[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrolamellar-hepatocellular-carcinoma-flc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrolamellar-hepatocellular-carcinoma-flc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100576738","phase-1-peptide-vaccine-for-fibrolamellar-hepatocellular-carcinoma-patients-and-other-tumor-entities-carrying-the-driver-fusion-dnajb1-prkaca-100576738",false,"NCT06789198","Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA","FusionVAC22_02: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Oncogenic Driver Fusion","FusionVAC22_02","Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written informed consent document.\n* Histologically confirmed Fibrolamellar hepatocellular carcinoma (FL-HCC) or other malignant disease in an adjuvant setting, defined as:\n\n  * Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based NGS or RT-PCR\n  * Achievement of complete remission (CR) according to RECIST1.1 by any of the following therapeutic measures:\n* surgical procedures,\n* radiotherapy,\n* local therapeutic measures (e.g. TACE, SIRT, etc.)\n* systemic treatment (e.g. chemotherapy)\n* Age ≥ 12 years. Note: Subjects aged ≥ 12 years but \\\u003C 18 are eligible to enroll only after 6 adult patients have been enrolled in the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate laboratory values for\n\n  * Absolute Lymphocyte Count \\> 500 \u002Fµl\n  * Platelets \\> 50.000 \u002Fµl\n  * Creatinine clearance GFR \\> 30 ml\u002Fmin\n  * Alanine aminotransferase (ALT) and aminotransferase (AST) ≤ 5 times upper limit range\n  * Bilirubin ≤ 3 mg\u002Fdl\n* Negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion.\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential who are sexually active must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last dose of the vaccination\n* For FCBP two negative pregnancy tests (sensitivity of at least 25 mIU\u002FmL) prior to first application of the study drug (vaccination at visit V1), one at screening and the other one at visit V1 prior (\\\u003C 24h) to first vaccination.\n* Postmenopausal or evidence of non-child-bearing status.\n* Be willing to minimize blood and body fluid exposure after vaccination until end of study\n\n  * Refrain from sperm or ovary egg donation\n  * Refrain from blood donation\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Concurrent or previous treatment within 14 days in another interventional clinical trial with an investigational anti-cancer treatment.\n* Concurrent treatment with any of the following therapeutic measures:\n\n  * surgical procedures,\n  * radiotherapy,\n  * local therapeutic measures (e.g. TACE, SIRT, etc.)\n  * systemic treatment (e.g. chemotherapy)\n* Concurrent or previous treatment within 6 months with an anti-cancer vaccine treatment.\n* Any live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment\n* Known sensitivity to or history of allergic reactions to investigational drug.\n* Active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg per day) or immunosuppressive agents (Please note, patients after liver transplantation requiring immunosupressants are allowed).\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","12 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript as adjuvant treatment",[27],"Fibrolamellar Hepatocellular Carcinoma (FLC)",[29,30],"DNAJB1-PRKACA fusion transcript","Fibrolamellar hepatocellular carcinoma (FL-HCC)","RECRUITING","2026-02-09",{"date":34,"type":35},"2026-02-12","ACTUAL",{"date":37,"type":35},"2025-07-08",{"date":39,"type":21},"2028-11",{"name":41,"class":42},"University Hospital Tuebingen","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100381589","phase-1-dnajb1-prkaca-fusion-kinase-peptide-vaccine-combined-with-nivolumab-and-ipilimumab-for-patients-with-fibrolamellar-hepatocellular-carcinoma-100381589","NCT04248569","DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma","A Pilot Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma","Inclusion Criteria for Cohort A, B and C:\n\n* Cohort A and B: Must have histologically confirmed FLC (fibrolamellar hepatocellular cancer) that is metastatic or unresectable.\n* Cohort C: Patients with histologically proven metastatic or unresectable DNAJB1-PRKACA fusion transcript positive solid tumor malignancies, non-FLC solid tumors.\n* Cohort A and B: Age \\> 12 years. Note: Subjects age \\> 12 years but \\\u003C18 are eligible to enroll only after 6 adult patients have enrolled on the study.\n* Cohort A and B: Patients \\\u003C 18 years old must have a body weight ≥40 kg.\n* Cohort C: Patients must be Age ≥ 18 years.\n\nAll Cohorts:\n\n* Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.\n* ECOG performance status of ≤2 (Karnofsky ≥60%)\n* Patients must have adequate liver, kidney and marrow function defined by study-specified laboratory tests prior to initial study drug.\n* Patients must have measurable disease per RECIST 1.1.\n* Must be willing to provide tissue and blood samples for mandatory translational research.\n* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.\n* Men must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Cohorts A, B and C:\n\n* Cohort A and C: Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies. NOTE: Prior therapy with interferon-alpha is allowed.\n* Cohort B: Participants a with history of unacceptable, life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1\u002FPD-L1 treatment, any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hormone replacement after endocrinopathy).\n\nAll Cohorts:\n\n* Have had chemotherapy or other systemic therapy or radiotherapy, as follows:\n\n  * Have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.\n  * Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.\n  * Have received other approved or investigational agents or device within 28 days of the first dose of study drug.\n  * Have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered.\n* Have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment\n* Known sensitivity to or history of allergic reactions to investigational drug (s).\n* Hypersensitivity reaction to any monoclonal antibody.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n* Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded.\n* Has a diagnosis of immunodeficiency.\n* Systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration.\n* Symptomatic interstitial lung disease.\n* Has a pulse oximetry of \\\u003C92% on room air or is on supplemental home oxygen.\n* Active or untreated brain metastases or leptomeningeal metastases.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Are pregnant or breastfeeding.\n* Infection with HIV or hepatitis B or C.\n* Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction.\n* Unwilling or unable to follow the study schedule for any reason.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Any illicit drugs or other substance abuse.\n* Clinically meaningful ascites.\n\nInclusion Criteria for Re-Enrolling Patients:\n\n* Patients previously treated with the vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with nivolumab and ipilimumab, who, in the opinion of the principal investigator, had clinical or radiological benefits.\n* Patients \\\u003C 18 years old must have a body weight ≥40 kg.\n* ECOG performance status of ≤2 (Karnofsky ≥60%, see Appendix A).\n* Patients must have adequate liver, kidney and marrow function defined by study-specified laboratory tests prior to initial study drug.\n* Patients must have measurable disease per RECIST 1.1.\n* Willingness to provide tissue and blood samples for mandatory translational research.\n* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.\n* Men must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria for Re-Enrolling Patients:\n\n* Participants with a history of prior unacceptable and\u002For life-threatening toxicities.\n* Patients who have had chemotherapy or other systemic therapy or radiotherapy, as follows:\n\n  * Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.\n  * Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.\n  * Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug.\n  * Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of alopecia or stable neuropathy, unless approved by the IND Sponsor.\n* Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.\n* Known sensitivity to or history of allergic reactions to investigational drug (s).\n* Hypersensitivity reaction to any monoclonal antibody.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n* Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded.\n* Has a diagnosis of immunodeficiency.\n* Systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration.\n* Symptomatic interstitial lung disease.\n* Has a pulse oximetry of \\\u003C92% on room air or is on supplemental home oxygen.\n* Active or untreated brain metastases or leptomeningeal metastases.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Are pregnant or breastfeeding.\n* Infection with HIV or hepatitis B or C.\n* Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction.\n* Unwilling or unable to follow the study schedule for any reason.\n* Any other sound medical, psychiatric, and\u002For social reason as determined by the Investigator.\n* Any illicit drugs or other substance abuse.\n* Clinically meaningful ascites.",{"count":51,"type":21},56,[24],"The primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC and with non-FLC solid tumors and to assess the T-cell response.",[27],[56,57,58,59,60,61,62,63,64],"DNAJB1-PRKACA Peptide Vaccine","Nivolumab","Ipilimumab","Anti-PD-1 (receptor blocking antibody)","Anti-CTLA-4 (receptor blocking antibody)","Neoantigen Vaccines","Cancer Vaccines","Immunotherapy","Fibrolamellar Hepatocellular Cancer (FLC)","2025-12-01",{"date":67,"type":35},"2025-12-03",{"date":69,"type":35},"2020-04-20",{"date":71,"type":21},"2034-03-01",{"name":73,"class":42},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",1]