[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-differentiated-thyroid-gland-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-differentiated-thyroid-gland-carcinoma":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":5},"100589840","phase-2-xl092-for-the-treatment-of-locally-advanced-or-metastatic-radioiodine-refractory-differentiated-thyroid-cancer-100589840",false,"NCT06959641","XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer","A Phase 2 Open Label Study of XL092 as First Line Therapy in Radioiodine Refractory Differentiated Thyroid Cancer","Inclusion:\n\n* 3.1.1 Patients must have a histologically confirmed locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer (including papillary, follicular, and oncocytic\u002FHurthle cell, and poorly differentiated thyroid cancer (PDTC)1 ), with progression within 12 months (per RECIST v1.1 response criteria) prior to study registration, and no prior therapy in the RAI-refractory setting and for which standard curative measures do not exist or are no longer effective. NOTE: availability of other standard TKI treatment options will not preclude patients from being eligible for this study. NOTE: RAI refractoriness is defined as absence of uptake of RAI on either a low-dose diagnostic test or a post-treatment RAI scan in measurable lesions or radiographic progression of disease within 12 months of the last course of RAI treatment despite the recorded uptake of RAI with that previous therapy or having a cumulative lifetime administered dose of ≥ 600mCi. Footnote 1: Poorly differentiated thyroid cancer (PDTC) is typically classified as a type of differentiated thyroid cancer (as opposed to undifferentiated thyroid cancer or anaplastic thyroid cancer)\n* 3.1.2 Patients must have measurable disease according to RECIST v1.1 (see Appendix B and Section 2).\n* 3.1.3 Patients must be age ≥ 18 years.\n* 3.1.4 Patients must exhibit an ECOG Performance Score of ≤ 2 (see Appendix C for ECOG Performance Status Scale).\n* 3.1.5 Patients must have adequate organ and bone marrow function as defined: Leukocytes (WBC) ≥ 3,000\u002FmcL, Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (see footnote 2 regarding use of growth factors for neutropenia), Hemoglobin (Hgb) ≥ 9 g\u002FdL (see footnote 1 regarding transfusions for anemia and thrombocytopenia), Platelets (PLT) ≥ 100,000\u002FmcL (see footnote 1 regarding transfusions for anemia and thrombocytopenia), Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN) ; for subjects with Gilbert's disease ≤ 3 x ULN, AST (SGOT) ≤ 3 x Institutional ULN, ALT (SGPT) ≤ 3 x Institutional ULN, ALP (alkaline phosphatase) ≤ 3 x Institutional ULN ; For subjects with documented bone metastasis, ≤ 5 x ULN., Creatinine Clearance (CrCl) ≥ 40 mL\u002Fmin (≥ 0.67 mL\u002Fsec) using the Cockcroft-Gault equation., INR ≤ 1.5 x Institutional ULN (in patients not currently on therapeutic anticoagulation), aPTT ≤ 1.2 × Institutional ULN (in patients not currently on therapeutic anticoagulation), Urine protein-to creatinine ratio (UPCR) ≤ 1 mg\u002Fmg (≤ 113.1 mg\u002Fmmol).\n* 3.1.6 For patients with a known history of Human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility. NOTE. To be eligible, patients must not have known uncontrolled infection with Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness NOTE: patients must meet all of the following criteria: (1) on stable anti-retroviral therapy; (2) CD4+ T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. NOTE: HIV testing will be performed at screening if it is required by local regulation or per SOC. NOTE: To be eligible, patients taking CYP inhibitors (e.g., 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. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. NOTE: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider.\n* 3.1.7 Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are stable for at least 4 weeks before the first dose of study treatment. NOTE: Patients with active brain metastases are not allowed. NOTE: Therapeutic doses of Low Molecular Weight Heparin (LMWH) are not permitted in patients with known brain metastases.\n* 3.1.8 Patients of child-bearing potential must have a negative pregnancy test prior to registration on study. NOTE: Patients of child-bearing potential are considered to be of child-bearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 consecutive months of amenorrhea in a patient of child-bearing potential \\> 45 years-of-age in the absence of other biological or physiological causes). In addition, a patient of child-bearing potential \\\u003C 55 years-of-age must have a serum follicle stimulating hormone (FSH) level \\> 40 mIU\u002FmL to confirm menopause).\n* 3.1.9 The effects of XL092 on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors (TKIs) as well as other therapeutic agents used in this trial are known to be teratogenic, sexually active fertile patients and their partners must agree to use highly effective methods of contraception during the course of the study and for the following durations after the last dose of study treatment (whichever is later): Through 186 days after the last dose of XL092 for patients of child-bearing potential or through 96 days after the last dose of XL092 for patients of sperm producing capacity. Because the effect of XL092 on the pharmacokinetics (PK) of contraceptive steroids has not been investigated, hormonal contraceptives may not achieve the level considered \"highly effective\". For this reason, an additional contraceptive method, such as a barrier method (e.g., condom), may be required. In addition, patients of sperm producing capacity must agree not to donate sperm and patients of child-bearing potential must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods. Should a patient of child-bearing potential become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. NOTE: See Appendix H for highly effective methods of contraception.\n* 3.1.10 Recovery to baseline or ≤ Grade 1 per NCI CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Treating Investigator and\u002For stable on supportive therapy. NOTE: Patients must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) except for alopecia, neuropathy, and other non-significant adverse events per NCI CTCAE v 5.0 (Appendix A).\n* 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the protocol requirements.\n* 3.1.12 Patients must have the ability to swallow, retain and absorb oral medications. NOTE: Patients must have the ability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube. NOTE: See Section 4 Treatment Administration for additional information.\n\nExclusion:\n\n* 3.2.1 Prior treatment with XL092 (zanzalintinib).\n* 3.2.2 Patient has Hepatitis B.\n* 3.2.3 Patient has Hepatitis C. NOTE: Patients with treated Hepatitis C and positive HCV antibody test are eligible only if followed by a negative HCV RNA test and no ongoing anti-HCV therapy. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n* 3.2.4 Patient is pregnant or nursing (lactating) NOTE: Pregnant patients are excluded from this study because XL092 is a tyrosine kinase inhibitor with 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 XL092, breastfeeding should be discontinued if the mother is treated with XL092.\n* 3.2.5 Receipt of any type of small molecule kinase inhibitor treatment before the first dose of study treatment NOTE: See Section 4 for additional information on concomitant medications including restricted medications and therapies.\n* 3.2.6 Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational therapy or investigational device) before the first dose of study treatment. NOTE: See Section 4 for additional information on concomitant medications including restricted medications and therapies. NOTE: RAI, a radionuclide therapy given systemically, is allowed prior therapy, see inclusion criterion 3.1.1 and criterion 3.2.7.\n* 3.2.7 Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. NOTE: Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible\n* 3.2.8 Previously identified allergy or hypersensitivity to components of the study treatment formulations, have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092 (zanzalintinib).\n* 3.2.9 Concomitant anticoagulation with oral anticoagulants (e.g., warfarin or other coumarinrelated agents, direct thrombin inhibitors, or anti-platelet agents such as clopidogrel, chronic use of aspirin above low dose levels for cardio-protection per institutional practice). NOTE: Allowed anticoagulants are the following: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparins (LMWH); 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: Patients must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer. NOTE: Therapeutic doses of LMWH are not permitted in subjects with known brain metastases.\n* 3.2.10 Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat cancer within 2 weeks before first dose of study treatment.\n* 3.2.11 Patient has uncontrolled, significant intercurrent or recent illness\n* 3.2.12 Other clinically significant disorders that would preclude safe study participation including having an uncontrolled intercurrent illness\n* 3.2.13 Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment.\n* 3.2.14 Symptomatic cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. NOTE: Asymptomatic or radiated endobronchial disease lesions allowed.\n* 3.2.15 Lesions invading major blood vessel(s), including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Subjects with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval.\n* 3.2.16 Major surgery (see Appendix D) e.g., GI surgery, removal, or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic surgeries (i.e., nephrectomy) within 4 weeks prior to first dose of study treatment. Minor surgery (e.g., simple excision, tooth extraction) within 5 days before the first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to the first dose of study treatment. NOTE: Fresh tumor biopsies should be performed at least 5 days before the first dose of study treatment for screening procedures. NOTE: Patients with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible.\n* 3.2.17 Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment. NOTE: ECG evaluation is required at screening; QT prolongation is a potential side effect of VEGFR associated TKIs, such as XL092; NOTE: see Section 4 regarding prohibited concomitant medications that are known to prolong the QT interval (see http:\u002F\u002Fwww.qtdrugs.org for a list of drugs which have the potential to prolong the QT interval); see Section 5 Study Procedures for full details on the ECG evaluation eligibility requirement.\n* 3.2.18 History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent\n* 3.2.19 Patients with: • any other active malignancy within 2 years prior to start of study treatment • a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen NOTE: Allowed: Superficial skin cancers, or localized, low-grade 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* 3.2.20 Administration of a live, attenuated vaccine (e.g., Intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin, yellow fever, varicella, and TY21a typhoid vaccines) is prohibited: • Within 30 days before the first dose of study treatment and • Prohibited for all patients while on study treatment NOTE: Experimental vaccines are not allowed while on study","ALL","18 Years",{"count":19,"type":20},33,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment with radioiodine (radioiodine refractory) and that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). XL092 is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"Locally Advanced Differentiated Thyroid Gland Carcinoma","Locally Advanced Poorly Differentiated Thyroid Gland Carcinoma","Locally Advanced Thyroid Gland Follicular Carcinoma","Locally Advanced Thyroid Gland Oncocytic Carcinoma","Locally Advanced Thyroid Gland Papillary Carcinoma","Metastatic Differentiated Thyroid Gland Carcinoma","Metastatic Poorly Differentiated Thyroid Gland Carcinoma","Metastatic Thyroid Gland Follicular Carcinoma","Metastatic Thyroid Gland Oncocytic Carcinoma","Metastatic Thyroid Gland Papillary Carcinoma","Refractory Differentiated Thyroid Gland Carcinoma","Refractory Poorly Differentiated Thyroid Gland Carcinoma","Refractory Thyroid Gland Follicular Carcinoma","Refractory Thyroid Gland Oncocytic Carcinoma","Refractory Thyroid Gland Papillary Carcinoma","Stage III Differentiated Thyroid Gland Carcinoma AJCC v8","Stage III Thyroid Gland Follicular Carcinoma AJCC v8","Stage III Thyroid Gland Papillary Carcinoma AJCC v8","Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8","Stage IV Thyroid Gland Follicular Carcinoma AJCC v8","Stage IV Thyroid Gland Papillary Carcinoma AJCC v8","RECRUITING","2026-06-24",{"date":50,"type":51},"2026-06-26","ACTUAL",{"date":53,"type":51},"2025-06-06",{"date":55,"type":20},"2030-09-11",{"name":57,"class":58},"Jochen Lorch","OTHER",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100552661","phase-3-study-of-targeted-therapy-vs-chemotherapy-in-patients-with-thyroid-cancer-100552661","NCT06475989","Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer","A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patient must have differentiated thyroid cancer (DTC) with BRAF V600E mutation as determined by local testing, including the following subtypes (Note: results of a previous biopsy will be accepted):\n\n  * Papillary thyroid carcinoma including histological variants of papillary thyroid carcinoma (PTC) such as follicular variant, tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated.\n  * Follicular thyroid carcinoma including histological variants of follicular thyroid carcinoma (FTC) such as Hürthle cell, clear cell, insular, and poorly differentiated\n* Patient must have been previously treated with or deemed ineligible for treatment with Iodine-131 for DTC, and must be receiving thyroxine suppression therapy\n* Patient must have had prior treatment with at least one of the following vascular endothelial growth factor receptors (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib.\n\n  * NOTE: Up to two prior VEGFR-targeting TKI agents are allowed including, but not limited to lenvatinib and sorafenib\n* Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1·1 on chest CT (computed tomography)\u002Fabdominal\u002Fpelvis CT\u002FMRI (magnetic resonance imaging) performed within 4 weeks prior to randomization\n* Patient must have radiographic progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 over any time interval on or after most recent prior systemic treatment\n* Patient must not have any of the following cardiovascular and thromboembolic disorders or medical conditions:\n\n  * Congestive heart failure class 3 or 4 as defined by the New York Heart Association, unstable angina pectoris, or serious cardiac arrhythmias.\n  * Uncontrolled hypertension defined as sustained blood pressure \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n  * Stroke, myocardial infarction, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months prior to randomization. Patients with more recent diagnosis of deep venous thrombosis are allowed if stable and treated with therapeutic anticoagulation for at least 6 weeks prior to randomization\n* Patient must not have any clinically significant hematemesis or haemoptysis of \\> 0·5 teaspoon (\\> 2·5 mL) of red blood or history of other significant bleeding within 3 months prior to randomization\n* Patient must not have any cavitating pulmonary lesion(s) or lesions invading major pulmonary blood vessels\n* Patient must not be on any concomitant anticoagulation with oral anticoagulants or platelet inhibitors, except for the following allowed agents:\n\n  * Low-dose aspirin for cardioprotection.\n  * Therapeutic anticoagulation with any agent in patients (1) without known brain metastases, (2) on a stable dose for at least 6 weeks prior to randomization, and (3) with no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Patient must not have any gastrointestinal (GI) disorders associated with a high risk of perforation or fistula formation:\n\n  * Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\n  * Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months prior to randomization\n* Patient must have completed any prior local therapy (e.g., surgery, radiation, ablation) at least 4 weeks prior to randomization, with complete wound healing and resolution of clinically relevant complications from prior local therapy\n* Patient must not have had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to randomization. Complete wound healing from major surgery must have occurred 4 weeks prior to randomization and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days prior to randomization\n* Patient must not have any lesion(s) with ≥ 2cm growth within 3 months or ≥ 1.5cm growth within 2 months prior to randomization, and must not have documented anaplastic histology at or following cancer recurrence\n* Patient must not have had prior treatment with cabozantinib or any prior BRAF targeted therapy for thyroid cancer\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n\nAll patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.\n\nA patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 2 weeks after the last dose of dabrafenib and 4 months after the last dose of trametinib or cabozantinib. Patients must also not breastfeed while on study treatment and for 2 weeks after the last dose of dabrafenib and for 4 months after the last dose of trametinib or cabozantinib.\n\n  * NOTE: Patients of childbearing potential who are on hormonal contraceptives may be at risks because dabrafenib may decrease the efficacy of hormonal contraceptives. An effective non-hormonal contraception should be used during therapy and for 2 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib and cabozantinib\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Hemoglobulin (Hgb) ≥ 8 g\u002FdL obtained ≤ 28 days prior to protocol randomization\n* Leukocytes ≥ 3,000\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Platelets ≥ 100,000\u002FmcL obtained ≤ 28 days prior to protocol randomization\n* Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) obtained ≤ 28 days prior to protocol randomization\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN or \\\u003C 5.0 x ULN with the presence of hepatic metastasis obtained ≤ 28 days prior to protocol randomization\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m² obtained ≤ 28 days prior to protocol randomization\n* Urine protein\u002Fcreatinine (UPC) ratio ≥ 1 obtained ≤ 28 days prior to protocol randomization\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\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 a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging obtained after central nervous system (CNS)-directed therapy (radiotherapy and\u002For surgery) shows no evidence of progression. CNS disease must be stable for at least 4 weeks prior to randomization; patients must be neurologically asymptomatic and without corticosteroid treatment at time of randomization\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) ≤ 500 ms obtained within 28 days prior to randomization.\n\n  * NOTE: If a single electrocardiogram (ECG) shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 minutes (min) must be performed within 30 min after the initial ECG, and the average of these 3 consecutive results for QTcF will be used to determine eligibility\n* Patient must be English or Spanish speaking to be eligible for the quality of life (QOL) component of the study.\n\n  * NOTE: Sites cannot translate the associated QOL forms",{"count":67,"type":20},264,[69],"PHASE3","This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and\u002For more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.",[36],"2026-06-16",{"date":74,"type":51},"2026-06-18",{"date":76,"type":51},"2024-08-22",{"date":78,"type":20},"2030-09-30",{"name":80,"class":81},"ECOG-ACRIN Cancer Research Group","NETWORK",301]