[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immunocore Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":175},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,72,94,131,152],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100630857","phase-1-study-of-imc-s118ai-in-type-1-diabetes-100630857",false,"NCT07493122","Study of IMC-S118AI in Type 1 Diabetes","A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes","Inclusion Criteria:\n\n* Body mass index (BMI): 18 to 25 kg\u002Fm2\n* History of a diagnosis of T1D\n* HLA type: HLA-A\\*02:01\n* Shows signs of remaining beta-cell function\n\nExclusion Criteria:\n\n* Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)\n* History of recurrent hypoglycaemia due to non-compliance with insulin regimens\n* Prior treatment with immunomodulating therapy for T1D\n* Have a history of cardiovascular disease or impaired cardiac function\n* Current diagnosis of a malignancy or any history of malignancy","ALL","18 Years","45 Years",{"count":20,"type":21},154,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.",[27,28,29],"Type 1 Diabetes","Type 1 Diabetes (T1D)","Diabetes Type 1",[31,32],"diabetes","type 1","NOT_YET_RECRUITING","2026-03-19",{"date":36,"type":37},"2026-03-25","ACTUAL",{"date":39,"type":21},"2026-04",{"date":41,"type":21},"2030-11",{"name":43,"class":44},"Immunocore Ltd","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100604947","phase-1-study-of-imc-p115c-in-advanced-prame-positive-cancers-100604947","NCT07156136","Study of IMC-P115C in Advanced PRAME-Positive Cancers","A Phase 1 First-in-Human Study of the Safety and Efficacy of IMC-P115C as a Single Agent and in Combination With Standard of Care Agents in HLA-A*02:01 Positive Participants With Advanced PRAME Positive Cancers","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* HLA-A\\*02:01-positive\n* Meeting PRAME-positive tumor testing requirements\n* Metastatic or unresectable solid tumors\n* Have received (or be receiving), relapsed from, be refractory to or intolerant of all therapies\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control\n\nExclusion Criteria:\n\n* Symptomatic or untreated central nervous system metastasis\n* Bowel obstruction, perforation, or fistula formation within 3 months prior to the planned first dose of study treatment\n* Ongoing ascites or effusion requiring recent drainages\n* Significant ongoing toxicity from prior anticancer treatment\n* Out-of-range laboratory values\n* Clinically significant lung, heart, or autoimmune disease\n* Ongoing requirement for immunosuppressive treatment\n* Significant secondary malignancy\n* Hypersensitivity to study drug or excipients\n* Pregnant or lactating",{"count":53,"type":21},140,[24],"Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.",[57,58,59],"PRAME Positive","Cancer","HLA-A*02:01-positive",[61],"PRAME","RECRUITING","2026-02-23",{"date":65,"type":37},"2026-02-25",{"date":67,"type":37},"2024-11-07",{"date":69,"type":21},"2029-08-30",{"name":43,"class":44},13,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100524713","phase-3-imc-f106c-regimen-versus-nivolumab-regimens-in-previously-untreated-advanced-melanoma-prism-mel-301-100524713","NCT06112314","IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)","A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301","PRISM-MEL-301","Inclusion Criteria:\n\n* Participants must be HLA-A\\*02:01-positive\n* Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma\n* Archived or fresh tumor tissue sample that must be confirmed as adequate\n* Participants must have measurable disease per RECIST 1.1\n* Participant must have BRAF V600 mutation status determined\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention\n\nExclusion Criteria:\n\n* Participants with a history of a malignant disease other than those being treated in this study\n* Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis\n* Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients\n* Participants with clinically significant pulmonary disease or impaired lung function\n* Participants with clinically significant cardiac disease or impaired cardiac function\n* Participants with active autoimmune disease requiring immunosuppressive treatment\n* Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results\n* Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma\n* Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3",{"count":81,"type":21},680,[83],"PHASE3","This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\\*02:01-positive participants with previously untreated advanced melanoma.",[86],"Advanced Melanoma",{"date":65,"type":37},{"date":89,"type":37},"2024-06-05",{"date":91,"type":21},"2027-10-16",{"name":43,"class":44},211,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100481461","phase-3-tebentafusp-regimen-versus-investigators-choice-in-previously-treated-advanced-melanoma-tebe-am-100481461","NCT05549297","Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)","Phase 2\u002F3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)","Inclusion Criteria:\n\n* HLA-A\\*02:01-positive\n* unresectable Stage III or Stage IV non-ocular melanoma\n* archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.\n* measurable or non-measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* If applicable, must agree to use highly effective contraception\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol\n* Must agree to provide protocol specified samples for biomarker analyses.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* diagnosis of ocular or metastatic uveal melanoma\n* history of a malignant disease other than those being treated in this study\n* ineligible to be retreated with pembrolizumab due to a treatment-related AE\n* known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)\n* active autoimmune disease requiring immunosuppressive treatment\n* known psychiatric or substance abuse disorders\n* received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications.\n* received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose\n* received cellular therapies within 90 days of study intervention\n* ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study\n* received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose\n* have not progressed on treatment with an anti-PD(L)1 mAb\n* have not received prior treatment with an approved anti-CTLA-4 mAb\n* have a BRAF V600 mutation, who have not received a prior BRAF\u002FMEK TKI regimen\n* currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose\n* known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function\n* Out of range Laboratory values\n* history of allogenic tissue\u002Fsolid organ transplant",{"count":102,"type":21},540,[83],"The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \\[SoC\\], best supportive care \\[BSC\\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.",[86],[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123],"Melanoma","IMCgp100","Tebentafusp","Cutaneous Melanoma","Immunotherapy","gp100","TCR","Pembrolizumab","Bispecific T cell receptor fusion protein","ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer)","Immune mobilizing monoclonal T cell receptor against cancer","KIMMTRAK","Acral Melanoma","Mucosal Melanoma","Blue Nevus","anti-PDL1","checkpoint therapy",{"date":65,"type":37},{"date":126,"type":37},"2022-12-19",{"date":128,"type":21},"2028-07",{"name":43,"class":44},82,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":71},"100580655","phase-1-phase-12-study-of-imc-r117c-in-selected-advanced-cancers-100580655","NCT06840119","Phase 1\u002F2 Study of IMC-R117C in Selected Advanced Cancers","A Phase 1\u002F2 First-in-Human Study of the Safety and Efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a Single Agent and in Combination in HLA-A*02:01-Positive Participants With Selected Advanced PIWIL1-Positive Cancers","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* HLA-A\\*02:01-positive\n* Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma\n* Archived or fresh tumor tissue sample that must be confirmed as adequate\n* Evaluable\u002FMeasurable disease per RECIST 1.1\n* Previously received applicable standard treatments\n* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control\n\nExclusion Criteria:\n\n* Symptomatic or untreated central nervous system metastasis\n* Recent bowel obstruction\n* Ongoing ascites or effusion requiring recent drainages\n* Significant ongoing toxicity from prior anticancer treatment\n* Out-of-range laboratory values\n* Clinically significant lung, heart, or autoimmune disease\n* Ongoing requirement for immunosuppressive treatment\n* Significant secondary malignancy\n* Hypersensitivity to study drug or excipients\n* Pregnant or lactating",{"count":139,"type":21},600,[24,141],"PHASE2","This phase 1\u002F2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\\*02:01-positive participants with selected advanced PIWIL1-Positive cancers.",[58,59],"2026-01-26",{"date":146,"type":37},"2026-01-28",{"date":148,"type":37},"2024-01-10",{"date":150,"type":21},"2027-11-30",{"name":43,"class":44},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":174,"locationsCount":4},"100436258","a-cohort-ind-expanded-access-program-for-supporting-patient-access-to-tebentafusp-100436258","NCT04960891","A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp","A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma","Non Applicable","Inclusion Criteria:\n\nAge\n\n1. Male or female patients age ≥ 18 years of age at the time of first dose\n\n   Type of Participant and Disease Characteristics\n2. Histologically or cytologically confirmed metastatic UM or unresectable UM patients\n3. HLA-A\\*02:01 positive\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\n   Informed Consent\n5. Ability to provide and understand informed consent prior to procedures \\[if required\\]\n\n   Contraception\n6. Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 1 week after the final dose of the program intervention; cessation of birth control after this point shall be discussed with a responsible physician.\n\n   1. Pregnant or lactating women are prohibited from enrolling on this program.\n   2. Male participants are not allowed to donate sperm from the time of enrolment until 3 months post- administration of program interventions.\n\nExclusion Criteria:\n\nDisease Under Study and Prior Anticancer Therapy\n\n1. Presence of untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or cord compression. NOTE: Participants with treated CNS lesions may enroll provided all of the following apply:\n\n   1. Treated CNS lesions must be radiographically stable for ≥ 2 weeks after intervention (surgery and\u002For radiation).\n   2. Participants must be neurologically stable off systemic corticosteroids for at least 2 weeks prior to first planned administration of tebentafusp.\n2. Receipt of anticancer therapy for the disease under study within the following times prior to the first planned dose of program intervention:\n\n   1. Cellular therapies (e.g., T-cell therapies): 90 days.\n   2. Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)- targeted immunotherapies (e.g., ipilimumab): 28 days\n   3. All other immunotherapies, including PD-(L)1-targeted immunotherapies (e.g., atezolizumab, pembrolizumab): 21 days\n   4. All other systemic therapies: 14 days\n   5. Radiotherapy: 14 days (excepting palliative radiotherapy to a limited field \\[e.g., for a focally painful tumor mass\\], which may be administered within 14 days provided there are no ongoing related Grade 2 or higher toxicities)\n\n   Medical Conditions and Concomitant Medications\n3. Systemic treatment with steroids or any other immunosuppressive drug use within 2 weeks of the planned first dose of program intervention, with the following exceptions:\n\n   1. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.\n   2. Local steroid therapies (e.g., optic, ophthalmic, intra- articular, or inhaled medications) are acceptable.\n   3. Premedication for allergy to contrast reagent.\n   4. Steroids for management of CNS metastases \\> 2 weeks prior to the planned first dose of program intervention.\n4. Any relevant medical condition, which in the opinion of the treating physician, would prevent the participant enrolling into the Program due to concerns related to safety, compliance with procedures, or interpretation of program results.\n5. Chronic viral infections as indicated below. NOTE: Testing for hepatitis C virus (HCV) status prior to enrollment is not necessary unless clinically indicated.\n\n   1. Known history of human immunodeficiency virus (HIV) infection.\n   2. Known HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of program intervention and viral load confirmed as undetectable during Screening.\n   3. Known HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable during Screening.\n\n   Diagnostic Assessments\n6. Participant with an out-of-range Screening laboratory values defined as shown below. NOTE: Hematology evaluations must be performed ≥ 7 days from any blood or blood product transfusion and ≥ 14 days from any dose of hematologic growth factor.\n\n   1. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 30 mL\u002Fminute\n   2. Total bilirubin \\> 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 × ULN or direct bilirubin \\> 1.5 × ULN\n   3. Alanine aminotransferase \\> 5 × ULN\n   4. Aspartate aminotransferase \\> 5 × ULN\n   5. Platelet count \\\u003C 50 × 109\u002FL\n   6. Hemoglobin \\\u003C 8 g\u002FdL\n7. Clinically significant cardiac disease or impaired cardiac function, including any of the following:\n\n   1. Congestive heart failure (New York Heart Association Class ≥ 3)\n   2. Uncontrolled hypertension defined as systolic blood pressure \\[BP\\] \\> 160 mmHg or diastolic BP \\> 110 mmHg with the following requirements:\n\n   \u003C!-- -->\n\n   1. If initial measurement is elevated, additional assessments should be taken where each assessment is the mean value of 3 measurements taken at least 5 minutes apart.\n   2. Eligibility is based on the average of at least 2 assessments taken at least 1 hour apart.\n   3. Acute myocardial infarction or unstable angina pectoris \\\u003C 6 months prior to the planned first dose of program intervention","EXPANDED_ACCESS","This Expanded Access Program aims to:\n\n1. Provide access to tebentafusp for mUM patients.\n2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window.\n3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.",[163],"Uveal Melanoma",[107,165,108,111,109,166,167,163,168,113,115,169,117],"Uveal Cancer","Ocular Melanoma","Eye Melanoma","Gp100","ImmTAC","AVAILABLE","2022-01-05",{"date":173,"type":37},"2022-01-21",{"name":43,"class":44},""]