[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neuroendocrine-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neuroendocrine-tumors":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,63,95,117,158,187,266,292,318,347,388,400,424,445,469,492,513,539,570,596,615,636,660,689,715],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405",false,"NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males 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 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* 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, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. 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. Subjects may receive non-live COVID-19 vaccine.\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 Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","18 Years","99 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[28,29,30,31,32,33,34,35,36],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer","Prostate Cancer",[38,39,40,41,42,43,44,45,46,47,48,49],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor","RECRUITING","2026-07-10",{"date":53,"type":54},"2026-07-13","ACTUAL",{"date":56,"type":54},"2021-12-07",{"date":58,"type":21},"2027-06",{"name":60,"class":61},"University of Florida","OTHER",1,{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":62},"100317456","phase-2-administration-of-autologous-t-cells-genetically-engineered-to-express-t-cell-receptors-reactive-against-neoantigens-in-people-with-metastatic-cancer-100317456","NCT03412877","Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer","A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer","* INCLUSION CRITERIA:\n* Metastatic, solid cancer that can be measured, and falls into one of five cohorts: (1) gastrointestinal and genitourinary cancers; (2) breast, ovarian, and other solid cancers; (3) non-small cell lung cancer (NSCLC); (4) endocrine tumors including neuroendocrine tumors; and, (5) multiple myeloma that includes measurable solid tumors (plasmacytomas). Participants with multiple myeloma are potentially eligible only if they have measurable multiple myeloma as defined in Section 16.7 after plasmacytoma resection.\n\nNote: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas.\n\n* Documented diagnosis of cancer.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Participants with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Participants with breast and ovarian cancer must be refractory to first- line treatment and refractory to or have refused second-line treatments.\n  * Participants with NSCLC must have received at least one platinum-based chemotherapy regimen and at least one FDA-approved targeted treatment (when appropriate).\n* Participants with endocrine tumors including neuroendocrine tumors must be refractory to first-line therapy (e.g., lanreotide, octreotide) and must be refractory or have refused second-line treatments such as everolimus, sunitinib, or 177 Lu-Dotatate, if indicated.\n* Participants with multiple myeloma must have received at least four prior lines of therapy that included at least one exposure to an immunomodulatory drug such as lenalidomide, a proteosome inhibitor, an anti-CD38 antibody treatment, and an autologous stem cell transplant.\n* Participants with three (3) or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the participant to be eligible. Participants with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Participants of both sexes must be willing to practice birth control from the time of enrollment on this study and for and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and four months after treatment for participants who can father a child.\n* Individuals of child-bearing potential must be willing to undergo a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nNOTE: Certain malignancies may secrete hormones that produce false positive pregnancy tests. Serial blood testing (e.g. HCG measurements) and\u002F or ultrasound may be performed for clarification.\n\n* Serology:\n\n  * Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n  * Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Hematology:\n\n  * ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n  * WBC greater than or equal to 2500\u002Fmm\\^3\n  * Platelet count greater than or equal to 80,000\u002Fmm\\^3\n  * Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n* Chemistry:\n\n  * Serum ALT\u002FAST less than or equal to 5.0 x ULN\n  * Serum creatinine less than or equal to 1.6 mg\u002FdL.\n  * Total bilirubin less than or equal to 2.0 mg\u002FdL, except in participants with Gilbert's Syndrome, who must have a total bilirubin less than or equal to 3.0 mg\u002FdL.\n* Participants must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Participants may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to grade 1 or less. In addition, participants with multiple myeloma may receive bridging therapy during the time between study enrollment and start of study therapy. This may be necessary due to the long time needed for cell production on this study. After bridging therapy and within 14 days of protocol treatment start, participants with multiple myeloma must still have measurable multiple myeloma.\n\n* For Cohort 3: More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient s toxicities must have recovered to a grade 1 or less.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* For Cohort 3: Any major bronchial occlusion or bleeding not amenable to palliation.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* For Arm 2: Grade 3 or 4 major organ irAEs following treatment with anti-PD-1\u002FPD-L1, including but not limited to myocarditis and pneumonitis.\n\nNote: Participants with grade 3 or 4 major organ irAEs may be enrolled on Arm 1 if all other eligibility criteria are met.\n\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* For Cohorts 1, 2, 4. or 5: Clinically significant participant history which in the judgment of the Principal Investigator (PI) would compromise the participants ability to tolerate high-dose aldesleukin.\n\nNote: At the discretion of the PI, participants enrolled in Cohort 3 may receive low-dose aldesleukin.\n\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50% predicted.\n* Participants who are receiving any other investigational agents.","72 Years",{"count":72,"type":21},285,[25],"Background:\n\nA person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person.\n\nObjective:\n\nTo see if gene transfer therapy of white blood cells can shrink tumors.\n\nEligibility:\n\nPeople with certain metastatic cancer for which standard treatments have not worked.\n\nDesign:\n\nParticipants may complete screening under another protocol. Screening includes:\n\n* Getting tumor cells from a previous procedure\n* Medical history\n* Physical exam\n* Scans\n* Blood, urine, heart, and lung tests\n\nThe study has 8 stages:\n\n1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm.\n2. Care at home over approximately 12 weeks.\n3. Stopping therapy for 4-6 weeks while their cells are changed in a lab.\n4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs.\n5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart.\n6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer.\n7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests.\n8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.",[76,77,32,30,78,31,79],"Endocrine Tumors","Non-Small Cell Lung Cancer","Gastrointestinal\u002FGenitourinary Cancers","Multiple Myeloma",[81,82,83,84],"Gene Therapy","Immunotherapy","Cell Therapy","Adoptive Cell Therapy","2026-07-01",{"date":87,"type":54},"2026-07-02",{"date":89,"type":54},"2018-09-06",{"date":91,"type":21},"2029-03-23",{"name":93,"class":94},"National Cancer Institute (NCI)","NIH",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100617095","study-of-cabozantinib-in-participants-with-neuroendocrine-tumors-who-have-already-received-prior-treatment-100617095","NCT07314164","Study of Cabozantinib in Participants With Neuroendocrine Tumors Who Have Already Received Prior Treatment","CaboLife: A Prospective Non-Interventional Study on Effectiveness and Safety of Cabozantinib in Real-Life Setting for Previously Treated Patients With Neuroendocrine Tumour","Inclusion Criteria:\n\nParticipants can join the study if they meet all of the following conditions:\n\n* Are 18 years or older and able to give informed consent.\n* Have a physician-initiated decision to start treatment with cabozantinib for neuroendocrine tumors (NETs), made before joining the study.\n* Have unresectable or metastatic, well-differentiated pancreatic (pNET) or extra-pancreatic neuroendocrine tumors (epNET).\n* Have already received at least one prior systemic therapy, other than somatostatin analogues.\n* Have signed a written informed consent form.\n\nExclusion Criteria:\n\nParticipants cannot join the study if:\n\n* They are currently participating in an interventional clinical trial, or have done so within the last 3 months before joining this study.\n* They have a contraindication to cabozantinib treatment, based on the product's official prescribing information.",{"count":103,"type":21},150,"OBSERVATIONAL","This study will assess how well cabozantinib works and how safe it is in adults with a type of cancer called neuroendocrine tumors (NETs).\n\nThese tumors can appear in all parts of the body. All participants in this study have already received at least one treatment that affects the whole body to help manage their cancer, but their disease has continued to grow.\n\nThe study will take place in regular hospitals and clinics in Germany and Austria.\n\nIt will follow about 150 participants who are taking cabozantinib as part of their usual care. Doctors will collect information from routine medical visits, tests, and scans to see how the cancer responds to treatment and how long participants stay on cabozantinib. They will also look at side effects and how the treatment affects participants' quality of life.\n\nThis is an observational study, which means that no extra tests or procedures will be done beyond what is normally used to care for participants with this condition.",[31],"2026-06-30",{"date":85,"type":54},{"date":110,"type":54},"2025-12-17",{"date":112,"type":21},"2028-12-31",{"name":114,"class":115},"Ipsen","INDUSTRY",34,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100602879","phase-1-a-study-to-investigate-safety-and-effectiveness-of-crn09682-in-participants-with-sst2-expressing-nens-and-other-solid-tumors-100602879","NCT07129252","A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors","A Phase 1\u002F2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants With Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors","BRAVESST2","Inclusion Criteria:\n\n* Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.\n* Have one or more measurable disease location per RECIST version 1.1.\n* Have a tumor that expresses SSR confirmed by SSR imaging.\n* Have an ECOG performance status of 0, 1, or 2.\n\nExclusion Criteria:\n\n* Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.\n* Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants with other non-NET solid tumors.\n* Use of anticancer agents within specified intervals prior to the first dose of study drug.\n* Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.\n* Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Participants with carcinoid syndrome.\n* Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial (noninvasive) bladder cancer, and non-melanoma skin cancer.\n* Have prior treatment with MMAE.\n* Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and\u002For MMAE.",{"count":103,"type":21},[24,25],"This Phase 1\u002F2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in participants with SST2-expressing NENs and other solid tumors. The study includes a Dose Escalation Phase to determine the MTD and DLTs. Following MTD identification, additional participants will be enrolled at the expansion dose to further assess safety, tolerability, PK, and antitumor activity.",[129,31,130],"SST2-positive Neuroendocrine Neoplasms","Neuroendocrine Neoplasm",[132,133,130,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149],"CRN09682","Crinetics","NEN","Neuroendocrine Tumor","NET","MMAE","SST2","Somatostatin","Metastatic","Solid Tumor","Dose Escalation","Dose Expansion","Phase 1","SSTR+","Phase 2","Phase 1\u002F2","Neuroendocrine Carcinoma","NEC",{"date":85,"type":54},{"date":152,"type":54},"2025-11-26",{"date":154,"type":21},"2029-08",{"name":156,"class":115},"Crinetics Pharmaceuticals Inc.",26,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":62},"100369142","phase-1-lu-177-dotatate-lutathera-in-combination-with-olaparib-in-inoperable-gastroenteropancreatico-neuroendocrine-tumors-gep-net-100369142","NCT04086485","Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)","Phase I\u002FII Study of Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)","* INCLUSION CRITERIA:\n* Clinical diagnosis of GEP-NET disease, histologically consistent with neuroendocrine tumor.\n* Inoperable disease (metastatic, non-candidate for surgery with curative intent, locally advanced into vessels or other critical structures, etc.)\n\nNOTE: Presence of at least one non-irradiated index lesion (Phase II only).\n\n* Patients on somatostatin analogue therapy (e.g., but not only limited to sandostatin or lanreotide therapy) must have initiated and been on a consistent dose of therapy for at least 3 months prior to study enrollment.\n* Patients on short-term octreotide must have dose held for 24 hours without octreotide because this is necessary for study Lu-177-DOTATATE therapy.\n* Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of Lu-177-DOTATATE in combination with olaparib in patients \\\u003C18 years of age, children are excluded from this study, but may be eligible for future pediatric trials.\n* Must have presence of somatostatin receptors (SSTR) positive disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks prior to enrollment. NOTE: Positivity of Ga-68-DOTATATE PET scan is defined as having at least one RECIST 1.1 measurable lesion that has an SUV higher than or equal to liver and is qualitatively higher and distinguishable from background activity.\n* Known BRCA mutation status (Cohort 3 only).\n* Progressive disease by RECIST 1.1, as compared to previous anatomic imaging no more than 36 months from the date of study enrollment, with at least 1 measurable lesion by RECIST 1.1.\n* ECOG Performance Status of \\\u003C=1.\n* Patients must have normal organ and bone marrow function measured within 28 days prior to enrollment as defined below:\n\n  * Hemoglobin \\>= 10.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n  * Platelet count \\>= 100 x 10\\^9\u002FL\n  * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) \u002F Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \\\u003C= 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be \\\u003C= 5x ULN\n  * Patients must have creatinine clearance estimated of \\>= 51 mL\u002Fmin using the Modification of Diet in Renal Disease (MDRD) study equation or based on a 24 hour urine test: eGFR = 175 x (SCr)\\^-1.154 x (age)\\^-0.203 x 0.742 \\[if female\\] x 1.212 \\[if Black\\]\n* Ability to understand and willingness to sign informed consent.\n* Postmenopausal or evidence of non-childbearing status. For individuals of childbearing potential (IOCBP): negative urine or serum pregnancy test within 28 days of study enrollment. Postmenopausal is defined as:\n\n  * Amenorrheic for 1 year (12 months in a row) or more without an alternative medical cause; if the individual received exogenous hormonal treatments, must be amenorrheic for 1 year or more following cessation of the same\n  * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post-menopausal range for individuals under 50\n  * Radiation-induced oophorectomy with last menses \\>1 year ago\n  * Chemotherapy-induced menopause with \\>1 year interval since last menses\n  * Surgical sterilization for IOCBP participants (bilateral oophorectomy or hysterectomy) and\u002For participants with partners that can bear children.\n* NOTE: An individual is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the patient surgically sterile, or \\>1 years since last menstruation. Must have outside endocrinologist\u002Fmedical oncologist who can follow the patient for standard of care follow-ups after receiving PRRT at the NIH.\n* Study drugs can have adverse effects on embryofetal survival and development. It is further not known whether olaparib or its metabolites are found in seminal fluid. For these reasons:\n\n  * Individuals of childbearing potential and their partners, who are sexually active, must agree to the use of 2 highly effective forms of contraception in combination (male condom plus one of the methods listed below) or must totally\u002Ftruly abstain from any form of sexual intercourse. This should be started from the signing of the informed consent, throughout study treatment and for at least 7 month for individuals of childbearing potential after the last dose of the study drugs.\n  * Patients with partners that can bear children must use a male condom during treatment and for 4 months after the last dose of study drugs when having sexual intercourse with a pregnant individual or with an individual of childbearing potential. Partners of patients should also use a highly effective form of contraception (see below) if they are of childbearing potential. Patients should not donate sperm throughout study treatment and for 4 months following the last dose of study drugs.\n  * Acceptable birth control methods include:\n\n    * Total sexual abstinence i.e., refrain from any form of sexual intercourse in line with the patients' usual and\u002For preferred lifestyle. Abstinence must be for the total duration of the study treatment and for at least 7 months (for IOCBP) or 4 months (for patients with partners of child bearing potential) after the last dose of study treatment. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Vasectomised sexual partner PLUS male condom (with participant assurance that partner received post-vasectomy confirmation of azoospermia)\n    * Tubal occlusion PLUS male condom\n    * Intrauterine Device (provided coils are copper-banded) PLUS male condom\n    * Mini pill PLUS male condom: Progesterone-based oral contraceptive pill using desogestrel. Cerazette (Merck Sharp \\& Dohme) is currently the only highly efficacious progesterone- based pill available\n    * Combined pill PLUS male condom: Normal and low-dose combined oral pills\n    * Injection PLUS male condom: Medroxyprogesterone injection (eg, Depo-Provera \\[Pfizer\\])\n    * Implants PLUS male condom: Etonorgestrel-releasing implants (eg, Nexplanon \\[Merck Sharp \\& Dohme\\])\n    * Patch PLUS male condom: Norelgestromin\u002Fethinyl estradiol transdermal system (eg, Xulane)\n    * Intravaginal device (eg, ethinyl estradiol-\u002Fetonogestrel-releasing intravaginal devices such as NuvaRing \\[Merck Sharp \\& Dohme\\]) PLUS male condom\n    * Levonorgestrel-releasing intrauterine system (eg, Mirena \\[Bayer\\]) PLUS male condom.\n\nEXCLUSION CRITERIA:\n\n* Patients who have any GEP-NET lesions that are negative by Ga-68-DOTATATE-PET imaging but positive by FDG-PET imaging, unless they have progressed on at least one other line of prior systemic treatment (such as chemotherapy or tyrosine kinase inhibitor) and the majority of their tumor lesions are Ga-68-DOTATATE-avid.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued if the mother is treated with study drugs.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n* Patients who are receiving any other investigational agents.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 4 weeks prior to study enrollment.\n* Patients with persistent toxicities (\\>= CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy and toxicities deemed irreversible\u002Fstable expected to interfere with study drug administration in the opinion of the Principal Investigator.\n* Patient's weight exceeding PET table tolerance (\\> 400 lbs).\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\\>180\u002F110), arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with symptomatic, uncontrolled brain metastases. NOTE: Patients with previously treated brain metastases are eligible if asymptomatic and may be on a stable dose of corticosteroids as long as these were started at least 4 weeks prior to treatment.\n* Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease by imaging and clinical assessment as assessed by the treating investigator for 28 days before enrollment.\n* Concomitant use of known strong or moderate CYP3A inhibitors within 2 weeks before enrollment.\n* Concomitant use of known strong or moderate CYP3A inducers within 5 weeks (for enzalutamide or phenobarbital) and 3 weeks for other agents before enrollment.\n* Patients that have had major surgery within 4 weeks prior to study enrollment and have not recovered from any effects of any major surgery.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Previous allogeneic hematopoietic stem cell transplant, allogeneic bone marrow transplant or double umbilical cord blood transplant (duCBT).\n* Patients with a known hypersensitivity to olaparib or Lutathera or any excipients of these products.\n* Resting ECG indicating uncontrolled cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or with features suggestive of MDS\u002FAML.\n* Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV). HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drugs. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Patients with known active hepatitis (i.e., Hepatitis B or C).\n* Any previous treatment with PARP inhibitor, including olaparib and\u002For any previous treatment with any systemic radionuclide agents.\n* Involvement in the planning and\u002For conduct of the study.\n* Previous treatment with Lu-177-DOTATATE.","100 Years",{"count":167,"type":21},56,[24,25],"Background:\n\nA neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors.\n\nObjective:\n\nTo learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink.\n\nEligibility:\n\nAdults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells.\n\nDesign:\n\nEligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein.\n\nParticipants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses.\n\nDuring the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer.\n\nParticipants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls....",[171,31,172],"Gastroenteropancreatico Tumors","Neuroendocrine Neoplasms",[174,175,176,177,178,179],"Somatostatin Receptors","Peptide receptor radionuclide therapy","Carcinoids","Radionuclide Therapy","olaparib","PARP Inhibitor","2026-06-27",{"date":107,"type":54},{"date":183,"type":54},"2022-10-03",{"date":185,"type":21},"2028-01-01",{"name":93,"class":94},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":194,"sex":16,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":199,"studyType":104,"phases":4,"briefSummary":200,"conditions":201,"keywords":246,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":265},"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",true,"19 Years","110 Years",{"count":198,"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.",[202,203,204,205,206,207,208,209,210,28,211,212,213,214,215,216,217,218,219,220,221,36,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,30,238,239,240,241,79,32,242,243,31,244,245],"Pancreatic Cancer","Thyroid Cancer","Lung Cancer","Esophageal Cancer","Thymus Cancer","Colon Cancer","Rectal Cancer","Gastrointestinal Stromal Tumors","Anal Cancer","Duodenal Cancer","Gallbladder Cancer","Gastric Cancer","Liver Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Bladder Cancer","Kidney Cancer","Penile Cancer","Testicular Cancer","Ureter Cancer","Urethral Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Salivary Gland Cancer","Skin Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Melanoma","Sarcoma","Unknown Primary Tumor","Endometrial Cancer","Vaginal Cancer","Plasma Cell Dyscrasia","Healthy Control",[202,203,247,248,249,250,251,252,253,254,30,255,244,245],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor","2026-06-25",{"date":258,"type":54},"2026-06-29",{"date":260,"type":54},"2013-11-01",{"date":262,"type":21},"2099-12",{"name":264,"class":61},"University of Nebraska",42,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":62},"100621133","phase-1-safety-tolerability-and-preliminary-efficacy-of-neuk203-13-in-refractory-neuroendocrine-tumor-patients-100621133","NCT07366658","Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroendocrine Tumor Patients","A Study to Explore the Safety, Tolerability, and Preliminary Efficacy of NEUK203-13 Injection in Patients With Neuroendocrine Tumors Who Have Failed Systemic Therapy","NEUK203-13","Inclusion Criteria:\n\n* 1\\. Understand and voluntarily sign the Informed Consent Form (ICF);\n* 2\\. Aged ≥ 18 years and \\\u003C 75 years at the time of signing the ICF, regardless of gender;\n* 3\\. Pathologically confirmed neuroendocrine tumors, including small cell lung cancer (SCLC), etc.;\n* 4\\. Previous failure or intolerance to systemic therapy, or recurrence after remission: among them, patients with small cell lung cancer must have received at least platinum-based chemotherapy with or without PD-1\u002FPD-L1 inhibitors in previous treatments, with imaging evidence of disease progression after treatment;\n* 5\\. Must provide tissue samples for biomarker analysis, preferably newly obtained tissues. For patients unable to provide newly obtained tissues, 4 unstained sections of archived formalin-fixed, paraffin-embedded (FFPE) tissues can be provided (at least 1 patient with high DLL3 expression shall be enrolled in each dose group: high expression is defined as positive staining in ≥ 50% of tumor cells; preference is given to enrolling DLL3-positive patients);\n* 6\\. Have at least one measurable lesion as the target lesion (per RECIST v1.1 criteria);\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* 9\\. Have adequate bone marrow reserve and organ function within 7 days before the first administration of NEUK203-13 Injection:\n* 10\\. Sufficient bone marrow function (no supportive therapy within 14 days before the first administration): hemoglobin (Hb) ≥ 90 g\u002FL, platelets (PLT) ≥ 75 × 10⁹\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n* 11\\. Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), total bilirubin (TBIL) \\\u003C 1.5 × ULN;\n* 12\\. Renal function: serum creatinine (Scr) ≤ 1.5 × ULN and creatinine clearance rate (Ccr) ≥ 60 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); Coagulation function: prothrombin time (PT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 2.0;\n* 13\\. Female patients of childbearing potential or male patients whose partners are of childbearing potential agree to use highly effective contraceptive measures from any dose administration in the study until 6 months after the last dose of the study.\n\nExclusion Criteria:\n\n* 1\\. Mixed carcinoma with non-neuroendocrine tumor components;\n* 2\\. Active brain metastases (patients with stable disease for 3 months after treatment without the need for continued glucocorticoid therapy are eligible for enrollment); known leptomeningeal metastases; isolated central nervous system (CNS) disease progression without evidence of progression outside the CNS;\n* 3\\. A history of hypersensitivity to interleukin-2 (IL-2), fludarabine, cyclophosphamide, tocilizumab, or any component of the infusion product formulation; or patients with a history of specific allergic disorders (asthma, rubella, eczematous dermatitis);\n* 4\\. Prior receipt of any of the following treatments:\n* 5\\. Any systemic antineoplastic therapy within 4 weeks or 5 half-lives prior to the first administration of NEUK203-13 Injection, whichever is shorter;\n* 6\\. Radiotherapy not involving the thoracic cavity within 2 weeks prior to the first administration of NEUK203-13 Injection, or radiotherapy involving the thoracic cavity within 4 weeks prior to the first administration of the study drug, whichever is longer;\n* 7\\. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study;\n* 8\\. Prior vaccination with an antineoplastic vaccine, or receipt of a live vaccine within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 9\\. Major surgery or severe trauma within 4 weeks prior to the first administration of NEUK203-13 Injection;\n* 10\\. Failure of toxicities from prior antineoplastic therapy to resolve to ≤ Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) (except alopecia) or to the level specified in the inclusion\u002Fexclusion criteria, whichever is more stringent;\n* 11\\. Active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); exceptions include patients with vitiligo, patients with a history of childhood asthma\u002Fallergies that have resolved completely and require no intervention in adulthood, patients with autoimmune-mediated hypothyroidism receiving a stable dose of thyroid replacement hormone, and patients with type 1 diabetes receiving a stable dose of insulin;\n* 12\\. A history of immunodeficiency, including positive HIV test results, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;\n* 13\\. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first administration of NEUK203-13 Injection, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating active pulmonary inflammation; or presence of signs and symptoms of infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first administration of the study drug (except for prophylactic antibiotic use);\n* 14\\. Tuberculosis infection identified by medical history or CT examination; Active hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (positive anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay), or positive syphilis test results (including positive RPR or TPPA);\n* 15\\. Prior diagnosis of any other malignant tumor, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, or adequately treated localized prostate cancer;\n* 16\\. Pregnant or lactating women;\n* 17\\. Uncontrolled concurrent diseases, including but not limited to: documented cerebrovascular events (stroke or transient ischemic attack) within 6 months prior to the first administration of the study drug, symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmias, severe chronic gastrointestinal disease with diarrhea, or severe dyspnea requiring oxygen therapy;\n* 18\\. A definite history of neurological or psychiatric disorders that, in the investigator's judgment, may affect the patient's cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.; or psychiatric illnesses\u002Fsocial conditions that may affect study compliance, significantly increase the risk of adverse events, or impair the patient's ability to provide written informed consent;\n* 19\\. Other factors judged by the investigator that may force the patient to terminate the study prematurely, such as severely abnormal laboratory test results, and\u002For family or social factors that may affect patient safety or the collection of trial data.","75 Years",{"count":276,"type":21},9,[24],"This is a Phase I clinical trial being conducted in humans for the first time, aiming to evaluate a novel cell therapy called NEUK203-13 Injection for the treatment of patients with advanced small cell lung cancer (SCLC) who have failed systematic therapy or late stage neuroendocrine tumors(NETs). The primary goal of the study is to determine the safety and tolerability of this new therapy and to preliminarily observe its anti-tumor effects.\n\nNEUK203-13 Injection is an \"off-the-shelf\" CAR-NK cell therapy developed based on induced pluripotent stem cell (iPSC) technology, targeting the DLL3 protein highly expressed in SCLC or other neuroendocrine tumors(NETs) .\n\nPrimary Objective Primary Endpoint aims to evaluate safety and tolerability Secondary Endpoints aim to preliminarily observe efficacy and investigate the pharmacokinetics of the drug in the body.\n\nTwo pre-set dose levels are planned, with an enrollment of 7-9 patients. Treatment Regimen\n\n1. Lymphodepletion Conditioning: Chemotherapy (Cyclophosphamide + Fludarabine) before cell infusion to clear lymphocytes in the body.\n2. Cell Infusion: NEUK203-13 is administered via intravenous infusion, d1，d4 and d7 for three doses.\n3. Supportive Medication: Concurrent use of IL-2 (Interleukin-2) d1, d4, d7 and d10 to support NK cell persistence.\n\nTarget Patient Population Patients with advanced SCLC who have progressed after prior platinum-based chemotherapy or late stage neuroendocrine tumors(NETs) and have a relatively good performance status.\n\nKey Monitoring Focus Close monitoring of risks specific to cell therapy, such as Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).\n\nIn short, this study represents the first clinical exploration of NEUK203-13 Injection in patients with advanced small cell lung cancer or other neuroendocrine tumors(NETs). Its primary focus is on safety, while simultaneously gathering preliminary signals on whether the therapy can control tumors, thereby laying the foundation for subsequent clinical development.",[280,31],"SCLC, Extensive Stage",[282,283],"Car-NK cells","iPSC","2026-06-23",{"date":256,"type":54},{"date":287,"type":54},"2026-02-20",{"date":289,"type":21},"2027-01-20",{"name":291,"class":61},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":62},"100641367","phase-1-211at-mabg-in-adults-with-advanced-neuroendocrine-cancers-100641367","NCT07661420","211At-MABG in Adults With Advanced Neuroendocrine Cancers","Inclusion Criteria:\n\n1. Adult patients, at least 18 years of age\n2. Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.\n3. I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator\u002FSub-Investigator assessment.\n4. Participants must provide written informed consent prior to study-specific procedures.\n5. ECOG performance status ≤ 2.\n6. Adequate organ function including:\n\n   1. Hemoglobin ≥ 9 g\u002FdL\n   2. Absolute neutrophil count ≥ 1,500\u002Fmm³\n   3. Platelet count ≥ 75,000\u002Fmm³\n   4. Measured or estimated GFR ≥ 60 mL\u002Fmin\n   5. Serum bilirubin ≤ 1.5x upper limit of normal\n   6. ALT\u002FAST each ≤ 2.5x upper limit of normal\n7. Life expectancy at least 3 months as judged by treating physician\n\nExclusion Criteria:\n\n1. Women who are pregnant or breast-feeding will not be eligible for this study.\n2. Inability to tolerate study procedures in the opinion of the investigator or treating physician.\n3. Serious or unstable medical, psychological, or social conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.\n4. Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).\n5. Anticancer therapy, except hormonal therapy or bone supportive therapies, within 14 days of cycle 1 day 1.\n6. Has a known additional malignancy (other than the disease under study) that has required active systemic treatment within the past 2 years AND for which the natural history or recent\u002Fongoing treatment could likely interfere with study endpoints or safety of the study treatment per Investigator and Medical Director assessment.",{"count":299,"type":21},16,[24],"Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma \u002F paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).",[303,304,31,305,306,307],"Pheochromocytoma","Paraganglioma","Medullary Thyroid Cancer","Bronchial Carcinoid","Gastroenteropancreatic Neuroendocrine Neoplasm","NOT_YET_RECRUITING","2026-06-16",{"date":311,"type":54},"2026-06-22",{"date":313,"type":21},"2026-08-01",{"date":315,"type":21},"2032-08-01",{"name":317,"class":61},"University of Pennsylvania",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":334,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":62},"100519282","phase-1-a-first-in-human-phase-i-trial-with-antibody-drug-conjugate-adct-701-in-neuroendocrine-tumors-carcinomas-and-malignant-peripheral-nerve-sheath-tumors-100519282","NCT06041516","A First-in-Human Phase I Trial With Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors, Carcinomas and Malignant Peripheral Nerve Sheath Tumors","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed neuroendocrine neoplasms or malignant adrenocortical carcinoma (ACC) or malignant peripheral nerve sheath tumors (MPNST).\n* Locally advanced, unresectable or metastatic disease (as confirmed by a radiological evaluation)\n* Participants must have measurable disease per RECIST 1.1.\n* Participants must have received prior standard of care treatment and be refractory to or intolerant to standard of care therapy(s). Note: Patients with MPNST who have refused cytotoxic chemotherapy or for whom treatment on this protocol prior to receiving cytotoxic\n\nchemotherapy is felt to be in the best interest for the patient by the local investigator and treating investigator will also be eligible.\n\n* Age \\>= 18 years.\n* ECOG performance status \\\u003C= 2.\n* Adequate hematologic function as follows:\n\n  * Leukocytes \\>= 3,000\u002Fmicroliter\n  * Absolute neutrophil count (ANC) \\>= 1,200\u002Fmicroliter (off-growth factors for 72 hours prior to treatment initiation)\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL with no blood transfusion within 2 weeks prior to treatment initiation\n  * Platelets \\>= 100,000\u002Fmicroliter with no platelet transfusion within 1 week.\n* Adequate renal and hepatic function as follows:\n\n  * Creatinine clearance (CrCl) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (calculated CrCl (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or calculated eGFR provided by a laboratory))\n  * Total bilirubin \\\u003C= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \\\u003C= 3.0 x ULN\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN, (unless liver metastases are present, then values must be \\\u003C= 5 x ULN).\n* Participants serologically positive for hepatitis C virus (HCV) must have an undetectable HCV viral load.\n* Participants serologically positive for Hepatitis B (HBV) core antibody or surface antigen must be on adequate anti-viral therapy and Hepatitis B Viral deoxyribonucleic acid (DNA) load must be \\\u003C2000 IU\u002FmL.\n* Participants serologically positive for human immunodeficiency virus (HIV) must be on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \\>= 200 cells per cubic millimeter.\n* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms.\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 9.5 months after the last dose of the ADCT-701 (restriction period).\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 6.5 months after the last dose of the ADCT-701.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6.5 months after study treatment discontinuation.\n* Participants or legally authorized representative (LAR) must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Major surgery, prior treatment with chemotherapy, hormonal therapy, immunotherapy, treatment with an investigational agent, and\u002For radiation therapy within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment initiation.\n* Participants taking any herbal supplements within 14 days prior to treatment initiation.\n* Participants who have wound dehiscence from prior surgeries.\n* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or any serosal effusion that is either requires drainage or is associated with shortness of breath) at screening.\n* Active infection requiring systemic antibiotic therapy at screening.\n* Active bleeding diathesis or therapeutic anticoagulation with an oral vitamin K antagonist with target international normalized ratio (INR) \\> 2 at screening.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.\n* An active autoimmune disease. Note: Participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\\\u003C= the equivalent of prednisone 10 mg\u002Fday), or other mild autoimmune disorders (Type 1 diabetes, eczema, vitiligo, alopecia, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, adrenal insufficiency due to Addison's disease, hypothyroidisms due to Hashimoto's thyroiditis, hyperthyroidisms due to Graves disease, Sjogren s syndrome, celiac disease, pernicious anemia) not requiring immunosuppressive treatment are eligible.\n* Congenital long QT syndrome, or a corrected QTcF interval of \\>=480 ms, at screening (unless secondary to the pacemaker or bundle branch block).\n* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that does not require current anticancer treatment per standard of care.\n* Live vaccine administration within 30 days prior to treatment initiation.\n* Pregnant individuals (confirmed by Beta-Human Chorionic Gonadotropin \\[Beta-HCG\\] serum or urine pregnancy test) performed at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.","120 Years",{"count":326,"type":21},70,[24],"Background:\n\nNeuroendocrine neoplasms (NENs) are rare cancers in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other areas of the body. Many of these cancers have a high risk of relapse and a low chance of survival. Better treatments are needed.\n\nObjective:\n\nTo test a new drug, ADCT-701, in people with NENs.\n\nEligibility:\n\nAdults aged 18 and older with NENs.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of heart functioning. Their ability to perform normal daily activities will be tested. A biopsy may be needed: A sample of tissue will be removed from the tumor.\n\nADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. Participants will receive the drug treatment on the first day of 21-day treatment cycles. They will visit the clinic a total of 10 times during the first two cycles. After that, they will visit the clinic 2 times during each cycle. Imaging scans, blood draws, heart function tests, and other tests will be repeated during study visits. Each visit will last up to 8 hours.\n\nParticipants may continue receiving treatment with the study drug for up to 2 years.\n\nAfter treatment ends, participants will have follow-up clinic visits 4 times in 4 months. They will have a physical exam, with heart and blood tests, at each visit. After that, they will have follow-up clinic visits every 9 weeks; these visits will include imaging scans.\n\nFollow-up visits will continue for up to 5 years after treatment began....",[330,31,331,332,333],"Neuroendocrine Carcinomas","Carcinoma, Neuroendocrine","Carcinoma, Adrenocortical","Carcinoma, Adrenal Cortical",[303,335,135,336,337,304,338],"Neuroblastoma","Neuroendocrine carcinoma","Neuroendocrine neoplasms","Adrenocortical Carcinoma","2026-06-12",{"date":341,"type":54},"2026-06-15",{"date":343,"type":54},"2024-06-17",{"date":345,"type":21},"2029-10-30",{"name":93,"class":94},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":366,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":276},"100605639","phase-1-study-of-ryz401-in-subjects-with-solid-tumors-expressing-sstrs-100605639","NCT07165132","Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.","Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.","Inclusion criteria:\n\n* At least 18 years old at the time of signing the main study informed consent form (ICF).\n* Histologically confirmed:\n\nDose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.\n\n* Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs\n* Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications:\n\n  * WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3)\n\n    * SSTR-positive disease, as assessed by SSTR-PET imaging\n    * Adequate renal, hematologic and hepatic function\n\nExclusion criteria:\n\n* Prior RPT, including Lu-177.\n* Prior solid organ or bone marrow transplantation.\n* Use of chronic systemic steroid therapy.\n* Significant cardiovascular disease\n* Resistant hypertension\n* Uncontrolled diabetes\n* Prior history of liver cirrhosis\n* HIV, hepatitis B infection or known active hepatitis C virus infection.\n\nNote: Additional criteria may apply and will be assessed by the study site",{"count":355,"type":21},104,[24],"The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.",[359,360,361,31,362,363,364,141,365],"GEP-NET","Gastroenteropancreatic Neuroendocrine Tumor","Gastroenteropancreatic Neuroendocrine Tumor Disease","Carcinoid","Carcinoid Tumor","Pancreatic NET","Somatostatin Receptor",[31,145,359,367,360,368,369,370,141,174,371,372,373,374,375,376,377,378],"Targeted Radiotherapy","Actinium","Ac 225","PRRT","Radiopharmaceutical","BMS","Bristol Myers Squibb","Rayze","SSTR","RayzeBio","Well-differentiated NET","WD NETs","2026-06-08",{"date":381,"type":54},"2026-06-09",{"date":383,"type":54},"2025-12-03",{"date":385,"type":21},"2033-04",{"name":387,"class":115},"RayzeBio, Inc.",{"id":389,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":26,"conditions":392,"keywords":393,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":399,"locationsCount":62},"100439284",{"count":20,"type":21},[24,25],[28,29,30,31,32,33,34,35,36],[38,39,40,41,42,43,44,45,46,47,48,49],"2026-06-04",{"date":396,"type":54},"2026-06-05",{"date":56,"type":54},{"date":58,"type":21},{"name":60,"class":61},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":423},"100435791","phase-2-assessment-of-retreatment-with-lutathera-in-patients-with-new-progression-of-intestinal-well-differenciated-net-100435791","NCT04954820","Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET","A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor","ReLUTH","Inclusion Criteria:\n\n* Age ≥ 18 years,\n* Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET),\n* Patient previously treated with 4 cycles of Lutathera® (defined as \"First PRRT\"),\n* Disease control after \"First PRRT\" ≥ 12 months,\n* Patient presenting a progression of disease (clinic, biologic and\u002For radiologic) after a first PRRT,\n* Decision of retreatment with Lutathera® (defined as \"Second PRRT\") validated by RENATEN and\u002For multidisciplinary tumor board and in the scope of the French reimbursement process,\n* ECOG performance status 0-2,\n* Life expectancy ≥ 6 months as prognosticated by the physician,\n* Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\\>= liver of surrounding tissue),\n* Measurable disease per RECIST 1.1 (Appendix 1), on CT\u002FMRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total,\n* Adequate bone marrow reserve (Hb \\> 8 g\u002Fdl, neutrophils ≥ 1500\u002Fmm³ and platelets ≥ 80 000\u002Fmm³),\n* Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy),\n* Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment,\n* Patient´s signed written informed consent,\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,\n* Affiliation to the French Social Security System\n\nExclusion Criteria:\n\n* Patient who did not respond (no CR, PR or SD) to \"first PRRT\".\n* Radiological progression after two cycles of \"Second PRRT\" according to RECIST version 1.1,\n* Grade 4 hematotoxicity and\u002For nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy,\n* Pancreatic NET,\n* NeuroEndocrine Carcinoma,\n* Prior external beam radiation therapy to more than 25% of the bone marrow,\n* Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \\\u003C 40 mL\u002Fmin or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)\u002F aspartate aminotransferase (AST) \\> 2.5 x ULN or ALT\u002FAST \\> 5 x ULN if liver function abnormalities are due to the underlying malignancy and\u002For total serum bilirubin \\> 2.5 x ULN),\n* Serum albumin \\\u003C 3.0 g\u002FdL unless prothrombin time is within the normal range,\n* Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN,\n* Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months,\n* Hypertension that cannot be controlled despite medications (≥ 160\u002F95 mmHg despite optimal medical therapy)\n* Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study),\n* Pregnancy or breast feeding,\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results,\n* Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products,\n* Concomitant participation or participation within the last 30 days in another clinical trial,\n* History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled.\n* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.",{"count":409,"type":21},146,[25],"In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.",[31,413,414],"Intestinal Well Differentiated Endocrine Tumor","Progressive Disease","2026-06-02",{"date":394,"type":54},{"date":418,"type":54},"2021-10-18",{"date":420,"type":21},"2033-10",{"name":422,"class":61},"Institut du Cancer de Montpellier - Val d'Aurelle",28,{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100388530","phase-2-captemy90-for-grade-23-net-liver-metastases-100388530","NCT04339036","CapTemY90 for Grade 2\u002F3 NET Liver Metastases","UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2\u002F3 Neuroendocrine Tumors","CapTemY90","Inclusion Criteria:\n\n* Patients with confirmed diagnosis of histologic grade 2 or 3 well differentiated neuroendocrine tumor with unresectable liver metastases (primary tumor or other extrahepatic disease may be present)\n* Patients with at least one measurable liver metastases, with size \\> 1cm (RECIST criteria)\n* Patients with liver dominant disease defined as ≥50% tumor body burden confined to the liver\n* Liver tumor burden does not exceed 50% of the liver volume\n* Patent main portal vein\n* At least 4 weeks since last administration of last chemotherapy and \u002For radiotherapy\n* Age \\>18 years.\n* Life expectancy of greater than 6 months.\n* ECOG performance status 0-2.\n* Adequate liver function as measured by: Total bilirubin ≤ 2.0mg\u002Fdl, ALT, AST ≤5 times ULN, albumin ≥2.5g\u002Fdl.\n* Patients must have adequate organ and marrow function as defined below:\n* platelets \\>100,000\u002FmcL (may be corrected by transfusion)\n* serum creatinine \\\u003C 2.0 mg\u002Fdl\n* INR \\\u003C1.6, (may be corrected by transfusion)\n* Ability to understand and the willingness to sign a written informed consent document.\n* Women of child bearing potential and fertile men are required to use effective contraception (negative urine or serum βHCG for women of child-bearing age)\n\nExclusion Criteria:\n\n* Contraindications to capecitibine or temozolomide\n* Contraindicated for both contrast-enhanced MRI and CT\n* Patients previously treated with transarterial embolization (with or without chemotherapy) or with radioembolization (Y-90 microspheres)\n* Contraindication for radioembolization procedures:\n* excessive hepatopulmonary shunt as determined by the investigator\n* inability to deliver Y90 microspheres without risk of non-target embolization of extra-hepatic structures\n* Subjects consenting to the trial who fail their simulation angiography will be removed from the study and replaced.\n* Patients may not be receiving any other investigational agents.\n* Absolute contraindication to intravenous iodinated contrast (Hx of significant previous contrast reaction, not mitigated by appropriate pre-medication).\n* Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla;\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and lactating women are ineligible",{"count":326,"type":21},[25],"This is a Phase 2 evaluation of hepatic-progression free survival among patients with Grade 2 liver-dominant NET metastases undergoing combination therapy with CapTem and Y90 radioembolization.The hypothesis is to confirm safety and to assess if disease control is improved relative to expectation from either therapy alone.\n\nA Grade 3 arm was added in 2025.",[436,31],"Neuroendocrine Tumor Grade 2",{"date":394,"type":54},{"date":439,"type":54},"2021-10-07",{"date":441,"type":21},"2028-07-01",{"name":443,"class":61},"Abramson Cancer Center at Penn Medicine",4,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":444},"100370529","clinico-biological-database-in-patients-treated-with-metabolic-radiotherapy-in-the-nuclear-medicine-department-100370529","NCT04104529","Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department","Establishment of a Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department","BCB RIV","Inclusion Criteria:\n\n* Age ≥ at 18 years old,\n* Patient treated in the Nuclear Medicine Department for the treatment by metabolic radiotherapy,\n* Patient treated as part of his treatment for:\n\n  * thyroid cancer,\n  * a neuroendocrine tumor or\n  * prostate cancer.\n* Patient having accepted the complementary blood sample,\n* Patient having given his informed, written and express consent.\n\nExclusion Criteria:\n\n* Patient not affiliated to a social security scheme,\n* Subject under tutelage, curatorship or safeguard of justice,\n* Patient in an emergency situation\n* Patient whose regular monitoring is a priori impossible for psychological, family, social or geographical reasons,\n* Pregnant and \u002F or breastfeeding woman",{"count":454,"type":21},350,[456],"NA","Development of a clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.",[203,36,31],[460,46,461,462],"thyroid cancer","neuroendocrine tumors","nuclear medecine",{"date":394,"type":54},{"date":465,"type":54},"2019-10-28",{"date":467,"type":21},"2026-10",{"name":422,"class":61},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":477,"enrollmentInfo":478,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":62},"100549131","study-of-the-value-of-hpg80-circulating-progastrin-for-the-diagnosis-of-neuroendocrine-tumours-in-patients-with-an-men1-mutation-100549131","NCT06430021","Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an MEN1 Mutation","Study of the Value of hPG80 (Circulating Progastrin) for the Diagnosis of Neuroendocrine Tumours in Patients With an NEM1 Mutation: the Progastrin-NEM1 Study","PRO-NEM1","Inclusion Criteria:\n\n* Patients with proven MEN1, symptomatic or not, confirmed on the basis of the following international criteria (Thakker et al.):\n* patients with an MEN1 mutation;\n* patients belonging to an identified MEN1 family in which at least one first-degree relative has been affected and has at least one MEN1-related lesion;\n* patients without a positive genetic test or a family history of the disease, but with at least two of the three main MEN1 lesions (parathyroid adenomas, duodenopancreatic NETs and pituitary tumours).\n* Majors patients,\n* Patients who have undergone thoracoabdominal imaging (MRI, and\u002For CT and\u002For somatostatin receptor imaging (PET or octreotide scan)) within 3 months prior to inclusion or are due to undergo imaging within 3 months of inclusion to document the presence of NETs,\n* Regardless of the treatment they are receiving (treatment naïve or treated patient),\n* Regardless of the type of disease associated with MEN1 (presence or absence of NET, adenoma....),\n* Patients who did not object to taking part in the study.\n\nExclusion Criteria:\n\n* Person not affiliated to national health insurance\n* Person subject to a measure legal protection (curatorship, guardianship, family empowerment) or a court order\n* Pregnant, parturient or breastfeeding mothers","60 Years",{"count":479,"type":21},297,"Multiple Endocrine Neoplasia type 1 (MEN1) is an autosomal dominant disease with a high degree of penetrance (\\>80% of patients). It is caused by the presence of the MEN1 mutation located on chromosome 11q13. The prevalence of this mutation is estimated at approximately 1\u002F30,000. This hereditary syndrome is characterized by the presence of tumours of the endocrine system (adenoma of the parathyroid, pituitary and adrenal glands, neuroendocrine tumors - NETs - of the endocrine pancreas, duodenum, lung or thymus), which threaten the health of these patients. Other malignant tumors such as breast cancer are also more common in patients with MEN1.\n\nThe clinical manifestations of MEN1 are linked to the location of the adenomas and NETs and their secretory products. Indeed, most NETs produce and secrete numerous peptide hormones (in the case of Insulinomas, Gastrinomas, VIPomas, Glucagonomas or PPomas for example). This causes a specific clinical syndrome, which can be detected in the blood serum. However, most NETs are \"non-functional\" tumors, which do not have specific secretions.\n\nAmong general tumor markers, chromogranin A (CgA) is widely used as a biomarker for monitoring NETs. CgA is a secretory protein released into the blood by neuroendocrine cells. However, the performance of CgA as a diagnostic biomarker is too limited to be used for the early identification of NETs, particularly in patients with MEN1.\n\nThis is why patients with MEN1 undergo regular biological and morphological examinations, at least once a year, to screen for the development of adenomas and NETs. However, CgA or hormone secretions assays, and imaging examinations (MRI, CT scan, or duodenopancratic endoscopic ultrasound (EUS)) are tedious and stressful for patients; in addition, they all have their limitations (poor performance for biological tests; irradiation for CT scan; need for anesthesia for endoscopic ultrasound, etc.). Consequently, there is a need for new markers to identify NETs in this population as early as possible.\n\nProgastrin is a pro-hormone that, under physiological conditions, is matured into gastrin in the G cells of the antrum of the stomach. The role of gastrin is to stimulate gastric acid secretion during digestion. It also plays an important role in regulating cell growth in the gastric mucosa. In pathological situations, it has been shown that the GAST gene, which codes for progastrin, is over-expressed in human tumor cells of different origins, leading to the accumulation of progastrin within them. Tumor cells that are unable to mature progastrin into gastrin, either because the maturation enzymes are not expressed or are inhibited, will secrete it. This circulating progastrin is then called hPG80 (to differentiate it from intracellular progastrin) and is detectable in patient blood. hPG80 is a new biomarker for the detection of different types of cancer. It appears to be elevated in the early stages of the disease, potentially more so than other biomarkers such as circulating tumor DNA (ctDNA) or NETest. In addition, hPG80 is easily measured in plasma using the DxPG80.Lab ELISA (Progastrin Manufacturing). The analytical characteristics of this CE-marked in vitro diagnostic test have been published in the Analytical Methods journal. It has been validated in numerous studies of various cancers, including NET patients. In addition, a study conducted by the team at Progastrin Manufacturing (formerly ECS-Progastrin) showed that hPG80 was unequivocally present in the peripheral blood of patients with 11 different types of cancer, with a concentration significantly higher than that found in blood donors considered to be healthy. We therefore hypothesize that hPG80 could also be a biomarker for NETs in MEN1.",[31,482],"MEN1 Mutation","2026-05-20",{"date":485,"type":54},"2026-05-22",{"date":487,"type":54},"2024-06-13",{"date":489,"type":21},"2026-12",{"name":491,"class":61},"Centre Hospitalier Universitaire Dijon",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":62},"100459471","phase-2-trial-of-an-alternative-cabozantinib-dosing-schedule-in-metastatic-renal-cell-carcinoma-and-neuroendocrine-tumors-100459471","NCT05263050","Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","GU-187: Phase II Trial of Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors","Inclusion Criteria\n\n* Cohorts A and B: Histologically or cytologically confirmed advanced RCC with any clear cell or non-clear cell component. 100% sarcomatoid is permissible.\n* Cohorts A and B: Patient may have had any number of prior therapies for Cohort A, but for Cohort B patients must not have received any systemic therapy in the metastatic setting\n* Patients who have received prior (neo)adjuvant immunotherapy with pembrolizumab or similar are eligible for Cohort B IF they completed the adjuvant therapy \\> 12 months from start of trial therapy\n* Treatment naïve patients may be treated in Cohort A if deemed not candidates for nivolumab or if felt single agent cabozantinib most appropriate by the treating clinician\n* Cohort C: Well differentiated NET, grades 1-3 (any primary site) who have progressed on or are not eligible for somatostatin analogs per treating physician discretion\n* Cohort C: Disease progression within prior 12 months\n* Cohort C: Prior or concurrent treatment with somatostatin analogue allowed but no limit on lines of therapy (stable dose of somatostatin for 2 months)\n\nAll Cohorts:\n\n* At least one measurable lesion as defined by RECIST version 1.1\n* No evidence of pre-existing uncontrolled hypertension as assessed by investigator. Patients may undergo adjustments or additions to their antihypertensive regimen before or during screening to achieve optimal BP control.\n* Age \\> 18 years.\n* ECOG performance status 0 - 2\n* Patients must have normal organ and marrow function as defined below\n\n  * Leukocytes, \\> 2,000\u002FmcL\n  * Absolute neutrophil count, \\> 1,500\u002FmcL\n  * Platelets, \\> 100,000\u002FmcL\n  * Hgb, \\> 9 g\u002FdL (\\>90 g\u002FL)\n  * Total bilirubin, ≤ 1.5 x ULN (with the exception of of individuals with Gilberts syndrome who may have a bilirubin \\<3.0 mg\u002FdL)\n  * AST\u002FALT (SGOT\u002FSGPT)\u002FALP, \\< 3 x ULN ALP ≤ 5x ULN with documented bone metastases.\n  * Albumin, \\> 2.8 g\u002FdL\n  * Creatinine clearance, \\> 30 Ml\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal\n  * PT\u002FINR or PTT, \\< 1.3 x the laboratory ULN\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment\n\nExclusion Criteria\n\n* Patients who have had systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives, whichever is shorter, prior to entering the study.\n* Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Ongoing clinically relevant complications from prior radiation therapy would preclude eligibility.\n* Patients with prior therapy with cabozantinib.\n* Prior systemic therapy directed at advanced RCC is not allowed for patients enrolled to Cohort B (treatment-naïve group).\n* Cohort B only: Active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Cohort B only: Patients have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients may not be receiving any other investigational agents\n* History of allergic reactions or hypersensitivity attributed to compound of similar chemical or biologic composition to the agent(s) used in this study\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4 inhibitors and inducers. Refer to Section 5.3.2 for detailed information. The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n* Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n* Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Cardiovascular disorders:\n* Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.\n* QTcF \\> 500 msec within 28 days before first dose of study treatment.\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 160 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose of study treatment.\n* Subjects with a diagnosis of incidental, sub-segmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with a stable dose of permitted anticoagulation (see exclusion criterion #6) for at least 1 week before first dose of study treatment.\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (e.g., Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n* Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose of study treatment.\n\nNote: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n\n* Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n* Lesions invading or encasing any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.",{"count":500,"type":21},111,[25],"This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.",[504,505,31,363],"Metastatic Renal Cell Carcinoma","Clear-cell Metastatic Renal Cell Carcinoma",{"date":485,"type":54},{"date":508,"type":54},"2022-01-21",{"date":510,"type":21},"2027-02",{"name":512,"class":61},"Fox Chase Cancer Center",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":528,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":62},"100536304","equity-gi-a-prospective-study-to-enhance-quality-inclusivity-and-trial-participation-in-black-patients-with-gastrointestinal-cancer-100536304","NCT06263088","EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.","Inclusion Criteria:\n\n1. Adult ≥ 18 years old.\n2. Newly diagnosed Black GI cancer participants irrespective of stage. Eligible tumor types include anal carcinoma, rectal cancer, colon cancer, small bowel cancer, appendix carcinoma, hepatobiliary cancer, pancreatic cancer, gastroesophageal cancer, gastrointestinal neuroendocrine tumors, and gastrointestinal stromal tumor.\n3. Patient able and willing to comply with study procedures\n4. The patient is able to understand and willing to sign and date the written informed consent form at the screening visit.\n\nExclusion Criteria:\n\n* NONE",{"count":520,"type":21},200,[456],"This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin).\n\nThis study has 3 components as follows-\n\n1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment.\n2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant.\n3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational\u002Finformational material appropriate for participant's diagnosis.",[524,207,208,210,205,525,526,527,214,31],"Gastrointestinal Cancer","Stomach Cancer","Appendix Cancer","Pancreas Cancer",[529,530],"Gastrointestinal cancer","African Americans","2026-05-19",{"date":485,"type":54},{"date":534,"type":54},"2024-12-01",{"date":536,"type":21},"2026-09-30",{"name":538,"class":61},"Case Comprehensive Cancer Center",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":554,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100572614","study-assessing-pet-imaging-with-zirconium-labelled-girentuximab-in-patients-with-hcc-btc-or-nen-100572614","NCT06735560","Study Assessing PET Imaging With Zirconium-labelled Girentuximab in Patients With HCC, BTC or NEN","Prospective Pilot Study Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Patients With HepatoCellular Carcinoma, Biliary Tract Carcers or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms.","ELEGANCE","Inclusion Criteria:\n\n1. Provided written informed consent.\n2. Patients aged ≥ 18 years.\n3. \\- For basket 1 and 2: HCC or ICC histologically proven: newly diagnosed patients or patients with suspected refractory, residual, or recurrent disease.\n\n   \\- For basket 3: Progressive GEP-NENs with low or heterogeneous expression of SSTR2 or progressive pancreatic NENs which previously received at least two systemic treatments (excluding SSA) or pancreatic NENs with germline or somatic VHL mutation or G3 GEP-NENs .\n4. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT\u002FMRI.\n5. Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2.\n6. For cirrhotic patients: Child-Pugh ≤ B7.\n7. Patient affiliated to or beneficiary of the National Health Service.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to zirconium-89, to any excipient or derivative or to radiographic contrast agents.\n2. Chemotherapy, extensive external beam radiation, immunotherapy, targeted therapy, or angiogenesis inhibitors within 2 weeks prior to 89Zr-TLX250 administration.\n3. Radionucleide targeted therapy prior to inclusion within 3 months prior to inclusion.\n4. Radioembolization within 3 months prior to inclusion.\n5. Uncontrolled brain or spinal cord metastasis.\n6. Cardiac disease with New York Heart Association classification of III or IV.\n7. Life expectancy shorter than 4 months.\n8. Any major surgery within 4 weeks before enrollment.\n9. Any uncontrolled significant medical, psychiatric or surgical condition (active infection (subjects with known human immunodeficiency virus (HIV) positive)), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus (glycated haemoglobin (HbA1c) ≥9%), uncontrolled congestive heart disease, etc.) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.\n10. Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years.\n11. Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study for all female subjects of childbearing potential.\n12. Patient under guardianship or trusteeship.\n13. Patient under judicial protection.",{"count":548,"type":21},60,[456],"Precision medicine represents a major goal in oncology. It has its underpinning in the identification of biomarkers with diagnostic, prognostic, or predictive values. Gastro-entero-pancreatic neuroendocrine neoplasia (GEP-NENs) are rare tumors, but their frequency is increasing. In this context, the tumor expression of carbonic anhydrase IX (CAIX), complemented by a restricted profile in normal tissues, provides an opportunity for therapeutic targeting and precision medicine. Indeed, radiolabeling the anti-CAIX monoclonal antibody girentuximab with Zirconium 89 has shown promise as a novel positron emission tomography (PET) tracer and labeling with 177 Lutetium promise as a therapeutic agent in clear cell renal cell carcinoma (ccRCC) in the context of a theranostic approach. The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET\u002FCT tracer for the imaging of Gastro-Entero-Pancreatic Neuroendocrine Neoplasms, Hepatocellular Carcinoma or IntraHepatic Cholangiocarcinoma.",[552,553,31],"Hepatocellular Carcinoma (HCC)","Intrahepatic Cholangiocarcinoma (Icc)",[555,556,557,558,559],"immunoPET","CAIX","GEP-NEN","ICC","HCC","2026-05-11",{"date":562,"type":54},"2026-05-13",{"date":564,"type":54},"2025-11-04",{"date":566,"type":21},"2027-08-04",{"name":568,"class":61},"Nantes University Hospital",2,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100509812","phase-3-efficacy-and-safety-of-radiotherapy-compared-to-everolimus-in-somatostatin-receptor-positive-neuroendocrine-tumors-of-the-lung-and-thymus-100509812","NCT05918302","Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","LEVEL","Inclusion Criteria:\n\n1. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent.\n2. Patients ≥ 18 years of age.\n3. Patients who have histologically confirmed metastatic or locally advanced unresectable well\u002Fmoderately differentiated; World Health Organization (WHO\\]) 2015 criteria; neuroendocrine tumor of lung (typical and atypical carcinoids) or thymus origin either functioning or non-functioning.\n4. Patients must have the appropriate pathological features based on WHO classification, and description of proliferation activity as indicated by mitotic count per 10 high-power fields (HPF) and presence of necrosis, or Ki67 index.\n5. In SSTR imaging all RECIST v1.1 selected target lesions and all other lesions considered dominant by the investigator should be positive. If an fluorodeoxyglucose (FDG)-positron emission tomography (FDG-PET) is performed (not mandatory), all FDG-PET positive RECIST v1.1 target lesions and all other FDG-PET positive lesions considered dominant by the investigator should also be positive in SSRT imaging.\n6. Lesions must have shown radiological evidence of disease progression in the 12 months prior to inclusion in the study. Patients who were receiving systemic anticancer therapy, progression should be documented on therapy or after stopping therapy due to adverse events or other reasons. Patients without prior therapy, documentation of progression is also mandatory to watch and wait strategy or during the follow up after surgery.\n7. Patients may be included in first-line therapy (systemic treatment naïve) or may have experienced progression on somatostatin analogues or additional systemic treatments, which may include but not limited to chemotherapy, targeted agents or immunotherapy (maximum of 2 prior systemic anti-tumor treatments).\n\n   Note: Somatostatin analogues for patients with functioning tumors are allowed.\n8. Patients have radiographically documented and measurable metastatic or locally advanced disease at baseline according to RECIST v1.1.\n9. An archival tumor tissue sample should be available for submission to the central laboratory prior to study treatment (36 months). If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided if feasible.\n10. Patients who have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n11. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria:\n\n    1. Neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3\n    2. Platelet count ≥ 75 × 10\\^9\u002FL\n    3. Hemoglobin ≥ 8 g\u002FdL\n    4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease or liver metastases\n    5. Creatinine clearance (CrCl) ≥ 40 mL\u002Fmin as estimated by the Cockcroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed.\n    6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases\n12. Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%) for the duration of the study treatment and for 6 months after the final dose of study treatment.\n13. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n14. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n15. Male patients with a pregnant or breastfeeding partner(s) must agree to abstinence or use a condom for the duration of the pregnancy or time the partner is breastfeeding throughout the study period and for at least 6 months after the final study drug administration.\n16. Subject agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patients who are not able to swallow tablets.\n2. Patients with poorly-differentiated or high-grade neuroendocrine carcinoma (i.e. large cell neuroendocrine carcinoma of lung, small cell lung cancer) or mixed tumors (i.e. adenocarcinoid tumor) are not eligible.\n3. Patients with brain mets unless stable on treatment for \\> 12 weeks and with no evidence of raised intracranial pressure or mass effect.\n4. Patients who have ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n5. Patients who have a recent diagnosis of another malignancy (within 12 months prior to inclusion), patients who are on active treatment for other cancer before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.\n6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., hepatitis C virus (HCV) RNA \\[qualitative\\] is detected). Patients who have a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).\n7. Patients who have received a live vaccine up to 4 weeks prior to the first dose of trial treatment.\n\n   Note:Live attenuated vaccines should not be administered during the trial treatment and over the next 3 months after the last treatment dose.\n8. Patients who have documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.\n9. Prior peptide receptor radionuclide therapy (PRRT) or mammalian target of rapamycin (mTOR) inhibitors (e.g. deforolimus, everolimus, sirolimus, temsirolimus, etc.); or hepatic radio-embolization (within 6 months prior to first dose of study treatment).\n10. Prior radiotherapy or major surgery within 12 weeks prior to the first dose of study drug.\n11. Patients who have had chemotherapy, biologics, investigational agents, and\u002For antitumor treatment with immunotherapy that is not completed 4 weeks prior to the first dose of study drug.\n12. Patients who have known hypersensitivity to Everolimus or to any excipient contained in the drug formulation of Everolimus.\n13. Patients who have known hypersensitivity to 177Lu-edotreotide or to any excipient contained in the drug formulation of 177Lu-edotreotide or the nephroprotective amino acid solution (AAS).\n14. Current spontaneous urinary incontinence preventing safe administration of the investigational medicinal product (IMP), in the investigator's opinion.\n15. Patients who have other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the subject to receive or tolerate the planned treatment and follow-up.",{"count":579,"type":21},170,[581],"PHASE3","LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.",[31,584,585],"Lung Neuroendocrine Neoplasm","Thymus Neoplasms","2026-05-08",{"date":588,"type":54},"2026-05-12",{"date":590,"type":54},"2023-10-27",{"date":592,"type":21},"2029-10",{"name":594,"class":61},"Grupo Espanol de Tumores Neuroendocrinos",27,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":22,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":62},"100430699","phase-2-68ga-ha-dotatate-imaging-of-suspected-somatostatin-receptor-positive-tumors-100430699","NCT04888481","68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors","Inclusion Criteria:\n\n* Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma\n* A standard clinical CT or MRI is obtained within 6 months of enrollment\n* Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)\n\nExclusion Criteria:\n\n* Weight \\> 225 kg (weight limit of the PET\u002FCT scanner)\n* Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging\n* Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation\n* Previous allergic reaction to DOTATATE or somatostatin analogues\n* Lack of intravenous access",{"count":603,"type":21},600,[25],"Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.\n\nThis study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).",[31],"2026-05-06",{"date":560,"type":54},{"date":610,"type":54},"2022-02-15",{"date":612,"type":21},"2028-08-31",{"name":614,"class":61},"University of Alberta",{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":630,"completionDateStruct":632,"leadSponsor":634,"locationsCount":62},"100584450","phase-1-svv-001-with-nivolumab-and-ipilimumab-in-patients-with-poorly-differentiated-neuroendocrine-carcinomas-nec-or-well-differentiated-high-grade-neuroendocrine-tumors-net-100584450","NCT06889493","SVV-001 With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas (NEC) or Well-Differentiated High-Grade Neuroendocrine Tumors (NET)","A Phase 1 Trial of the Oncolytic Virus SVV-001 in Combination With Nivolumab and Ipilimumab in Patients With Poorly Differentiated Neuroendocrine Carcinomas or Well-Differentiated High-Grade (Grade 3) Neuroendocrine Tumors","Inclusion Criteria:\n\n1. Male or female patients, 18 years of age or older at the time of consent.\n2. Life expectancy of 6 months or greater as assessed by the treating oncologist.\n3. Have advanced metastatic disease that has progressed on at least one line of available therapy.\n4. Histologically or cytologically confirmed diagnosis of Grade 3 well-differentiated neuroendocrine tumor (NET) or poorly differentiated neuroendocrine carcinoma (NEC; large-cell neuroendocrine carcinoma, small-cell carcinoma, mixed neuroendocrine non neuroendocrine carcinoma). Note: if an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening for diagnostic confirmation, at the Principal Investigator's (PI's) discretion, a screening biopsy will be ordered.\n5. For patients in Part 1A, in addition to histological or cytological confirmation of NEC or NET (see Inclusion #4), radiological confirmation of tumor is required.\n6. Parts 1B and 2 only: Measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or immune-related Response Evaluation Criteria in Solid Tumors (iRECIST). At least one lesion must be suitable for multiple injections (up to 6 injections every 2 weeks) with SVV-001. Lesions for injection must be ≥10 mm in longest diameter and deemed safe and suitable for injection by the Investigator.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Recovered to Grade 1 or baseline from any clinically significant toxicity associated with prior treatments (excluding alopecia) prior to initiation of investigational medicinal product (IMP) administration.\n9. Adequate hematological, renal, and liver function defined as follows:\n\n   * a. Hepatic:\n\n     * i. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN) (≤5 × ULN if liver metastases are present)\n     * ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis)\n   * b. Renal:\n\n     * i. Creatinine clearance ≥50 mL\u002Fminute using Cockcroft Gault equation\n   * c. Hematologic:\n\n     * i. Absolute neutrophil count ≥1500 cells\u002FµL\n     * ii. Platelet count ≥100,000 platelets\u002FµL\n     * iii. Hemoglobin ≥9.0 g\u002FdL\n     * iv. International normalization ratio (INR) within the institutional normal range\n     * v. Normal prothrombin time (PT) and partial thromboplastin time (PTT)\n10. For Part 2 Expansion Cohort patients only, patients will submit archival tissue at Screening and undergo a post-treatment biopsy according to the treating institution's guidelines with the following exceptions:\n\n    * a. If an archival tissue sample collected ≤ 2 years from enrollment is unavailable at Screening, at the PI's discretion, a screening biopsy will be ordered.\n    * b. Participants will not undergo a biopsy procedure for collection of the post-treatment biopsy if, in the discretion of their treating physician, the participant's condition has deteriorated to the point where performance of a biopsy procedure would place the participant at an increased risk for complications beyond what is reasonably expected for a biopsy collected as part of the participant's standard medical care.\n11. Women of childbearing potential must agree to use a reliable form of contraceptive during the trial treatment period and for at least 7 months following the last dose of IMP.\n12. Male patients must agree to use an adequate method of contraception during the trial treatment period and for at least 7 months following the last dose of IMP.\n13. Patient is willing and able to comply with all protocol-required assessments, visits, and procedures.\n14. Provide written informed consent prior to performing any trial-related procedure.\n\nExclusion Criteria:\n\n1. Any active second malignancy within the 2 years prior to the screening visit, unless the patient has undergone curative surgery for the tumors such as in situ cervical cancer or squamous cell cancer of the skin.\n2. Has had cytotoxic chemotherapy or radiation therapy within 3 weeks; and less than 5 half-lives or 6 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of SVV-001.\n3. Has undergone a major surgical procedure (as defined by the Investigator) or significant traumatic injury within 28 days prior to the first dose of SVV-001.\n4. Has any physical abnormality of the tissue\u002Forgan to be biopsied that would put the patient at increased risk of bleeding secondary to the injection and\u002For biopsy.\n5. Has received a live-virus immunization within 30 days prior to the screening visit or anticipates receiving a live virus immunization during the trial or within 30 days of the last treatment with IMP.\n6. Presence of an active autoimmune or inflammatory disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or other immunosuppressive medications. Local steroid injections, intermittent use of topical, inhaled, ophthalmologic, intra-articular, or intranasal corticosteroids, or systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or equivalent would not result in exclusion from the trial.\n7. Presence of primary immunodeficiency or receiving systemic steroids of \\>10 mg\u002Fday prednisone or equivalent or other immunosuppressive agents within 14 days prior to the first dose of SVV-001.\n8. Any active infection, including known infection with human immunodeficiency virus (HIV), active hepatitis, or seropositive for hepatis B immunoglobulin (Ig) M core antibody or hepatitis C ribonucleic acid (RNA) at the screening visit.\n9. Patients with a history of solid-organ or bone marrow transplant.\n10. Known hypersensitivity to ipilimumab or nivolumab or their excipients\n11. Has known untreated central nervous system metastases. Patients with treated brain metastases are eligible as long as they are stable and there is no evidence of progression for at least 4 weeks after central nervous system-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT)) during the screening period.\n12. Any clinically significant (i.e., active) cardiovascular disease, including cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n13. Patients with an ejection fraction (EF) \\\u003C 50 on a 2D echocardiogram (ECHO).\n14. Patients whose baseline pulse oximetry (saturation of peripheral oxygen (SpO2)) is \\\u003C 92% on Room air.\n15. Any chronic illness, psychiatric condition, or social situation that is life threatening or, in the opinion of the Investigator, renders the patient unsuitable for participation in a clinical trial due to possible noncompliance or would place the patient at an unacceptable risk and\u002For have the potential to affect interpretation of the results of the trial.\n16. Female participants who are breastfeeding and\u002For who have a positive pregnancy test result prior to receiving any treatment with IMP.\n17. Patients with impaired decision-making capacity.",{"count":623,"type":21},36,[24],"The purpose of this study is to determine:\n\n1. The highest dose of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n2. The highest frequency of dosing of the trial intervention that targets neuroendocrine tumors and is tolerated by patients.\n3. The highest dose and frequency of dosing of the trial intervention that targets neuroendocrine tumors with at least the same degree of effectiveness and tolerability as currently available (standard of care) treatments for patients with neuroendocrine tumors.",[148,31],"2026-04-27",{"date":629,"type":54},"2026-04-28",{"date":631,"type":54},"2025-05-19",{"date":633,"type":21},"2030-06-01",{"name":635,"class":61},"Peter Hosein, MD",{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":62},"100301589","phase-2-lu-177-dotatate-lutathera-in-therapy-of-inoperable-pheochromocytoma-paraganglioma-100301589","NCT03206060","Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma\u002F Paraganglioma","* INCLUSION CRITERIA:\n* Surgically inoperable participants with clinical diagnosis of PHEO\u002FPGL who also have demonstrated disease histologically consistent with pheochromocytoma or paraganglioma (preferably confirmed by research site pathology review if initial pathology was done outside of research site, but not mandatory)\n* Progressive disease by RECIST 1.1 with or without symptoms within the last 12 months. NOTE: Untreated participants with existing histologic diagnoses are eligible if progression can be demonstrated\n* PHEO\u002FPGL that is not associated with any known susceptibility genetic mutations for PHEO\u002FPGL except SDHx mutation (a.k.a. \"apparent sporadic\"), based on documented genetic testing results obtained prior to study enrollment. PHEO\u002FPGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.\n* Both metastatic and inoperable primary-only participants are eligible.\n* Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks of anticipated treatment.\n\nNOTE:\n\n* Positivity of Ga-68-DOTATATE PET scan defined as having at least one lesion that is greater than or equal to 10 mm in diameter with uptake that is higher than or equal to liver and is qualitatively higher and distinguishable from background activity.\n* Measurable disease as defined by RECIST 1.1.\n\n  * Age greater than or equal to 18\n  * Karnofsky Performance Score greater than or equal to 60 or ECOG Performance Status of 2 or better.\n  * Able to understand and willing to sign informed consent.\n  * Ability and willingness to obtain all required scans per study schedule.\n  * Negative serum pregnancy test for women of child-bearing potential. NOTE: A female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the participant surgically sterile, or \\>2 years since last menstruation.\n  * Female participants of childbearing potential and male participants who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation, and for 4 months for male participants or 7 months for female participants (10 half-lives of Lu-177) after the last dose of Lu-177-DOTATATE.\n  * Must have outside endocrinologist\u002Fmedical oncologist who can follow the participant after receiving PRRT (NIH only requirement).\n  * Patients with secreting tumors must be receiving adequate pharmacologic catecholamine blockade as determined by the treating physician.\n  * Ineligible, unable to or unwilling to receive standard first line therapy for PHEO\u002FPGL.\n\nEXCLUSION CRITERIA:\n\n* Creatinine clearance \\\u003C50 mL\u002Fmin calculated by the MDRD method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods.\n* Serum albumin less than or equal to 3.0 g\u002FdL unless prothrombin time is within the normal range.\n* Liver dysfunction as evidenced by Child s Class C Liver Disease or worse Alternatively, AST or ALT \\> 2.5 times institutional upper limit of normal (ULN) unless liver metastases are present, in which case up to 5 times ULN would be allowed.\n* Hb \\\u003C 8.0 g\u002FdL; WBC \\\u003C 2.0 x 10\\^9\u002FL (or Absolute Neutrophil Count \\\u003C 1000); Platelets \\\u003C 100 x 10\\^9\u002FL\n* In participants with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV\n* Pregnancy or lactation.\n* Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.\n* Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion.\n* Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT or MRI scan with contrast to document stable disease for at least 24 weeks prior to enrolment in the study.\n* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.\n* Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days.\n* Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy). However, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrolment. Patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy. Those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor.\n* Patient weight \\> 400 lbs (table limit for PET scanner) or per local institutional standard for participating sites.\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\\>180\u002F110), arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.",{"count":643,"type":21},130,[25],"Background:\n\nPheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help.\n\nObjective:\n\nTo learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return.\n\nEligibility:\n\nAdults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET\u002FCT imaging\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nEligible participants will be admitted to the NIH Clinical Center.\n\nParticipants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart.\n\nBetween 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table.\n\nParticipants will have vital signs taken. They will give blood and urine samples.\n\nDuring the study, participants will have other scans taken. Some scans will use a radioactive tracer.\n\nParticipants will complete quality of life questionnaires.\n\nParticipants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.",[303,304,31,172],[648,649,650,174,651],"Hypertension","Catecholamine","Familial Syndromes","Ionizing Radiation","2026-04-23",{"date":654,"type":54},"2026-04-24",{"date":656,"type":54},"2017-10-10",{"date":658,"type":21},"2033-01-01",{"name":93,"class":94},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":12,"sex":16,"minAge":667,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":675,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":62},"100368194","phase-2-natural-history-and-management-of-von-hippel-lindau-vhl-associated-pancreatic-neuroendocrine-tumors-100368194","NCT04074135","Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors","Evaluation of the Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors","* INCLUSION CRITIERIA:\n\n  1. Participants who have been diagnosed with VHL using the following criteria:\n\n     \\-- Identification of a heterozygous germline pathogenic variant in VHL by molecular genetic testing.\n\n     or\n\n     \\-- Clinical criteria\n  2. Participants with at least 1 pancreatic manifestation of VHL as documented on any non-invasive imaging study. These manifestations may include:\n\n     * Pancreatic cyst(s)\n     * Solid lesions suspicious for microcystic adenoma(s)\n     * Solid enhancing lesions suspicious for PNET(s)\n     * Any other solid lesion(s) of the pancreas\n  3. Age greater than or equal to 12 years.\n  4. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1\\. Inability of participant to undergo serial non-invasive imaging.","12 Years",{"count":669,"type":21},740,[25],"Background:\n\nPeople with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as the pancreas. The disease can cause tumors of the pancreas. This can result in life-threatening complications. Researchers want to learn more about these pancreatic tumors and how to better detect them. This may help them design better future treatment and care for people with VHL disease.\n\nObjective:\n\nTo better understand VHL disease that affects the pancreas and to test whether adding a certain type of scan (68-Gallium DOTATATE PET\u002FCT) can further detect tumors.\n\nEligibility:\n\nPeople ages 12 and older with VHL that causes tumors and cysts to grow in the pancreas\n\nDesign:\n\nParticipants will be screened with their medical records and imaging studies.\n\nParticipants will have an initial evaluation:\n\nParticipants will have their body examined by different doctors. This will depend on what types of symptoms they have.\n\nParticipants will have blood and urine tests\n\nParticipants will have images made of their body using one or more machines: They made have a CT or PET\u002FCT scan in which they lie on a table that moves through a big ring. They may have an MRI in which they lie on a table that moves into a big tube. They may have an ultrasound that uses a small stick that produces sound waves to look at the body.\n\nAfter the first visit, participants will be asked to return to the NIH. Some of the tests performed at the first visit will be repeated. Depending on their disease status, visits will be once a year or every 2 years for life.",[673,674,31],"VHL Pancreatic Neuroendocrine Tumors","Von Hippel-Lindau Disease",[676,677,678,679,680],"Pancreatic tumors","68-Gallium DOTATATE","MEN1 syndrome","NETest","PNET","2026-04-17",{"date":683,"type":54},"2026-04-20",{"date":685,"type":54},"2020-06-02",{"date":687,"type":21},"2036-07-01",{"name":93,"class":94},{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":16,"minAge":696,"maxAge":18,"enrollmentInfo":697,"targetDuration":4,"studyType":22,"phases":698,"briefSummary":699,"conditions":700,"keywords":703,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":569},"100222543","phase-1-dose-defining-study-of-tirapazamine-combined-with-embolization-in-liver-cancer-100222543","NCT02174549","Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer","Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer","Inclusion Criteria:\n\n1. Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. Patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic.\n2. No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.\n3. Patients are allowed to have prior US Food and Drug Administration (FDA)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic NET.\n4. Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.\n5. Are candidates for TAE or TACE and without portal vein occlusion per treating interventional radiologists.\n6. ANC no less than 1000 \u002FμL. Hemoglobin ≥ 9 gm\u002FdL. Platelets no less than 50,000 \u002FμL. Creatinine no more than 2.0 mg\u002FdL. AST, ALT no more than 5X upper limit of normal. Bilirubin no more than 2.5 mg\u002Fdl. PT prolongation ≤ 4 sec above upper limit of normal.\n7. Woman of child-bearing potential (WOCBP) should use highly effective contraception during trial participation and for 6 months after the last dose of tirapazamine and men who are partners with WOCBP should use highly effective contraception, including barrier contraception, during trial participation and for 3 months after the last dose of tirapazamine.","20 Years",{"count":7,"type":21},[24,25],"This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.",[701,702,31],"Hepatocellular Carcinoma","Gastrointestinal Cancer Metastatic",[704,705,706],"Hypoxia","Embolization","Tirapazamine","2026-04-15",{"date":683,"type":54},{"date":710,"type":4},"2014-09",{"date":712,"type":21},"2028-09-30",{"name":714,"class":115},"Teclison Ltd.",{"id":716,"slug":717,"hasResults":12,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":721,"eligibilityCriteria":722,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":22,"phases":724,"briefSummary":725,"conditions":726,"keywords":764,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":777,"lastUpdatePostDateStruct":778,"startDateStruct":779,"completionDateStruct":781,"leadSponsor":783,"locationsCount":785},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":423,"type":21},[25],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[727,728,729,730,731,732,733,734,735,736,737,738,739,237,335,740,741,742,743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,34,760,761,762,31,763],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Hepatoblastoma","Fallopian Tube Neoplasms","Leiomyosarcoma","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Osteosarcoma","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Trophoblastic Tumor",[765,728,766,729,730,767,210,733,768,735,215,737,769,770,771,772,237,335,773,221,742,743,744,745,203,747,774,749,243,751,212,753,775,755,756,776,35,758,759,34,224,761,739,762,31,763],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Chromophobe Renal Carcinoma","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Fallopian Tube Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","2026-04-10",{"date":707,"type":54},{"date":780,"type":54},"2024-07-16",{"date":782,"type":21},"2028-05",{"name":784,"class":61},"Instituto do Cancer do Estado de São Paulo",8]