[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma-skin-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma-skin-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,54,100,126,151,184,208,254,276,297,326,347,364,387,414,447,472,496,518,545,567,591,611,632,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100645299","clinical-study-on-high-fiber-diet-and-short-term-fasting-in-melanoma-under-immunotherapy-with-checkpoint-inhibition-100645299",false,"NCT07680452","Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Exploratory Clinical Study on High-fiber Diet and Short-term Fasting in Melanoma Under Immunotherapy With Checkpoint Inhibition","Melafit","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIB-IIIC melanoma\n* Indication for immune checkpoint inhibition as monotherapy as determined by the tumor board\n* No prior systemic melanoma therapy\n* ECOG 0 or 1\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Underweight (BMI ≤19.5)\n* Pre-existing eating disorder\n* Severe internal medical conditions (e.g., renal insufficiency with creatinine \\> 2 mg\u002FdL) or secondary malignancy\n* Current vegan diet or prolonged fasting (≤ 4 days) within the last 6 months\n* Use of antibiotics within 4 weeks prior to the start of the study intervention","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","The treatment of melanoma has improved significantly in recent years. A modern form of cancer treatment known as immunotherapy with checkpoint inhibitors plays a key role in this. These drugs help the immune system better recognize and fight cancer cells. Nevertheless, it remains a challenge to maximize treatment effectiveness while minimizing side effects.\n\nOne possible approach to influencing treatment efficacy and tolerability is diet. A high-fiber diet, as recommended by the German Nutrition Society, increases the effectiveness of immunotherapy, in part through its influence on gut bacteria (the gut microbiota). Initial studies also show that short-term fasting (i.e., eating nothing or very little for a limited period) reduces the side effects of immunotherapy in mouse models and improves the tolerability of chemotherapy in humans.\n\nThis study investigates the feasability of a study on short-term fasting, in addition to a high-fiber diet in patiens with melanoma undergoing immunotherapy.\n\n40 participants will follow a high-fiber diet based on the recommendations of the German Nutrition Society. Additionally, half of the participants will undergo periodic cycles of short-term fasting of 72h with each immunotherapy. Another 20 participants will not undergo any intervention and serve as a control group.\n\nThe goal is to determine whether this study concept is feasible. Exploratory outcomes include, quality of life, fatigue, tolerability of the therapy, impact on disease progression, immune system (flow cytometry) and gut bacteria (microbiome).\n\nThe results are intended to help understand whether targeted dietary measures can support the effectiveness of modern cancer treatments.",[28],"Melanoma (Skin Cancer)",[30,31,32,33,34,35,36,37,38,39,40],"fasting","diet","fiber","high-fiber","melanoma","STF","short-term fasting","microbiome","checkpoint-inhibitor","checkpoint-inhibition","immunotherapy","NOT_YET_RECRUITING","2026-06-25",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":22},"2026-06-30",{"date":49,"type":22},"2028-12-05",{"name":51,"class":52},"Charite University, Berlin, Germany","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":81,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":63,"type":22},2000,"OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,28],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer",[68,82,83,67,84,85,86,87,88,89],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","RECRUITING",{"date":92,"type":45},"2026-06-29",{"date":94,"type":45},"2025-04-14",{"date":96,"type":22},"2038-04",{"name":83,"class":98},"INDUSTRY",8,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100641950","gustabor-phase-2---treating-taste-changes-during-cancer-therapy-a-randomized-study-evaluating-an-ai--based-nutrition-intervention-100641950","NCT07649681","Gustabor Phase 2 - Treating Taste Changes During Cancer Therapy: A Randomized Study Evaluating an AI- Based Nutrition Intervention","GustaborRCT","Inclusion Criteria:\n\n* Age ≥ 18\n* Suffering from one of the following tumor entities: Multiple myeloma, melanoma, urogenital cancer or malignant tumor of the gastrointestinal tract\n* Mainly oral nutrition\n* Subjectively perceived tumor therapy-related taste disorder\n* At least two clinical presentations planned within 12 weeks with a minimum interval of three weeks\n* Ability to participate in nutritional intervention, including use of the online portal and implementation of recipe suggestions (e.g. resources and access to a kitchen), either independently or with third-party support (e.g. by relatives, outpatient care services).\n\nExclusion Criteria:\n\n* Pregnancy\n* Taste disorder explained by other causes (e.g. existing before therapy or COVID disease)\n* Placement in an inpatient care facility",{"count":108,"type":22},198,[25],"The study investigates taste disorders that commonly occur during or after cancer treatment, often leading to issues such as malnutrition and treatment discontinuation. Although many non-pharmacological recommendations exist, it is unclear which methods are suitable for which individuals.\n\nThis randomized study aims to compare the effectiveness of individualized dietary recommendations (Gustabor group) with the current standard of care -general recommendations (Control group). Participants will undergo an objective assessment of taste disorders using taste strips and questionnaires. Based on the results, the Gustabor group will receive both general and specific dietary suggestions. These will be accomapnied by AI-generated recipe suggestions tailored to specific taste disorders (e.g., more cold foods in cases of metallic taste). The control group will receive the current standard: a flyer containing general dietary advice for oncology patients previously shown to be beneficial for managing taste alterations. The primary endpoint is the PG-SGA score within 12 weeks of inclusion.",[112,113,114,28,115],"Multiple Myeloma (MM)","GI Cancer","Taste Disorder","Urogenital Cancers","2026-06-23",{"date":118,"type":45},"2026-06-26",{"date":120,"type":22},"2026-07-01",{"date":122,"type":22},"2026-12-31",{"name":124,"class":52},"Wuerzburg University Hospital",6,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":53},"100641208","bright-light-therapy-in-patients-with-melanoma-or-non-small-cell-lung-cancer-nsclc-who-are-receiving-first-line-immune-checkpoint-blockade-100641208","NCT07661966","Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade","A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade","IIT BLT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.\n3. Presence of measurable tumor burden.\n4. Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).\n5. ECOG performance status 0-2.\n6. Able to provide informed consent.\n7. Access to reliable internet connection via WiFi or personal hotspot\n\nExclusion Criteria:\n\n1. Previous exposure to immune checkpoint blockade.\n2. Pregnant or breastfeeding.\n3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.\n4. Diagnosis of bipolar disorder or history of mania or hypomania.\n5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\\\u003C3 months).\n6. Poorly controlled seizures.\n7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \\\u003C 2:00 or \\> 5:00).\n8. Night shift work within the past 30 days or expected during the intervention.\n9. Travel across ≥2 time zones within the past 14 days.\n10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.\n11. Migraine with photophobia.\n12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).",{"count":135,"type":22},12,[25],"This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy.\n\nThis trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and\u002For anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application.\n\nThere is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy.\n\nThe idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.",[28,139],"NSCLC (Non-small Cell Lung Cancer)",[132,141,142,143],"Bright Light Therapy","Circadian","Circadian Rhythm",{"date":118,"type":45},{"date":146,"type":22},"2026-06",{"date":148,"type":22},"2027-12",{"name":150,"class":52},"Weill Medical College of Cornell University",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":53},"100642267","phase-2-a-phase-ii-trial-of-tumour-infiltrating-lymphocyte-adoptive-cell-therapy-in-patients-with-immune-checkpoint-inhibitor-resistant-unresectable-or-metastatic-melanoma-100642267","NCT07651618","A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01: A Phase II Trial of Tumour Infiltrating Lymphocyte Adoptive Cell Therapy in Patients With Immune Checkpoint Inhibitor Resistant Unresectable or Metastatic Melanoma","PERTIL-01","Inclusion Criteria:\n\n1. Adult patients = 18 years = 70 years of age.\n2. ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of \\> 6 months\n3. Histologically confirmed unresectable or stage IV melanoma as per AJCC 8th edition. Unresectable melanoma is defined where the lesions are deemed to be unresectable by the treating surgeon.\n4. Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm\n5. Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion).\n6. At least one anti-PD1 containing line of systemic therapy for unresectable or metastatic melanoma. Alternatively, one prior line of an adjuvant or neoadjuvant anti-PD1 containing regimen and all related adverse events have either returned to baseline or stabilized.\n\nExclusion Criteria:\n\n1. Life expectancy of less than 3 months.\n2. Metastatic uveal melanoma.\n3. Requirement for immunosuppressive doses of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs (e.g. mycophenolate, infliximab, or others) within the last 3 weeks prior to patient screening. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at =10 mg\u002Fday of prednisone or another steroid equivalent dose are acceptable.\n4. Participant has symptomatic untreated brain metastases.\n\n   * A participant with historically treated brain metastases (ie, treatment was completed \\>60 days prior to consenting for study participation) may be considered for study participation if the participant is clinically and radiologically stable for = 60 days\n   * Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled.\n5. More than three melanoma brain metastases or evidence of leptomeningeal disease\n\nOther protocol defined exclusion criteria could apply.","70 Years",{"count":161,"type":22},10,[163],"PHASE2","The goal of this study is to determine the activity of Perkileucel, a tumour infiltrating lymphocyte (TIL) adoptive cell transfer therapy (ACT), in patients with unresectable stage III or metastatic melanoma who have progressed on previous treatment with immune checkpoint inhibitors in the adjuvant or metastatic setting.\n\nStudy details:\n\nAll participants will receive the investigational treatment, Perkileucel. To create this therapy, participants need to undergo surgical excision of a melanoma lesion to harvest the TILs prior to treatment. Once the TILs have been manufactured, participants will be admitted to hospital to receive 5 days of chemotherapy to prepare their body (lymphodepletion) for the TIL-ACT. Treatment with TIL-ACT will then be given on Day 0 as a single intravenous infusion followed by up to 6 intravenous infusions of high-dose interleukin 2. Blood tests and other assessments will be performed regularly to monitor safety and response.\n\nThe total duration of the study is 8 years. Safety will be assessed throughout the full duration of the study. Patients will be monitored for delayed adverse events.\n\nThis study will show whether Perkileucel can help control melanoma that has not responded to other treatments and demonstrate feasibility of manufacture and delivery of this treatment in an Australian healthcare setting.",[28,166],"Melanoma Metastatic",[168,169,170,171,172,173],"Unresectable Melanoma","Melanoma","Perkileucel","TILs","Tumour Infiltrating Lymphocytes","Metastatic Melanoma","2026-06-11",{"date":176,"type":45},"2026-06-16",{"date":178,"type":22},"2026-07",{"date":180,"type":22},"2032-04",{"name":182,"class":183},"East Metropolitan Health Service, Australia","OTHER_GOV",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":53},"100641655","evaluating-a-decision-aid-for-sentinel-lymph-node-biopsy-in-intermediate-risk-melanoma-100641655","NCT07653087","Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma","Mel73","Inclusion Criteria:\n\n1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.\n2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.\n3. Patients with either:\n\n   * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or\n   * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\\\u003C5%, 5-10%, or \\>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.\n4. Willingness and ability to comply with study procedures.\n5. Ability to provide informed consent.\n6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.\n\nExclusion Criteria:\n\n1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.\n2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.\n3. Inability to speak or read English.\n4. Inability or unwillingness to provide informed consent.\n5. Prisoners",{"count":192,"type":22},66,[25],"This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma.\n\nSentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision.\n\nPatients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.",[196,28],"Sentinel Lymph Node Biopsy (SLNB)",[198,169,199,200],"SLNB","Sentinel Lymph Node Biopsy","Decision Aid",{"date":202,"type":45},"2026-06-17",{"date":146,"type":22},{"date":205,"type":22},"2028-01",{"name":207,"class":52},"University of Virginia",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":250,"leadSponsor":252,"locationsCount":4},"100641002","phase-2-phoenix-ecp--extracorporeal-photopheresis-for-immune-related-colitis-andor-hepatitis-in-advanced-melanoma-with-inadequate-response-to-steroid-exposure-100641002","NCT07619898","PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and\u002For Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure","PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety\u002FTolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)","PHOENIX-ECP","Inclusion Criteria:\n\n1. Participants diagnosed with unresectable or metastatic melanoma ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.\n2. Participants diagnosed with ir-colitis and\u002For ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (\n3. Participants with endoscopic evidence of ir-colitis\n4. Participants with inadequate response to corticosteroids, as defined per protocol\n5. Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Presence of irAEs in addition to and other than ir-colitis and\u002For ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis\u002Fir-hepatitis) based on ASCO guidelines.\n2. Participant has a diagnosis of uveal melanoma as the sole melanoma subtype\n3. Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids\n4. Concurrent conditions which may require treatment with high dose corticosteroid (\\> 1 milligram per kilogram per day \\[mg\u002Fkg\u002Fday\\]) and interfere with the corticosteroid tapering schedule recommended by the protocol.\n5. Pre-existing liver disease\n6. Active alcohol use disorder\n7. Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.\n8. Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.\n9. Contraindications or known allergic reaction to any of study intervention and\u002For procedures\n10. Participants unable to tolerate the fluid shift associated with the ECP procedure.\n11. Positive result for active or previous viral infections: covid-19, hepatitis B\u002FC, CMV, EBV, adenovirus\n12. History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.",{"count":217,"type":22},112,[163],"Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.\n\nImmune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately.\n\nThe purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.",[221,222,28],"Colitis","Hepatitis",[169,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,221,243,244,245],"Immune-related adverse events","Immune-related colitis","Immune checkpoint inhibitor toxicity","Checkpoint inhibitor-induced colitis","Checkpoint inhibitor-induced hepatitis","Metastatic melanoma","Unresectable melanoma","Immune checkpoint Inhibitors","Extracorporeal photopheresis","ECP","UVADEX","Device","Methoxsalen","Steroid-refractory","Corticosteroid refractory","Phase 2 clinical trial","Randomized controlled trial","Cellex","8-Mop","Ir-AE","Ir-AE Colitis","Ir-AE Hepatitis","2026-05-27",{"date":248,"type":45},"2026-06-02",{"date":178,"type":22},{"date":251,"type":22},"2029-12",{"name":253,"class":98},"Therakos LLC",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100640202","phase-1-comparing-intravenous-or-intradermal-administration-of-anti-ctla-4-in-combination-with-anti-pd1-treatment-in-patients-with-melanoma-100640202","NCT07615881","Comparing Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","Changes in the Tumour Microenvironment After Intravenous or Intradermal Administration of Anti-CTLA-4 in Combination With Anti-PD1 Treatment in Patients With Melanoma","IpiD","Inclusion Criteria:\n\n* Patient must be of age ≥ 18 years, and have a histologically confirmed diagnosis of locally advanced, surgically incurable, or metastatic cutaneous melanoma.\n* European Cooperative Oncology Group (ECOG)\u002FWorld Health Organisation (WHO) performance status of 0 or 1.\n* Patient must be eligible for anti-PD-1 treatment with nivolumab (group 1) or with ipilimumab + nivolumab (group 2) according to the treating physician.\n* Patient must have one or more tumour lesions of which a biopsy can safely be obtained according to standard clinical practice.\n* Patients must have a life expectancy of 3 months or greater.\n* Patients must have measurable disease (according to RECIST v1.1) with at least one cutaneous metastasis. Note: measurable disease defined as: at least 1 visceral or nodal\u002Fsoft tissue melanoma lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by CT scan or MRI. Lymph nodes must measure ≥ 15 mm in their short axis to be considered measurable by CT-scan or MRI.\n* Adequate bone marrow, hepatic, renal and coagulation function (to be conducted within 7 days prior to start therapy, during the baseline period):\n\n  * Leukocyte count ≥ 3,5 × 109 \u002F L\n  * Platelets ≥ 100 × 109 \u002F L.\n  * Total bilirubin ≤ 3 × the upper limit of normal (ULN).\n  * ASAT and ALAT ≤ 3.0 × ULN; except patients with documented liver metastases ASAT and\u002For ALAT ≤ 5.0 × ULN.\n  * (Estimated) creatinine clearance ≥ 45 mL\u002Fmin\u002F1,73 m2.\n  * Albumin ≥ 30g \u002F L\n  * LDH ≤ 2 x ULN\n* Women of childbearing potential (WOCBP) must use contraception during the study and for 23 weeks after the last dose of nivolumab.\n* Men who are sexually active with WOCBP must use contraception during the study plus 7 months after the last dose of nivolumab.\n* Written and signed informed consent.\n\nExclusion Criteria:\n\n* Primary uveal or mucosal melanoma.\n* Prior treatment with CTLA-4 inhibitor or agonist, or anti-PD1, except for adjuvant nivolumab \\> 6 months ago.\n* Prior radiotherapy is permitted except on RECIST v1.1 target lesions within 2 weeks of start of trial treatment. Irradiated lesions without progression before start of treatment cannot be target lesions. Note: Patients must have recovered from all radiation-related toxicities, and not require corticosteroids.\n* Patient has 12-lead ECG significant findings during screening, per Investigator's as sessment.\n* History of another malignancy (that is progressing or requires active treatment) within the previous 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cancer that has undergone potentially curative therapy.\n* Patient has a confirmed active SARS-CoV-2 infection.\n* Patient has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Active systemic infections requiring therapy, or signs or symptoms of a systemic infection within two weeks prior to baseline.\n* Patient has used systemic corticosteroids to treat inflammatory or autoimmune symptoms within 15 days or other immunosuppressive drugs within 30 days prior to screening. Exceptions:\n\n  * Patients that require intermittent use of inhalation or topical corticosteroids are eligible for the study.\n  * Patient has received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) that, in the opinion of the Investigator, will not compromise protocol objectives.\n* Patient has had treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor agents) within 2 weeks prior to baseline.\n* Patient has had treatment with systemic immunostimulatory agents (including but not limited to interferons \\[IFNs\\] or interleukin-2 \\[IL-2\\]) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to baseline.\n* Known history or evidence of immunodeficiency states (e.g., organ transplant, leukaemia, human immunodeficiency virus (HIV), hepatitis B, hepatitis C or known acquired immunodeficiency syndrome (AIDS)). NOTE: Testing for HIV must be performed at sites were mandated locally.\n* Patient has had any major surgery within 4 weeks prior to enrolment or major surgery is scheduled during the study, with the exception of procedures that are part of the study site IIS.\n* Patient has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise patient safety or protocol objectives.\n* Patient has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the patient at high risk from complications.\n* Patient has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and\u002For the proposed ICI therapy.\n* Pregnancy or breastfeeding.\n* Patient has a history of alcohol or drug abuse within the last year.\n* Currently participating in or has participated in a study of an investigational agent within 30 days of baseline or has not recovered from adverse events due to agents administered more than 4 weeks earlier, except A Phase 1a\u002F1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients with Solid Tumor Malignancies to Evaluate GEH200520 Injection \u002F GEH200521 (18F) Injection Safety and Tolerability, Positron Emission Tomography Imaging, Pharmacokinetics, and Changes in Imaging after Treatment; NCT05629689, EU Trial number: 2024-515218-42-00.\n* For any reason, patient is considered by the local investigator to be an unsuitable candidate to participate in this study.",{"count":263,"type":22},18,[265,163],"PHASE1","This study investigates whether a single intradermal (i.d.) injection of low-dose anti-CTLA-4 (ipilimumab), given at the tumour site, can enhance immune activation when combined with standard intravenous (i.v.) anti-PD-1 therapy in patients with advanced melanoma. While combined checkpoint inhibition is effective, it is associated with high toxicity, creating a need for strategies that maintain efficacy with fewer side effects.\n\nPreclinical and early clinical data suggest that local (intradermal) CTLA-4 blockade can stimulate systemic anti-tumour immune responses with reduced toxicity, potentially by reactivating suppressed T cells in tumour-draining lymph nodes. This study compares systemic immune effects of intradermal versus standard intravenous CTLA-4 administration, both combined with nivolumab.\n\nThe primary objective is to assess systemic immune activation by measuring changes in CD4+ and CD8+ T-cell frequencies and ICOS expression in peripheral blood. Additional immune monitoring includes blood sampling, tumour biopsies, and advanced imaging using FDG-PET\u002FCT and a novel CD8-targeted PET tracer. The study is a prospective, open-label pilot trial in patients with metastatic melanoma, with follow-up for clinical outcomes and immune response over approximately 13 weeks.",[28],"2026-05-22",{"date":270,"type":45},"2026-05-29",{"date":178,"type":22},{"date":273,"type":22},"2029-07",{"name":275,"class":52},"Amsterdam UMC, location VUmc",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":53},"100640574","liquid-biopsy-multi-omics-and-biomarker-development-in-melanoma-100640574","NCT07584291","Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma","Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study","Inclusion Criteria:\n\n* Diagnosed with acral or cutaneous melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Underwent sentinel lymph node biopsy with complete information available.\n* Archived melanoma tissue samples available with complete information.\n* Complete basic demographic and clinical information.\n* Age 18-80 years, any sex.\n\nExclusion Criteria:\n\n* Patients with severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation.\n* Patients diagnosed with mucosal melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Patients with other concurrent malignant tumors (e.g., basal cell carcinoma, lung cancer).\n* Incomplete patient information or pathological sample data.","80 Years",{"count":285,"type":22},200,"This prospective, observational cohort study aims to explore the multi-omics profiles of liquid biopsies and develop clinical biomarkers in melanoma. Two hundred participants with pathologically confirmed acral or cutaneous melanoma who are scheduled to receive standard first-line immunotherapy will be enrolled. Blood samples will be collected at baseline and every 3 weeks during treatment, along with radiological assessments every 12 weeks. Tumor tissue will be obtained at surgery after approximately 3 months of therapy. Using microfluidic-based circulating tumor cell isolation, exosome enrichment, ctDNA analysis, and integrative multi-omics approaches, the study will compare molecular features across primary tumors, metastases, and liquid biopsy components. The primary outcomes are progression-free survival and overall survival, assessed up to 36 months. Secondary outcomes include changes in circulating tumor cell counts, ctDNA concentrations, exosomal biomarker levels, pathological response rate at surgery, and the predictive accuracy of a multi-omics model for treatment response. The findings are expected to provide a basis for personalized monitoring and treatment strategies in melanoma.",[28],"2026-05-12",{"date":290,"type":45},"2026-05-13",{"date":292,"type":45},"2025-07-01",{"date":294,"type":22},"2028-05-30",{"name":296,"class":52},"Xijing Hospital",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":135},"100615077","phase-1-study-of-amxt-1501-and-dfmo-in-combination-with-standard-therapies-in-advanced-solid-tumors-100615077","NCT07287917","Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors","A Phase 1b\u002F2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies","Inclusion Criteria:\n\nPatients will be eligible for study participation only if they meet ALL the inclusion criteria applicable to their diagnosis.\n\n1. Understand and sign the informed consent form (ICF) and be willing to comply with all study procedures before any study specific procedures are conducted.\n2. ≥18 years old at the time of signing the informed consent.\n3. Diagnosed with unresectable, locally advanced, or metastatic solid tumors including ER+ HER2- breast cancer (Cohort 1) or melanoma (Cohort 2)\n\n   a.Underlying malignant disease must be histologically or cytologically documented b.For breast cancer patients: locally advanced or metastatic breast cancer with one or more actionable PIK3CA\u002FAKT1\u002FPTEN-alterations following progression on at least 2 endocrine-based regimens in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. Patients who are candidates to start therapy with capivasertib are eligible for enrollment. Patients previously treated with PIK3CA inhibitors will be allowed into the study. Premenopausal patients with ER+ HER2-breast cancer may be enrolled and should be maintained on an agent for ovarian suppression (i.e., luteinizing hormone-releasing hormone \\[LHRH\\] agonist) as part of SOC.\n\n   c.For melanoma patients: patients with unresectable metastatic cutaneous melanoma that progressed on any prior immune checkpoint inhibitor and, if BRAF600 mutant positive, a BRAF or mitogen-activated protein kinase (MEK) inhibitor or both as shown below: i.Patient have to have resolution of all immune checkpoint inhibitor-related adverse events to Grade 0-1 and prednisone ≤10 mg\u002Fday for at least 2 weeks. Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy.\n\n   ii.Patients must have progressed or shown intolerance to any prior immune checkpoint inhibitors.\n\n   iii.Patients with BRAF gene mutant melanoma must have had a prior treatment regimen (progressed or shown intolerance) that included vemurafenib, dabrafenib, or an approved BRAF gene and or MEK protein inhibitor. However, patients who may continue to be candidates for second line immune check point inhibitors can be enrolled prior to initiation for BRAF gene or MEK inhibitors.\n\n   iv.Patients with incurable malignancies may be enrolled regardless of the number of prior treatment lines, as long as in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from other available treatment options (FDA Guidance for Industry: Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings. July 2022).\n\n   d.Has evaluable or measurable disease by tumor Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1) at the time of enrollment. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\n   e.Patients with brain previously treated stable brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n4. Patients must be willing to undergo a fresh tumor biopsy at Screening and during treatment if safe and clinically feasible. An archival sample is allowed if obtained within 1 year prior to the first dose of study drug. However, lack of tumor biopsy by itself will not preclude patients from enrollment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening or Day 1.\n6. Life expectancy of at least 12 weeks.\n7. Adequate organ function defined as:\n\n   a.Absolute neutrophil count (ANC) ≥1.5×109\u002FL without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the laboratory assessment b.Platelet ≥100×109\u002FL, without transfusion within 7 days preceding the laboratory assessment c.Hemoglobin ≥9 g\u002FdL, without transfusion support within 7 days preceding the laboratory assessment d.Activated partial thromboplastin time\u002Fpartial thromboplastin time (aPTT\u002FPTT) ≤1.5×ULN e.Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (if liver metastases are present, then ≤5×ULN is allowed) f.Total serum bilirubin ≤1.5×ULN, except for patients with known Gilbert's Syndrome in whom ≤3×ULN is permitted. Confirmation of Gilbert's diagnosis requires elevated unconjugated (indirect) bilirubin values; normal complete blood count in previous 12 months, blood smear, and reticulocyte count; normal aminotransferases and alkaline phosphatase in previous 12 months g.The patient is clinically euthyroid (whether treated or untreated) h.Renal: Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for patients with serum creatinine levels \\>1.5×ULN i.Any Grade 3 or higher laboratory abnormalities should be discussed and approved by the Sponsor Medical Monitor or designee prior to enrollment (even if not considered clinically significant)\n8. Fully recovered from acute toxic effects of prior anti-neoplastic therapies. The following minimum periods from treatment apply:\n\n   1. Myelosuppressive chemotherapy: At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea).\n   2. Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta) or 7 days for short-acting growth factor.\n   3. Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   The duration of this interval must be discussed with the Sponsor Medical Monitor or designee.\n\n   d.Monoclonal antibodies: \\>21 days must have elapsed from the infusion of last dose of antibody and toxicity related to antibody therapy must be recovered to Grade ≤1.\n\n   e.Radiation therapy: Patients must have had their last fraction of craniospinal or focal irradiation a minimum of 8-12 weeks prior to enrollment.\n\n   f.Stem cell transplant: Patients must be ≥3 months since autologous stem cell transplant. Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study.\n\n   g.For combination with pembrolizumab cohort: Patients with Grade ≤2 neuropathy may be eligible, as may patients with endocrine-related Grade ≤2 AEs requiring treatment or hormone replacement.\n9. Active secondary malignancies will not be allowed, with the exception of:\n\n   a.Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer b.Adequately treated Stage 1 cancer from which the patient is currently in remission and has been in remission for ≥2 years c.Low-risk prostate cancer with Gleason score \\\u003C7 and prostate-specific antigen \\\u003C10 ng\u002FmL d.Any other cancer from which the patient has been disease-free for ≥3 years\n10. Patient compliance and geographic proximity (as determined by the Investigator) to allow adequate follow-up.\n11. Both male and female patients must be willing to consent to using highly effective contraception (refer to Section 9.1.10) prior to study entry, while on treatment, and at least 3 months thereafter.\n12. Able to take oral medications.\n\nExclusion Criteria:\n\nPatients will not be eligible for study participation if they meet ANY of the exclusion criteria.\n\n1. Patients with melanoma only:\n\n   i. Radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier ii.Expected to require any other form of systemic or localized antineoplastic therapy while on study.\n\n   iii.Chronic systemic steroid therapy within 2 weeks before the planned date of the first dose of randomized treatment or on any other form of immunosuppressive medication.\n2. Intolerant to any component of combination or standard of care therapies.\n3. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Patient has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.\n4. Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).\n5. Treatment with radiation therapy, surgery, chemotherapy, or immunotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C). No prior use of Adriamycin is allowed. Limited prior palliative radiation may be permissible no less than 2 weeks prior to C1D1 with approval from the Sponsor Medical Monitor or designee.\n6. Targeted small molecule therapy within 7 days prior to initiation of trial therapy. Chemotherapy within 14 days prior to initiation of trial therapy.\n7. Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n8. History of or presence of clinically significant cardiovascular disease, e.g.,\n\n   a. Inadequately controlled or uncontrolled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg on antihypertensive medications.) b. Atherosclerotic cardiovascular disease including history of myocardial infarction, unstable angina, angina, coronary artery disease, cerebrovascular accident (CVA) or transient ischemic attack (TIA). History of coronary revascularization including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or stent placement is excluded. c. Elevated Troponin I or BNP (or NT-proBNP) blood levels above the upper limit of normal at screening or baseline on C1D1.\n\n   d. Heart failure or abnormal left ventricular ejection fraction (e.g., EF \\\u003C50%).\n\n   e. Atrial or ventricular arrhythmias, including atrial fibrillation, ventricular tachycardia. Patients with pacemakers or ICDs (implantable cardioverter defibrillators) are excluded.\n\n   f. Known cardiac involvement of a systemic disease (e.g., as in SLE, rheumatoid arthritis, psoriatic arthritis, systemic sclerosis\n9. History or presence of ECG abnormalities, e.g.,\n\n   a. Congenital or acquired prolonged QTc. Screening QTcF \\> 450ms is excluded. b. Bundle branch block including right or left bundle branch block, left anterior or posterior fascicular block, second, and 3rd degree AV block, clinically significant ST segment elevations or depressions (e.g., ≥1 mm elevation or ≥0.5 mm depression), arrhythmias. Sinus arrhythmia is not excluded. Asymptomatic sinus bradycardia is not excluded.\n10. Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1.\n11. Have active bacterial, viral, or fungal infections requiring systemic therapy.\n12. Women who are pregnant or lactating. NOTE: Women of childbearing potential (WOCBP) must have a \"negative\" serum pregnancy test within 1 week prior to treatment.\n\n    a.Women not OCBP is defined as: i.Postmenopausal with \\>1 year since last menses and:\n\n1.If \\\u003C65 years old, follicle-stimulating hormone (FSH) \\>40 mIU\u002FmL. 2.If ≥65 years old and not on hormone replacement therapy (HRT), FSH \\>30 mIU\u002FmL.\n\n3.If ≥65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥6 months prior to dosing of study drug(s).\n\n4.Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥6 months prior to dosing study drug(s).\n\nNote: Tubal ligation is not considered a form of permanent sterilization. 13.Patients may not have any unresolved toxicity Grade \\>1 from previous anticancer therapy, except for stable chronic toxicities that are not expected to resolve (i.e., peripheral neuropathy, alopecia, etc.). Patients who have an ongoing requirement for thyroid replacement therapy from prior exposure to an immune checkpoint inhibitor but who are clinically euthyroid are permitted (whether treated or untreated).\n\n14.Have an unwillingness or inability to comply with required procedures in this protocol.\n\n15.Current active liver disease from any cause, including hepatitis A (hepatitis A virus immunoglobulin M \\[Hep A IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV ribonucleic acid). Patients with HCV with undetectable virus after treatment are eligible. Patients with a prior history of HBV are eligible if quantitative polymerase chain reaction (PCR) for HBV DNA is negative. Note that elevated levels of biotin may interfere with viral serology testing.\n\n16.Have a serious nonmalignant disease that, in the opinion of the Investigator or the Sponsor Medical Monitor or designee, could compromise protocol objectives.\n\n17.Patients who are currently receiving any other investigational agent or who have received an investigational agent within the last 28 days, with the exception of any patient who participated in Study AMXT1501-101A.\n\n18.Known gastrointestinal (GI) disease or procedure that could interfere with the absorption of study drug, including inability to swallow whole capsules or tablets or conditions that may interfere with absorption. The Sponsor Medical Monitor or designee should be contacted for any questions regarding this exclusion criterion.\n\n19.Patients who have exhibited allergic reactions or intolerability to a similar structural compound, biological agent, or formulation as study drugs used in this study, including AMXT 1501, DFMO, and SOC therapies.\n\n20.Use of other hormonal therapies are not permitted during the study in the breast cancer cohort (Cohort 1). Exception: premenopausal women with ER+\u002FHER2- breast cancer should be maintained on an LHRH agonist for ovarian suppression.\n\n21.Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Patients who switch from a high dose to a dose of ≤30 μg\u002Fday are eligible for study entry.\n\n22.Uncontrolled, acute, or life-threatening bacteria, viral, or fungal infection. Patients with ongoing use of prophylactic antibiotics, antifungals, or antivirals are eligible if no evidence of active infection, this includes COVID patients.\n\nException: Patients with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible.\n\n23.Patient has an active or prior history of autoimmune disease. Exception: patients with type 1 diabetes (if stable, well-controlled, and not brittle), vitiligo, hypo- or hyperthyroid disease, or autoimmune alopecia are permitted if the condition does not require immunosuppressive treatment.\n\n24.Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n\n25.Combination with pembrolizumab specific additional exclusion criteria:\n\n1. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n2. Has received radiation therapy to the lung that is \\>30 Gy within 6 months of the first dose of trial treatment.\n3. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n4. Has history of an allogeneic stem cell transplant or a solid organ transplant.\n5. Has a history of radiation pneumonitis. (Note: Cannot receive prior radiotherapy within 2 weeks of start of pembrolizumab. Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation \\[≤2 weeks of radiotherapy\\] to non-CNS disease.",{"count":305,"type":22},92,[265,163],"This study will evaluate the safety, tolerability, and preliminary effectiveness of AMXT 1501 and DFMO when combined with standard treatments for advanced solid tumors. The trial includes two groups:\n\n* Cohort 1: Patients with ER+ \u002F HER2- breast cancer receiving fulvestrant and capivasertib\n* Cohort 2: Patients with unresectable or metastatic cutaneous melanoma receiving pembrolizumab\n\nThe Phase 1b portion will find the recommended Phase 2 dose (RP2D). The Phase 2 portion will further evaluate clinical activity at the RP2D using response criteria for solid tumors (RECIST 1.1).\n\nThe study will also evaluate pharmacokinetics, pharmacodynamics, disease control, and overall safety.",[28,309],"HER2-low Hormone Receptor Positive Breast Cancer",[311,34,312,313,314,315,316,317],"breast cancer","AMXT 1501","DFMO","polyamine inhibitor","advanced solid tumor","combination therapy","polyamine","2026-05-10",{"date":288,"type":45},{"date":321,"type":45},"2026-01-26",{"date":323,"type":22},"2028-12-29",{"name":325,"class":98},"Aminex Therapeutics, Inc.",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":53},"100640582","exploratory-study-with-parallel-controls-on-the-safety-and-efficacy-of-neoadjuvant-low-branched-chain-amino-acid-diet-in-combination-with-anti-pd-1-monoclonal-antibody-for-stage-iii-melanoma-100640582","NCT07586891","Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","A Randomized, Double-Blind, Single-Center, Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","Inclusion Criteria:\n\n* Patients with histopathologically or cytologically confirmed Stage III malignant melanoma. Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis. Patients with mucosal or ocular melanoma are excluded; those with melanoma of unknown primary are also excluded.\n* No prior radiotherapy or systemic chemotherapy. No treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal antibody, interferon (IFN), or targeted agents within the last month.\n* Life expectancy ≥ 6 months.\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Patients must have provided written informed consent to participate voluntarily in this trial and must be between 18 and 75 years of age on the day of signing the consent form.\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n* Adequate organ function as assessed by the following laboratory values (within 4 weeks prior to the start of study drug treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant).\n* For women of childbearing potential, a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n* Female patients of childbearing potential who enroll in the study must be willing to use adequate contraception for up to 12 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* The patient is currently participating, or has participated in a clinical trial of an investigational drug or medical device within 4 weeks prior to the first dose of the study drug.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic corticosteroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive therapy.\n* The patient has a known history of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity reaction to another monoclonal antibody (mAb) therapy.\n* The patient has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with corticosteroids or immunosuppressive drugs). Replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed. Exceptions include patients with vitiligo, type I diabetes mellitus, or childhood asthma\u002Fatopy.\n* Any other severe, uncontrolled co-morbid condition that may compromise protocol compliance or interfere with the interpretation of results, including metabolic diseases, active opportunistic or advanced (severe) infections, cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months), or pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm). Also included are HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitation limit: 500 IU\u002FmL); or a known history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose. The patient has received hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation. The patient has undergone major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.\n* The patient is pregnant or breastfeeding, or plans to conceive or father children during the study period.\n* Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.","75 Years",{"count":335,"type":22},80,[25],"1. Primary Objective:\n\n   To evaluate the safety of a low branched-chain amino acid diet (60% of the normal dietary BCAA content) combined with anti-PD-1 monoclonal antibody as neoadjuvant therapy in patients with stage III melanoma, by documenting the incidence of all adverse events (AEs) and serious adverse events (SAEs), and analyzing changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Secondary Objectives:\n\n   To assess the pathological response rates (including pCR, near-pCR, pPR, and pNR) of the combination therapy in stage III melanoma; to evaluate the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the immune-related RECIST (irRECIST) criteria; and to estimate event-free survival (EFS) and overall survival (OS) through long-term follow-up.\n3. Exploratory Objectives:\n\nTo investigate the quality of life (QoL) in patients receiving the low BCAA diet combined with anti-PD-1 therapy; and to identify predictive biomarkers for treatment outcome differences, such as immune-related gene signatures (e.g., PD-L1 expression) and driver gene mutations in somatic variants.",[28],"2026-05-07",{"date":341,"type":45},"2026-05-14",{"date":343,"type":45},"2024-07-01",{"date":345,"type":22},"2027-06",{"name":296,"class":52},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":363,"locationsCount":53},"100637911","early-phase-1-efficacy-and-safety-of-neoadjuvant-cadonilimab-plus-high-dose-recombinant-human-interferon-1b-in-stage-iiiiv-melanoma-100637911","NCT07586904","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma.","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma: A Single-Center, Open-Label, Phase Ib Trial","Inclusion Criteria:\n\n* Voluntarily participate in this trial, sign the informed consent form, and be between 18 and 75 years of age, regardless of gender.\n* Patients with histopathologically or cytologically confirmed stage III or resectable stage IV malignant melanoma.\n\n  * Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis.\n  * Resectable stage IV is defined as a single distant metastasis, excluding brain metastases or any other metastases that cannot be completely surgically resected.\n  * Mucosal or ocular melanomas are excluded.\n  * Melanomas of unknown primary origin are excluded.\n* Have not received treatment with PD-1, PD-L1, or PD-L2 antibodies, anti-CTLA4 antibodies, interferon (IFN), targeted therapy, radiotherapy, or systemic chemotherapy within the past month.\n* Have an expected survival period of ≥ 6 months.\n* Have at least one measurable lesion according to RECIST version 1.1.\n* Have an ECOG performance status score of 0 or 1.\n* Have adequate organ function, as indicated by the following laboratory values (within 4 weeks prior to the start of study treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant used).\n\n     8.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n\n     9.Female patients enrolled in the study must be willing to use appropriate contraception methods until 12 months after the last dose of the study drug.\n\n     Exclusion Criteria:\n* The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another interventional clinical trial of drugs or medical devices.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic steroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive medication.\n* The patient has a known history of hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity to another monoclonal antibody (mAb) therapy.\n* The patient has had an active autoimmune disease requiring systemic treatment (e.g., with corticosteroids or immunosuppressive drugs) within the past 2 years, and related replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency). Exceptions include patients with vitiligo, type I diabetes, childhood asthma\u002Fatopy.\n* Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of results, including active opportunistic or advanced (severe) infections; uncontrolled diabetes; cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months); pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm); HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitative limit ≥500 IU\u002FmL); or a documented history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose; hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation; or major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance use disorder that would interfere with cooperation with trial requirements.\n* The patient is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period.\n* Any other severe, acute, or chronic medical or laboratory abnormality that, in the investigator's judgment, could increase the risk associated with study participation or could interfere with the interpretation of study results.",{"count":161,"type":22},[356],"EARLY_PHASE1","1. Primary Objective\n\n   To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III\u002FIV melanoma. Assessments include:\n\n   Target lesion response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) Objective response rate (ORR) Pathological response rate (pathological complete response \\[pCR\\], near pCR, pathological partial response \\[pPR\\], pathological non-response \\[pNR\\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Exploratory Objectives To investigate the correlation between treatment efficacy\u002Fpatient outcomes and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB).\n3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.",[28],{"date":341,"type":45},{"date":361,"type":45},"2025-05-01",{"date":345,"type":22},{"name":296,"class":52},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":53},"100614524","investigating-real-time-immunotherapy-symptoms-study-100614524","NCT07280715","Investigating Real-Time Immunotherapy Symptoms Study","Digital Remote Patient Monitoring and Triage During Cancer Immunotherapy","IRIS","Inclusion Criteria:\n\n* within three months of starting immune checkpoint inhibitor therapy at UPMC Hillman Cancer Center for advanced melanoma;\n* age 18 years or older;\n* ability to read and write in English;\n* owns and uses a smartphone capable of running study applications\n\nExclusion Criteria:\n\n* under 18 years old; and\n* unable to read and write in English",{"count":373,"type":22},40,[25],"The goal of this study is to evaluate the feasibility of using information from wearable devices and self-reported symptoms to remotely monitor patients during immunotherapy. The main questions it aims to answer are:\n\n* Is the digital remote patient monitoring tool feasible and acceptable to patients?\n* Do the alerts and guidance improve symptom management, quality of life, and engagement with the care team during treatment?\n\nParticipants will:\n\n* Complete a demographic questionnaire at the beginning of the study and quality-of-life and health questionnaires at the beginning, midpoint, and end of study.\n* As feasible: At the beginning and end of the study, complete an in-person physical function assessment measuring balance (Short Physical Performance Battery).\n\nIf participant is randomly assigned to the intervention group, they will also:\n\n* Complete weekly symptom ratings via digital remote patient monitoring tool\n* Wear a Fitbit activity tracker for 90 days.\n* At the end of the study, complete a semi-structured interview to provide feedback on the study.",[67,28,68],[378,379],"quality of life","adverse events","2026-05-05",{"date":382,"type":45},"2026-05-11",{"date":146,"type":22},{"date":122,"type":22},{"name":386,"class":52},"University of Pittsburgh",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":53},"100635632","pilot-study-of-bone-mineral-density-changes-during-anti-pd-1-immunotherapy-100635632","NCT07555210","Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy","Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).\n3. Life expectancy of at least 12 months per the discretion of the treating physician.\n\nExclusion Criteria:\n\n1. Patients ineligible for anti-PD-1 therapy.\n2. Patients with metastatic disease.\n3. Patients planning treatment with dual immune checkpoint inhibitor therapy.\n4. Bony fractures in the pelvis, bilateral hips\u002Ffemurs, thoracic spine, or lumbar spine.\n5. Known osteoporosis or osteopenia.\n6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.\n7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV\u002FV, or ESRD.\n8. Inability to comply with study procedures.\n9. Inability to lie flat for 20-25 minutes during an imaging session.\n10. Pregnant or breastfeeding patients.\n11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":7,"type":22},[25],"Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.\n\nA rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.\n\nThe investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.",[398,399,28,400,401,402,403,404],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","Renal Cell Carcinoma (Kidney Cancer)","Non-Small Cell Lung Cancer","MSI-H\u002FdMMR Rectal Cancer","Squamous Cell Carcinoma Mouth","Invasive Mammary Carcinoma","Classic Hodgkin Lymphoma","2026-05-04",{"date":407,"type":45},"2026-05-06",{"date":409,"type":45},"2025-08-25",{"date":411,"type":22},"2028-07-01",{"name":413,"class":52},"Jessica Mezzanotte Sharpe",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100635722","sun-exposure-and-activities-after-skin-cancer-optimization-of-mhealth-interventions-100635722","NCT07556380","Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions","SESAME: Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions","SESAME","Inclusion Criteria:\n\n* Is able to speak, read and write in English\n* Had previous melanoma diagnosis with no melanoma treatment in the last three months\n* Has no current Melanomas or untreated skin cancer\n* Reports spending at least 15 minutes outside per day during Spring\u002F Summer on both weekdays and weekends\n* Owns a smartphone with access to both Bluetooth and WIFI\n* Is willing to use the UV device and Actigraph during waking hours\n* Is willing to download and use a study app\n* Is willing to actively participate in the study for up to 1 year\n\nExclusion Criteria:\n\n* Has a medical condition preventing moderate-to-vigorous physical activity (MVPA) or a doctor recommendation to avoid MVPA\n* Is currently enrolled in another study on MVPA",{"count":423,"type":22},150,[25],"The purpose of this study is to evaluate 5 different smartphone administered sun protection interventions that aim to reduce unprotected sun exposure in melanoma survivors. Participants are asked to wear an ultraviolet (UV) device and an activity monitor (Actigraph) to measure their daily UV exposure and track their physical activity for three separate assessment weeks and complete daily surveys. After the first assessment week, eligible participants are assigned up to 5 different sun protection interventions that are administered through a smartphone application for 8 weeks. Following 8-week use of the sun protection interventions, participants complete another assessment week. At the end of the assessment week, participants provide feedback on the design and usability of the UV device, smartphone application and each of the sun protection interventions that they experienced. One year later, participants are contacted again to complete a final assessment week.",[28],[428,429,235,169,430,67,431,432,433,434,435,436],"Wearable","Smartphone","Physical activity","Actigraph","Sun protection","Sunscreen","Goals","Health","Ultraviolet radiation","2026-04-22",{"date":439,"type":45},"2026-04-29",{"date":441,"type":22},"2026-04-01",{"date":443,"type":22},"2027-09",{"name":445,"class":52},"Northwestern University",2,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":468,"leadSponsor":470,"locationsCount":4},"100635431","phase-3-superparamagnetic-iron-oxide-for-sentinel-lymph-node-localization-in-patients-with-cutaneous-melanoma-a-randomized-phase-iii-multi-center-non--inferiority-trial-magmen-ii-100635431","NCT07552597","Superparamagnetic Iron Oxide for Sentinel Lymph Node Localization in Patients With Cutaneous Melanoma, a Randomized Phase III Multi-center Non- Inferiority Trial: MagMen-II","MagMen-II","Inclusion criteria:\n\n1. Male or female aged above 18 years\n2. Signed and dated written informed consent before the start of specific protocol procedures\n3. Histologically confirmed melanoma planned for wide local excision and sentinel lymph node biopsy\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding\n2. Inability to undergo any of the study procedures\n3. Iron overload disease\n4. Known hypersensitivity to iron or dextran compounds",{"count":455,"type":22},254,[457],"PHASE3","A randomized, international, phase III, multi-center, non- inferiority trial assessing the safety and efficacy of Magtrace® (superparamagnetic iron oxide, SPIO) in identification of lymph nodes in patients with cutaneous melanoma undergoing a sentinel lymph node biopsy (SLNB). Participants will be injected with both tracer methods Technetium (Tc99) plus Blue Dye (BD) and Magtrace®). They will undergo both a lymphoscintigraphy and a Magnetic Resonance Imaging (MRI) of the SLN basins. Before surgery, the participants will be randomly assigned on a 1:1 basis to either start the SLNB procedure using Tc99\u002FBD and gamma-probe followed by Magtrace® and magnetic probe, or SLNB using Magtrace® followed by Tc99\u002FBD. Randomization will be stratified by study site using permuted variable block sizes.",[28],[34,461,462,463],"sentinel node biopsy","magnetic tracer","Magtrace","2026-04-20",{"date":466,"type":45},"2026-04-27",{"date":405,"type":22},{"date":469,"type":22},"2029-12-31",{"name":471,"class":183},"Vastra Gotaland Region",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":481,"briefSummary":482,"conditions":483,"keywords":486,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":495},"100564090","phase-2-a-trial-of-lns8801-with-or-without-pembrolizumab-in-patients-with-refractory-melanoma-100564090","NCT06624644","A Trial of LNS8801 With or Without Pembrolizumab in Patients With Refractory Melanoma","A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma","Inclusion Criteria:\n\n* Confirmed unresectable and\u002For metastatic cutaneous melanoma.\n* 2 copies of the fully functional form of GPER protein-coding sequence.\n* Eligible for and willing to receive 1 or more of the physician's choice (PC) therapies.\n* Able to swallow tablets.\n* Progressed on treatment with an anti-PD-1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other therapies.\n* Received an anti-CTLA-4 and\u002For BRAF containing regimen or is not eligible for or has declined anti-CTLA-4 and\u002For BRAF therapy prior to and for this study.\n* Measurable disease.\n* Eastern Cooperative Oncology Group Performance Status of 0 to 1.\n\nExclusion Criteria:\n\n* Blue nevus subtype, mucosal, acral lentiginous, or uveal\u002Focular\u002Fchoroidal Melanoma.\n* Previous anti-cancer or investigational drug\u002Fdevice treatment within 4 weeks of the first dose of study drug.\n* Radiotherapy within 2 weeks of starting study drug.\n* Allogeneic tissue\u002Fsolid organ transplant.\n* Unstable autoimmune or immunodeficiency disease.\n* Other concurrent health issues that would make participation or completion of the study difficult.\n* Prior reaction to anti PD-1 therapy that would make treatment with pembrolizumab unadvisable.\n* Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":480,"type":22},135,[163,457],"The goal of this clinical trial is to understand if a new drug called LNS8801 can safely treat patients with melanoma. The primary question to be answered is what is the average length of time during which melanoma does not grow or spread after starting treatment with LNS8801? Researchers will compare LNS8801 taken alone or LNS8801 taken together with another drug called pembrolizumab to other therapies as decided by the treating doctor.\n\n135 patients will be randomly (like flipping a coin) placed in 3 treatment groups.\n\nIn the first group (LNS8801 only) - Patients will take 125mg tablet of LNS8801 by mouth once per day every day for up to 2 years.\n\nIn the second group (LNS8801 + pembrolizumab) - Patients will take 125mg tablet of LNS8801 by mouth once per day plus 200 mg of pembrolizumab by IV infusion once every 3 weeks for up to 2 years.\n\nIn the third group, called Physician's Choice (PC), patients will receive chemotherapy (dacarbazine or temozolomide) or immunotherapy (pembrolizumab, nivolumab\u002Frelatlimab or nivolumab\u002Fipilimumab) as determined by their treating physician.\n\nHow often the patient visits the clinic visits will depend on the treatment group. Besides returning to the clinic for treatment, the patient will undergo periodic safety assessments and other required study procedures such as imaging assessments.",[28,484,485,168],"Melanoma Stage IIIB-IV","Cutaneous Melanoma",[169],"2026-04-18",{"date":437,"type":45},{"date":490,"type":45},"2025-08-06",{"date":492,"type":22},"2031-02",{"name":494,"class":98},"Linnaeus Therapeutics, Inc.",9,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":23,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":53},"100558020","phase-1-phase-ib-study-of-alpelisib-with-pembrolizumab-in-patients-with-metastatic-breast-cancer-or-melanoma-selena-100558020","NCT06545682","Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)","Inclusion Criteria:\n\n1. Patients must be 18 years or older.\n2. Patients must be willing and able to provide informed consent.\n3. In the dose escalation, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has progressed on treatments that are known to prolong survival or for which no standard treatment is available or refused such therapy. Presence of active brain metastases is not required. Patients with active metastases as defined below can be eligible in the dose escalation.\n4. In the dose expansion, patients must have histologically documented locally advanced, unresectable, or metastatic melanoma or TNBC that has progressed on treatments that are known to prolong survival or for which no standard treatment is available or refused such therapy.\n\n   1. Melanoma patients without brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.\n   2. Melanoma patients with active and untreated brain metastases who have progressed on an anti-PD-1 or anti-PD-L1-based regimen.\n   3. TNBC patients (defined as ER \\\u003C1%, HER2 0, 1+, 2+, and fluorescence in situ hybridization negative) with active untreated brain metastases. Prior treatment with anti-PD-1\u002Fanti-PD-L1 is not required.\n5. All patients must have had a brain magnetic resonance imaging (MRI) scan in the previous 28 days to confirm eligibility for the following cohorts:\n\n   1. Dose escalation and dose expansion Cohort 1: Confirmed absence of untreated brain metastases in patients with histologically confirmed advanced melanoma. Prior surgery for brain metastases must have been completed at least 4 weeks prior study treatment initiation, whole brain radiation therapy must have been completed at least 3 weeks prior to study treatment initiation, and stereotactic radiosurgery must have been completed within 7 days prior to study treatment initiation.\n   2. Dose escalation and dose expansion Cohorts 2 and 3: At least one confirmed measurable untreated brain lesion ≥ 0.5 cm and \\\u003C 3.0 cm in the longest axis.\n6. Has measurable disease based on the RECIST v1.1.\n7. Has adequate organ function as defined in Table 2:\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 4).\n9. Has a life expectancy of at least 12 weeks.\n10. Able to swallow and retain orally administered medication.\n11. In the dose expansion, patients with EC disease must be willing to provide tissue from a newly obtained, safely accessible core or excisional biopsy lesion at pre-treatment and at least one time point while on study treatment. Correlative biopsies will be optional in the dose escalation portion of the study. Newly obtained biopsy is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of study treatment on Day 1 without intervening systemic therapy.\n12. Women of childbearing potential (WOCBP) should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Alpelisib and pembrolizumab can cause fetal harm when administered to a pregnant woman. Therefore, WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of screening through 4 months after the last dose of study treatment. Refer to Pregnancy Assessment Policy MD Anderson Cancer Center (MDACC) Institutional Policy # CLN1114. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor such as one of the following:\n\n    1. Postmenopausal (no menses in ≥ 12 consecutive months)\n    2. History of hysterectomy or bilateral salpingo-oophorectomy\n    3. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy)\n    4. History of bilateral tubal ligation or another surgical sterilization procedure\n14. Approved methods of birth control are as follows: hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation or hysterectomy, patient\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the study and the study treatment washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n15. Male patients with partner(s) of childbearing potential must agree to use adequate contraception from the time of screening through 4 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Has a history of or active autoimmune disease, as follows: history of inflammatory bowel disease, history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's granulomatosis\\]), motor neuropathy considered of autoimmune origin (e.g., Guillain-Barré syndrome and myasthenia gravis), or history of autoimmune thyroiditis (patients may be eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy).\n2. Has active infection or had a serious general medical condition(s) (such as vascular accident) in the past 6 months.\n3. Any unresolved \\> Grade 1 toxicity (per CTCAE v5.0) from previous anticancer therapy or previously administered agent at the time of enrollment, except for alopecia and Grade 2 anemia (if hemoglobin is \\> 9 g\u002FdL). Note: If the patient received major surgery, he\u002Fshe must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Patients who received chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to starting study treatment.\n5. Presence of any clinically significant gastrointestinal abnormality or other condition(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) that may alter absorption such as malabsorption syndrome or major resection of the stomach or substantial portion of the small intestine based on investigator discretion.\n6. Previous major surgery within 14 days prior to enrollment.\n7. Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).\n8. Established diagnosis of diabetes mellitus type I or uncontrolled type II (based on fasting blood glucose and HbA1c \\[see inclusion criteria #4\\]).\n9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.\n10. History of severe cutaneous reaction, such as SJS, erythema multiforme (EM), TEN, or drug reaction with eosinophilia and systemic symptoms (DRESS).\n11. Based on average of triplicate 12-lead electrocardiogram (ECG), a mean resting QTc interval using Fridericia formula \\> 450 msec for males and \\> 470 msec for females at screening or a history of congenital long QT syndrome or QTc \\> 480 msec for patients with a bundle branch block.\n12. History or evidence of cardiovascular risk including any of the following:\n\n    1. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to enrollment.\n    2. Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n    3. Known left ventricular ejection fraction \\\u003C 50%.\n    4. Known cardiac metastases.\n13. Poorly controlled hypertension (defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure \\>100 mmHg based on a mean of three measurements taken at approximately 2-minute intervals).\n\n    Note: Initiation or adjustment of antihypertensive medication(s) is permitted if done 30 or more days prior to enrollment.\n14. For dose expansion Cohorts 2 and 3 with active brain metastases:\n\n    1. Patients must not have any of the following on the screening brain MRI:\n\n       * Any untreated brain lesions \\> 3.0 cm in size.\n       * Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to the patient (e.g., brainstem lesions). Patients who undergo local treatment for such lesions may still be eligible for the study.\n    2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of dexamethasone (or equivalent) \\> 4 mg.\n\n       * Poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifestation of neurologic progression due to brain metastases notwithstanding CNS-directed therapy.\n15. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorder that in the opinion of the treating physician or principal investigator (PI) would interfere with cooperation with the requirements of the trial.\n18. Known history of hepatitis B or C or positive test for human immunodeficiency virus.\n19. Has received a live vaccine within 30 days of planned start of study treatment.\n\n    Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; COVID-19 vaccines are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n20. Current use of or anticipated requirement during the study of any prohibited medication(s) (See Section 5.5.2).\n21. History of allergic reactions attributed to compounds of similar chemical or biologic composition to alpelisib and pembrolizumab.\n22. Pregnant or nursing.",{"count":503,"type":22},50,[265],"To find a recommended dose of the combination of alpelisib and pembrolizumab that can be given to patients with metastatic breast cancer or melanoma.",[28,507,508],"Breast Cancer","Brain Metastasases","2026-04-13",{"date":511,"type":45},"2026-04-16",{"date":513,"type":45},"2024-10-15",{"date":515,"type":22},"2029-08-03",{"name":517,"class":52},"M.D. Anderson Cancer Center",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":544},"100633761","phase-3-no-re-excision-melanoma---norma-2-100633761","NCT07530887","NO Re-excision MelanomA - NORMA 2","Multicenter Phase 3 Randomized Controlled Trial of NO Re-excision MelanomA - NORMA 2","NORMA-2","Inclusion Criteria:\n\n* Patients must be 18 years or older at time of consent\n* Patients must have an ECOG performance score between 0 and 2\n* Histologically confirmed, stage pT1b - pT4b (TNM AJCC 8th edition) cutaneous primary melanoma\n* Histological subtypes that are eligible are:\n\n  * Superficial Spreading Melanoma (SSM)\n  * Nodular Melanoma (NM)\n* The primary melanoma must have been removed by diagnostic excision and must have at least a minimum of 1 mm tumor free margin for invasive melanoma AND any in situ melanoma\n* Patient must provide informed consent and comply with the treatment protocol and follow-up plan\n* Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the investigator\n* A survivor of prior cancer is eligible provided that ALL of the following criteria are met and documented:\n\n  * The patient has undergone potentially curative therapy for all prior malignancies\n  * Life expectancy should be at least 5 years and\n  * The patient is deemed by their treating physician to be at low risk of recurrence from previous malignancies.\n\nExclusion Criteria:\n\n* Non-cutaneous melanoma (uveal, mucosal)\n* Acral melanoma\n* Lentigo malignant melanoma (LMM)\n* Desmoplastic melanoma\n* Neurotropic melanoma\n* Spitz melanoma\u002Fmalignant Spitz tumor melanoma\n* Satellites, in-transit melanomas or macroscopic melanoma metastases\n* Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesions of unknown malignant potential' (MELTUMP or STUMP)\n* Other non-SSM or NM subtypes\n* Melanoma removed by shave excision, excogliation or core biopsy\n* Patient has already undergone a local flap reconstruction of the defect after excision of the primary\n* History of previous or concurrent (i.e., second primary) invasive melanoma\n* Multiple melanomas\n* Patient has undergone surgery on a separate occasion to clear the lymph nodes of the probable draining lymphatic field, except for previous SLNB\n* Any additional solid tumor or hematologic malignancy during the past 5 years with a life expectancy of less than 5 years\n* History of organ transplantation",{"count":527,"type":22},1749,[457],"This multicenter, phase III randomized controlled trial evaluates whether omitting re-excision after complete primary excision of cutaneous melanoma affects patient outcomes. A total of 1,749 patients with pT1b-pT4b cutaneous melanoma without evidence of metastases will be randomized to either standard re-excision according to current guidelines or no re-excision. Sentinel lymph node biopsy and adjuvant systemic therapy will be performed as indicated in both groups.\n\nThe primary objective is to compare relapse-free survival (RFS) between the two groups. Secondary objectives include comparisons of overall survival (OS), local recurrence rates, recurrence of in-transit and lymph node metastases, distant metastasis-free survival (DMFS), surgical morbidity, quality of life, and health economic outcomes.",[28],[532,533,534],"primary cutaneous melanoma","re-excision","de-escalation","2026-04-08",{"date":537,"type":45},"2026-04-15",{"date":539,"type":45},"2025-11-13",{"date":541,"type":22},"2033-11",{"name":543,"class":52},"Marieke Goodijk",21,{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":4},"100631471","phase-2-neoadjuvant-pucotenlimab-combined-with-lenvatinib-and-temozolomide-in-resectable-stage-iibiii-acral-melanoma-100631471","NCT07501104","Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB\u002FIII Acral Melanoma","A Single-Arm, Single-Center, Phase II Exploratory Study of Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB\u002FIII Acral Melanoma（TRIUMPH-AM）","TRIUMPH-AM","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form (ICF). (Note: Items 1 and 10 are similar, but both are translated here) Age ≥ 18 and ≤ 75 years old. Histologically or cytologically confirmed resectable Stage IIB-III melanoma. Have at least one measurable lesion according to RECIST 1.1 criteria. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n\nLife expectancy of ≥ 6 months. No prior systemic drug therapy for melanoma.\n\nAdequate major organ function meeting the following criteria:\n\nHematology (without blood transfusion or use of hematopoietic stimulating factors within 14 days): Hemoglobin (Hb) ≥ 90 g\u002FL; Absolute Neutrophil Count (ANC) ≥ 1.5×10\\^9\u002FL; Platelets (PLT) ≥ 100×10\\^9\u002FL; White Blood Cell (WBC) count ≥ 3.0×10\\^9\u002FL.\n\nBiochemistry: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (upper limit of normal) (for patients with liver metastasis, ≤ 5 × ULN); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (for patients with Gilbert's syndrome, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 50 ml\u002Fmin.\n\nCoagulation: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and Prothrombin Time (PT) ≤ 1.5 × ULN.\n\nDoppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ 50%. Women of childbearing potential must agree to use acceptable methods of contraception (e.g., intrauterine device \\[IUD\\], oral contraceptives, or condoms) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use acceptable methods of contraception during the study and for 6 months after the end of the study.\n\nAgree to and sign the study Informed Consent Form (ICF) before initiating any study-related procedures.\n\nExclusion Criteria:\n\n* Prior treatment with immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab) or lenvatinib.\n\nReceived anti-cancer therapy within 28 days (or 5 times the half-life, whichever is shorter) prior to the first dose of study treatment, or received any investigational drug therapy within 30 days.\n\nUnderwent major surgery, open biopsy, or experienced major trauma within 4 weeks prior to enrollment.\n\nUse of immunosuppressive medications within 14 days prior to the start of treatment, excluding intranasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., daily dose of prednisolone ≤ 10 mg or equivalent physiological doses of other corticosteroids).\n\nAny active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; except for subjects with vitiligo or asthma that completely resolved in childhood and currently do not require medical intervention, or a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant).\n\nINR \\> 1.5 or APTT \\> 1.5 × ULN. Currently poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg.\n\nSubjects with proteinuria \\> 1+ on urinalysis will undergo a 24-hour urine collection to quantitatively assess proteinuria; those with urine protein ≥ 1 g\u002F24 hours will be ineligible.\n\nAny current disease or condition that affects drug absorption, or inability to take lenvatinib orally.\n\nCurrent digestive tract diseases such as active gastric\u002Fduodenal ulcers or ulcerative colitis, active bleeding from an unresected tumor, or other conditions judged by the investigator as likely to cause gastrointestinal bleeding or perforation.\n\nEvidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \\> 30 mL within 3 months, hematemesis, melena, hematochezia), hemoptysis (\\> 5 mL of fresh blood within 4 weeks), or occurrence of thromboembolic events (including stroke and\u002For transient ischemic attack) within 12 months.\n\nClinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class \\> 2 congestive heart failure; ventricular arrhythmias requiring medical treatment; LVEF \\\u003C 50%.\n\nHistory of other malignancies within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n\nActive or poorly controlled severe infections (≥ CTCAE v5.0 Grade 2 infection). Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., HBV DNA positive (\\> 1×10\\^4 copies\u002FmL or \\> 2000 IU\u002FmL); known hepatitis C virus (HCV) infection with positive HCV RNA (\\> 1×10\\^3 copies\u002FmL), or other hepatitis, cirrhosis\\] (excluding patients whose relevant test results returned to normal after prior antiviral treatment).\n\nUnstable or clinically symptomatic brain metastases. Persistent toxicities from any prior anti-tumor therapies that have not recovered to ≤ CTCAE v5.0 Grade 2, though patients with any grade of alopecia are permitted to participate.\n\nPregnant (positive pregnancy test prior to administration) or breastfeeding women.\n\nReceived brachytherapy (radioactive seed implantation) within 60 days prior to enrollment.\n\nAny other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion that the patient has a disease or condition unsuitable for the use of the study drug (e.g., seizures requiring treatment), or that would affect the interpretation of study results or place the patient at high risk.",{"count":554,"type":22},30,[163],"This is a single-arm, open-label, single-center, Phase II exploratory clinical study evaluating the efficacy, safety, and tolerability of neoadjuvant pucotenlimab combined with lenvatinib and temozolomide in patients with resectable Stage IIB\u002FIII acral melanoma.\n\nAfter providing written informed consent, eligible subjects will receive neoadjuvant combination therapy consisting of pucotenlimab, lenvatinib, and temozolomide, with each treatment cycle lasting 3 weeks. Surgical resection will be performed after 3 cycles of treatment. Postoperative adjuvant therapy will be determined based on the pathological results of the surgical specimens. Subjects who do not achieve a major pathological response (MPR) will receive pucotenlimab maintenance therapy for a total of 1 year, while subjects who achieve an MPR will be exempt from adjuvant therapy.\n\nTreatment will continue until the completion of adjuvant therapy, disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or discontinuation determined by the investigator, whichever occurs first.",[28],"2026-03-24",{"date":560,"type":45},"2026-03-30",{"date":562,"type":22},"2026-05-01",{"date":564,"type":22},"2029-09-01",{"name":566,"class":52},"Shanghai Zhongshan Hospital",{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":575,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":53},"100629058","a-study-of-biological-genetic-and-constitutional-factors-and-non-invasive-monitoring-to-assess-personal-cancer-risks-100629058","NCT07469709","A Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring to Assess Personal Cancer Risks","A Platform for Assessing Personal Risk of Developing or Recurring of Cancer: Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring of Subclinical Recurrences With Therapeutic Impact","PRO-ACTIVE","Inclusion Criteria:\n\n* Age \\>18 years;\n* Patients with breast cancer, including patients who meet the AIOM criteria for eligibility for BRCA testing and patients with lobular breast cancer;\n* Patients with radically resected colon cancer, including patients with stage III colon cancer and vascular invasion;\n* Patients with ovarian carcinomas;\n* Patients with metastatic melanoma;\n* Patients with stage IIB and IIIA non-small cell lung cancer.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years;\n* Unwillingness or inability to give informed consent",{"count":576,"type":22},850,"The PRO-ACTIVE study aims to develop a clinical-translational program in the field of cancer prevention in all its phases (primary, secondary, and tertiary) to intervene before the clinical and radiological manifestation of the disease. It starts with risk prediction and leads to early diagnosis of the disease or recurrence in the subclinical phase.\n\nThe PRO-ACTIVE study includes the following activities:\n\n* WP1: Integrated DNA-RNA approach for the identification of hereditary markers of predisposition to tumors\n* WP2: Global biological and molecular analysis of the host and tumor for the prevention and monitoring of recurrences\n* WP3: Analysis of the immunological status for the diagnosis of primary prevention and relapses in correlation to genetic and environmental factors\n* WP4: Study of the tumor microenvironment for recurrence prediction",[507,579,580,28,581],"Colo-rectal Cancer","Ovarian Cancer","Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung)","2026-03-09",{"date":584,"type":45},"2026-03-13",{"date":586,"type":45},"2024-02-01",{"date":588,"type":22},"2027-12-31",{"name":590,"class":52},"Fondazione del Piemonte per l'Oncologia",{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":609,"locationsCount":53},"100627453","phase-2-a-phase-ii-clinical-trial-on-neo-adjuvant-pembrolizumab-in-patients-with-pt3b-t4ab-cn0m0-melanoma-100627453","NCT07448831","A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a\u002Fb cN0M0 Melanoma.","A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination.","NeoSenti","Inclusion Criteria:\n\n≥ 18 years of age on the day of signing the informed consent.\n\nHistologically confirmed high risk primary cutaneous pT1b-4b melanoma High risk primary melanoma is defined in this study as the following AJCC8 T-stages:\n\n* pT1b-3a, with a poor prognostic score on the Merlin™ test (\"Merlin™ high risk\");\n* pT3b-4b, irrespective of their Merlin™ test result\n\nAmendable to sentinel lymph node biopsy.\n\nNo evidence of metastatic dissemination as demonstrated by PET\u002FCT, ultrasound of the draining lymph node basin, and clinical examination.\n\nNo prior exposure to systemic treatment for melanoma (adjuvant or curative).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 assessed within 7 days prior to the first dose of study treatment.\n\nAdequate baseline organ function as defined by local institutional standards.\n\nWomen:\n\n* Female patients must be surgically sterile or be postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause).\n* If a female patient is a woman of childbearing potential (WOCBP) they must agree to use highly effective contraception measures during the period of therapy, which should be continued for at least 4 months following the last dose of pembrolizumab as indicated in the SmPC. A list of highly effective contraceptive measures is included in appendix 1 All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and pregnancy testing should be conducted within 24h prior to the first dose of immune checkpoint inhibitors and thereafter monthly until 4 months following the last dose study treatment.\n* Should not be breastfeeding at screening or during study treatment.\n\nMen with a female partner of childbearing potential must agree to use highly effective contraception from 14 days prior to administration of the first dose of study treatment or have either had a prior vasectomy, throughout the treatment period, and for 16 weeks after the last dose of study treatment.\n\nCapable of providing documented informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\nPatients with uveal melanoma, mucosal melanoma and melanoma of unknown primary origin.\n\nActive autoimmune disease requiring systemic treatment.\n\nPatients with a history of previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: gastric, colon, cervical\u002Fdysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 3 years prior to screening and no additional therapy is required or anticipated to be required during the study period.\n\nKnown Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: subjects with laboratory evidence of cleared HBV and HCV infection will be permitted.\n\nAny serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.\n\nActive infection at the time of screening (e.g. wound infection).\n\nKnown immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatment, or excipients.\n\nHistory of organ allograft.\n\nPatients who have previously been exposed to checkpoint inhibitors.\n\nPrior transplantation of human cells, tissues and organs (e.g. liver transplant) or candidates for any type of transplantation.\n\nHistory or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n\nKnown psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\nAny contra-indication for evaluation by whole body 18F-FDG-PET\u002FCT or MRI.",{"count":600,"type":22},49,[163],"This study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans. Participants receive a single infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy. The goal is to see if this early treatment can reduce or eliminate tiny cancer cells that might already be in the lymph nodes but are too small to detect.\n\nAfter surgery, patients whose melanoma stage normally requires further treatment will continue with standard immunotherapy for one year. Others will move directly into follow-up care. All participants are monitored closely for five years with regular scans, blood tests, and check-ups to watch for any signs of recurrence and to ensure their safety.",[28],"2026-03-05",{"date":582,"type":45},{"date":607,"type":45},"2025-04-17",{"date":251,"type":22},{"name":610,"class":52},"Universitair Ziekenhuis Brussel",{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":333,"enrollmentInfo":618,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":630,"locationsCount":4},"100626950","pd-l1-targeting-peptide-probe-for-pet-imaging-of-solid-tumor-100626950","NCT07442292","PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor","PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor","Inclusion Criteria:\n\n1. Aged 18-75, male and female, with ECOG score of 0 or 1;\n2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;\n3. underwent PD-L1 IHC examination before therapy;\n4. The expected survival was more than 26 weeks;\n5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC \\>= 4.0 x 10\\^9\u002FL or neutrophil \\>= 1.5 x 10\\^9\u002F:, PLT \\>= 100 x 10\\^9 \u002F L, Hb \\>= 90g \u002F L; Pt or APTT \\\u003C= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \\\u003C= 1.5 x ULT (upper limit of normal value), ALT \u002F AST \\\u003C= 2.5 upper limit of normal value or \\\u003C= 5 x ULT (subject with liver metastasis), ALP \\\u003C= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP \\\u003C= 4.5 upper limit of normal value); BUN \\\u003C= 1.5 x ULT, SCR \\\u003C= 1.5 x ULT;\n6. According to RECIST1.1, there was at least one measurable target lesion;\n7. Understand and sign informed consent voluntarily with good compliance.\n\nExclusion Criteria:\n\n1. The function of liver and kidney was seriously abnormal;\n2. Preparation for pregnant, pregnant and lactating women;\n3. Inability to lie flat for half an hour;\n4. Suffering from claustrophobia or other mental disorders;\n5. Other researchers considered it unsuitable to participate in the trial.",{"count":373,"type":22},"The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET\u002FCT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.",[621,622,28,166,623,624],"Lung Cancer (NSCLC)","Lung Cancer (SCLC)","PD-L1","PET \u002F CT","2026-03-03",{"date":604,"type":45},{"date":628,"type":22},"2026-02",{"date":345,"type":22},{"name":631,"class":52},"Peking University Cancer Hospital & Institute",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":18,"minAge":639,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":642,"briefSummary":643,"conditions":644,"keywords":650,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":663,"locationsCount":4},"100624165","navigation-intervention-for-adolescent-and-young-adult-cancer-survivors-100624165","NCT07406087","Navigation Intervention for Adolescent and Young Adult Cancer Survivors","Adaptation and Implementation of an Evidence-Based Patient Navigation Intervention for Adolescent and Young Adult Cancer Survivors","Inclusion Criteria:\n\n* Received diagnosis of local or regional breast, ovarian, cervical, testicular, colon\u002Frectal, melanoma, endometrial, sarcoma, or thyroid cancer between the ages of 15-39 years (\"index cancer\")\n* Current age 21-45 years\n* Diagnosed and treated for index cancer within Kaiser Permanente Southern California\n* Current Kaiser Permanente insurance coverage\n\nExclusion Criteria:\n\n* Patients with a history of or current diagnosis of leukemia or lymphoma\n* Patients with metastatic disease at diagnosis","21 Years","45 Years",{"count":7,"type":22},[25],"The investigators propose to: 1) Adapt an evidence-based cancer-focused patient navigation (PN) program for the Adolescent and Young Adult (AYA) cancer survivor population; and 2) Plan and conduct an effectiveness-implementation trial of this program within Kaiser Permanente Southern California (KPSC). PLEASE NOTE: This study is awarded in two phases. The UG3 phase has been awarded for the first two years; upon successful completion of this phase by meeting pre-defined milestones, the National Cancer Institute (NCI) will provide funding for the second phase of the study (Years 3-6), which will allow our team to conduct a trial to determine the effectiveness of the implementation of the adapted PN program for the AYA cancer survivor population. This application is focused on the initial UG3 phase and will update the protocol for the UH3 trial upon successful completion of the UG3 milestones and receipt of the UH3 award.\n\nThe primary objectives in the UG3 phase of the study are to adapt and tailor an existing PN program to meet the needs of AYA cancer survivors and the local clinical context via (a) interviews with key stakeholders (patients, clinicians, administrators) and (b) guidance from our AYA Primary Care Survivorship Council. The investigators will conduct a pilot study of the adapted PN program and refine the program to enhance acceptability to patients and clinicians, enhance feasibility and effectiveness, and develop and pilot evaluation tools and methods prior to the start of the UH3 phase of the trial, which will be a larger trial. Objectives will be updated for the UH3 phase once awarded.",[507,580,645,646,647,28,75,648,649],"Cervical Cancer","Testicular Cancer","Colon Rectal Cancer","Sarcoma","Thyroid Cancer",[651,652,653,654,655],"Adolescent and Young Adult","Cancer Survivors","Patient Navigation","Adaptations","Implementation Science","2026-02-23",{"date":658,"type":45},"2026-02-25",{"date":660,"type":22},"2026-11-01",{"date":662,"type":22},"2027-08",{"name":664,"class":52},"Kaiser Permanente",{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":670,"acronym":671,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":18,"minAge":673,"maxAge":674,"enrollmentInfo":675,"targetDuration":4,"studyType":23,"phases":677,"briefSummary":678,"conditions":679,"keywords":688,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":705,"lastUpdatePostDateStruct":706,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":53},"100624504","phase-1-biomarker-guided-allogeneic-single-target-or-dual-target-car-nk-cell-therapy-for-advanced-solid-tumors-100624504","NCT07410494","Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors","A Phase 1\u002F2, Open-Label, Biomarker-Driven Study of Allogeneic Donor-Derived CAR-NK Cells With Antigen Selection by Tissue Biopsy and\u002For Liquid Biopsy Profiling in Participants With Relapsed\u002FRefractory Advanced Solid Tumors (Single-Target vs Dual-Target Strategy)","SELECT-CAR-NK","Inclusion Criteria:\n\n* Age 18-75 years.\n* Histologically or cytologically confirmed advanced\u002Funresectable or metastatic solid tumor that is relapsed\u002Frefractory after standard therapy, or no standard therapy available.\n* Targetable antigen positivity from the protocol target menu based on:\n\ntissue biopsy and\u002For liquid biopsy platform (as defined in the lab manual).\n\n* Arm assignment rules :\n* Arm A: ≥1 antigen meets \"positive\" threshold\n* Arm B: ≥2 antigens meet \"positive\" threshold\n* ECOG performance status 0-1 (or 0-2 ).\n* At least one measurable lesion by RECIST 1.1.\n* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.\n* Willingness to undergo blood draws and required biopsies (when medically feasible).\n* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.\n\nExclusion Criteria:\n\n* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .\n* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV\u002FHCV with detectable viral load (per local policy).\n* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).\n* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.\n* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.\n* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).\n* Pregnant or breastfeeding.","8 Years","85 Years",{"count":676,"type":22},85,[265,163],"This Phase 1\u002F2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors. The CAR target antigen is selected for each participant after tumor profiling using a tissue biopsy and\u002For liquid biopsy. Participants will receive either a single-target or dual-target CAR-NK product based on the antigen profile.",[67,507,680,681,682,683,580,684,28,685,686,687,78],"Non-Small Cell Lung Cancer (NSCLC)","Colorectal Cancer (Locally Advanced or Metastatic)","Prostate Cancer - Recurrent","Pancreatic Ductal Adenocarcinoma (PDAC)","Glioblastoma","Acute Myeloid Leukemia (AML)","Non Hodgkin Lymphoma","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma",[689,690,691,692,693,694,695,696,697,698,699,700,169,701,702,703,704],"CAR-NK","Solid tumor","Dual-target CAR","ctDNA","CAR-T","Breast cancer","Non-small cell lung cancer (NSCLC)","Colorectal cancer (CRC)","Prostate cancer","Pancreatic ductal adenocarcinoma (PDAC)","Ovarian, fallopian tube, and primary peritoneal cancers","Glioblastoma and other high-grade gliomas","Acute myeloid leukemia (AML)","Non-Hodgkin lymphoma (NHL), especially DLBCL and follicular lymphoma","Multiple myeloma (especially relapsed\u002Frefractory)","Liver cancer (hepatocellular carcinoma, HCC)","2026-02-14",{"date":707,"type":45},"2026-02-18",{"date":709,"type":45},"2026-02-01",{"date":711,"type":22},"2028-12-28",{"name":713,"class":52},"Essen Biotech"]