[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-thyroid-gland-medullary-carcinoma-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-thyroid-gland-medullary-carcinoma-ajcc-v8":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100659331","phase-2-enfortumab-vedotin-for-the-treatment-of-unresectable-or-metastatic-radioiodine-refractory-differentiated-thyroid-cancer-anaplastic-thyroid-cancer-medullary-thyroid-cancer-or-nut-carcinoma-100659331",false,"NCT07863765","Enfortumab Vedotin for the Treatment of Unresectable or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer, or NUT Carcinoma","Phase II Multi-Center Open-Label Trial of Enfortumab Vedotin Treatment for Patients With Aggressive Radioiodine Refractory Differentiated Thyroid Cancer, Aggressive Poorly Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer and NUT Carcinoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed:\n\n  * radioiodine refractory (RAIR) differentiated thyroid cancer (DTC)\\^A (including RAIR poorly differentiated thyroid cancer \\[PDTC\\])\\^A\n\n    * radioiodine refractory (RAIR) differentiated thyroid cancer (DTC\\^1), (including RAIR poorly differentiated thyroid cancer (\\[PDTC\\^2\\]), that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective\n\n      * ≥ 1 line of systemic therapy allowed including radioactive iodine (RAI) therapy, tyrosine kinase inhibitors (TKIs), targeted therapies, radiation therapy, chemotherapy and immunotherapy. NOTE: prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (anti-drug congigates \\[ADCs\\] is not allowed.)\n      * Washout of 2 weeks from prior anti-cancer treatments before start of study treatment (C1D1) required OR\n  * anaplastic thyroid cancer (ATC)\\^B\n\n    * anaplastic thyroid cancer (ATC)\\^4 that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective\n\n      * For BRAF V600E mutated: 2 lines as TKIs and ≥ 1 line of immunotherapy allowed; all other systemic therapies, ≥ 1 line, including radiation therapy and chemotherapy;\n      * wild type (WT) for BRAF: ≥ 1 line of systemic therapy allowed including TKIs, targeted therapies, radiation therapy, chemotherapy and immunotherapy\n      * For both: Washout of 2 weeks from prior anti-cancer treatments before start of study treatment (C1D1) required. NOTE: prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs is not allowed.\n\nOR\n\n* medullary thyroid cancer (MTC)\\^C\n\n  * medullary thyroid cancer (MTC) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective\n\n    * ≥ 1 line of systemic therapy allowed including TKIs, targeted therapies, radiation therapy, chemotherapy and immunotherapy. NOTE: prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs is not allowed.\n    * Washout of 2 weeks from prior anti-cancer treatment before start of study treatment (cycle 1 day 1 \\[C1D1\\]) required OR\n* NUT carcinoma\\^D\n\n  * NUT carcinoma\\^3 that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective\n\n    * Any number of lines allowed. NOTE: prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs is not allowed).\n    * Washout of 2 weeks from prior anti-cancer treatments before start of study treatment (C1D1) required\n* Footnote 1: Main histological types of differentiated thyroid carcinoma (DTC) include: papillary, follicular and oncocytic thyroid carcinoma. Differentiated cancers are classified as such as they tend to grow and spread slowly compared to undifferentiated cancers, which are faster growing and spread rapidly. This study is for RAIR-DTC (or RAIR PDTC) patients that have failed Radioactive iodine therapy (radioactive iodine \\[RAI\\], and those that have failed are called RAI refractory or RAIR), have metastatic or unresectable disease; original histology\u002Fcytology\u002Fpathology reports for diagnosis of DTC (or PDTC) and most recent imaging (ultrasound\u002FCT\u002FMRI\u002Fradioiodine imaging and recent Tg lab results) for review of disease progression and RAI uptake for RAIR determination. Also, pathology report of most recent biopsy if available.\n* Footnote 2: Poorly differentiated thyroid cancer (PDTC) is typically classified as a type of differentiated thyroid cancer (unlike an undifferentiated thyroid cancer such as anaplastic thyroid cancer4); see footnote 1.\n* Footnote 3: Patients must have histologically or cytologically confirmed NUT carcinoma based on the ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) and\u002For detection of NUT gene translocation as determined by fluorescence in situ hybridization (FISH) at a Clinical Laboratory Improvement Act (CLIA) certified laboratory and\u002For by detection of the NUT gene translocation as determined by sequencing (e.g., dioxyribonucleic acid \\[DNA\\] next generation sequencing (NGS) or ribonucleic acid \\[RNA\\] sequencing) at a CLIA certified laboratory.\n* Footnote 4: Anaplastic Thyroid Carcinoma (ATC) is an aggressive undifferentiated tumor, the least common type of thyroid carcinoma, and develops from more differentiated tumors as a result of one or more dedifferentiating (transforming) steps leading to its fast growth and capacity to spread rapidly; in particular, via loss of the p53 tumor suppressor protein. ATC is an undifferentiated cancer that is refractory to iodine-131 (radioiodine) imaging and radioiodine therapy (RAI) and is considered RAIR and is generally incurable. The original histology\u002Fcytology\u002Fpathology reports for diagnosis of the original thyroid malignancy and for confirmation of ATC by surgical biopsy (pathology report for biopsy results) and most recent imaging (ultrasound\u002FCT\u002FMRI\u002Fradioiodine imaging) and recent lab results (including complete blood count \\[CBC\\], complete metabolic panel \\[CMP\\], thyroid stimulating hormone \\[TSH\\] and molecular testing) for review of disease progression.\n\n  * Patients must have measurable disease by RECIST v 1.1\n  * Patients must be age ≥ 18 years\n  * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n  * Leukocytes (white blood cell \\[WBC\\]) ≥ 3,000\u002FmcL\n  * Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n  * Hemoglobin (Hgb) ≥ 9 g\u002FdL\n  * Platelets (PLT) ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x institutional ULN\n  * Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n  * Creatinine ≤ 1.5 x Institutional ULN\n  * Glomerular filtration rate (GFR) ≥ 40 mL\u002Fmin\u002F1.73 m\\^2\n* estimated glomerular filtration rate (eGFR) is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation\n\n  * The effects of enfortumab vedotin (EV) on the developing human fetus are unknown. For this reason and because ADC agents as well as other therapeutic agents used in this trial are known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of start of study therapy (C1D1), for the duration of study participation, and for 60 days following completion of study drug therapy. Should a person of child bearing potential (POCBP) become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of start of study therapy (C1D1), for the duration of study participation, and 120 days after completion of administration\n* Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy\n  * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n\n    * POCBP must have a negative pregnancy test prior to registration on study\n    * Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the study requirements\n\nExclusion Criteria:\n\n* Patients who have had prior treatment with chemotherapy, radiotherapy, biologics, investigational agents or devices, and\u002For anti-cancer treatment with immunotherapy ≤ 14 days prior to planned treatment start date\n* Patients who have had prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs)\n* Patients who have had major surgery within 4 weeks of the planned date of the start of study treatment (C1D1)\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0\n* Patients with untreated brain metastases\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs)\n* Patients with a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes (within 3 months before first dose) is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained. \\* NOTE: The lowest HbA1c during the screening period will be used to determine eligibility\n* Patients with a known history of Human immunodeficiency virus (HIV).\n\n  * NOTE: Infected patients on effective HIV anti-retroviral therapy with an undetectable HIV viral load for 6 months prior to the start of study participation are eligible to participate.\n  * NOTE: CD4+ T cell counts and viral load are monitored per standard of care\n* Patients with a known history of chronic hepatitis B infection.\n\n  * NOTE: Patients with hepatitis B virus (HBV) and an undetectable HBV viral load on HBV suppressive therapy are eligible to participate.\n  * NOTE: CD4+ T cell counts, and viral load are monitored per standard of care\n* Patients with a known history of chronic hepatitis C infection.\n\n  * NOTE: For patients with a known hepatitis C virus (HCV) infection who are currently on HCV treatment, are eligible if they have an undetectable HCV viral load OR\n  * NOTE: Patients with an HCV infection must have been treated and cured in order to participate.\n  * NOTE: CD4+ T cell counts, and viral load are monitored per standard of care\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Hypertension that is not controlled on medication\n  * Ongoing or active infection requiring systemic treatment\n\n    * Routine microbial prophylaxis is allowed (e.g., uncomplicated urinary tract infections, sinus infections and are on antibiotics).\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness, laboratory finding or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with a concurrent malignancy or prior malignancy diagnosed within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.\n\n  * NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance\u002Fwatchful waiting without intent to treat, or in situ cervical cancer that has undergone potentially curative therapy are allowed\n* Patients with 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\n* Patients who are pregnant or nursing. Pregnant patients are excluded from this study because is enfortumab vedotin has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with enfortumab vedotin breastfeeding should be discontinued if the mother is treated with enfortumab vedotin","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This trial tests how well giving enfortumab vedotin works for the treatment of differentiated thyroid cancer that does not respond to treatment with radioiodine (refractory), anaplastic thyroid cancer, medullary thyroid cancer or NUT carcinoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Metastatic Differentiated Thyroid Gland Carcinoma","Metastatic NUT Carcinoma","Metastatic Thyroid Gland Anaplastic Carcinoma","Metastatic Thyroid Gland Medullary Carcinoma","Refractory Differentiated Thyroid Gland Carcinoma","Stage III Differentiated Thyroid Gland Carcinoma AJCC v8","Stage III Thyroid Gland Medullary Carcinoma AJCC v8","Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8","Stage IV Thyroid Gland Medullary Carcinoma AJCC v8","Unresectable Differentiated Thyroid Gland Carcinoma","Unresectable NUT Carcinoma","Unresectable Thyroid Gland Anaplastic Carcinoma","Unresectable Thyroid Gland Medullary Carcinoma","NOT_YET_RECRUITING","2026-10-02",{"date":42,"type":43},"2026-10-07","ACTUAL",{"date":45,"type":20},"2027-05-05",{"date":47,"type":20},"2031-05-05",{"name":49,"class":50},"Northwestern University","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":5},"100379142","natural-history-of-medullary-thyroid-cancer-to-inform-advanced-disease-management-100379142","NCT04216732","Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management","Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management","Inclusion Criteria:\n\n* Aims 1 and 2: A diagnosis of MTC\n* Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment\n* Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team\n* Aim 3: A current registrant in the MTCR",{"count":60,"type":20},2030,"OBSERVATIONAL","This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.",[64,32,34,65,66,67],"Advanced Thyroid Gland Medullary Carcinoma","Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8","Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8","Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8","RECRUITING","2026-09-23",{"date":71,"type":43},"2026-09-25",{"date":73,"type":43},"2020-01-10",{"date":75,"type":20},"2028-09-01",{"name":77,"class":50},"M.D. Anderson Cancer Center"]