[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"melanoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:melanoma":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,217,0,25,[9,47,107,146,171,183,266,286,328,348,387,432,500,530,552,577,598,622,669,689,726,746,773,784,807],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":46},"100054248","phase-1-a-study-of-ln-144-or-ln-145-in-people-with-advanced-uveal-melanoma-undifferentiated-pleomorphic-sarcoma-dedifferentiated-liposarcoma-or-angiosarcoma-100054248",false,"NCT05607095","A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma","Inclusion Criteria:\n\n* Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.\n\n  o Patients will be eligible regardless of the number of prior systemic therapies received.\n* Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* Cohort 3: Must have a confirmed diagnosis of unresectable or metastatic angiosarcoma that is refractory to at least 1 prior line of systemic therapy\n\n  * Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure\n  * Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy\n  * Patients who refuse standard of care chemotherapy will be eligible\n* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).\n* Patients must be ≥ 18 years of age at the time of consent.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.\n* Patients must have the following hematologic parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n  * Hemoglobin (Hb) ≥ 9.0 g\u002FdL\n  * Platelet ≥ 100,000\u002Fmm\\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period\n* Patients must have adequate organ function:\n\n  * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (≤ 3 × ULN); patients with liver metastasis ≤ 5 × ULN\n  * Estimated creatinine clearance (eCrCl) ≥ 40 mL\u002Fmin using the Cockcroft-Gault formula at Screening\n  * Total bilirubin ≤ 2 mg\u002FdL\n  * Patients with Gilbert's syndrome must have a total bilirubin ≤ 3 mg\u002FdL\n* Patients must be seronegative for the following:\n\n  * Human immunodeficiency virus (HIV)-1 or HIV-2 antibodies\n  * Hepatitis B antigen (HBsAg), hepatitis B core antibody (anti- HBc), or hepatitis C antibody (HCV Ab). Patients with acute or chronic hepatitis infections may be enrolled if the viral load by polymerase chain reaction (PCR) is undetectable with\u002Fwithout active treatment.\n  * Syphilis (Rapid Plasma Reagin \\[RPR\\] test or venereal disease research laboratory \\[VDRL\\] test)\n  * Cytomegalovirus (CMV) IgM antibody titer or PCR assay; and Epstein-Barr virus (EBV) IgM or PCR assay indicating active infection\n  * Herpes simplex virus (HSV)-1 and HSV-2 IgM serology or PCR assay\n* Patients who are HSV immunoglobulin M (IgM) or PCR assay positive will need to receive appropriate treatment and become IgM or PCR assay negative prior to starting the NMA-LD pre-conditioning regimen\n* Anyone with prior COVID-19 infection must be asymptomatic for \\>30 days prior to NMA-LD.\n* Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD):\n\n  * Targeted therapy: prior targeted therapy with an EGFR, MEK, BRAF, ALK, ROS1, or other-targeted agents (eg, erlotinib, afatinib, dacomitinib, osimertinib, crizotinib, ceritinib, lorlatinib) is allowed provided the washout is a minimum of 14 days or 5 half-lives (whichever is longer) prior to the start of treatment\n  * Chemotherapy: minimum of 21 days prior to the start of treatment\n  * Immunotherapy: checkpoint-targeted therapy with an anti PD-1\u002Fanti PD-L1, other monoclonal antibodies, or vaccines are allowed, provided the washout is a minimum of 21 days prior to the start of study treatment\n* Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 5.0.\n* Patients must have recovered from all prior anti-cancer therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\] v 5.0), except for alopecia or vitiligo, prior to enrollment.\n\n  * Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and\u002For had a normal colonoscopy post-immune checkpoint inhibitortreatment, by visual assessment, prior to tumor resection.\n  * Patients with immunotherapy-related endocrinopathies (e.g. hypothyroidism) stable for at least 6 weeks and controlled with hormonal replacement are allowed.\n* Previous surgical procedure(s) is\u002Fare permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.\n* Patients of childbearing potential (or female partners of male participants) must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after their last dose of IL-2. Approved methods of birth control are as follows:\n\n  * Combined (estrogen and progesterone containing) hormonal birth control associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progesterone-only hormonal birth control associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner\n  * True sexual abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, post-ovulation methods) is not acceptable\n* Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.\n\nExclusion Criteria:\n\n* Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.\n* Patients who have a history of hypersensitivity to any component or excipient of LN-144\u002FLN-145 or other study drugs:\n\n  * NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)\n  * Proleukin®, aldesleukin, IL-2\n  * Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity\n  * Any component of the LN-144\u002FLN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.\n* Patients with symptomatic brain metastases (of any size and any number).\n\n  o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.\n* Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.\n* Patients who are pregnant or breastfeeding.\n* Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.\n* Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \\[SCID\\] and acquired immunodeficiency syndrome \\[AIDS\\]).\n* Patients who have a left ventricular ejection fraction (LVEF) \\\u003C45% or New York Heart Association (NYHA) functional classification \\> Class 1.\n\n  * Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and\u002For ventricular arrhythmias must have a cardiac stress test.\n  * Patients with any irreversible wall movement abnormalities are excluded.\n* Patients who have a smoking history or signs or symptoms of obstructive or restrictive pulmonary disease and have a documented forced expiratory volume in 1 second (FEV1) of ≤ 60% of predicted normal:\n\n  * If a patient is not able to perform reliable spirometry due to abnormal upper airway anatomy (i.e., tracheostomy), a 6-minute walk test may be used to assess pulmonary function.\n  * Patients who are unable to walk a distance of at least 80% predicted for age and sex or demonstrates evidence of hypoxia at any point during the test (SpO2 \\\u003C 90%) are excluded.\n* Active, uncontrolled systemic infections, including COVID-19, within 30 days of surgery or NMA-LD. An uncomplicated bacterial UTI treated successfully with symptom resolution is not an exclusion.\n* Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD.\n* No other active, concurrent malignancy that requires ongoing systemic treatment (e.g. indolent prostate) or interferes with radiographic assessment of response as determined by the investigator. Exceptions may allow for adjuvant NED cancers undergoing hormone-based therapy assuming the other eligibility criteria are met and the PI affirms the hormonal agent would not change the response.\n\nEligibility Designation for Lymphodepletion\n\nPatients meeting eligibility criteria above between Day -21 and Day -8 prior to the planned initiation of lifileucel will be enrolled to the therapeutic portion of the protocol.\n\nAll patients' eligibility criteria, including repeating cardiopulmonary function tests as necessary, will be reassessed within several days prior to the scheduled lymphodepletion in all cases.\n\nPrior to beginning the NMA-LD preparative regimen the following requirements must be met:\n\n* Patients must meet all eligibility criteria at the time of NMA-LD.\n* Full resolution of any active infection should be documented\n* Critical evaluation of changes in cardiovascular, respiratory, renal, coagulopathy, or immune problems and other major illnesses that may have developed or worsened must be documented\n* Patients with symptomatic, recurrent, pleural effusions that require drainage should not proceed to lymphodepletion without prior placement of a temporary in-dwelling pleural drain\n* All active medical issues must be addressed by Investigator or designee. Re-evaluation with additional imaging or testing may be required\n\nBenefit over risk should be assessed and reassessed throughout the treatment course. Successive lifileucel components (preparative lymphodepleting chemotherapy, LN-144\u002FLN-145 and IL-2 ) should be withheld or discontinued if at any time during the treatment course, at the discretion of the treating physician, benefit may not be justified by risks to the patient\n\nSubsequent delays of lymphodepletion up to 14 days due to logistical issues such as production of lifileucel and\u002For major weather events will not constitute protocol violations and out of window assessments will not need to be repeated unless there is a change in clinical status.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.",[27,28,29,30],"Uveal Melanoma","Melanoma","Metastatic Uveal Melanoma","Metastatic Melanoma",[27,28,29,30,32,33,34],"LN-144","22-109","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2022-11-01",{"date":43,"type":21},"2027-05-01",{"name":34,"class":45},"OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100053960","phase-1-intratumoral-n17350-in-advanced-solid-tumors-100053960","NCT07339176","Intratumoral N17350 in Advanced Solid Tumors","A Phase 1\u002F2 Open-Label, Dose Finding and Expansion Study to Investigate the Safety and Effectiveness and Determination of the Optimal Dose of N17350 Administered Intratumorally in Participants With Advanced Solid Tumors","OP-NEU-101","Inclusion Criteria:\n\n1. Age ≥18 years (or legal age of consent in the study jurisdiction).\n2. Able to provide written informed consent and willing\u002Fable to comply with study procedures, visits, and follow-up.\n3. Advanced solid tumor malignancy (excluding lymphoma and other hematologic malignancies), with disease that has progressed on, is intolerant of, or is ineligible for standard therapies known to provide clinical benefit, or for whom no standard therapy is available.\n4. ECOG performance status 0-1.\n5. Measurable disease per IT-RECIST (Parts A1\u002FA2) and RECIST v1.1 (Part A3), as applicable.\n6. At least one injectable tumor lesion, meeting superficial or visceral criteria and deemed safe\u002Faccessible for injection:\n\n   1. Superficial lesions: ≥10 mm in longest diameter (or multiple lesions each ≥5 mm with aggregate longest diameter ≥10 mm), and ≤80 mm, accessible for direct injection (± ultrasound guidance).\n   2. Visceral lesions: ≥10 mm and ≤50 mm in longest diameter, accessible for direct injection.\n   3. Injected lesions must not involve\u002Fencase major blood vessels or otherwise pose an unacceptable bleeding\u002Fvascular risk, per investigator assessment and imaging review (as applicable).\n   4. Expansion (Part A3): at least 1 measurable lesion and at least 1 additional injectable lesion suitable for injection.\n7. Adequate recovery from prior therapy: toxicities from prior anticancer treatment resolved to Grade ≤1 or baseline (except alopecia, controlled endocrine toxicities, or other stable toxicities as allowed per protocol\u002Fsponsor).\n8. Adequate organ function, including hepatic, renal, and coagulation parameters per protocol-defined thresholds.\n9. Adequate bone marrow function without transfusion support within 7 days prior to enrollment, per protocol-defined thresholds.\n10. Tumor tissue requirements: willingness to provide a pre-treatment tumor biopsy and on-study post-treatment biopsy, if an accessible lesion is available and safe for biopsy, and biopsy does not interfere with injection\u002Fresponse assessment; and\u002For availability of archival tumor tissue (obtained within 2 years prior to treatment), per protocol.\n11. Contraception requirements: participants of reproductive potential agree to use effective contraception and avoid pregnancy\u002Ffathering children from screening through 30 days after last dose; women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose, per protocol.\n\nExclusion Criteria:\n\n1. Serious psychiatric, medical, or other condition that would interfere with study participation or protocol procedures, in the investigator's judgment.\n2. History of solid organ transplant.\n3. Alpha-1 antitrypsin deficiency.\n4. Hereditary or acquired bleeding disorder\u002Fcoagulation factor deficiency.\n5. Active autoimmune disease requiring systemic treatment within the past 6 months, except clinically stable autoimmune conditions in remission not requiring systemic therapy (per protocol).\n6. Baseline QTcF \\>480 ms.\n7. Pregnant or breastfeeding.\n8. Prior severe immune-mediated adverse event (imAE) from immunotherapy: ≥Grade 3 imAE within the past 16 weeks, any Grade 4 life-threatening imAE, or any neurologic\u002Focular AE of any grade (except controlled endocrine AEs on stable replacement therapy per protocol).\n9. Another active malignancy (current or within the past 2 years) other than the disease under study, except specified low-risk cancers treated with curative intent or under active surveillance (per protocol).\n10. Recent anticancer therapy: receipt of systemic anticancer therapy (including investigational agents) within 2 weeks prior to first dose (or 4 weeks for monoclonal antibodies\u002FADCs\u002Fother long half-life biologics), or within 5 half-lives, whichever is shorter.\n11. Recent radiotherapy within 2 weeks prior to first dose.\n12. Unresolved toxicity from prior anticancer therapy to \\>Grade 1 or not at baseline (except Grade ≤2 neuropathy and other allowed exceptions per protocol).\n13. Uncontrolled or unstable brain metastases (eligible only if neurologically stable for ≥4 weeks, and off steroids or on stable\u002Fdecreasing steroids ≤10 mg\u002Fday prednisone equivalent; carcinomatous meningitis excluded).\n14. Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose.\n15. Chronic viral infections not meeting protocol criteria:\n\n    1. HBV with detectable DNA unless on appropriate antiviral therapy\n    2. Active HCV with detectable HCV RNA (treated HCV permitted if RNA undetectable)\n    3. HIV infection with CD4+ count \\\u003C300\u002FμL, detectable viral load, or HIV-related illness within 6 months\n16. Use of systemic anticoagulants (e.g., warfarin, LMWH, DOACs) within 14 days prior to first dose.\n17. Chronic systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent, or systemic immunosuppressive\u002Fanti-inflammatory medications within 4 weeks prior to first dose, except permitted topical\u002Finhaled\u002Flocal formulations or short courses for premedication per protocol.\n18. Known allergy\u002Fhypersensitivity to N17350 or any excipients.",{"count":56,"type":21},275,[24,58],"PHASE2","The goal of this clinical trial is to learn if N17350 works to treat advanced solid tumors in adults. It will also learn about the safety of N17350 and help determine the best dose to use in future studies.\n\nThe main questions it aims to answer are:\n\n1. Does N17350 cause tumors to shrink or stop growing in some participants with advanced solid tumors?\n2. Are there any side effects for participants when taking N17350?\n3. What is the safest dose of N17350 and the dose that should be used for further study?\n4. Researchers will give N17350 directly into tumor lesions using a needle (intratumoral injection). This is an open-label study, meaning all participants will receive N17350 and there is no placebo.\n\nParticipants will:\n\n1. Receive injections of N17350 into tumor lesions every second week for 8 or 12 weeks\n2. Visit the clinic regularly for checkups, blood tests, and monitoring for side effects\n3. Have imaging scans (such as CT or MRI) to measure tumors and assess response\n4. Provide blood samples and, when required, tumor samples to help researchers understand how N17350 affects the tumor and the immune system",[61,62,63,28,64,65,66],"Neoplasms, Solid Tumor","Breast Neoplasms, Triple-Negative","Squamous Cell Carcinoma of Skin","Head and Neck Neoplasms","Carcinoma, Squamous Cell","Carcinoma, Non-Small-Cell Lung",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,28,82,83,53,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"N17350","Intratumoral injection","Intralesional injection","Dose escalation","Dose finding","Dose expansion","Phase 1","Open-label","Safety","Tolerability","Biomarkers","Advanced solid tumors","Triple-negative breast cancer","Cutaneous squamous cell carcinoma","Head and neck squamous cell carcinoma","Non-small cell lung cancer","Onchilles","Onchilles Pharma","ELANE","Phase 2","ELANE pathway","TNBC","cuSCC","HNSCC","SCCHN","metastatic","elastase","therapeutic elastase","neutrophil elastase","New cancer therapy",{"date":38,"type":39},{"date":100,"type":39},"2026-05-25",{"date":102,"type":21},"2029-11",{"name":104,"class":105},"Onchilles Pharma Inc","INDUSTRY",6,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":130,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":145},"100054169","clinical-genetics-branch-eligibility-screening-survey-100054169","NCT07005297","Clinical Genetics Branch Eligibility Screening Survey","Clinical Genetics Branch (CGB) Eligibility Screening Survey","* INCLUSION CRITERIA\n\nThere is no age restriction; therefore, viable neonates may be included. This eligibility screening protocol is intended for individuals meeting one or more of the following criteria:\n\n1. Personal or family history of a diagnosis of a syndrome being actively investigated in one of the following CGB study protocol:\n\n   * Protocol 000678: Medical history of neoplasia of an unusual type, pattern, or number.\n   * Protocol 11C0255: A personal history of adrenal cortical carcinoma or choroid plexus carcinoma at any age, regardless of family history, or family or personal medical history of neoplasia consistent with the diagnosis of LFS or LFL.\n   * Protocol 20C0107: Individuals with a clinical diagnosis of a RASopathy, including Costello syndrome, Noonan syndrome, Noonan syndrome with multiple lentigines, Cardiofaciocutaneous syndrome, Legius syndrome, capillary arteriovenous malformation syndrome, or others, are eligible. Published clinical diagnostic criteria exist for most of the clinical RASopathy syndromes and differ by syndrome. It will be uncommon for individuals to have a clinical diagnosis and not have had molecular genetic testing. All individuals considered by the study team to be at risk for a RASopathy who have not had prior genetic testing will have this completed as part of the study. The rare individuals with a clinical diagnosis of a RASopathy who are not found to carry a corresponding pathogenic or likely pathogenic variant in a known RASopathy gene will be considered for exome analysis for identification of potentially novel RASopathy germline variation.\n   * Protocol 11C0034: An individual with histologically-confirmed PPB and\u002For other DICER1-related tumors\n   * Protocol 02C0052: The participants will be affected by an IBMFS, or be members of a family with an IBMFS, and be at risk of being affected or carriers of the syndrome. Except for the rare X-linked recessive disorder (e.g. some dyskeratosis congenita patients), there should be equal numbers of male and female probands and family members. These IBMFS have been reported in most racial and ethnic groups, and thus all such groups will be included. The age range will be from birth to old age (grandparents of probands). The majority of the probands will be children (10-20% will be adults), and their parents and grandparents will be adults. All racial\u002Fethnic groups are eligible.\n   * Protocol 02C0211: Personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age.\n   * Protocol 78C0039: Family or personal medical history of neoplasia of an unusual type, pattern, or number\n2. Personal or family history of medical condition, malignancy, and\u002For benign neoplasm suggestive of hereditary cancer predisposition being actively investigated in the following CGB study protocol:\n\n   * Protocol 000678: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.)\n   * Protocol 11C0255: An individual with a sarcoma diagnosed under the age of 45; AND - At least one first-degree relative (parents, brothers, sisters and children) with a cancer of any kind diagnosed under the age of 45; AND - A third family member who is either a first- or second-degree relative (such as grandparents, aunts, uncles, nieces, nephews, and grandchildren) with cancer diagnosed under the age of 45 or having a sarcoma at any age.\n   * Protocol 001109: On referral, persons \\>= 12 years with Fanconi Anemia (FA) primarily from North America will be included. An individual with FA who is 8 -11 years can also be included if they have a history of persistent oral potentially malignant lesion (OPMLs), dysphagia, or other concerning symptoms. Individuals with prior cancer diagnosis are eligible.\n   * Protocol 11C0034: An individual from the general population with one or more of the unique tumors of the types associated with DICER1 including (but not exclusively), PPB, cystic nephroma, ovarian Sertoli-Leydig cell and other sex cordstromal tumors, ocular medulloepithelioma, nasal chondromesenchymal hamartoma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, pituitary blastoma, ovarian sarcoma, CNS sarcoma and\u002For thyroid cancer - regardless of their family history. Additional DICER1-related neoplasms may be identified in the future, and they will be added to the protocol as needed\n   * Protocol 02C0052: Fanconi anemia: FA patients have relatively specific birth defects, aplastic anemia, increased chromosome breakage in cells cultured with a DNA crosslinking agent such as mitomycin C (MMC) or diepoxybutane (DEB), pathogenic variant(s) in one of the cloned genes (six genes at this time), or assignment to one of the 7 or more complementation groups. Bone marrow failure is NOT required for the diagnosis, and approximately 25% do not have birth defects. FA has been diagnosed from birth to \\>50 years of age. FA Proven = positive chromosome breakage result, and\u002For pathogenic variant(s) in a known FANC gene. Patients in whom FA is suspected but whose chromosome breakage test is negative will still be considered if they have sufficient findings that lead the Principal Investigator to think they may be somatic mosaics and warrant further evaluation. Diamond Blackfan anemia: DBA patients have pure red cell aplasia with reticulocytopenia. Approximately 30% have physical abnormalities, often involving malformations of the thumbs. Approximately 90% are diagnosed within the first year of life. A pathogenic variant in a known DBA gene (RPS19 is currently the only known gene) is diagnostic, but lack of a pathogenic variant does not rule out DBA, since the cloned gene is responsible for only approximately 25% of the disease. Since many cases are sporadic or occur in families with silent carriers, patients without a positive family history will be included. Currently DBA is diagnosed by clinical findings after exclusion of known causes of red cell aplasia. Approximately 90% have elevated red cell adenosine deaminase levels, a finding which is supportive, but not diagnostic, of DBA. Dyskeratosis congenita: DC patients develop dyskeratotic nails, lacy hyperpigmentation of the skin and mucous membrane leukoplakia as they age (the diagnostic clinical triad; two of the three are required for a firm diagnosis). Findings in young patients may be very subtle, and diagnoses are usually made in teenagers or young adults. More than 75% are male. DC patients are often diagnosed without hematologic abnormalities by dermatologists; however, some patients present with aplastic anemia prior to the evolution of the syndrome-related physical features. A pathogenic variant in the DKC1 gene is diagnostic, but normal DKC1 does not exclude DC. The diagnosis is often clinical, after exclusion of FA and other IBMFS. Shwachman Diamond Syndrome: SDS patients have neutropenia, malabsorption and failure to thrive due to exocrine pancreatic insufficiency. The gene has not yet been cloned. Pancreatic insufficiency is documented by direct measurement of pancreatic enzymes, low serum immunoreactive trypsinogen, or elevated fecal fat levels. Neutropenia requires an absolute neutrophil count of \\\u003C1500\u002Fmm3 on multiple occasions. Other causes of malabsorption such as cystic fibrosis, Pearson syndrome, and Johansson-Blizzard syndrome must be excluded. Cystic fibrosis will be excluded in patients who have a positive sweat test performed at an approved CF center. Amegakaryocytic thrombocytopenia: These patients have early onset thrombocytopenia (\\\u003C150,000\u002Fmm3), usually within the first year of life, due to absent, diminished, or abnormal bone marrow megakaryocytes, without antiplatelet antibodies. Physical examination is often normal; in particular, there are no abnormalities of the radial rays. Pathogenic variant(s) in the MPL gene are diagnostic, but normal MPL does not exclude this diagnosis. Thrombocytopenia absent radii: TAR patients have absent radii, usually bilateral, with intact thumbs (in contrast with FA and trisomy 18, where thumbs are absent if radii are absent), and thrombocytopenia at birth. Other radial aplasia syndromes such as Holt-Oram syndrome or VATER syndrome must be excluded. Severe Congenital Neutropenia: Patients with SCN have persistent and noncyclic low absolute neutrophil counts, with more than 2 measurements \\\u003C200\u002Fmm3, and a history of pyogenic infections during the first year of life, and bone marrow maturation arrest at the promyelocyte\u002Fmyelocyte stage. They do not have birth defects, and they usually have normal hemoglobin and platelet counts. They are designated Kostmann Syndrome (KS) only if there is a pattern of autosomal recessive inheritance. Pathogenic variant(s) in the neutrophil elastase gene (ELA2) are supportive of the diagnosis of SCN, but do not distinguish SCN patients from those with cyclic neutropenia, which is milder and not preleukemic. Many of the cases of SCN have been shown to be due to dominant pathogenic variant(s)s in ELA2. Pearson Syndrome: Pearson syndrome consists of malabsorption, neutropenia, alone or with anemia and\u002For thrombocytopenia, and metabolic acidosis. Onset is in infancy or early childhood. The diagnosis is strongly suspected if bone marrow examination reveals vacuoles in myeloid and erythroid progenitors, and ring sideroblasts. Confirmation derives from detection of deletions in mitochondrial DNA, which range from 2 to 8 kb in size, and include the respiratory enzymes. Absence of reports to date of cancer or leukemia in this syndrome may derive from early death due to the metabolic problems. Other bone marrow failure syndromes: There are occasional patients with a pattern of hematologic abnormalities, physical findings, malignancies, or family histories which are not characteristic of the syndromes described above, but which nonetheless suggests that they have a genetic bone marrow failure syndrome. There may be similar cases in the literature, or in the experience of the investigator, which may ultimately lead to assignment of these patients to a known or new syndrome. There are additional bone marrow failure syndromes which are even more rare, such as Revesz, WT, IVIC, radio-ulnar synostosis, ataxia-pancytopenia, etc. Syndromic classification of extremely rare disorders is facilitated if they are collected in one center. Since malignancy is often part of these syndromes, they will be eligible for enrollment in this protocol.\n   * Protocol 02C0211: Known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin's disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n   * Protocol 10CN188: Diagnose with chordoma or related tumor at any age and any primary site.\n   * Protocol 78C0039: Known or suspected factor(s) predisposing to neoplasia, either genetic and\u002For congenital factors (birth defects, metabolic phenotype, chromosomal anomalies or Mendelian traits associated with tumors), environmental exposure (medications, occupation, radiation, diet, infectious agents, etc.), or unusual demographic features (very young age of onset, multiple tumors, etc.). Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records. For familial neoplasms, two or more living affected cases among family members are required. The types of familial tumors that we are currently actively accruing include Familial Cancers: bladder, brain, chordoma, lung, nevoid basal cell carcinoma syndrome (NBCC) Familial Benign Neoplasms: meningiomas, neurofibromatosis 2 (bilateral acoustic neurofibromatosis) The types of familial tumors under active accrual and study are predominantly investigator- and hypothesis-driven. This approach permits CGB investigators to remain alert to the opportunities afforded by clusters of rare tumors in families and individuals, and to be more responsive to the dynamic research priorities in cancer genetics.\n3. Personal or family history of a genetic variant in a hereditary cancer predisposition being actively investigated in the following CGB study protocols:\n\n   * Protocol 11C0255: A personal history of a germline TP53 mutation; or, - A first or second- degree relative of a TP53 mutation carrier, regardless of mutation status\n   * Protocol 20C0107: Individuals with a germline variant (P\u002FLP or a variant of uncertain significance but predicted bioinformatically to be damaging) in a RASopathy-associated gene are eligible. These include but are not limited to: BRAF, CBL, HRAS, KRAS, LZTR1, MAP2K1, MAP2K2, MAP3K8, MRAS, NRAS, PPP1CB, PTPN11, RAF1, RASA1, RASA2, RIT1, RRAS, SHOC2, SOS1, SPRED1. From herein, we refer to 1) individuals with germline pathogenic variation in a RAS pathway gene AND 2) individuals with a clinical RASopathy diagnosis but in whom a genetic variant has not yet been identified as \"carriers.\" The first member of a family to be identified is termed a \"proband.\"\n   * Protocol 11C0034: An individual with a known or suspected DICER1 disease associated variant.\n   * Protocol 02C0052: An individual with a pathogenic variant(s) in a known FANC gene. Individual with Diamond Blackfan Anemia with a pathogenic variant in a known DBA gene (RPS19). Individuals with Dyskeratosis congenita with a pathogenic variant in the DKC1 gene. Individuals with Amegakaryocytic thrombocytopenia with pathogenic variants) in the MPL gene. Individuals with Severe Congenital Neutropenia with a pathogenic variant(s) in the neutrophil elastase gene (ELA2).\n\nEXCLUSION CRITERIA\n\nWhile this protocol is intended to be used by those meeting the inclusion criteria above, there are no explicit exclusion criteria for this study, since the initiative to complete the eligibility screener survey is at the will of the participant or his or her parent\u002Fguardian\u002FLAR.","1 Year","99 Years",{"count":117,"type":21},1000,"OBSERVATIONAL","Background:\n\nClinical Genetics Branch (CGB) researchers study individuals and populations at high genetic risk of cancer in order to improve our understanding of cancer and to improve cancer care. There are currently 6 open clinical genetics studies at the CGB eligible for this screening process.\n\n* 02C0052: Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study (Cancer in Bone Marrow Failure)\n* 11C0255: Clinical, Epidemiologic, and Genetic Studies of Li-Fraumeni Syndrome (Li Fraumeni Syndrome Study)\n* 11C0034: DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study (Pleuropulmonary Blastoma)\n* 02C0211: Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma (Melanoma-Prone Families)\n* 10CN188: Genetic Clues to Chordoma Etiology: A Protocol to Identify Sporadic Chordoma Patients for Studies of Cancer-susceptibility Genes (Sporadic Chordoma Study)\n\nThe following studies have their own study-specific screeners. If you are interested in these studies, please click the links below to fill out the relevant study screener:\n\n* 001109: Defining the Natural History of Squamous Cell Carcinoma in Fanconi anemia (SCC Screening in FA): https:\u002F\u002Fservice.cancer.gov\u002Ffanconi\n* 20C0107: Clinical, Genetic, and Epidemiologic Study of Children and Adults with RASopathies (RASopathies Study): https:\u002F\u002Fservice.cancer.gov\u002Fmyras\n\nObjective:\n\nTo find people to participate in active CGB cancer research studies.\n\nEligibility:\n\nPeople of any age who meet the eligibility criteria for one of the open CGB cancer research studies. You can learn more about the CGB cancer research studies by clicking on the links to the study-specific websites above. This typically involves a personal or family history of certain cancers that are being studied by researchers at CGB.\n\nDesign:\n\nParticipants will fill out a screening questionnaire to determine if they are eligible to participate in one or more CGB clinical genetics studies. The survey asks about personal health history, including cancer; family history; and genetic testing results and takes 15 to 20 minutes.\n\nEach study has its own eligibility criteria. Survey respondents will select which study (or studies) that are interested in participating in, and the relevant study team(s) will review the screener to determine eligibility to participate in the study. Participants who are determined to be eligible for a study based on their screener will be contacted by the respective study team to learn more about the study and to consent to enroll in the study if they choose to do so. Participants who consent to enroll in a study may be asked to provide medical records; samples such as blood, saliva, or other tissues; and to participate in activities such as phone interviews or surveys. They may be invited for evaluations at the clinical center. Every study activity is voluntary. None of the studies provide treatments. Participants may be contacted to consider enrolling in future studies.",[28,121,122,123,124,125,126,127,128,129],"Li-Fraumeni Syndrome","Pulmonary Blastoma","Chordoma","Congenital Bone Marrow Failure Syndromes","Costello Syndrome","Fanconi Anemia","CFC Syndrome (CFCS)","Legius Syndrome","RASopathies",[126,121,131,132,123,133,129,134,135],"Clinical Genetics Branch, NCI","Hereditary Melanoma","DICER-1 syndrome","Cancer","Inherited Bone Marrow Failure Syndromes","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":139,"type":21},"2026-07-16",{"date":141,"type":21},"2036-01-01",{"name":143,"class":144},"National Cancer Institute (NCI)","NIH",1,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":145},"100054048","phase-1-novel-rna-lipid-particle-rna-lp-vaccine-for-anti-pd-1-antibody-therapy-sensitization-100054048","NCT05264974","Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization","Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* ECOG performance ≤ 2\n* Lab values within the specified ranges:\n\n  * Hemoglobin ≥ 8G\u002FDL\n  * Platelets ≥ 100 thou\u002Fcumm\n  * Absolute Neutrophil Count (ANC) ≥ 1000 thou\u002Fcumm\n  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * AST and ALT ≤ 2.5 x ULN; If confirmed liver metastases: AST and ALT ≤ 5 x ULN\n  * Creatinine clearance (CrCl) ≥ 15 ml\u002Fmin (based on modified Cockcroft and Gault formula)\n* Must have measurable disease that is amenable to surgical sampling for RNA extraction, amplification, and loading of lipid particles\n* Subjects must not have more than one active malignancy at the time of enrollment (subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included)\n* Written informed consent obtained from the subject.\n* Participants of childbearing potential must have a negative serum pregnancy test at screening\n* Participants of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least four months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, participants of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n* Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for four months following the last dose of study treatment and must agree to not donate sperm during the study treatment period or for four months following the last dose of study treatment.\n\nAdditional eligibility criteria for subjects with melanoma:\n\n* Patients with stage II, stage III, or resected stage IV melanoma who received anti-PD-1-based therapy in the adjuvant or neoadjuvant setting (either monotherapy or combination therapy) and experienced progressive disease (PD) per RECIST 1.1 during treatment or within 6 months of completing the planned course of therapy. This includes patients who:\n\n  * Were planned to receive approximately 1 year of anti-PD-1-based therapy in the adjuvant setting but discontinued early due to toxicity and relapsed within 6 months of discontinuation;\n  * Received neoadjuvant anti-PD-1-based therapy (with or without subsequent surgery), including patients planned to complete approximately 1 year of total perioperative anti-PD-1-based therapy (neoadjuvant ± adjuvant), and experienced PD during therapy or within 6 months of completion or discontinuation;\n  * Received short-course neoadjuvant anti-PD-1-based therapy (including combination regimens), underwent surgery, were subsequently managed with surveillance (including those achieving pathologic complete response), and experienced relapse within 6 months of completion of neoadjuvant therapy.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who experienced PD per treating physician while receiving anti-PD-1-based therapy (either monotherapy or combination therapy) in any line of treatment.\n* Patients with unresectable or widespread metastatic (stage IV) melanoma who:\n\n  * Completed a planned course of anti-PD-1-based therapy (monotherapy or combination), including planned treatment durations of approximately 1 year or 2 years, and experienced PD within 6 months of completion; or\n  * Were planned to receive anti-PD-1-based therapy (for either 1 year or 2 years) but discontinued early due to toxicity and experienced PD within 6 months of discontinuation.\n* Both cutaneous and non-cutaneous melanoma subtypes (including uveal, mucosal, and acral lentiginous) are eligible.\n* Patients must:\n\n  * Have no contraindication to continued immune checkpoint therapy;\n  * Not have rapidly progressive disease requiring urgent alternative therapy; and\n  * Have no other viable approved salvage treatment options available, or decline currently approved salvage therapies.\n\nAdditional eligibility criteria for subjects with soft tissue sarcoma:\n\n* Evidence of spindle cell, pleomorphic, round cell, or epithelioid morphology on pathology suggestive of sarcoma as determined by a sarcoma pathologist\n* Evidence of progression or resistance to therapy as defined by the treating physician.\n* Must have measurable disease per RECIST 1.1\n* Original tumor site from soft tissue location i.e. lipomatous tissue, musculature, skin\n* Evidence of unresectable stage II disease; stage III or stage IV disease\n* Subjects with prior exposure to an immune checkpoint inhibitor (ICI) are eligible for enrollment; however, prior ICI therapy is not required unless receipt of an ICI constitutes part of the FDA-approved standard of care for their disease.\n\nExclusion Criteria:\n\n* Subjects that have an active second malignancy, however, previously treated early stage malignancies with no evidence of disease recurrence after 3 years of follow-up will be allowed\n* Subjects with a history of immune-mediated treatment-related adverse reactions leading to discontinuation of prior aPD1 therapy or severe hypersensitivity reaction to any monoclonal antibody or any other baseline risk in the opinion of the investigator that precludes continued use of aPD1 therapy\n* Patients with known active and symptomatic brain metastases or leptomeningeal metastases at time of inclusion. Patients with isolated brain lesions that have been treated with stereotactic radiosurgery or surgical resection as part of oligometastatic initial management prior to start of immunotherapy may be eligible as long as they have no new disease and are asymptomatic at time of inclusion.\n* If patients develop new brain metastases during the time between tumor sampling and vaccine generation and administration, patients may remain on study as long as they can receive definitive stereotactic radiosurgery or surgery to brain metastases and be able to resume systemic therapy within 6 weeks of discovery of new brain metastases.\n* Subjects who received an investigational drug in another clinical trial must wait 28 days or at least 5 half-lives of the study drug, whichever is shorter, prior to enrollment in this study\n* Patients must not have required systemic corticosteroids (anything greater than 10mg of prednisone of equivalent, daily) or other immunosuppressive medications within 14 days of the start of trial treatment.\n* Subjects with known active infection or immunosuppressive disease within seven days prior to tissue collection for vaccine creation or within seven days prior to vaccine administration (subjects on prophylactic agents are acceptable)\n* Subjects with any known life-threatening illness, medical condition, or organ system dysfunction (aside from their cancer), which in the investigator's opinion, could compromise subject safety\n* Subjects with known active hepatitis B virus or untreated hepatitis C virus, and, patients with previous history of hepatitis C who completed treatment for HCV are not excluded as long as they have no detectable viral load.\n* Subjects with known human immunodeficiency virus with CD4+T cells ≤ 350 cells\u002Ful, a positive viral load as determined by institutional standard testing, or a known history of AIDS defining opportunistic infection within the last 12 months per subject medical records.\n* Known clinically relevant active autoimmune disease that would pose significant risk to the patient's life should a flare ensue. Patients with chronic autoimmune rheumatologic endocrine, or psoriatic skin diseases may still be eligible pending they are not receiving systemic immunosuppression at the time of treatment as previously described and that patients are aware of the increased risk of flare provocation with treatment.\n* Symptomatic congestive heart failure (NYHA Class 3 or 4)\n* Subjects with unstable angina pectoris\n* Known unstable cardiac arrythmias, abnormalities or transmural myocardial infarction within the last 6 months of treatment\n* Subjects who are post-splenectomy, otherwise asplenic, or have moderate to severe splenomegaly (defined as a spleen larger than 13 cm in cranial-caudal height or longest diameter)\n* Personal history of anaphylactic reaction to previous vaccination\n* Known hypersensitivity to the active substance or to any of the excipients\n* Participants of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 months after the last dose of study treatment\n* Participants who are confirmed to be pregnant or breastfeeding\n* Known history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Non-live versions of the COVID vaccine are allowed.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with sarcoma originating from bone or cartilage\n* Sarcomatous malignancies lacking metastatic potential i.e. well-differentiated liposarcoma, dermatofibrosarcoma protuberans, desmoid fibromatosis, etc.",{"count":153,"type":21},18,[24],"The goal of this phase I trial is to evaluate the toxicity and feasibility of a tumor-specific RNA-NP vaccine in patients with stage IIB-IV melanoma who have evidence of progressive disease by RECIST 1.1 criteria while receiving adjuvant aPD1 therapy, or those who progress within 6 months of completion of adjuvant treatment, or unresectable stage II soft tissue sarcoma or stage III-IV soft tissue sarcoma.",[28,157],"Soft Tissue Sarcoma",[159,160,161,162,163],"melanoma","immunotherapy","vaccines","RNA-NP","soft tissue sarcoma",{"date":38,"type":39},{"date":166,"type":39},"2026-03-17",{"date":168,"type":21},"2026-12",{"name":170,"class":45},"University of Florida",{"id":172,"slug":4,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":173,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":174,"keywords":175,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":145},"100593350",{"count":117,"type":21},[28,121,122,123,124,125,126,127,128,129],[126,121,131,132,123,133,129,134,135],"2026-07-01",{"date":178,"type":39},"2026-07-02",{"date":180,"type":21},"2026-07-07",{"date":141,"type":21},{"name":143,"class":144},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":190,"sex":17,"minAge":191,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years","75 Years",{"count":194,"type":21},2000,"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,28,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":178,"type":39},{"date":260,"type":39},"2022-08-18",{"date":262,"type":21},"2027-02-28",{"name":264,"class":45},"Alliance for Clinical Trials in Oncology",745,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":145},"100544187","phase-2-neoadjuvant-ipilimumabnivolumab-for-patients-with-recurrent-high-risk-resectable-melanoma-100544187","NCT06365619","Neoadjuvant Ipilimumab\u002FNivolumab for Patients With Recurrent, High Risk, Resectable Melanoma","Phase II Study of Neoadjuvant Ipilimumab\u002FNivolumab for Patients With Recurrent, High Risk, Resectable Melanoma","NeoRelapse","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist.\n* Recurrent disease at eligibility must have been confirmed with biopsy after receiving prior anti-PD1 based systemic therapy (either adjuvant, neoadjuvant, or definitive therapy).\n* ECOG Performance Status ≤ 1.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n    * Platelet count ≥ 100,000\u002Fmm3\n    * Hemoglobin ≥ 10 g\u002FdL\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n\n      * Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula:\n* For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Subjects \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Subjects ≥ 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n* Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy per the treating investigator.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Prior exposure to anti-CTLA4 therapy.\n* Receiving other investigational agents currently or within 28 days of study treatment.\n* Prior systemic anti-cancer therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.\n* Prior radiotherapy 45 days prior to the first dose of study treatment.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* Active infection requiring the use of systemic antibiotics.\n* Systemic steroid therapy greater than physiologic equivalent (10mg prednisone\u002Fday) or any other form of systemic immunosuppressive therapy within 7 days prior to registration.\n* Active secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety\n* Known brain metastases or cranial epidural disease.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 140\u002F90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002Fpsychological issues, etc.)\n* HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.\n\n  --Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (positive HBV surface antigen (HBsAg) result), or hepatitis C.\n\n  --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.7.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.",{"count":7,"type":21},[58],"The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.\n\nParticipants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.",[28],"2026-06-30",{"date":178,"type":39},{"date":281,"type":21},"2026-07",{"date":283,"type":21},"2030-08",{"name":285,"class":45},"University of Utah",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":311,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":295,"type":21},124,[24],"The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[28,299,300,301,302,303,304,305,306,307,308,309,310],"Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[312,313,314,315,316,317,318],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","2026-06-29",{"date":176,"type":39},{"date":322,"type":39},"2022-11-30",{"date":324,"type":21},"2029-06-18",{"name":326,"class":105},"Pfizer",83,{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":20},"100466589","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799933-in-people-with-advanced-solid-tumors-with-braf-alterations-100466589","NCT05355701","A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS","This study is seeking participants who meet the following key eligibility criteria:\n\nInclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor including primary brain tumor.\n* Qualifying BRAF alteration (V600 or non-V600 Class II\u002FClass III BRAF alteration), in tumor tissue and\u002For blood (ie circulating tumor deoxyribonucleic acid \\[DNA\\], or ctDNA).\n* Disease progressed during\u002Ffollowing last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).\n* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies\n* Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.\n* Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor\u002FEGFR inhibitor allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n* Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor\u002FEGFR inhibitors allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n* Brain metastasis larger than 4 cm\n* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).",{"count":336,"type":21},267,[24],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.\n\nThis study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called \"BRAF\" and available treatments are no longer effective in controlling their cancer.\n\nAll participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:\n\n* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.\n* People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).\n\nParticipants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.",[28,340,300,299,341],"Non-Small-Cell Lung Cancer","Advanced Colorectal Cancer (Part 1)",{"date":176,"type":39},{"date":344,"type":39},"2022-07-05",{"date":346,"type":21},"2029-10-25",{"name":326,"class":105},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":369,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":386},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":356,"type":21},1109,[24,58],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[360,361,362,340,363,364,365,366,28,367,368],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Urothelial Carcinoma","Pancreatic Adenocarcinoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[370,360,371,372,373,361,91,362,374,375,340,376,92,363,364,365,366,28,367,368,377,378],"BMS-986340","CRC","First-in-human","GEJ","MSS CRC","Nivolumab","NSCLC","Docetaxel","Pumitamig",{"date":278,"type":39},{"date":381,"type":39},"2021-05-27",{"date":383,"type":21},"2031-08-31",{"name":385,"class":105},"Bristol-Myers Squibb",47,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":431},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":397,"type":21},100,"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[400,401,402,360,403,404,405,406,407,408,28,409,410,411,412,413,414,415,416,216,417,418,419,300,420,421,422],"Adenocarcinoma (NOS)","Anal Cancer","Bladder Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastrointestinal Stromal Tumour","Head and Neck Cancer","Liver Cancer","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-06-26",{"date":319,"type":39},{"date":426,"type":39},"2025-09-18",{"date":428,"type":21},"2028-03-30",{"name":430,"class":105},"AstraZeneca",17,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":190,"sex":17,"minAge":439,"maxAge":440,"enrollmentInfo":441,"targetDuration":443,"studyType":118,"phases":4,"briefSummary":444,"conditions":445,"keywords":481,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":499},"100210159","integrated-cancer-repository-for-cancer-research-100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals","19 Years","110 Years",{"count":442,"type":21},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[413,300,446,404,447,448,449,450,401,451,452,453,454,408,455,456,457,458,402,459,460,414,418,461,420,462,463,464,465,466,467,468,469,416,470,471,472,473,474,475,28,216,476,477,412,403,421,478,479,480],"Lung Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Kidney Cancer","Penile Cancer","Ureter Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Breast Cancer","Leukemia","Unknown Primary Tumor","Multiple Myeloma","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[413,300,482,483,484,485,486,487,488,489,474,490,479,480],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","2026-06-25",{"date":319,"type":39},{"date":494,"type":39},"2013-11-01",{"date":496,"type":21},"2099-12",{"name":498,"class":45},"University of Nebraska",42,{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":22,"phases":510,"briefSummary":511,"conditions":512,"keywords":517,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":529},"100520749","phase-1-safety-and-efficacy-of-obx-115-in-advanced-solid-tumors-100520749","NCT06060613","Safety and Efficacy of OBX-115 in Advanced Solid Tumors","A Phase 1\u002F2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors","Agni-01","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing the informed consent.\n2. Participant has a histologically confirmed diagnosis of advanced\u002Fmetastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).\n3. Cohort and indication specific criteria as follows:\n\n   1. Phase 1 and Phase 2 Cohort 1 (enrollment complete):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n   2. Phase 1 and Phase 2 Cohort 2 (recruiting):\n\n      * Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and\u002For an approved targeted therapy for known molecular abnormalities if applicable to their disease).\n      * Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting.\n   3. Phase 2 Cohort 3 (recruiting):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n      * Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF\u002FMEK inhibitor that was given as the most recent line of therapy.\n   4. Phase 2 Cohort 4 (recruiting):\n\n      * Participants with frontline unresectable or metastatic melanoma.\n      * Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression.) Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible.\n4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.\n5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.\n7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\]).\n8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.\n9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and\u002For abstinence requirements.\n10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.\n11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).\n2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.\n3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.\n4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.\n5. Participant has any form of primary or acquired immunodeficiency.\n6. Participant has a history of hypersensitivity to any component of the study intervention.\n7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).\n8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.\n9. Participant requires systemic steroid therapy of greater than10 mg\u002Fday of prednisone or equivalent.\n10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).\n11. Participant has evidence of positive infectious disease screening and\u002For any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.",{"count":509,"type":21},208,[24,58],"This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.",[513,30,28,446,514,515,516],"Tumor Skin","Metastatic Lung Cancer","Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[518,519,520,28,446],"Adoptive cell therapy","Tumor Infiltrating Lymphocytes","TIL","2026-06-24",{"date":319,"type":39},{"date":524,"type":39},"2023-10-25",{"date":526,"type":21},"2029-06-30",{"name":528,"class":105},"Obsidian Therapeutics, Inc.",10,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":190,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100439630","dermoscopy-augmented-histology-trial-a-randomized-controlled-trial-100439630","NCT05004792","Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial","Correlation Between Online Case-based Training of Pathologists in Dermoscopic Images and Diagnostic Accuracy in Histopathological Interpretation of Skin Lesions Suspicious of Melanoma","DAHT-RCT","Inclusion Criteria:\n\n* Pathologists are required to evaluate melanocytic lesions routinely\n* Doctors must be registered authorized health personnel\n* Access to a smartphone\u002Ftablet\u002Fcomputer with internet\n\nExclusion Criteria:\n\n\\- Assessment of less than 30 DAHT cases",{"count":539,"type":21},258,[541],"NA","Pathologists provide the current gold standard in skin lesion diagnostics, most often primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images.\n\nThis study aims to evaluate the impact of dermoscopy training on pathologists' assessment of melanoma-suspected skin lesions.\n\nData collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021,\n\nDAHT platform: Made in 2021-2023 by Melatech,\n\nConsensus agreement: Four dermatopathologists assess all DAHT cases, year 2023-2024\n\nEnrollment of pathologists: Randomization and assessment DAHT cases, year 2026.",[28,544],"Pigmented Lesions",{"date":491,"type":39},{"date":547,"type":21},"2026-08-13",{"date":549,"type":21},"2027-12-13",{"name":551,"class":45},"Herlev Hospital",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":559,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":575,"locationsCount":145},"100633622","personalized-cancer-support-thrive-track-to-manage-the-emotional-needs-of-young-adults-with-thyroid-melanoma-and-testicular-cancer-percs-ya-trial-100633622","NCT07529080","Personalized Cancer Support (Thrive Track) to Manage the Emotional Needs of Young Adults With Thyroid, Melanoma and Testicular Cancer, PerCS-YA Trial","Personalized Cancer Support for Young Adults","Inclusion Criteria:\n\n* PARTICIPANTS RECRUITED FROM SURVEILLANCE, EPIDEMIOLOGY, AND END RESULTS PROGRAM (SEER)-GEORGIA: Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer), melanoma, or testicular cancer at any stage and reported to the SEER-Georgia registry\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: 2-10 years after diagnosis with cancer\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: English speaking (able to read and speak English)\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate \"not at all\" will be told the study is focused on those who experience worry)\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Residing in the United States\n* PARTICIPANTS RECRUITED FROM THYROID CANCER SURVIVORS' ASSOCIATION INC. (THYCA): Age 18-37 at time of cancer diagnosis and age 20-39 at time of enrollment\n* PARTICIPANTS RECRUITED FROM THYCA: Diagnosed with differentiated thyroid cancer (papillary or follicular thyroid cancer) at any stage\n* PARTICIPANTS RECRUITED FROM THYCA: 2-10 years after diagnosis with cancer\n* PARTICIPANTS RECRUITED FROM THYCA: English speaking (able to read and speak English)\n* PARTICIPANTS RECRUITED FROM THYCA: Report of any cancer-related worry (on a 5-point Likert scale from not at all to very worried; those who indicate \"not at all\" will be told the study is focused on those who experience worry)\n* PARTICIPANTS RECRUITED FROM THYCA: Residing in the United States\n\nExclusion Criteria:\n\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects from certain vulnerable populations will be excluded as appropriate: fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)\n\n  * It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman\n* PARTICIPANTS RECRUITED FROM SEER-GEORGIA: Subjects that do not meet the inclusion criteria\n* PARTICIPANTS RECRUITED FROM THYCA: Subjects from certain vulnerable populations will be excluded as appropriate fetuses, neonates, children under age 18, prisoners, institutionalized individuals, or others who may be considered vulnerable populations per the National Institutes of Health (NIH) and Office for Human Research Protections (OHRP)\n\n  * It is possible that a subject might be pregnant. Because this involves surveys and reviewing an informational website, participation should have no additional risk for a pregnant woman\n* PARTICIPANTS RECRUITED FROM THYCA: Subjects that do not meet the inclusion criteria","20 Years","39 Years",{"count":562,"type":21},142,[541],"This pilot clinical trial is intended to compare the effect of a psychosocial support tool for young adult (YA)cancer survivors - including high-quality information about their cancer combined with evidence-based psychosocial support - to a support tool providing cancer-specific information alone (minus psychosocial modules). This tool, called Thrive Track, will be for YA patients aged 20-39 with thyroid, melanoma, or testicular cancer. Young adult survivors frequently experience persistent worry and distress that can interfere with coping and reduce quality of life. They are also particularly vulnerable to the emotional impact of cancer and may not have adequate support to manage these concerns. The enhanced version of Thrive Track includes personalized emotional support content and strategies designed to help patients better manage worry and distress. Adding these emotional support tools may provide greater benefit than survivorship education alone in strengthening young adult survivors' ability to manage their emotional well-being.",[566,567,28,568,569],"Differentiated Thyroid Gland Carcinoma","Malignant Testicular Neoplasm","Thyroid Gland Follicular Carcinoma","Thyroid Gland Papillary Carcinoma","2026-06-23",{"date":521,"type":39},{"date":281,"type":21},{"date":574,"type":21},"2027-08",{"name":576,"class":45},"University of Michigan Rogel Cancer Center",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":590,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":597},"100610195","phase-1-a-study-of-bi-3810944-in-patients-with-advanced-cancer-100610195","NCT07224425","A Study of BI 3810944 in Patients With Advanced Cancer","A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma","Inclusion Criteria:\n\n1. Trial participant population specifically to Part A and B:\n\n   * Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.\n   * Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received \\>3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening\n2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n3. Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)\n4. Age ≥18 years\n5. Adequate organ function\n6. Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator\n7. All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be CTCAE Grade ≤2 and amenorrhea\u002Fmenstrual disorders which can be any Grade) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and\u002For carcinomatous meningitis\n\n   * Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:\n\n     * Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944\n     * Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease\n2. A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of BI 3810944\n3. Prior anticancer therapy:\n\n   * Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944\n   * Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944\n4. Prior treatment with organ transplant or hematopoietic stem-cell transplant\n5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)\n6. Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 Further exclusion criteria apply.",{"count":585,"type":21},69,[24],"This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer.\n\nParticipants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects.\n\nThe doctors also regularly check the size of the tumour with imaging methods.",[589,28],"Solid Tumours",{"date":521,"type":39},{"date":592,"type":39},"2026-02-24",{"date":594,"type":21},"2029-10-05",{"name":596,"class":105},"Boehringer Ingelheim",7,{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":610,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":145},"100589972","phase-1-clinical-trial-of-cd40l-augmented-til-for-patients-with-advanced-melanoma-100589972","NCT06961357","Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma","Phase I\u002FII Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced Melanoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed, unresectable (Stage III\u002FIV) or metastatic melanoma as follows: Cutaneous, non-acral, melanoma (including melanoma of unknown primary); Cutaneous acral melanoma; Mucosal melanoma; Ocular melanoma (including uveal, iris, conjunctival melanoma).\n* Participants must have failed, be refractory to, or unable to tolerate at least one line of standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care therapy includes a PD-1\u002FL1 or combination therapy with anti-PD1 and anti-CTLA4 or combination therapy of anti-PD1 and anti-LAG3 or if BRAF V600 activating mutation positive, a BRAF ± MEK inhibitor. Participants are allowed to be enrolled in this trial if they failed one line of any of those standards of care therapy regimens.\n* Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting therapy, and any prior therapy-related AEs must have resolved to Grade ≤ 1 except for alopecia and vitiligo.\n* Participants must be ages ≥18. Additionally, participants who are ≥ 65 years of age may need to undergo a cardiology evaluation including a cardiac stress test or coronary computed tomography after which they must be deemed to be low\u002Facceptable risk. This cardiac evaluation may be omitted for patients who underwent testing within 6 months and have no interval change in cardiopulmonary clinical status. Note 1: Cardiac stress test may be omitted for patients ≥65 years old (y\u002Fo) who are fully functional with no relevant medical comorbidities and are able to carry ≥4 METS activities at baseline. For patients who demonstrate abnormal cardiac stress test cardiac evaluation by cardiologist will be done and if deemed low acceptable risk, will be allowed to participate in this trial per PI discretion. Cardiac stress test may be indicated for any patient \\\u003C65 y\u002Fo who have relevant medical comorbidities or demonstrate clinically worrisome symptoms. Note 2: While age preference will be between 18-75 years, this study allows age \\>75 years if the patient meets eligibility criteria and demonstrates no significant medical comorbidities per PI.\n* ECOG performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined within the protocol.\n* Seronegative for Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C (HCV) antibody (if HCV antibody positive, must be tested for HCV RNA, which must be negative to be eligible).\n* Participants with brain metastases are eligible provided that the brain metastases have been successfully treated with stereotactic radiosurgery or resection and clinically stable for at least 4 weeks (±14 days). Note: Participants who develop brain metastases after tumor harvest and\u002For lymphodepleting therapy will be allowed to remain on study and may proceed with cell therapy after undergoing definitive radiation therapy and\u002For surgery. For those participants who develop brain metastases during lymphodepleting therapy and undergo definitive radiation therapy and\u002For surgery careful decision will be made to proceed with TIL infusion after discussion with treating physician, neurosurgeon, radiation oncologist and PI.\n* Women of child-bearing potential must have a negative pregnancy test.\n* The effects of CD40L-augmented TIL on the developing human fetus are unknown. For this reason and because TIL agents, as well as other therapeutic agents used in this trial including IL-2 are known to be teratogenic, both males and females of childbearing potential must be willing to practice birth control starting with screening through 1 year after the last study drug is administered for females or 6 months for males.\n* Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Participants should have at least one surgically accessible lesion for tumor harvest for preparation of TIL, and at least one RECIST v1.1 measurable lesion after tumor harvest to follow for response assessment. Note: Tumor harvest lesion will be considered as target lesion if after harvest remaining portion of tumor meets RECIST v1.1 measurable lesion criteria.\n\nExclusion Criteria:\n\n* Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or ventricular rhythm abnormality are excluded unless they undergo a cardiac stress test and cardiology clearance examination and are determined to be low or acceptable risk.\n* Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV\u002FAIDS).\n* Pregnant women are excluded from this study because the agents used in this study have teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CD40L-augmented TIL or the other agents in the study, breastfeeding should be discontinued if the mother is enrolled in the study.\n* Participants taking systemic steroid therapy (other than replacement therapy or prednisone equivalent of ≤10mg daily) or therapy with any immunosuppressive medications such as mycophenolate mofetil (MMF). Participants who require more than 10mg of prednisone or equivalent other steroid therapy should taper their steroid therapy to 10 mg prednisone 1 week prior to planned first interventional drug therapy (lymphodepleting therapy). Participants who are on baseline replacement therapy or prednisone equivalent of ≤10mg daily and require stress doses of steroid therapy will be allowed to receive stress dose steroids during the trial interventions. Participants who require dapsone for pneumocystis pneumonia (PCP) prophylaxis during TIL therapy are eligible.\n* Participants who have a history of severe immediate hypersensitivity reaction to the study agents including cyclophosphamide, fludarabine, or IL-2 or any of their constituents.\n* Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification \\> 1.\n* Forced expiratory volume (FEV1) ≤ 60% of predicted value and DLCO (corrected) \\\u003C 60% of predicted value. Participants who underwent pulmonary function testing within 6 months of screening may omit PFTs if they demonstrate stable cardiopulmonary status.\n* Participants who, in the opinion of the Investigator, have a medical condition that would subject the patient to prohibitive risk by participation in this study, or who may be unable to safely complete tumor harvest, lymphodepletion regimen, TIL infusion, or aldesleukin administration.\n* Participants with active infections requiring antibiotics.\n* Participants with active autoimmune diseases currently requiring systemic treatment with immunosuppressive doses of corticosteroids (\\>10 mg of prednisone-equivalent daily dosing), immunosuppressive biologic agents, or disease modifying antirheumatic drug agents (DMARDs).\n* Patients who received prior live cell therapy are excluded, unless express written permission is provided by the clinical PI.",{"count":606,"type":21},36,[24,58],"This is a phase I\u002FII clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL. Eligible patients with progressive disease after standard of care therapy will undergo lymphodepletion with cyclophosphamide and fludarabine followed by CD40L-augmented TIL and standard of care bolus dose interleukin-2 (short-course IL-2).",[28],[611,612,613,614],"Mucosal melanoma","Uveal melanoma","Cutaneous acral melanoma","Cutaneous non-acral melanoma",{"date":423,"type":39},{"date":617,"type":39},"2025-12-03",{"date":619,"type":21},"2030-05",{"name":621,"class":45},"H. Lee Moffitt Cancer Center and Research Institute",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":629,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":668},"100495186","phase-3-study-to-investigate-lifileucel-regimen-plus-pembrolizumab-compared-with-pembrolizumab-alone-in-participants-with-untreated-advanced-melanoma-100495186","NCT05727904","Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.","A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma","Inclusion Criteria:\n\n1. Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.\n2. In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \\> 6 months.\n3. Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.\n4. Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.\n5. Participants must have adequate organ function.\n6. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.\n7. Participants who are \\> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal\u002Focular origin.\n2. Participant has symptomatic untreated brain metastases.\n3. Participant received more than 1 prior line of therapy.\n4. Participant received prior therapy for metastatic disease\n5. Participants with a BRAF V600 mutation-positive tumor received prior adjuvant\u002Fneoadjuvant ICI therapy only\n6. Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.\n7. Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).\n8. Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \\>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)\n9. Participant has a history of allogeneic cell or organ transplant.\n\nOther protocol defined inclusion\u002Fexclusion criteria could apply.","70 Years",{"count":631,"type":21},670,[633],"PHASE3","This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.",[30,636,28],"Unresectable Melanoma",[519,520,30,636,638,639,640,641,642,28,643,644,645,646,647,648,649,650,32,651,652,653,654,655,656,657,658,659,660],"Cell Therapy","Cellular Immuno-therapy","IL-2","Non-myeloablative lymphodepletion (NMALD)","Check point inhibitor","Lifileucel","Stage III Melanoma","Stage IV Melanoma","Skin cancer","Skin cancer types","Malignant melanoma","Autologous Adoptive Cell Therapy","Autologous Adoptive Cell Transfer","Pembrolizumab","Pembro","Adjuvant\u002FNeo-adjuvant","BRAF\u002FMEK","ICI","BRAF v600","Immune checkpoint inhibitor","Tumor infiltrating T-cells","TILVANCE","TILVANCE-301",{"date":423,"type":39},{"date":663,"type":39},"2023-03-30",{"date":665,"type":21},"2030-03-01",{"name":667,"class":105},"Iovance Biotherapeutics, Inc.",81,{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":673,"acronym":4,"eligibilityCriteria":674,"healthyVolunteers":190,"sex":17,"minAge":675,"maxAge":115,"enrollmentInfo":676,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":678,"conditions":679,"keywords":681,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":685,"startDateStruct":686,"completionDateStruct":4,"leadSponsor":688,"locationsCount":46},"100061062","clinical-laboratory-and-epidemiologic-characterization-of-individuals-and-families-at-high-risk-of-melanoma-100061062","NCT00040352","Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma","* INCLUSION CRITERIA:\n* On referral, persons \\>=4 weeks old of any sex, race or ethnicity will be considered for inclusion in the study because of the criteria noted below.\n* Affected: An individual who meets any of the following criteria will be eligible to participate in this study:\n\n  * personal medical history of melanoma of an unusual type, pattern, or number diagnosed at any age; or,\n  * known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi, Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n  * Ability of the individual or their parent or legal guardian, to understand, and their willingness to provide informed consent.\n* Unaffected: An individual who meets any of the following criteria will be eligible to participate in this study:\n\n  * family medical history of melanoma of an unusual type, pattern, or number; or,\n  * known or suspected factor(s) predisposing to melanoma, either genetic or congenital factors (giant congenital nevi, dysplastic nevi. Spitzoid tumors), or unusual demographic features (e.g., very young age of onset, multiple melanomas, previous history of heritable retinoblastoma, Hodgkin s disease, lymphoma, immunodeficiency syndrome, or organ transplant).\n  * Ability of the individual or their parent, or legal guardian to understand, and their willingness to provide informed consent.\n* Personal and family medical history must be verified through questionnaires, interviews, and review of pathology slides and medical records.\n\nEXCLUSION CRITERIA:\n\n* Referred individuals and families for whom reported diagnoses cannot be verified;\n* Inability to provide informed consent","4 Weeks",{"count":677,"type":21},3000,"This study will investigate how genetic and environmental factors contribute to the development of melanoma, a type of skin cancer, and related conditions.\n\nIndividuals \\>=4 weeks with a personal or family history of melanoma or atypical spitzoid\u002FSpitz tumor may be eligible for this study. Participants will:\n\n* Fill out one or two questionnaires about their personal and family medical history.\n* Provide written consent for researchers to review their medical records and pathology materials related to their care and those of deceased relatives with melanomas, tumors, cancer, or other related illnesses for whom they are the next-of-kin or legally authorized representative.\n* Donate a blood or cheek cell sample to be used for genetic studies. (The blood sample is collected through a needle in an arm vein. The cheek cell sample is obtained either by gently brushing the inside of the mouth with a soft brush or by swishing a tablespoon of mouthwash and then spitting it into a container.)\n* Undergo a skin biopsy (removal of a small piece of skin tissue) for genetic study. For this procedure, the area of skin to be removed is numbed with a local anesthetic and a 1\u002F4-inch piece of skin is excised with a cookie cutter-like instrument. The wound is then covered with a band-aid.\n\nParticipants may be asked to travel to the NIH Clinical Center for evaluation, including a medical history, physical examination, and some of the following procedures:\n\n* Full body skin examination to evaluate the type and number of moles and document any evidence of sun damage to the skin. The examination involves all the skin from the scalp to the bottoms of the feet. After the examination, a medical photographer will photograph the skin, with close-ups of skin lesions marked by the examiner. If there are parts of the skin the participant does not want examined or photographed, he or she can tell the examiner.\n* Blood draw of about 120 milliliters (4 ounces) or less\n* Skin biopsy\n* Cheek cell sample\n* X-rays, ultrasound and magnetic resonance imaging (MRI) studies to detect tumors or changes in tumors or other types of changes in specific tissues. MRI is a diagnostic test that uses strong magnetic fields and radiowaves to examine body tissues. The subject lies on a table that is moved into a large tunnel-like machine (the scanner) for about 45 minutes to 1 hour.\n\nWhen the tests are finished, a doctor will discuss the results with the participant and the need, if any, for clinical follow-up.",[28,680],"Dysplastic Nevus Syndrome",[470,682,683,684,28],"Risk Factors","Melanoma Precursors","Genetics",{"date":521,"type":39},{"date":687,"type":39},"2002-07-01",{"name":143,"class":144},{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":696,"enrollmentInfo":697,"targetDuration":4,"studyType":22,"phases":698,"briefSummary":700,"conditions":701,"keywords":704,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":719,"completionDateStruct":721,"leadSponsor":723,"locationsCount":725},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":397,"type":21},[699],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[28,515,702,703,308],"Solid Tumor","Rare Cancers",[705,706,707,708,709,28,710,30,711,446,712,515,713,714,715,716,308],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Advanced Melanoma","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers","2026-06-22",{"date":570,"type":39},{"date":720,"type":39},"2017-12-28",{"date":722,"type":21},"2032-12-28",{"name":724,"class":105},"Novartis Pharmaceuticals",31,{"id":727,"slug":728,"hasResults":12,"nctId":729,"briefTitle":730,"officialTitle":731,"acronym":4,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":733,"targetDuration":4,"studyType":22,"phases":735,"briefSummary":736,"conditions":737,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":739,"startDateStruct":740,"completionDateStruct":742,"leadSponsor":744,"locationsCount":145},"100622093","studying-quality-of-life-inclusive-of-mental-health-and-cognitive-behavioral-therapy-for-cancer-distress-for-the-improvement-of-quality-of-life-in-stage-iii-iv-melanoma-patients-100622093","NCT07379138","Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improvement of Quality of Life in Stage III-IV Melanoma Patients","Launching the Era of Melanoma Survivorship: Defining Benchmarks in Quality of Life Inclusive of Mental Health (QOL-MH)","Inclusion Criteria:\n\n* Age \\>= 18-years\n* Stage III-IV melanoma and =\\\u003C 2 month duration of this diagnosis\n* Able to read English sufficient to complete survey, informed consent\n\nExclusion Criteria:\n\n* Does not meet inclusion criteria",{"count":734,"type":21},350,[541],"This clinical trial studies how people feel and live during the first two years after being treated for melanoma and whether cognitive behavioral therapy for cancer distress (CBT-C) works to improve quality of life in patients with stage III-IV melanoma. The melanoma survivorship population is rapidly growing, given the increasing survival rates due to treatment advancements. An urgent need to better define and optimize comprehensive quality of life inclusive of mental health (QOL-MH) has been identified. Cognitive behavioral therapy is a type of psychotherapy that helps patients change their behavior by changing the way they think and feel about certain things. CBT-C is a new type of care that helps patients cope with cancer-related stress, which can include problems like trouble sleeping, trouble focusing, or changes in social life and daily activities. Gathering information on how melanoma patients feel and live during the first two years after treatment may help promote improved care and continued scientific advancements in the understanding of melanoma specific QOL-MH and survivorship as a whole, and may also help determine whether CBT-C improves qualify of life in patients with stage III-IV melanoma.",[28],"2026-06-18",{"date":717,"type":39},{"date":741,"type":39},"2025-12-10",{"date":743,"type":21},"2031-12-31",{"name":745,"class":45},"Mayo Clinic",{"id":747,"slug":748,"hasResults":12,"nctId":749,"briefTitle":750,"officialTitle":751,"acronym":4,"eligibilityCriteria":752,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":753,"targetDuration":4,"studyType":22,"phases":755,"briefSummary":756,"conditions":757,"keywords":763,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":738,"lastUpdatePostDateStruct":766,"startDateStruct":767,"completionDateStruct":769,"leadSponsor":771,"locationsCount":145},"100371266","phase-2-anti-pd-1-mab-plus-metabolic-modulator-in-solid-tumor-malignancies-100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":754,"type":21},72,[58],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[28,376,758,759,760,91,761,762],"Hepatocellular Carcinoma","Urothelial Cancer","Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor",[764,765],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)",{"date":570,"type":39},{"date":768,"type":39},"2020-09-14",{"date":770,"type":21},"2032-04-30",{"name":772,"class":45},"Dan Zandberg",{"id":774,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":775,"targetDuration":4,"studyType":22,"phases":776,"briefSummary":59,"conditions":777,"keywords":778,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":779,"lastUpdatePostDateStruct":780,"startDateStruct":781,"completionDateStruct":782,"leadSponsor":783,"locationsCount":46},"100619019",{"count":56,"type":21},[24,58],[61,62,63,28,64,65,66],[68,69,70,71,72,73,74,75,76,77,78,79,80,81,28,82,83,53,84,85,86,87,88,89,90,91,92,93,94,95,96,97],"2026-06-17",{"date":717,"type":39},{"date":100,"type":39},{"date":102,"type":21},{"name":104,"class":105},{"id":785,"slug":786,"hasResults":12,"nctId":787,"briefTitle":788,"officialTitle":789,"acronym":4,"eligibilityCriteria":790,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":791,"targetDuration":4,"studyType":22,"phases":793,"briefSummary":794,"conditions":795,"keywords":796,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":779,"lastUpdatePostDateStruct":799,"startDateStruct":800,"completionDateStruct":802,"leadSponsor":804,"locationsCount":806},"100535060","phase-3-a-study-with-combinations-of-anti-lag-3-and-anti-pd-1-antibodies-in-adult-participants-with-advanced-or-metastatic-melanoma-harmony-head-to-head-100535060","NCT06246916","A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)","A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma","Key Inclusion Criteria:\n\n1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.\n2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.\n3. Measurable disease per RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate bone marrow, hepatic, and kidney function\n6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions:\n\n1. Uveal, acral or mucosal melanoma.\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.\n3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.\n\n   Prior\u002FConcomitant Therapy:\n4. Prior immune checkpoint inhibitor therapy other than anti-PD1\u002FPD-L1 as described in the protocol\n5. Systemic immune suppression as described in the protocol.\n\n   Other Comorbidities:\n6. Participants with a history of myocarditis.\n7. Troponin T (TnT) or troponin I (TnI) \\>2x institutional upper limit of normal (ULN).\n8. Active or untreated brain metastases or spinal cord compression as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply.",{"count":792,"type":21},560,[633],"This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called \"study drugs\". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs.\n* How much study drug is in the blood at different times.\n* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)",[28],[636,30,711,797,798],"Stage III","Stage IV",{"date":717,"type":39},{"date":801,"type":39},"2024-09-09",{"date":803,"type":21},"2033-07-10",{"name":805,"class":105},"Regeneron Pharmaceuticals",110,{"id":808,"slug":809,"hasResults":12,"nctId":810,"briefTitle":811,"officialTitle":812,"acronym":4,"eligibilityCriteria":813,"healthyVolunteers":190,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":814,"targetDuration":4,"studyType":22,"phases":816,"briefSummary":817,"conditions":818,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":819,"lastUpdatePostDateStruct":820,"startDateStruct":821,"completionDateStruct":823,"leadSponsor":825,"locationsCount":145},"100641614","feasibility-of-an-enhanced-symptom-monitoring-and-expedited-subspecialty-care-referral-intervention-to-improve-side-effect-management-for-patients-with-melanoma-receiving-an-immune-checkpoint-inhibitor-100641614","NCT07660666","Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor","EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care","Inclusion Criteria:\n\n* PATIENT: Age 18 years or older\n* PATIENT: Histologically confirmed diagnosis of melanoma\n* PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and\u002For National Comprehensive Cancer Network (NCCN) guidelines\n* PATIENT: Willing and able to provide informed consent\n* CAREGIVER: Age 18 years or older\n* CAREGIVER: Family member or primary caregiver of a study participant\n\nExclusion Criteria:\n\n* PATIENT: Previously received ICI therapy\n* PATIENT: Life expectancy of \\\u003C 6 months at time of enrollment\n* PATIENT: Concurrently receiving a non-ICI systemic therapy\n* PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)\n* PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments\n* PATIENT: Unwilling or unable to complete surveys electronically\n* CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)\n* CAREGIVER: Unwilling or unable to complete surveys electronically",{"count":815,"type":21},50,[541],"This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.",[28],"2026-06-16",{"date":717,"type":39},{"date":822,"type":21},"2026-11-01",{"date":824,"type":21},"2029-06-01",{"name":826,"class":45},"OHSU Knight Cancer Institute"]