[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-basal-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-basal-cell-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,75,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100609546","studying-off-label-insurance-coverage-for-patients-with-cutaneous-cancers-a-filter-observational-study-100609546",false,"NCT07215988","Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a \"Filter\" Observational Study","Inclusion Criteria:\n\n* \\* MERKEL CELL CARCINOMA\n\n  * Signed informed consent\n  * Pathology report confirming Merkel at the time of screening\n  * Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149)\n\n    * 2 cycles will be given prior to surgery (=12 weeks).\n\n      * MUCOSAL MELANOMA\n  * Signed informed consent\n  * Pathology report confirming mucosal melanoma at the time of screening\n  * Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -\\> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks)\n\n    * BASAL CELL CARCINOMA\n  * Signed informed consent\n  * Pathology report confirming basal cell carcinoma with subtype at the time of screening\n  * Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response.\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists)\n\n    * RARE CUTANEOUS CANCERS\n  * Signed informed consent\n  * Pathology report confirming squamous cell carcinoma at the time of screening\n  * Stage II, III, or IV resectable or (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * Planned SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK\n\n    * 4 cycles will be given prior to surgery (= 12 weeks)\n\nExclusion Criteria:\n\n* \\* MERKEL CELL CARCINOMA\n\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * MUCOSAL MELANOMA\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * BASAL CELL CARCINOMA\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this basal cell carcinoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * RARE CUTANEOUS CANCERS\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.","ALL","18 Years",{"count":18,"type":19},70,"ESTIMATED","OBSERVATIONAL","This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving \"off label\" and \"on label\" neoadjuvant treatment. \"Neoadjuvant therapy\" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an \"off-label\" approach for several types of skin cancers. \"Off-label\" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these \"off-label\" treatments could be delayed compared to label use, and \"off-label\" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.",[23,24,25,26,27,28,29,30],"Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8","Locally Advanced Basal Cell Carcinoma","Locally Advanced Malignant Skin Neoplasm","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Mucosal Melanoma","Locally Advanced Squamous Cell Carcinoma","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2026-02-04",{"date":39,"type":19},"2027-12-31",{"name":41,"class":42},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100610420","phase-2-l19il2-or-l19tnf-or-l19il2tnf-in-patients-with-basal-cell-carcinoma-bcc-100610420","NCT07227350","L19IL2 or L19TNF or L19IL2\u002FTNF in Patients With Basal Cell Carcinoma (BCC)","A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2\u002FL19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)","Inclusion Criteria:\n\n* Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.\n* Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must not have received prior checkpoint inhibitors systemic treatment.\n* Patients may have received prior surgery and\u002For radiation therapy.\n* Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.\n* Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, plastic surgeon or surgical\u002Fmedical oncologist. Acceptable medical contraindications to surgery include:\n\n  * BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely\n  * Anticipated substantial morbidity and\u002For deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)\n  * Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing)\n  * Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 1.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogenand progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin (surgically removed 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, targeted therapy immunotherapy.\n* Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.","100 Years",{"count":53,"type":19},180,"INTERVENTIONAL",[56],"PHASE2","Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2\u002FL19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Newly injectable lesions occurring within the 4-week treatment period of the initial target lesion will also receive multiple intratumoral administrations of immunocytokines once weekly for up to 4 weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment",[26],[60,61,62,63],"Basal Cell Carcinoma","locally advanced","subcutaneous lesions","cutaneous lesions","2026-05-29",{"date":66,"type":35},"2026-06-02",{"date":68,"type":19},"2026-06",{"date":70,"type":19},"2031-02",{"name":72,"class":73},"Philogen S.p.A.","INDUSTRY",3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":82,"targetDuration":4,"studyType":54,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":95,"locationsCount":74},"100610460","phase-2-l19il2tnf-in-patients-with-basal-cell-carcinoma-100610460","NCT07227870","L19IL2\u002FTNF in Patients With Basal Cell Carcinoma","A Phase 2 Study of Intratumoral Administration of L19IL2\u002FL19TNF in Locally Advanced Basal Cell Carcinoma Patients Progressing or Intolerant to Systemic Treatment.","Inclusion Criteria:\n\n* Patients must have histologically documented, locally advanced BCC.\n* Patients must have at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must have locally advanced BCC that has progressed on or cannot tolerate ICI treatment as assessed by a local multidisciplinary tumor board.\n* Patients with nodal, regional or in transit injectable BCC lesions.\n* Patients must be willing to provide tissue from a core or excisional biopsy of a tumor lesion at screening and for confirmation of Objective Response or Stable Disease.\n* Male or female patients, age 18 - 100 years.\n* ECOG Performance Status\u002FWHO Performance Status ≤ 2.\n* Hemoglobin \\> 10.0 g\u002FdL.\n* Platelets \\> 100 x 109\u002FL.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* Chronically impaired renal function as indicated by creatinine clearance \\\u003C 60 mL\u002Fmin\u002F1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesteronecontaining) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated cutaneous squamous cell carcinoma of the skin (surgically removed at least 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Radiation therapy on the tumor sites in the 4 weeks prior to study drug administration.\n* Current topical or systemic chemotherapy, immunotherapy.\n* Presence of visceral metastasis.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease\u002Finfection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma\u002FCOPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins\u002Fpeptides\u002Fantibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.",{"count":83,"type":19},92,[56],"Open-label, single-arm, multicentre study in patients with locally advanced BCC amenable to intratumoral injection, who have progressed on or are intolerant to systemic therapy as determined by a local multidisciplinary tumor board. The primary objective of the study is to evaluate the activity of intratumoral L19IL2\u002FL19TNF, while the secondary objective is to assess the safety and efficacy. The patients will receive multiple intratumoral administrations of combined L19IL2 and L19TNF to all injectable cutaneous and subcutaneous lesions once weekly for up to 4 weeks: for those who have a partial response or stable disease as their best response, a second 4-week course L19IL2\u002FL19TNF of four weekly injections may be administered as per treating physician judgement. Patients will be followed for a maximum of 160 weeks after beginning of treatment.",[26],[60,61,62,63],"NOT_YET_RECRUITING","2026-03-06",{"date":91,"type":35},"2026-03-09",{"date":93,"type":19},"2026-02",{"date":70,"type":19},{"name":72,"class":73},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":105,"studyType":20,"phases":4,"briefSummary":106,"conditions":107,"keywords":117,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100474888","oral-hedgehog-inhibitors-in-the-treatment-of-basal-cell-carcinoma-in-the-netherlands-a-prospective-registration-study-100474888","NCT05463757","Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study","Registration of Oral Hedgehog Inhibitors Vismodegib and Sonidegib in the Treatment of Advanced and Multiple Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study.","Inclusion Criteria:\n\n* Men and women\n* All ages\n* Diagnosed with locally advanced basal cell carcinoma (laBCC), metastatic basal cell carcinoma (mBCC), multiple basal cell carcinomas or Gorlin syndrome\n* Use of oral hedgehog inhibitor vismodegib or sonidegib\n\nExclusion Criteria:\n\n* None",{"count":104,"type":19},80,"3 Years","Background: Oral hedgehog inhibitors vismodegib and sonidegib have been used for the treatment of locally advanced (laBCC), metastatic basal cell carcinoma (mBCC) and in basal cell nevus syndrome (BCNS) patients. In the Netherlands, targeted therapy with vismodegib and sonidegib has been available since 2013 and 2021, respectively. No direct comparative studies have been performed between the two oral hedgehog inhibitors (HHI) vismodegib and sonidegib yet . In addition, data for sonidegib are not yet available.\n\nObjective: The aim of this study is 1) to evaluate the effectiveness of oral HHIs in the treatment of laBCC, mBCC and BCNS patients and 2) to compare the oral HHIs vismodegib and sonidegib.\n\nStudy design: prospective registration study that includes all patients, regardless of age and gender, with histologically proven basal cell carcinoma receiving treatment with either vismodegib or sonidegib in the Netherlands. Patient, tumor and treatment information was gathered from patient records.\n\nMain study parameters\u002Fendpoints: The primary outcome for measuring efficacy\u002Ftumor response was median progression free survival (PFS) where the decrease, stagnation or increase in tumor size is measured by maximum diameter. Secondary outcomes are frequency, severity and reversibility of treatment-emergent adverse events and disease-specific quality of life expressed as mean scores on the EORTC-QLQ-C30 and aBCCdex questionnaires.",[60,26,108,109,110,111,112,113,114,115,116],"Metastatic Basal Cell Carcinoma","Gorlin Syndrome","Basal Cell Nevus Syndrome","Carcinoma, Basal Cell","Carcinoma","Basal Cell Tumor","Skin Cancer","Neoplasm of Skin","Neoplasms, Basal Cell",[118,119,120,121,122],"Oral hedgehog inhibitors","Vismodegib","Sonidegib","Erivedge","Odomzo","2025-04-02",{"date":125,"type":35},"2025-04-04",{"date":127,"type":35},"2021-11-01",{"date":129,"type":19},"2026-12",{"name":131,"class":42},"Maastricht University Medical Center",8]