[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inge Marie Svane\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,100],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100631472","phase-1-neoadjuvant-immunotherapy-for-patients-with-high-risk-eye-melanoma-100631472",false,"NCT07501117","Neoadjuvant Immunotherapy for Patients With High-risk Eye Melanoma","Neoadjuvant Ipilimumab and Nivolumab for Patients With High-risk Uveal Melanoma","Inclusion Criteria:\n\n* Age ≥ 18 ≤ 80\n* The patient is able to read and understand Danish.\n* Primary, localized and treatment-naive uveal melanoma planned for enucleation (high risk\u002FT3-T4) and available for transvitreal biopsies. The initial diagnosis of uveal melanoma is based on ophthalmologic and clinical findings.\n* ECOG performance status of 0 or 1 (appendix 2)\n* The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin level \\> 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000\u002FmcL, e) Platelets ≥ 75,000 \u002FmcL, f) Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n* Signed statement of consent after receiving oral and written study information\n* Willingness to participate in the planned treatment and follow-up schedule\n* For women of childbearing potential (WOCBP) a negative serum pregnancy test at time of screening and the use of highly effective contraception is required. This applies from screening and until 6 months after treatment.\n\nThe following is considered highly effective methods of contraception: 1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal or transdermal), 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3. Intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5. Bilateral tubal occlusion, 6. Vasectomised partner provided that the vasectomy is confirmed successful, 7. Sexual abstinence defined as refraining from heterosexual intercourse. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods.\n\n\\- Men with female partner of childbearing potential must: 1. Use a condom during sexual intercourse from screening and until 6 months after treatment. 2.\n\nEnsure that their partner uses a highly effective method of contraception (as described above) 3. Agree to refrain from sperm donation, storage, or banking\n\nExclusion criteria\n\n* A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n* Requirement for immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening\n* The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)\n* The patient is pregnant or breastfeeding\n* The patient has an active infection requiring systemic therapy\n* Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus.\n* Concurrent treatment with other experimental drugs\n* Any significant active autoimmune disease\n* Severe allergy or anaphylactic reactions earlier in life\n* Known hypersensitivity to one of the active drugs or one or more of the excipients.","ALL","18 Years","80 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to investigate the safety and feasibility of neoadjuvant immunotherapy for patients with high-risk uveal melanoma. The main question is:\n\n\\- Is neoadjuvant treatment with nivolumab and ipilimumab safe and feasible for patientt with high-riks uveal melanoma? In addition pathological response, distant metastases-free survival, overall survival and immunological changes in the tumor microenviroenment after therapy will be assesed.",[27],"Uveal Melanoma",[29,30,31,32,33],"Immunotherapy","Neoadjuvant therapy","High-risk uveal melanoma","Nivolumab","Ipilimumab","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":35,"type":38},{"date":41,"type":21},"2029-06-01",{"name":43,"class":44},"Inge Marie Svane","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100531837","phase-1-to-evaluate-the-safety-and-efficacy-of-adp-tilil7-in-patients-with-locally-advanced-or-metastatic-melanoma-100531837","NCT06204991","To Evaluate the Safety and Efficacy of ADP-TILIL7 in Patients With Locally Advanced or Metastatic Melanoma","Phase 1 Study to Evaluate the Safety and Efficacy of TILs Transduced With IL-7 (ADP-TILIL7) in Patients With Locally Advanced or Metastatic Melanoma","ADP-TILIL7","Inclusion Criteria:\n\n* All the criteria listed in the following need to be met before patient inclusion.\n\n  1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).\n  2. Progressive disease after standard treatment with PD-1 check-point inhibition or combination of aforementioned with CTLA-4 check-point inhibition.\n  3. Age: 18 - 75 years at time of signed Informed consent.\n  4. ECOG performance status of ≤ 1 (Appendix 2).\n  5. Is fit for tumor resection and has at least one lesion (\\> 1 cm3) available for surgical resection for manufacture of TIL.\n  6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding lesion to be resected).\n  7. LVEF assessment with documented LVEF ≥50% by either TTE (transthoracic echocardiography) or MUGA (multigated acquisition scan).\n  8. Sufficient organ function, including:\n\n     * Absolute neutrophil count (ANC) ≥ 1.500 \u002Fµl\n     * Leucocyte count ≥ lower normal limit\n     * Platelets ≥ 100.000 \u002Fµl and \\\u003C700.000 \u002Fµl\n     * Hemoglobin ≥ 6.0 mmol\u002Fl\n     * eGFR \\> 70 ml\u002Fmin\\*\n     * S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN)\n     * ASAT\u002FALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN)\n     * Alkaline phosphatase ≤ 5 times upper normal limit\n     * Lactate dehydrogenase ≤ 5 times upper normal limit\n     * Sufficient coagulation: APPT\\\u003C40 and INR\\\u003C1.5\n* \\* In selected cases it can be decided to include a patient with an eGFR \\\u003C 70 ml\u002Fmin with the use of a reduced dose of chemotherapy.\n\n  9\\. Signed statement of consent after receiving oral and written study information 10. Willingness to participate in the planned controls and capable of handling toxicities.\n\n  11\\. Subject must receive T-cell therapy as the next therapy following tumor resection, unless bridging therapy is administered:\n  * Bridging therapy is discouraged. However, if in the opinion of the Investigator, the subject requires immediate therapy after tumor resection, the subject may receive bridging therapy for the period during which the subject is awaiting the manufacture of TIL-infusion product. Bridging therapy may be a continuation of the therapy the subject was receiving prior to tumor resection or may be a new therapy.\n  * Following this bridging therapy, the subject must adhere to the mandatory washout periods (exclusion criterion 1) and must continue to have measurable disease prior to receiving T-cell therapy.\n\n    12\\. Age and Reproductive Status:\n  * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test AND must agree to use an effective method of contraception starting at the first dose of chemotherapy for at least 12 months. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods. The following are considered safe methods of contraception:\n* Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch)\n* Intrauterine device\n* Surgical sterilization\n* Surgical sterilization of male partner with verification of no sperm after the procedure\n* Menopause (for more than 12 months) o Male subjects must be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with an WOCBP starting at the first dose of chemotherapy and for 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking.\n\nExclusion Criteria:\n\n* Patients will be excluded if they meet one of the criteria's listed below\n\n  1. Subject has received or plans to receive the following therapy\u002Ftreatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC):\n\n     * Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC\n     * Small molecules\u002FTKI: Washout period 1 week before TR and LDC\n     * Immune therapy (monoclonal AB therapy, CPI and biologics): 2 weeks before TR and LDC\n     * Prior T-cell therapy, including gene therapy using an integrating vector\n     * Corticosteroids at dose equivalent \\> 10 mg prednisone or any other immunosuppressive therapy. 2 weeks before TR and LDC. Note: Use of topical steroids is not an exclusion\n     * Investigational treatment: 4 weeks or 5 half-lives, whichever is shorter before TR and LDC\n     * Radiation to the pelvis and\u002For multiple bones containing ≥ 25% of bone marrow: 4 weeks before TR and LDC\n     * Whole brain radiotherapy or brain stereotactic radiosurgery: 4 weeks before TR and LDC\n     * Radiotherapy to the target lesions: 3 months prior to TIL-infusion. A lesion with unequivocal progression post-radiotherapy may be considered a target lesion.\n  2. A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n  3. Patients with metastatic ocular\u002Fmucosal or other non-cutaneous melanoma. Unknown primary melanoma is eligible.\n  4. Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non-clinically significant toxicities e.g., alopecia, vitiligo).\n\n     Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n  5. Patients who have more than 2 CNS metastases or who have any CNS lesion that is symptomatic, greater than 1 cm in diameter or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clincal or radiologic CNS progression for at least 2 months.\n  6. The following patients will be excluded because of inability to receive high dose interleukin-2:\n\n     * History of coronary revascularization\n     * Patients with clinically significant atrial and\u002For ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, 2o or 3o heart block\n     * Documented FEV-1 less than or equal to 60% predicted value for patients with: A prolonged history of cigarette smoking (greater than 20 pack years), large tumor burden in the lungs or Symptoms of respiratory distress.\n  7. Known hypersensitivity to one of the active drugs or one or more of the excipients.\n  8. Severe medical conditions, such as severe asthma\u002FCOLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.\n  9. Acute\u002Fchronic infection with HIV, hepatitis, syphilis among others.\n  10. Severe allergies or previous anaphylactic reactions.\n  11. Active autoimmune or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible:\n\n      * Immune-mediated AEs secondary to immunotherapy which has resolved to ≤ Grade 1 off steroids;\n      * Hypothyroidism, Type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy;\n      * Disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression;\n      * Other stable immune conditions that do not require prednisone higher than 10 mg\u002Fday or their equivalent dose for other corticosteroid agents may be acceptable with the agreement of the Sponsor.\n  12. Pregnant women and women breastfeeding.\n  13. Subject who, in the opinion of the Investigator, will be unlikely to fully comply with protocol requirements.","75 Years",{"count":56,"type":21},10,[24],"The primary objective of this Phase 1 clinical trial is to evaluate the feasibility and tolerability of a novel generation of gene-modified tumor infiltrating lymphocytes (TILs) in a cohort of 10 patients aged 18-75 diagnosed with unresectable or metastatic melanoma. TILs will undergo transduction with the Interleukin-7 (IL-7) gene, for IL-7 production upon antigen engagement.\n\nParticipants will undergo:\n\n* screening\n* tumor operation following autologous TIL production (incl. transduction) - takes approximately 4-6 weeks\n* admission for lymphodepleting chemotherapy (Cyclophosphamide and Fludarabine phosphate), TIL infusion and high-dose IL-2 infusions for a maximum of 6 doses\n* Following treatment, patients will undergo systematic and regularly planned assessments, encompassing clinical evaluation, biochemistry analyses, and PET\u002FCT scans. This thorough follow-up regimen will be continued until any of the following events occur: progressive disease, withdrawal from study, or end of study, which spans a duration of 15 years for trials involving genetically modified organisms.",[60,61,62],"Melanoma Stage III","Melanoma Stage IV","Melanoma",[64,65,66,67],"adoptive cell therapy","immunetherapy","genemodified tumor infiltrating lymphocytes","IL-7","2025-08-19",{"date":70,"type":38},"2025-08-24",{"date":72,"type":38},"2025-04-01",{"date":74,"type":21},"2028-04-01",{"name":43,"class":44},2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100576282","phase-1-t-cell-therapy-with-crispr-pd1-edited-tumor-infiltrating-lymphocytes-for-patients-with-metastatic-melanoma-100576282","NCT06783270","T-cell Therapy with CRISPR PD1-edited Tumor Infiltrating Lymphocytes for Patients with Metastatic Melanoma","CRISPR-TIL","Inclusion Criteria:\n\n1. Histologically confirmed inoperable or metastatic melanoma (stage IIIc or IV).\n2. Progressive disease after standard treatment with anti-PD-1 check-point inhibition or combination of aforementioned with anti-CTLA-4 check-point inhibition.\n3. Age: 18 - 75 years at the time of signed Informed consent.\n4. ECOG performance status of ≤1 (Appendix 2).\n5. Is fit for tumor resection and has at least one lesion (\\> 1 cm3) available for surgical resection for manufacture of TIL. (Unless TILs are already available through metastasectomy prior to enrollment in this study, as described in step one under study design)\n6. At least one measurable parameter in accordance with RECIST 1.1 -criteria (excluding the lesion to be resected).\n7. LVEF assessment with documented LVEF ≥50% by either TTE or MUGA.\n8. Sufficient organ function, including:\n\n   * Absolute neutrophil count (ANC) ≥ 1.500 \u002Fμl\n   * Leucocyte count ≥ lower normal limit\n   * Platelets ≥ 100.000 \u002Fμl and \\\u003C700.000 \u002Fμl\n   * Hemoglobin ≥ 6.0 mmol\u002Fl\n   * eGFR \\> 70\n   * S-bilirubin ≤ 1.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 2.5 × ULN)\n   * ASAT\u002FALAT ≤ 2.5 times upper normal limit (Exception: Subjects with liver metastasis ≤ 5.0 × ULN)\n   * Alkaline phosphatase ≤ 5 times upper normal limit\n   * Lactate dehydrogenase ≤ 5 times the upper normal limit\n   * Sufficient coagulation: APPT\\\u003C40 and INR\\\u003C1.5\n9. Signed statement of consent after receiving oral and written study information\n10. Willingness to participate in the planned controls and capable of handling toxicities.\n11. Subject must receive CRISPR-TIL as the next therapy following tumor resection unless bridging therapy is administered:\n\n    * Bridging therapy is discouraged. However, if in the opinion of the Investigator, the subject requires immediate therapy after tumor resection, the subject may receive bridging therapy for the period during which the subject is awaiting the manufacture of TIL-infusion product. Bridging therapy may be a continuation of the therapy the subject was receiving prior to tumor resection or may be a new therapy.\n    * Following this bridging therapy, the subject must adhere to the mandatory washout periods (described in exclusion criterion 1) and must continue to have measurable disease prior to receiving CRISPR-TIL.\n12. Age and Reproductive Status:\n\n    * Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test AND must agree to use an effective method of contraception starting at the first dose of chemotherapy for at least 12. WOCB must also agree to refrain from egg donation, storage, or banking during these same time periods. The following are considered safe methods of contraception:\n\n      * Hormonal anticonception (birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patch)\n      * Intrauterine device\n      * Surgical sterilization\n      * Surgical sterilization of male partner with verification of no sperm after the procedure\n      * Menopause (for more than 12 months)\n    * Male subjects must be surgically sterile or agree to use a double-barrier contraception method or abstain from sexual activity with an WOCBP starting at the first dose of chemotherapy and for 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking.\n\nExclusion Criteria:\n\n1. Subject has received or plans to receive the following therapy\u002Ftreatment prior to tumor resection (TR) or lymphodepleting chemotherapy (LDC):\n\n   * Cytotoxic chemotherapy: Washout period 3 weeks before TR and LDC.\n   * Small molecules\u002FTKI: Washout period 1 week before TR and LDC.\n   * Immune therapy (monoclonal AB therapy, CPI, and biologics): 2 weeks before TR and LDC\n   * Prior T-cell therapy, including gene therapy using an integrating vector.\n   * Corticosteroids at dose equivalent \\> 10 mg prednisone or any other immunosuppressive therapy. 2 weeks before TR and LDC. Note: Use of topical steroids is not an exclusion.\n   * Investigational treatment: 4 weeks or 5 half-lives, whichever is shorter before TR and LDC.\n   * Radiation to the pelvis and\u002For multiple bones containing ≥ 25% of bone marrow: 4 weeks before TR and LDC.\n   * Whole brain radiotherapy or brain stereotactic radiosurgery: 4 weeks before TR and LDC.\n   * Radiotherapy to the target lesions: 3 months prior to TIL infusion. A lesion with unequivocal progression post-radiotherapy may be considered a target lesion.\n2. A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable.\n3. Patients with metastatic ocular\u002Fmucosal or other non-cutaneous melanoma. Unknown primary melanoma is eligible.\n4. Toxicity from previous anti-cancer therapy must have resolved to ≤ Grade 1 or baseline prior to enrollment (except for non-clinically significant toxicities e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities who are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.\n5. Patients who have more than 2 CNS metastases or who have any CNS lesion that is symptomatic, greater than 1 cm in diameter, or show significant surrounding edema on MRI scan will not be eligible until they have been treated and demonstrated no clinical or radiologic CNS progression for at least 2 months.\n6. The following patients will be excluded because of their inability to receive high-dose interleukin-2 (See appendix 5):\n\n   * History of coronary revascularization\n   * Documented LVEF of less than 45% in patients with clinically significant atrial and\u002For ventricular arrhythmias including but not limited to atrial fibrillation, ventricular tachycardia, 2o or 3o heart block\n   * Documented FEV-1 less than or equal to 60% predicted value for patients with: A prolonged history of cigarette smoking (greater than 20 pack years), large tumor burden in the lungs, or Symptoms of respiratory distress.\n7. Known hypersensitivity to one of the active drugs or one or more of the excipients.\n8. Severe medical conditions, such as severe asthma\u002FCOLD, significant cardiac disease, and poorly regulated insulin-dependent diabetes mellitus among others.\n9. Creatinine clearance (eGFR) \\\u003C 70 ml\u002Fmin\\*.\n10. Acute\u002Fchronic infection with HIV, hepatitis, and syphilis among others.\n11. Severe allergies or previous anaphylactic reactions.\n12. Active autoimmune or immune-mediated disease that has not yet resolved. Subjects with the following will be eligible:\n\n    * Immune-mediated AEs secondary to immunotherapy which have resolved to ≤ Grade 1 without steroids;\n    * Hypothyroidism, Type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy;\n    * Disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well-controlled without requiring systemic immunosuppression;\n    * Other stable immune conditions that do not require prednisone higher than 10 mg\u002Fday or their equivalent dose for other corticosteroid agents may be acceptable with the agreement of the Sponsor.\n13. Pregnant women and women breastfeeding.\n14. Subjects deemed unlikely to fully comply with protocol requirements by the study investigator.\n\n    * In selected cases it can be decided to include a patient with a eGFR \\\u003C 70 ml\u002Fmin with the use of a reduced dose of chemotherapy.",{"count":56,"type":21},[24],"The purpose of this study is to assess wether it is safe and feasible to treat patients with tumor infiltrating lymphocytes that have been silenced for PD-1, using CRISPR-Cas9.",[88],"Melanoma Metastatic",[90,91],"TIL-therapy","TIL-ACT","2025-01-14",{"date":94,"type":38},"2025-01-20",{"date":96,"type":38},"2024-12-16",{"date":98,"type":21},"2028-01-01",{"name":43,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100329016","phase-2-melanoma-metastasized-to-the-brain-and-steroids-100329016","NCT03563729","Melanoma Metastasized to the Brain and Steroids","Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids","MEMBRAINS","Inclusion Criteria:\n\n* Histologically confirmed metastatic melanoma with radiologically verified brain metastasis\n* Need for systemic steroid treatment (prednisolone \\> 10 mg daily; dexamethasone \\> 1.6 mg daily, hydrocortisone \\> 40 mg daily or equivalent) due to brain metastasis\n* At least one measurable lesion according to RECIST version 1.1 guidelines\n* Evaluable intracranial disease\n* 18 years of age or older\n* Performance status 0-2\n* Able to undergo MRI with gadolinium contrast agent\n* Adequate hematological and organ function\n* No significant toxicity from previous cancer treatments (CTC\\\u003C1)\n* Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives\n* Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition documented vasectomy and sterility or double barrier contraception are considered effective contraceptives\n* Signed statement of consent after receiving oral and written study information.\n* Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.\n* For arm E specifically: Tumor cells must harbor BRAF mutation.\n\nExclusion Criteria:\n\n* Another malignancy or concurrent malignancy unless disease-free for 3 years\n* Ocular melanoma\n* Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery\n* Known hypersensitivity to one of the active drugs or excipients\n* Acute or chronic infections with HIV or hepatitis\n* Any medical condition that will interfere with patient compliance or safety\n* Prior treatment with anti-PD-1\u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibodies in the metastatic setting\n* Prior systemic treatment with anti-PD-1\u002FPD-L1\u002FPD-L2\u002FCTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study\n* Simultaneous treatment with other experimental drugs or other anti-cancer drugs\n* Pregnant or breastfeeding females.\n* For arm E specifically: Prior treatment with BRAF\u002FMEK inhibitors.",{"count":109,"type":21},80,[111],"PHASE2","This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\\> 10 \\\u003C 25 mg prednisolone or \\> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).",[114],"Malignant Melanoma",[116,117,118,119,120,121,122,123,124],"Immune therapy","checkpoint inhibitor","pembrolizumab","ipilimumab","nivolumab","steroid","brain metastasis","BRAF inhibitor","MEK inhibitor","2023-07-12",{"date":127,"type":38},"2023-07-13",{"date":129,"type":38},"2018-06-06",{"date":131,"type":21},"2028-06-06",{"name":43,"class":44},3,""]