[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anaplastic-thyroid-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anaplastic-thyroid-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,48,71,104,130,158,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100630276","phase-1-drug-repurposing-in-thyroid-carcinoma-a-feasibility-trial-100630276",false,"NCT07485569","Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial","Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial","REPOTHYROID-II","Inclusion Criteria:\n\n* Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.\n* Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).\n* Measurable disease per RECIST 1.1\n* ECOG performance status ≤ 2\n* Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to obtain a (new) biopsy for molecular profiling\n* Pregnancy or breastfeeding.\n* Other active malignancies requiring therapy.\n* Neutropenia (ANC \\\u003C 1.5 × 10⁹\u002FL).\n* Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).","ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.",[27,28,29,30],"Thyroid Cancer Stage IV","Anaplastic Thyroid Cancer","Differentiated Thyroid Cancer","Poorly Differentiated Thyroid Carcinoma",[32,33,34,35],"Drug repurposing","Thyroid cancer","Network pharmacology","Personalized therapy","NOT_YET_RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":21},"2026-06-01",{"date":44,"type":21},"2027-09-01",{"name":46,"class":47},"Radboud University Medical Center","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100629118","phase-2-zanzalintinib-plus-cemiplimab-for-the-treatment-of-braf-wild-type-anaplastic-thyroid-cancer-100629118","NCT07470489","Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer","A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation\u002Frandomization.\n* Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma. Diagnosis may include consistent with or suggestive of terminology associated with anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.\n* Patients deemed to have unresectable locoregional disease (stage IVB) or metastatic disease (stage IVC). Patients who are unwilling to undergo surgery or external beam radiation are also eligible.\n* Patients with BRAF-wild type ATC will be eligible for this study. Patients with a BRAFV600E mutation who are unable to receive the FDA approved drugs, dabrafenib\u002Ftrametinib, are also eligible as long as this is documented.\n* Unless clinically contraindicated, all patients with active neck disease who have not received prior neck radiation will be considered for palliative-dose EBRT to the neck (preferably 14 Gy, but 7 to 30 Gy is acceptable) within one month prior to the initiation of study drugs. All patients eligible for palliative neck EBRT who do not undergo radiation will need to be discussed with the PI for study eligibility. In patients with unstable airway, an intervention to stabilize the airway must be implemented prior to enrollment.\n* Patients must have adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (≥ 1.5 GI\u002FL) without granulocyte colonystimulating factor support within 2 weeks of screening laboratory sample collection.\n* Platelets ≥ 100,000\u002Fmm3 (≥ 100 GI\u002FL) without transfusion within 2 weeks of screening laboratory sample collection.\n* Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL) without transfusion within 2 weeks prior to screening laboratory sample collection.\n* International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN).\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN. For subjects with concurrent liver metastases, AST\u002FALT ≤ 5 x ULN\n* Total bilirubin ≤ 1.5 x ULN (for subjects with Gilbert's disease ≤ 3 x ULN).\n* Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft Gault equation. Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.2 mg\u002Fmmol) creatinine.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be \\\u003C class II.\n* Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix A) during the course of the study for 186 days after the last dose of zanzalintinib or 4 months after the last dose of cemiplimab, whichever is later. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n* Women of childbearing potential (WOCBP) must not be pregnant at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n* Postmenopausal, i.e.no menses in greater than or equal to 12 consecutive months in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating hormone \\[FSH\\] level \\> 40 mIU\u002FmL to confirm menopause\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nExclusion Criteria:\n\n* Prior treatment with zanzalintinib or any other multikinase inhibitor (e.g. lenvatinib, sorafenib, vandetanib, cabozantinib).\n* Prior treatment with cemiplimab or any other immune checkpoint inhibitor or immunotherapy (e.g. anti-CTLA4, anti-PD-1, anti-PD-L1, BITEs).\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives before first dose of study treatment, whichever is longer.\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Subjects with clinically relevant ongoing complications from prior radiation therapy that have not completely resolved (eg, radiation esophagitis or other inflammation of the viscera).\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n* Concomitant anticoagulation with oral anticoagulants (e.g, warfarin, direct thrombin inhibitors) and platelet inhibitors (eg, clopidogrel), except:\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. Note: Subjects must have discontinued oral anticoagulants (eg, warfarin, direct thrombin inhibitors) within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Electrolyte abnormalities that have not been corrected, with the exception of calcium if oral calcium and calcitriol are being titrated.\n* Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval\n* Subjects having \\> 2+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \\\u003C1 g\u002F24 hours.\n* The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n* Unstable of deteriorating cardiovascular disorders:\n* Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).\n* Uncontrolled hypertension defined as sustained blood pressure (BP) \\> 140 mm Hg systolic or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment.\n* Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 12 months before first dose of study treatment.\n* Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous events within 3 months before first dose of study treatment. Note: Subjects with a diagnosis of DVT within 6 months are allowed if asymptomatic and stable at screening and 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.\n\nNote: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator.\n\n* Prior history of myocarditis.\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n* Tumors invading the GI-tract from external viscera\n* Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n* Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months before first dose unless cause of obstruction is definitively managed and subject is asymptomatic\n* Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intraabdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment.\n* Known gastric or esophageal varices\n* Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment. Patients with suspected tracheal or esophageal invasion can be included on a case-by-case basis after a discussion with the principal investigator. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage and tracheoesophageal fistula associated with tumor shrinkage\u002Fnecrosis following zanzalintinib therapy.\n* Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)\n* Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n* Other clinically significant disorders that would preclude safe study participation.\n* Active infection requiring systemic treatment. Note: Prophylactic antimicrobial treatments (antibiotics, antimycotic, antiviral) are allowed.\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n* Malabsorption syndrome.\n* Pharmacologically uncompensated, symptomatic hypothyroidism.\n* Moderate to severe hepatic impairment (Child-Pugh B or C).\n* Requirement for hemodialysis or peritoneal dialysis.\n* History of solid organ or allogeneic stem cell transplant.\n* Uncontrolled infection with HIV, hepatitis B or hepatitis C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n* Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen are eligible.\n\nFor these participants monitoring will be performed per local standards.\n\n* Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study medication.\n* Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: If serum HBV DNA PCR is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.\n* Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are eligible\n\n  * Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Antiretroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose.\n  * Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n* Recent major (as defined in Appendix B) or minor surgery. Some patients may be eligible on a case-by-case basis after a discussion with the principal investigator. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment.\n* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n* Pregnant or lactating females.\n* Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.\n* Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n* Another malignancy that requires active therapy and in the opinion of the Investigator would interfere with monitoring of radiologic assessments of response to Investigational Product, within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, lowgrade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* Other conditions, which in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* Any active, known, or suspected autoimmune disease within two years of enrollment. Note: Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed. Note: Adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease. Transient short-term use of higher doses of systemic corticosteroids (up to 2 days in the week before enrollment) for allergic conditions (eg, contrast allergy) or tumor-related respiratory distress is also allowed.\n* Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n* Patients taking any of the other prohibited concomitant therapies as detailed in section 5.4.1.",{"count":56,"type":21},12,[58],"PHASE2","The goal of the trial is to improve this OS by 4 months (to 9.9 months) using the zanzalintinib + cemiplimab treatment combination. Given an accrual period of 24 months and a maximum follow-up time of 36 months, at the significance level of 0.1, to achieve the power of 0.8, the sample size needed is 24 patients and the number of events required is 17. These results are based on a one-sided test with exponential assumption for survival time.",[28],"2026-04-13",{"date":63,"type":40},"2026-04-16",{"date":65,"type":21},"2026-09-30",{"date":67,"type":21},"2032-09-01",{"name":69,"class":47},"M.D. Anderson Cancer Center",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100585439","phase-1-xl092-and-cemiplimab-in-braf-wt-thyroid-cancer-100585439","NCT06902376","XL092 and Cemiplimab in BRAF WT Thyroid Cancer","NEO-COMBAT XL: Neoadjuvant and Maintenance XL092 and Cemiplimab in BRAF V600E-wildtype Anaplastic Thyroid Cancer: a Phase 1B Study","NEO-COMBATXL","Inclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for the release of personal health information.\n* Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* the Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n* Pathologic findings supporting the clinical impression of anaplastic thyroid cancer. Terminology consistent or suggestive of diagnosis may include the following: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.\n* Subject is willing to have a fresh biopsy at least 3 days prior to neoadjuvant therapy if archival tissue is unavailable. Also willing to have a biopsy at the time of SOC surgery, if applicable.\n* Must have BRAF V600E mutation-negative tumor, as determined by BRAF V600E immunohistochemistry on tumor tissue or genetic\u002Fmolecular testing of the tumor.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study). Females should not breastfeed while receiving study treatment and for 1 month from the last dose of XL092.\n* Patients who have had prior exposure to any immune modulating agents or any type of small molecule kinase inhibitor (including investigational agents) and have documented disease progression on these agents will not be eligible.\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments (i.e., with use of disease modifying agents, corticosteroids (\\>10 mg of prednisone or equivalent) or immunosuppressive drugs) which may suggest risk of immune-mediated Adverse Events.\n* Replacement therapy (e.g.: thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment.\n* Subject history of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments.\n* Subject is receiving prohibited medications or treatments as listed in the protocol that cannot be discontinued\u002Freplaced by an alternative therapy within 7 days of initiating treatment.\n* Participation in another clinical study with an investigational product during the last 3 weeks.",{"count":56,"type":21},[24],"This multicenter study examines the safety and feasibility of the combination of neoadjuvant XL092 and cemiplimab prior to surgical resection in participants with wild-type (WT) anaplastic thyroid cancer (ATC) that has a BRAF mutation (BRAF V600E).",[28,83,84],"Thyroid Cancer","BRAF Mutation-Related Tumors",[86,87,88,89,90,91,92],"neoadjuvant chemotherapy","neoadjuvant immunotherapy","standard of care","BRAF V600E-WT ATC","XL092","cemiplimab","receptor tyrosine kinase inhibitor","RECRUITING","2025-11-03",{"date":96,"type":40},"2025-11-05",{"date":98,"type":40},"2025-06-03",{"date":100,"type":21},"2028-08-31",{"name":102,"class":47},"UNC Lineberger Comprehensive Cancer Center",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":70},"100544877","phase-2-efficacy-of-pembrolizumab-and-lenvatinib-in-patients-with-anaplastic-thyroid-cancer-100544877","NCT06374602","Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer","Inclusion Criteria:\n\n* immunohistochemically verified anaplastic thyroid cancer that is not eligible to R0-R1 surgery;\n* age ≥ 18 years;\n* functional status of ECOG 0-2;\n* adequate function of internal organs and bone marrow;\n* the ability to give written informed consent.\n\nExclusion Criteria:\n\n* patients with a mutation in the BRAF V600 gene without previous targeted therapy with BRAF\u002FMEK inhibitors;\n* patients with clinically significant hemoptysis and bleeding (for example, from the gastrointestinal tract or tumor-associated bleeding);\n* tumor invasion into large vessels;\n* patients with open wounds and fistulas;\n* contraindications to taking any of the studied drugs;\n* patients with poor functional status (ECOG 3-4);\n* continuous use of immunosuppressive therapy;\n* prior therapy with investigational drugs;\n* pregnancy, breast-feeding",{"count":111,"type":21},20,[58],"This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints.",[28],[116,117,118,119,120],"Anaplastic thyroid cancer","Immunotherapy","Targeted therapy","Lenvatinib","Pembrolizumab","2025-08-29",{"date":123,"type":40},"2025-09-05",{"date":125,"type":40},"2024-03-25",{"date":127,"type":21},"2026-06-25",{"name":129,"class":47},"Saint Petersburg State University, Russia",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100534160","phase-2-sacituzumab-govitecan-in-thyroid-cancers-100534160","NCT06235216","Sacituzumab govitEcan in THYroid Cancers","A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.","SETHY","Inclusion Criteria:\n\n1. Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written informed consent.\n2. Patient is ≥ 18 years of age.\n3. Patient has histologically confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer (cohort A) or anaplastic thyroid carcinoma (cohort B).\n4. Prior therapy in each cohort:\n\n   1. Cohort A: Patients must have experienced progression on at least one previous treatment line with approved systemic therapies (Sorafenib, Lenvatinib or Cabozantinib) and a maximum of 3 prior systemic therapies.\n   2. Cohort B: Patients should be included in first-line setting or after failure of any systemic therapy (up to 1 prior treatment lines).\n5. Patient has radiographically documented and measurable metastatic or locally advanced disease at baseline.\n6. An archival tumor tissue sample should be available for submission to the central laboratory for translational studies. If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided. No central pathological review will be needed to include the patient in the trial.\n7. Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. The following baseline laboratory data without transfusional support:\n\n   1. Neutrophil count (ANC) ≥ 1,500\u002Fmm3.\n   2. Platelet count ≥ 100 × 109\u002FL.\n   3. Hemoglobin ≥ 9 g\u002FdL.\n   4. Serum bilirubin ≤ 1.5 × upper limit of normal (ULN). Note: patients with Gilbert's disease are excluded.\n   5. Serum albumin \\> 3 g\u002FdL.\n   6. Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl).\n   7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for patients with liver metastases.\n9. Female patients must either:\n\n   1. Be of nonchildbearing potential:\n\n      I)Postmenopausal \\*(defined as at least 1 year without any menses) prior to screening , or II) Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).\n\n      \\*Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects.\n\n      OR\n   2. If of childbearing potential:\n\n   I) Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, II) And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), III) And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.\n10. 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.\n11. Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.\n12. Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.\n13. Patient agrees not to participate in another interventional study while on treatment in the present study.\n\nExclusion Criteria:\n\n1. Patient has central nervous system (CNS) metastases.\n2. Patient has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n\n   Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n3. Patient has a history of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.\n\n   Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n4. Patient has known active Hepatitis B or active hepatitis C:\n\n   1. Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n   2. Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n   3. Patients who test positive for HIV antibody.\n5. Patient has a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n6. Patient has documented history of a cerebral vascular event (stroke or transient ischemic attack), or the following criteria for cardiac disease:\n\n   1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n   2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n   3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n7. Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose of study drug.\n8. Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of gastrointestinal obstruction or perforation within 6 months of enrollment.\n9. Patient has uncontrolled hypertension or diabetes.\n10. Patient has radiotherapy or major surgery within 4 weeks prior to the first dose of study drug.\n11. Patients has received a live vaccine within 30 days, or antibiotics within one week prior to the first dose of study drug.\n12. Patient has had chemotherapy, biologics, investigational agents, and\u002For antitumor treatment with immunotherapy that is not completed 2 weeks prior to the first dose of study drug.\n\n    Note: Patients participating in observational studies are eligible.\n13. Patient has previously received topoisomerase 1 inhibitors.\n14. Patient has known hypersensitivity to sacituzumab govitecan or to any excipient contained in the drug formulation.\n15. Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.",{"count":139,"type":21},42,[58],"SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC).\n\nThe main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.",[29,28],[144,145,146,147],"TROP-2","sacituzumab govitecan","Antibody-drug conjugate","SN-38","2024-10-31",{"date":150,"type":40},"2024-11-01",{"date":152,"type":40},"2024-09-13",{"date":154,"type":21},"2027-12",{"name":156,"class":47},"Grupo Espanol de Tumores Neuroendocrinos",11,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":179,"locationsCount":70},"100543962","phase-2-study-of-the-rechallenge-concept-in-patients-with-braf-positive-anaplastic-thyroid-cancer-after-progression-on-anti-braf-therapy-100543962","NCT06362694","Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy","Inclusion Criteria:\n\n* immunohistochemically verified anaplastic thyroid cancer;\n* presence of a mutation in the BRAF V600 gene;\n* documented progression during targeted therapy with dabrafenib + trametinib;\n* documented progression during at least one line of chemotherapy (use of taxane-containing chemotherapy is mandatory);\n* age ≥ 18 years;\n* ECOG performance status 0-2;\n* adequate function of internal organs and bone marrow;\n* ability to give written informed consent.\n\nExclusion Criteria:\n\n* primary resistance (absence of initial clinical and radiological response to therapy with dabrafenib and trametinib (response criteria - primary objective response according to RECIST 1.1 criteria and duration of response of at least 3 months);\n* absence of taxane-containing chemotherapy as second or third line;\n* contraindication to taking any of the study drugs (including severe toxicity that occurred during a previous dose, which led to discontinuation of treatment);\n* patients with unsatisfactory functional status (ECOG 3-4);\n* pregnancy and breastfeeding.",{"count":20,"type":21},[58],"This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints.",[28],[169,170,171,172,173],"anaplastic thyroid cancer","rechallenge","dabrafenib","trametinib","targeted therapy","2024-04-08",{"date":176,"type":40},"2024-04-12",{"date":125,"type":40},{"date":127,"type":21},{"name":129,"class":47},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":70},"100522185","phase-2-neo--and-adjuvant-targeted-therapy-in-braf-mutated-anaplastic-cancer-of-the-thyroid-neo-atact-study-100522185","NCT06079333","NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)","NEO-ATACT","Inclusion Criteria:\n\n1. Informed consent.\n2. Age over 18 years old.\n3. World Health Organization (WHO) Performance Status 0 or I.\n4. Histologically confirmed ATC (centrally reviewed).\n5. Confirmed presence of BRAFV600E\u002FK mutation in primary tumor tissue.\n6. No distant metastases (M0).\n7. Free or secured airway.\n8. Able to swallow pills.\n9. Patients must have undergone complete disease staging including: PET-CT scan and CT-neck\u002Fthorax\u002Fabdomen.\n10. No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies).\n11. No prior radiotherapy to site of interest.\n12. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109\u002FL, Neutrophils ≥ 1.0x109\u002FL, Platelets ≥ 100 x109\u002FL, Hemoglobin ≥ 6.5 mmol\u002FL, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH \\\u003C 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft-Gault formula; or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73m2.\n13. Absence of additional severe and\u002For uncontrolled concurrent disease.\n\nExclusion Criteria:\n\n1. No informed consent.\n2. History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).\n3. Poorly differentiated transformation of previous differentiated thyroid cancer.\n4. Presence of distant metastases.\n5. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events\n6. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia.\n7. Pregnancy or nursing.",{"count":111,"type":21},[58],"Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans.\n\nMost patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and\u002For chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF\u002FMEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF\u002FMEK inhibitor treatment.",[28],"2023-10-05",{"date":193,"type":40},"2023-10-12",{"date":195,"type":40},"2023-01-01",{"date":197,"type":21},"2028-01-01",{"name":199,"class":47},"Leiden University Medical Center"]