakai","Osaka","590-0197",{"lat":369,"lon":370},34.58216,135.46653,{"facility":372,"status":8,"city":373,"state":374,"zip":375,"country":351},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"facility":377,"status":8,"city":378,"zip":379,"country":351,"geoPoint":380},"National Hospital Organization Kyushu Cancer Center","Fukuoka","811-1395",{"lat":381,"lon":382},33.6,130.41667,{"facility":384,"status":8,"city":385,"state":386,"zip":387,"country":388,"geoPoint":389},"Pan American Center for Oncology Trials, LLC - Dorado Office","Dorado","United States of America","00646","Puerto Rico",{"lat":390,"lon":391},18.45883,-66.26767,{"facility":393,"status":8,"city":394,"state":386,"zip":395,"country":388,"geoPoint":396},"Pan American Center for Oncology Trials, LLC - Mayaguez Office","Mayagüez","00680",{"lat":397,"lon":398},18.20107,-67.13962,{"facility":400,"status":8,"city":401,"state":386,"zip":402,"country":388,"geoPoint":403},"Pan American Center for Oncology Trials, LLC - Ponce Office","Ponce","00730",{"lat":404,"lon":405},18.01031,-66.62398,{"facility":407,"status":8,"city":408,"zip":409,"country":388,"geoPoint":410},"Pan American Center for Oncology Trials, LLC","San Juan","00909",{"lat":411,"lon":412},18.46633,-66.10572,{"facility":414,"status":8,"city":415,"zip":416,"country":417,"geoPoint":418},"Taichung Veterans General Hospital","Taichung","407","Taiwan",{"lat":419,"lon":420},24.1469,120.6839,{"facility":422,"status":8,"city":423,"zip":424,"country":417,"geoPoint":425},"National Cheng Kung University Hospital","Tainan","704",{"lat":426,"lon":427},22.99083,120.21333,{"facility":429,"status":8,"city":430,"zip":431,"country":417,"geoPoint":432},"National Taiwan University Hospital","Taipei","10002",{"lat":433,"lon":434},25.05306,121.52639,{"facility":436,"status":8,"city":430,"zip":437,"country":417,"geoPoint":438},"Taipei Veterans General Hospital","112",{"lat":433,"lon":434},[440],{"name":441,"role":442,"phone":443,"email":444},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[446],{"name":441,"affiliation":13,"role":447},"STUDY_DIRECTOR",[],[450],{"label":451,"url":452},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6461013",{"nct_id":4,"conditions":454,"biomarkers":455},[21],[],{"nct_id":4,"found":457,"summary":458,"prompt_version":468},true,{"design":459,"status":460,"heading":461,"summary":462,"follow_up":463,"word_count":464,"commitments":465,"compensation":466,"drugs_mentioned":467},"This is an interventional study, meaning participants will receive specific treatments. It will involve approximately 138 participants.","completed","Study of PF-08634404 for Advanced Liver Cancer","This study is looking into a new treatment called PF-08634404, given alone or with another medicine called ipilimumab, for adults with a type of liver cancer called hepatocellular carcinoma (HCC). This is for HCC that is too advanced for surgery or has spread to other parts of the body. The main goals are to see how safe the treatments are and how well they shrink the cancer. You might be able to join if you are 18 or older, have advanced HCC, and haven't had other whole-body treatments for it. The study plans to include about 138 participants.","Participants will be followed for adverse events through the end of the study and up to approximately 24 months. Dose-limiting toxicities will be measured through 90 days after the last dose of study intervention.",98,"Participants will receive PF-08634404, either alone or with ipilimumab, through intravenous (IV) infusions directly into a vein.","Not stated in the trial record.",[39,45],"v2"]