[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-neuroendocrine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-neuroendocrine":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,64,96,124,149],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053992","phase-2-a-ugt1a1-genotype-directed-study-of-belinostat-pharmacokinetics-and-toxicity-100053992",false,"NCT06406465","A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity","-INCLUSION CRITERIA:\n\n1. Participants must have histologically confirmed diagnosis of Extrapulmonary High-Grade Neuroendocrine Neoplasms (HGNENs) for which there is no known standard therapy capable of extending life expectancy.\n2. Age \\>= 18 years.\n3. Participants with neuroendocrine prostate cancer may continue ongoing LHRH agonist therapy.\n4. Participants with bone metastases or hypercalcemia who began intravenous bisphosphonate treatment prior to study entry may continue this treatment while on study.\n5. Evaluable (measurable or non-measurable) disease, per RECIST 1.1.\n6. ECOG performance status \\\u003C=2 at screening\n7. Participants must have adequate organ and marrow function as defined below:\n\n   * Leukocytes \\>=3,000\u002FmcL\n   * Hemoglobin \\>= 10 g\u002FdL\n   * Absolute neutrophil count (ANC) \\>=1,500\u002FmcL\n   * Platelets \\>=100,000\u002FmcL\n   * Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transaminase (SGOT) \u002F Alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT): \\\u003C=3 X institutional upper limit of normal\n   * Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal (ULN).\n\n   NOTE: In participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0 X ULN is allowed\n   * Serum Creatinine \\\u003C= 1.5 X institutional ULN OR\n   * An estimated Creatinine clearance (CrCL) \\>=60 mL\u002Fmin\u002F1.73 m\\^2 based on the Cockcroft Gault equation\n   * Prothrombin time (PT) \u002F International normalized ratio (INR) and Partial thromboplastin time (PTT) \\\u003C= 1 X institutional ULN\n8. Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable. Hepatitis C virus (HCV)-infected participants can be enrolled if HCV RNA level is undetectable\n9. Women of child-bearing potential (WOCBP) must agree to use effective contraception (hormonal, intrauterine device (IUD), tube ligation, a partner has had a previous vasectomy, abstinence) prior to study entry, during the study, and for 14 months for women after the last dose of the study drug(s). Men with partners of childbearing potential must agree to use effective contraception (abstinence, condoms, previous vasectomy) or request partners to use effective contraception (per above) during the study and for 11 months after the last dose of study therapy.\n10. Breastfeeding participants must be willing to discontinue breastfeeding starting with prior to study entry, during the study, and for 3 months after the last dose of the study drug(s).\n11. Willing to comply with study procedures and follow-up.\n12. Participants must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 14 days prior to the first drug administration. Additionally, FDA-approved hormonal therapy for the treatment or prevention of other malignancies (e.g., breast cancer, prostate cancer) may be continued where in the opinion of the investigator stopping such therapies may increase the risk of disease progression. Potential drug-drug interactions with the hormonal agent will be assessed by the investigator prior to enrollment.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to belinostat, cisplatin, etoposide or other agents used in study. Participants with a history of allergic reactions to medications containing polysorbate 80 will be evaluated on a case-by-case basis.\n3. Participants with treated brain metastases are not eligible except if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n4. Participants who have not recovered (CTCAE \\\u003C= grade 1) from non heme adverse events due to prior treatments, except for alopecia, or stable grade 2 tinnitus (not interfering with ADL's) or baseline hearing loss by audiometry or stable grade 2 sensory neuropathy (moderate symptoms; limiting instrumental ADL) without pain or motor component, and not interfering with ADL's.\n5. Participants taking strong UGT1A1 inhibitors or CYP3A4 inhibitors or inducers must discontinue their use a minimum of 5 half-lives prior to starting treatment on this trial\n6. Participants with platinum-refractory disease.\n7. Participants who have had another histone deacetylase inhibitor (e.g., valproic acid, vorinostat) for at least 2 weeks prior to enrollment.\n8. Participants who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case-by-case basis and may be excluded if the bone marrow reserve is not considered adequate (\\>25% of bone marrow).\n9. Pregnancy (confirmed with beta-Human chorionic gonadotropin (HCG) serum or urine pregnancy test performed in WOCBP at screening)\n10. Significant cardiovascular disease (New York Heart Association Class III or IV cardiac disease), myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia, or a need for anti-arrhythmic therapy (use of medication to control heart rate in participants with atrial fibrillation is allowed, if stable medication for at least last month prior to enrollment and medication not listed as causing Torsade de Points), or evidence of acute ischemia on ECG.\n11. Baseline prolongation of QT\u002FQTc interval, i.e., defined as an average QTc interval \\> 450 msec calculated using the Fridericia formula for QT correction; Long QT Syndrome; or the required use of concomitant medication that may cause Torsade de Pointes.\n12. Participants with HIV infection if CD4 count \\\u003C200 cells per cubic millimeter before treatment initiation\n13. Uncontrolled intercurrent illness that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nHigh-grade neuroendocrine carcinomas (HGNEC) are cancers that develop in different parts of the body, including the digestive tract, genitals, neck, and head. One drug (belinostat), combined with 2 other drugs (etoposide and cisplatin), is approved to treat HGNEC. But some people may have a gene variant that affects how quickly their body gets rid of the drug; these people may do better with different dosages of belinostat.\n\nObjective:\n\nTo test higher or lower doses of belinostat based on gene variants in people with HGNEC.\n\nEligibility:\n\nPeople aged 18 years and older with HGNEC.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Some blood will be used for genetic testing. They will have imaging scans and a test of their heart function. Samples of tumor tissue may be collected.\n\nAll 3 study drugs (belinostat, etoposide, cisplatin) are given through a tube attached to a needle inserted into a vein. Treatment will be given in 21-day cycles.\n\nFor cycles 1 through 6: Participants will come to the clinic for the first 4 days. They will be given all 3 drugs. Imaging scans and other tests will be repeated. Each visit will last 4 to 8 hours.\n\nAfter cycle 6: Participants may continue treatment with belinostat alone. They will come to the clinic for the first 3 days of each cycle. They may continue treatment for up to 5 years if the drug is helping them.\n\nParticipants will have a follow-up visit 30 days after their last dose of belinostat. Then they will receive follow-up visits by phone or email every 3 to 6 months.",[26,27,28,29,30],"Carcinoma, Neuroendocrine","Tumor, Neuroendocrine","Tumors, Neuroendocrine","Neuroendocrine; Carcinoma","Small Cell; Receptors",[32,33,34,35,36,37],"High-grade carcinomas","Resemble small cell carcinoma","Large cell NEC","Histone Deacetylase","Genotypes","Neuroendocrine malignancies","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":20},"2026-07-16",{"date":46,"type":20},"2028-07-30",{"name":48,"class":49},"National Cancer Institute (NCI)","NIH",1,{"id":52,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":24,"conditions":55,"keywords":56,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":50},"100547322",{"count":19,"type":20},[23],[26,27,28,29,30],[32,33,34,35,36,37],"2026-07-01",{"date":59,"type":42},"2026-07-02",{"date":61,"type":20},"2026-07-07",{"date":46,"type":20},{"name":48,"class":49},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":50},"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.",{"count":71,"type":20},70,[73],"PHASE1","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....",[76,77,26,78,79],"Neuroendocrine Carcinomas","Neuroendocrine Tumors","Carcinoma, Adrenocortical","Carcinoma, Adrenal Cortical",[81,82,83,84,85,86,87],"Pheochromocytoma","Neuroblastoma","Neuroendocrine Tumor","Neuroendocrine carcinoma","Neuroendocrine neoplasms","Paraganglioma","Adrenocortical Carcinoma","2026-06-12",{"date":90,"type":42},"2026-06-15",{"date":92,"type":42},"2024-06-17",{"date":94,"type":20},"2029-10-30",{"name":48,"class":49},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":123},"100618886","phase-2-trial-of-folfiri--zimberelimab--domvanalimab-vs-folfiri-with-a-hybrid-synthetic-control-arm-in-second-line-treatment-of-neuroendocrine-carcinoma-of-gastro-enteropancreatic-or-unknown-origin-rewenec-01-100618886","NCT07337447","Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01)","PRODIGE 113 (FFCD 2314) - REWENEC 01 STUDY Randomized Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin. Phase II Comparative Randomized Study - Multicentric","REWENEC 01","Inclusion Criteria:\n\n* Man or woman aged ≥ 18 years old,\n* Poorly differentiated neuroendocrine carcinoma (NEC) \\[or mixed tumor with NEC component is \\> 30%, the patient is eligible\\] with ki 67 \\> 20% from a gastrointestinal tract (from esophagus to anal canal) or biliopancreatic primary or an unknown primary cancer, locally advanced and\u002For metastatic,\n* Centralized review of the diagnostic by a consulting pathologist specialized in NET (TENPATH network),\n* Recommendation of a second-line chemotherapy after progression (documented using the RECIST criteria v.1.1) and after a first-line chemotherapy treatment by cisplatin (or carboplatin) + etoposide or in the event of progression in the 6 months following the discontinuation of this first-line treatment,\n* Patient presenting at least one measurable target lesion according to the RECIST criteria v.1.1, in an area not previously irradiated,\n* General condition ≤ 1 (ECOG-PS),\n* Patient of childbearing age accepting to use a highly effective method of contraception during treatment and until 6 months after discontinuation of chemotherapy and 4 months after the last dose of domvanalimab and zimberelimab. Men sexually active must agree to use a highly effective method of contraception during treatment and for at least 6 months after discontinuation of chemotherapy and 4 months after the last dose of domvanalimab and zimberelimab,\n* Patient who signed the informed consent form.\n* Patient affiliated to National French social security system\n\nExclusion Criteria:\n\n* Well differentiated neuroendocrine tumor whatever the grade,\n* First-line chemotherapy other than cisplatin (or carboplatin) and etoposide,\n* Prior immunotherapy,\n* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer,\n* Pregnant or breastfeeding woman,\n* Lack of efficient contraception (for men or women of reproductive age),\n* All medical, geographical, social, and psychological conditions or a legal situation that will not allow the patient to finish the study or sign an informed consent form,\n* Patient with asymptomatic brain metastasis or with previously treated brain metastasis relating to the study drugs\n* Any of the following uncontrolled progressive diseases in the 6 months before randomization: liver failure, renal insufficiency, respiratory distress, congestive heart failure (NYHA III-IV), unstable angina, myocardial infarction, significant arrhythmia,\n* Partial and complete dihydropyrimidine dehydrogenase (DPD) deficiency: uracil level ≥ 16 ng\u002Fml,\n* Known Gilbert's syndrome,\n* Total bilirubin level \\>1.5 x the upper limit of normal (ULN); ASAT and\u002For ALAT \\> 5 x ULN; TP \\\u003C 50 % (Except for patient's treated with Vitamin K antagonists or direct oral anticoagulants with INR \\\u003C3 ),\n* Neutrophils \\\u003C1.5x109\u002Fl, platelets \\\u003C100x109\u002Fl, hemoglobin \\\u003C 9 g\u002Fdl,\n* Chronic uncontrolled diarrhea, unresolved intestinal occlusion or subocclusion,\n* History of anaphylactic reaction or known intolerance to atropine (sulfate) or to loperamide or to antiemetics administered in association with Folfiri,\n* All treatment with concomitant anticonvulsive agents, CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine); patients with these treatments should have stopped them, for at least 7 days before inclusion in the study,\n* Chronic medical condition requiring the ongoing use of supra-physiologic doses of systemic corticosteroids (\\>10 mg\u002Fday of oral prednisone or equivalent) or systemic immunosuppressive medications. Immunosuppressive medications, including chronic systemic corticosteroids at supraphysiologic doses should have been stopped 14 days before the first dose (except for participants who require hormone replacement therapy such as hydrocortisone).\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.\n* History of severe hypersensitivity reaction to any monoclonal antibody (mAb) therapy.\n* Live attenuated vaccines within 28 days prior enrolment.\n* Any concurrent anticancer therapy, including chemotherapy, radiotherapy (except palliative radiotherapy), immunotherapy, biologic, or hormonal treatment. Concurrent use of hormones for noncancer-related conditions is permitted.\n* Known hypersensitivity to any investigational product (IP), or any excipient contained in the formulations of the study interventions.\n* Known immunodeficiency or human immunodeficiency virus (HIV) infection with HIV viral load ≥200 copies\u002FmL or CD4+ T-cell count \\\u003C350 cells\u002FμL, or taking medications that may interfere with metabolism of study drugs.\n* Known acute hepatitis B, known chronic hepatitis B infection with active untreated disease, or known active hepatitis C infection. In participants with a history of HBV or HCV, participants with detectable viral loads will be excluded.",{"count":105,"type":20},122,[23],"Background Neuroendocrine carcinomas (NECs) of gastro-entero-pancreatic (GEP) or unknown (UK) origin are rare and highly aggressive diseases. The recommended first-line (L1) treatment is platinum-etoposide combination therapy, which has a progression-free survival (PFS) of only 4-9 months and a median overall survival (OS) of approximately 12 months. All patients experience relapse, often rapidly after this first line of chemotherapy. The standard second-line (L2) chemotherapies recommended by ESMO, ENETS, and NCCN, FOLFIRI and FOLFOX, have modest efficacy with a PFS of 3 months and a median OS of 6 months. The BEVANEC study (PHRCK 2014, NCT02820857) reported no benefit of FOLFIRI + bevacizumab compared to FOLFIRI in a randomized phase II study that enrolled 150 patients in 26 centers over a period of 5 years in France.\n\nTo date, the most promising efficacy data for this highly aggressive cancer come from clinical trials of immune checkpoint inhibitors (ICIs) targeting the PD-1\u002FPD-L1 checkpoint. For example, in France, the non-comparative phase II NIPINEC trial (NCT03591731) randomized patients to receive nivolumab +\u002F- ipilimumab in L2\u002F3 and achieved its primary evaluation criterion (ORR-8 weeks\\>10%). Other trials in Europe and worldwide have also reported efficacy data in the context of single-arm studies.\n\nScientific Questions and Unmet Needs:\n\n1. New therapeutic options\u002Fperspectives are necessary for patients with GEP\u002FUK NECs given the limited overall survival.\n2. Approximately 50% of patients experienced early progression under immunotherapy in the NIPINEC trial and other trials, which may be explained by the absence of chemotherapy combined with immunotherapy and\u002For the existence of resistance mechanisms.\n3. In the GEP\u002FUK NEC indication, the design of these immunotherapy trials has been non-comparative single-arm studies because the realization of randomized comparative trials is considered very difficult for these very rare cancers (incidence \\\u003C5\u002Fmillion).\n\nRationale for the REWENEC-01 Trial The DURIGAST PRODIGE 59 study, conducted by the FFCD, demonstrated the feasibility and safety of the FOLFIRI + double immune checkpoint inhibitor (anti-PD-1 and anti-CTLA4) combination, as well as for the combination Folfox-Domvanalimab-Zimberelimab (anti-PD-1 and anti-TIGIT). In a translational study of the immune phenotype in patients with NECs treated with the anti-PD1 pembrolizumab, an increase in TIGIT expression was observed after pembrolizumab treatment and higher TIGIT expression on T cells in the blood of patients with high Ki67 expression in their tumors. These data suggest that TIGIT is a potential complementary therapeutic target to PD-1\u002FPD-L1 checkpoint inhibition in GEP\u002FUK NECs. Domvanalimab has been developed as an anti-TIGIT monoclonal antibody and zimberelimab as an anti-PD-1.\n\nDesign and primary objective of the REWNEC-01 Trial The REWENEC-01 trial is a comparative phase II trial that will randomize GEP\u002FUK NEC patients between an experimental arm FOLFIRI+Zimberelimab + Domvanalimab and a control arm FOLFIRI in L2. The FOLFIRI arm will be a \"hybrid\" synthetic control arm composed of patients from historical\u002Fexternal data from the FOLFIRI arm of BEVANEC and French retrospective studies RBNEC and CEPD, mixed with patients recruited prospectively during the trial and randomized to the control arm. The randomization ratio for patients included prospectively during the trial will be 4:1 (4 patients assigned to FOLFIRI+Zimberelimab + Domvanalimab for 1 patient assigned to FOLFIRI). The randomization algorithm will take into account \"external\" patients assigned progressively to the control arm to obtain a 1:1 ratio between the trial arms, with balanced distributions of stratification factors between the two arms.\n\nWith 77 patients to be included, this strategy will provide statistical power equivalent to that of a trial including 122 patients, sufficient to demonstrate an advantage in overall survival rate at 12 months from 32% to 50%.\n\nThe hypotheses related to efficacy criteria are formulated a priori, as recommended by the FDA guidance document on trials with synthetic\u002Fexternal control arms. The proof of concept has been reported at ESMO 2023. The primary judgment criterion will be the overall survival rate at 12 months because it is a strong and significant criterion for translating the clinical benefit of the Chemotherapy + Zimberelimab + Domvanalimab combination. The design with a hybrid synthetic control arm allows for the consideration of a randomized comparative study in a cancer as rare as neuroendocrine carcinoma.",[26],[26,110,111],"gastro-enteropancreatic or unknown origin","GEP\u002FUK NEC","NOT_YET_RECRUITING","2026-01-07",{"date":115,"type":42},"2026-01-13",{"date":117,"type":20},"2026-04",{"date":119,"type":20},"2030-04",{"name":121,"class":122},"Hospices Civils de Lyon","OTHER",21,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":130,"targetDuration":4,"studyType":132,"phases":4,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":50},"100457541","tissue-procurement-and-natural-history-study-of-neuroendocrine-neoplasms-nens-including-adrenocortical-carcinoma-acc-100457541","NCT05237934","Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC)","* INCLUSION CRITERIA:\n* Age \\>= 18 years old\n* The ability of the participant to understand and the willingness to sign a written consent document.\n* Participants with the documentation of:\n\n  * histological or cytological confirmation of NENs or adrenocortical cancer\n\nOR\n\n--biochemical evidence of neuroendocrine tumor (serum\u002Furinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-hydroxyindoleacetic acid (5-HIAA)), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, Cpeptide (proinsulin), glucagon, anterior pituitary hormones\n\nOR\n\n--Suspicion of NEN (from any site\u002Forigin) on axial imaging (computed tomography (CT)\u002F magnetic resonance imaging (MRI) \u002F fluorodeoxyglucose (FDG) positron emission tomography (PET) \u002F 68Ga-Dotatate scan\n\nOR\n\n--a germline genetic variant that predisposes to NETs including ACC.\n\nEXCLUSION CRITERIA:\n\nNone",{"count":131,"type":20},300,"OBSERVATIONAL","Background:\n\nNeuroendocrine neoplasm (NENs)are rare cancers arising from the neuroendocrine cells and can affect almost any part of the body. They vary from low grade neuroendocrine tumors (NETs) to high grade neuroendocrine carcinomas (NECs). These tumors often occur in the gastrointestinal tract, pancreas, lungs, adrenal medulla (pheochromocytomas) or adrenal cortex (adrenocortical cancer) and other areas of the body mentioned below:\n\n* Gastroenteropancreatic neuroendocrine tumors (GEP-NET): stomach, duodenum, pancreas, colon, appendix, etc.\n* Liver and gallbladder\n* Adrenal tumors\n* Pituitary gland\n* Thyroid gland: medullary thyroid carcinoma\n* Parathyroid tumors\n* Pulmonary neuroendocrine tumors: typical and atypical carcinoid, small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC)\n* Extrapulmonary small cell cancer\n* Peripheral nervous system tumors: paraganglioma, neuroblastoma)\n* Breast and genitourinary tract\n\nTheir rates are rising in the United States and worldwide. Researchers want to learn more about NENs through this natural history study.\n\nObjective:\n\nTo study the natural history of people with NENs and obtain samples from them to learn more about the disease. The clinical management of all NETs is not standardized, with only a few FDA-approved therapies and we would like to learn which combination therapeutic approach should be used, how long treatment should be continued, and in what subgroup of NENs a particular treatment option should be used.\n\nEligibility:\n\nPeople aged 18 and older who have or are suspected to have NENs or ACC.\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nParticipants will have a physical exam. Their symptoms and their ability to perform their normal activities will be reviewed. They will have blood and urine tests.\n\nParticipants will receive recommendations for managing their disease and potential treatment options. They will be able to ask as many questions as they would like.\n\nParticipants may provide saliva and blood, a for research. They will give tumor samples from a previous surgery or biopsy.\n\nParticipants may have optional biopsies. During biopsies, cancer tissue will be obtained using a needle and syringe. Tissue will be taken from the liver, lung, or a lymph node. Participants may have an imaging scan or ultrasound to help locate the tumor or area to be biopsied. They will receive local anesthesia and may be sedated.\n\nParticipants will complete a questionnaire about their family medical history.\n\nParticipants will have follow-up visits every 12 months. They will have physical exams and give samples. If their health changes, they may have extra visits. If they cannot visit NIH, they (or their doctor) will be contacted by phone or email.\n\nParticipants will take part in the study for all their life.",[77,26],[136,137,138,139,140],"Clinical Outcome","Advice in the Management of Cancer","Patterns of Disease Progression","Response or Lack of Response to Therapeutic Interventions","Natural History","2025-11-11",{"date":143,"type":42},"2025-11-12",{"date":145,"type":42},"2022-04-25",{"date":147,"type":20},"2032-12-31",{"name":48,"class":49},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":15,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":50},"100199765","phase-2-a-trial-to-assess-the-safety-and-effectiveness-of-lutetium-177-octreotate-therapy-in-neuroendocrine-tumours-100199765","NCT01876771","A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours","An Open-label Phase II Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours","Group A (Primary Therapy) Inclusion Criteria:\n\n1. Male or female ≥ 14 - 90 years of age.\n2. At least 1 tumour site reliably evaluable by CT or magnetic resonance imaging (MRI) of at least 1.0 cm (smallest dimension) or ≥ 1.5 cm lymph node disease (smallest dimension) (the target lesion) within 26 weeks of enrolment, with documented presence of somatostatin receptors on radionuclide imaging, with uptake greater than liver background as assessed by planar Octreoscan® images or Ga-68 labelled somatostatin analogue (68Ga-DOTATATE or 68Ga-HA-DOTATATE) PET imaging (or other available somatostatin receptor targeting PET agents) obtained within 1 year of enrolment. Patients with bone-only disease can be enrolled provided there is presence of somatostatin receptor positive tumour(s) on radionuclide imaging corresponding to osteolytic or osteoblastic bone lesions on CT or MRI, with uptake greater than liver background as assessed by planar Ocgtreoscan(R) images or somatostatin receptor PET imaging regardless of size.\n3. Histologically confirmed diagnosis of neuroendocrine tumor.\n4. Progressive disease documented by anatomic imaging and\u002For presence of new lesions on somatostatin receptor imaging assessed by comparable studies. In the opinion of the investigator, patients with no progression on imaging may still be considered eligible in presence of carcinoid symptoms refractory to treatment with somatostatin receptor analogues or functional Pheochromocytoma\u002FParaganglioma symptoms that are not well controlled with current medical treatment.\n5. 18F-FDG PET\u002FCT whole-body imaging within 26 weeks of enrolment.\n6. Life expectancy greater than 12 weeks from enrollment.\n7. Serum creatinine ≤ 150 µmol\u002FL, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL\u002Fmin measured within 2 weeks of enrollment.\n8. Haemoglobin concentration ≥ 90 g\u002FL; white blood cell (WBC) count ≥ 2 x 10\\^9\u002FL; platelets ≥ 100 x 10\\^9\u002FL measured within 2 weeks of enrolment.\n9. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g\u002FL within 2 weeks of enrolment.\n10. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.\n11. Provide written informed consent prior to enrolment.\n\nGroup B (Maintenance Therapy) Inclusion Criteria:\n\n1. Male or female ≥ 14 - 90 years of age.\n2. Have previously received Lu-DOTA-TATE treatment under the SAP.\n3. Life expectancy greater than 12 weeks from enrolment.\n4. Serum creatinine ≤ 150 μmol\u002FL, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL\u002Fmin measured within 2 weeks of enrolment.\n5. Haemoglobin concentration ≥ 90 g\u002FL; white blood cell (WBC) count ≥ 2 x 10\\^9\u002FL; platelets ≥ 100 x 10\\^9\u002FL measured within 2 weeks of enrolment.\n6. Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g\u002FL within 2 weeks of enrolment.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.\n8. Provide written informed consent prior to enrolment.\n\nGroup A (Primary Therapy) Exclusion Criteria:\n\n1. Have previously received Lu-DOTA-TATE therapy.\n2. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.\n3. Major surgery within 12 weeks of enrolment. Minor surgeries such as removal of superficial skin lesions, laser eye surgery, cataract surgery, laparoscopic procedures and other procedures that are minimally invasive are permitted at the Investigator's discretion.\n4. Liver embolization \\[transcatheter arterial embolization (TAE), TACE, or TARE\\] within 4 weeks of enrolment.\n5. Radioisotope therapy within 12 weeks of enrolment.\n6. Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment.\n7. Change in long-acting somatostatin analogues, dosage, or dosage frequency within 12 weeks of enrolment unless changes are required to manage uncontrolled symptoms.\n8. Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted.\n9. Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment\n10. Uncontrolled diabetes mellitus defined as random glucose ≥ 2X the upper limit of normal (or HbA1c \\> 10%, if results available) within 12 weeks of enrolment.\n11. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).\n12. Pregnancy.\n13. Breast feeding.\n14. Prior radiation therapy to more than 25% of the bone marrow.\n15. If, in the opinion of the investigator, other treatments are considered more appropriate than the investigational therapy, based on patient and disease characteristics.\n16. Known allergy to somatostatin analogues or any components of the study medication.\n\nGroup B (Maintenance Therapy) Exclusion Criteria:\n\n1. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence or co-existing malignancies).\n2. Pregnancy.\n3. Breast feeding.\n4. Known allergy to somatostatin analogues or any components of the study medication.","14 Years","90 Years",{"count":159,"type":20},500,[23],"Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300 patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under Health Canada's Special Access Programme (SAP), with each individual treatment requiring separate approval. In 2014, Health Canada requested we conduct a clinical trial with Lu-DOTA-TATE instead.\n\nThe purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess the effect of Lu-DOTA-TATE on Quality of Life and survival.",[26],[164],"177lutetium-DOTA(O)Tyr3)octreotate","2025-08-05",{"date":167,"type":42},"2025-08-08",{"date":169,"type":42},"2014-04-29",{"date":171,"type":20},"2042-12",{"name":173,"class":122},"AHS Cancer Control Alberta"]