[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"H. Lee Moffitt Cancer Center and Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":555},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,78,0,25,[9,42,67,91,115,138,163,189,210,232,250,271,293,313,331,352,375,395,413,430,450,476,495,516,535],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100580146","phase-2-phase-ii-study-of-systemic-screening-in-pathologic-node-positive-breast-cancer-100580146",false,"NCT06833502","Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer","Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status.\n* HR+ will be defined as ER and\u002For PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO \u002F CAP Guidelines27. Triple negative will be classified as ER and PR \\\u003C10% and HER2-.\n* Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+\u002FHER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.\n* Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and\u002For taxane-based regimen. To include HER2 directed therapy for HER2+ patients.\n* Age ≥ 18.\n* Life expectancy ≥ 6 months.\n* Eastern Cooperative Oncology Group performance status 0 to 2.\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures.\n* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* Prior diagnosis of systemic metastases.\n* Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.\n* Contraindication towards CT IV contrast.\n* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\\u003C30 ml\u002Fmin).","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.",[27,28],"Breast Cancer","Node-positive Breast Cancer","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2025-02-24",{"date":37,"type":21},"2026-10",{"name":39,"class":40},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100496608","ending-tobacco-use-through-interactive-tailored-messaging-for-cambodian-people-living-with-hivaids-100496608","NCT05746442","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS","Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV\u002FAIDS (Project END-IT)","ProjectENDIT","Inclusion Criteria:\n\n* 1\\) being aged ≥18 years\n* 2\\) being HIV-positive\n* 3\\) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes\u002Fday)\n* 4\\) willing to set a date for a quit attempt within 2 weeks of study enrollment\n* 5\\) being able to provide written informed consent to participate\n* 6\\) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form\n\nExclusion Criteria:\n\n* 1\\) history of a medical condition that precludes use of nicotine replacement therapy\n* 2\\) physician\u002Fclinician deemed ineligible to participate based on medical or psychiatric condition\n* 3\\) enrolled in another cessation program or use of other cessation medications.",{"count":51,"type":21},800,[53],"NA","The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.",[56,57],"Smoking Cessation","HIV","2026-06-24",{"date":60,"type":33},"2026-06-26",{"date":62,"type":33},"2023-01-11",{"date":64,"type":21},"2027-09-30",{"name":39,"class":40},3,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":41},"100437352","phase-1-neoadjuvant-cemiplimab-in-newly-diagnosed-or-recurrent-stage-i-ii-merkel-cell-carcinoma-and-locoregionally-advanced-cutaneous-squamous-cell-carcinoma-100437352","NCT04975152","Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma","Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma: Safety and Biomarker Analysis","Inclusion Criteria:\n\n* Histologically proven diagnosis of Merkel cell carcinoma (MCC).\n* Clinical stage I-II MCC (AJCC 8th edition) either newly diagnosed or previously diagnosed with recent disease recurrence. This includes patients with a previous diagnosis of clinical Stage I-II who present with local or regional disease recurrence.\n* Patients must be considered candidates for wide local surgical excision and may be candidates for sentinel lymph node biopsy. If sentinel biopsy is determined to not be clinically indicated then it would not be required to be completed and only the tumor excision would be required.\n* Patients with stage III to stage IV (M0) CSCC of the head\u002Fneck, extremity, or trunk, and selected patients with stage II CSCC (≥3 cm longest diameter lesion in an aesthetically-sensitive region), for whom surgery is planned.\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged at least 18 years\n* ECOG performance Status of 0, 1, or 2\n* Adequate baseline laboratory assessments within 28 days of study registration:\n\n  1. Adequate hepatic function: i. Total bilirubin ≤1.5 x upper limit of normal (ULN) (NOTE: For patients with Gilbert's syndrome, total bilirubin ≤3 x ULN) ii. Transaminases (aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\]) ≤3 x ULN iii. Alkaline phosphatase (ALP) ≤2.5 x ULN\n  2. Adequate renal function: Serum creatinine ≤1.5 x ULN or estimated creatinine clearance (CrCl) \\>30 mL\u002Fmin according to the method of Cockcroft and Gault.\n  3. Adequate bone marrow function: i. Hemoglobin ≥9.0 g\u002FdL ii. Absolute neutrophil count (ANC) ≥1.0 x 109\u002FL iii. Platelet count ≥75 x 109\u002FL\n* Patients who are HIV+ with undetectable HIV viral load are eligible.\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of cemiplimab administration.\n* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner\n\nExclusion Criteria:\n\n* Concurrent malignancy other than localized CSCC and\u002For history of malignancy other than Merkel cell carcinoma within 3 years of date of registration on the study, except for tumors with negligible risk of metastasis or death, such as adequately treated (BCC) of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low- risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score ≤6 and prostate-specific antigen (PSA) ≤10 ng\u002FmL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of \\>12 months for which the management plan is active surveillance.\n* Patients with hematologic malignancies (eg, chronic lymphocytic leukemia \\[CLL\\]).\n* Ongoing or recent (within 5 years of registration date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). Further, patients requiring chronic immune-suppressive therapy are excluded. 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* Pregnancy or lactation.\n* Has participated in a study of an investigational agent or an investigational device within weeks of the enrollment date.\n* Receipt of a live vaccine within 28 days of the registration date.\n* Has had prior systemic anti-cancer immunotherapy for MCC. Examples of immune modulating agents include but are not limited to blockers of CTLA-4, 4-1BB (CD137), or OX-40, therapeutic vaccines, anti-PD-1\u002FPD-L1.\n* Immunosuppressive corticosteroid doses (\\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab\u002Fplacebo.\n\nNOTE: Patients who require brief course of corticosteroids (eg, prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded. People taking steroids for physiologic replacement (ie, adrenal insufficiency) are NOT excluded.\n\n\\- Has received treatment with an approved anticancer systemic therapy within 4 weeks of the registration date or has not yet recovered (ie, ≤ grade 1 or baseline) from any acute toxicities except for laboratory changes as described in the inclusion criteria.\n\nNOTE: Patients receiving bisphosphonates or denosumab are not excluded.\n\n* Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n* Patients who have permanently discontinued anti-cancer immune modulating therapies due to drug-related toxicity.\n* Encephalitis, meningitis, or uncontrolled seizures in the year prior to screening.\n* Patients with myocardial infarction within 6 months prior to the registration date.\n* Any infection requiring hospitalization and\u002For intravenous antibiotic therapy within 2 weeks of the registration date.\n* Active tuberculosis.\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.\n\nNOTES:\n\n* Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n* Patients with HBV (hepatitis B surface antigen positive; HepBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection AND receiving anti- viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n\nPatients who are HCV antibody positive (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 permitted.\n\n* History of immune related pneumonitis within the last 5 years.\n* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to the registration date.\n* History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.\n* Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.\n* Patients with a history of solid organ transplant (exception: patients with prior corneal transplant are not excluded).\n* Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that, in the opinion of the investigator, renders the patient unsuitable for participation in a clinical trial due to high safety risks and\u002For potential to affect interpretation of results of the study.\n* Known psychiatric or substance abuse disorders that would interfere with participation with the requirements of the study.",{"count":75,"type":21},36,[77],"PHASE1","The goal of this clinical research study is to determine if Cemiplimab-rwlc (called Cemiplimab in this document) given prior to tumor resection surgery is safe and effective in treating (1) Merkel Cell Carcinoma or (2) Cutaneous Squamous Cell Carcinoma (CSCC).",[80,81],"Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma",[83],"Skin Cancer",{"date":85,"type":33},"2026-06-25",{"date":87,"type":33},"2021-10-22",{"date":89,"type":21},"2028-03",{"name":39,"class":40},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":41},"100589972","phase-1-clinical-trial-of-cd40l-augmented-til-for-patients-with-advanced-melanoma-100589972","NCT06961357","Clinical Trial of CD40L-augmented TIL for Patients With Advanced Melanoma","Phase I\u002FII Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced Melanoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed, unresectable (Stage III\u002FIV) or metastatic melanoma as follows: Cutaneous, non-acral, melanoma (including melanoma of unknown primary); Cutaneous acral melanoma; Mucosal melanoma; Ocular melanoma (including uveal, iris, conjunctival melanoma).\n* Participants must have failed, be refractory to, or unable to tolerate at least one line of standard of care in the opinion of the Investigator. For participants with cutaneous non-acral melanoma, standard of care therapy includes a PD-1\u002FL1 or combination therapy with anti-PD1 and anti-CTLA4 or combination therapy of anti-PD1 and anti-LAG3 or if BRAF V600 activating mutation positive, a BRAF ± MEK inhibitor. Participants are allowed to be enrolled in this trial if they failed one line of any of those standards of care therapy regimens.\n* Any systemic therapy, including anti-cancer monoclonal antibodies, must have been completed at least 4 weeks from the start of lymphodepleting therapy, and any prior therapy-related AEs must have resolved to Grade ≤ 1 except for alopecia and vitiligo.\n* Participants must be ages ≥18. Additionally, participants who are ≥ 65 years of age may need to undergo a cardiology evaluation including a cardiac stress test or coronary computed tomography after which they must be deemed to be low\u002Facceptable risk. This cardiac evaluation may be omitted for patients who underwent testing within 6 months and have no interval change in cardiopulmonary clinical status. Note 1: Cardiac stress test may be omitted for patients ≥65 years old (y\u002Fo) who are fully functional with no relevant medical comorbidities and are able to carry ≥4 METS activities at baseline. For patients who demonstrate abnormal cardiac stress test cardiac evaluation by cardiologist will be done and if deemed low acceptable risk, will be allowed to participate in this trial per PI discretion. Cardiac stress test may be indicated for any patient \\\u003C65 y\u002Fo who have relevant medical comorbidities or demonstrate clinically worrisome symptoms. Note 2: While age preference will be between 18-75 years, this study allows age \\>75 years if the patient meets eligibility criteria and demonstrates no significant medical comorbidities per PI.\n* ECOG performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined within the protocol.\n* Seronegative for Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C (HCV) antibody (if HCV antibody positive, must be tested for HCV RNA, which must be negative to be eligible).\n* Participants with brain metastases are eligible provided that the brain metastases have been successfully treated with stereotactic radiosurgery or resection and clinically stable for at least 4 weeks (±14 days). Note: Participants who develop brain metastases after tumor harvest and\u002For lymphodepleting therapy will be allowed to remain on study and may proceed with cell therapy after undergoing definitive radiation therapy and\u002For surgery. For those participants who develop brain metastases during lymphodepleting therapy and undergo definitive radiation therapy and\u002For surgery careful decision will be made to proceed with TIL infusion after discussion with treating physician, neurosurgeon, radiation oncologist and PI.\n* Women of child-bearing potential must have a negative pregnancy test.\n* The effects of CD40L-augmented TIL on the developing human fetus are unknown. For this reason and because TIL agents, as well as other therapeutic agents used in this trial including IL-2 are known to be teratogenic, both males and females of childbearing potential must be willing to practice birth control starting with screening through 1 year after the last study drug is administered for females or 6 months for males.\n* Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Participants should have at least one surgically accessible lesion for tumor harvest for preparation of TIL, and at least one RECIST v1.1 measurable lesion after tumor harvest to follow for response assessment. Note: Tumor harvest lesion will be considered as target lesion if after harvest remaining portion of tumor meets RECIST v1.1 measurable lesion criteria.\n\nExclusion Criteria:\n\n* Participants, regardless of age, who have a current or past medical history of ischemic heart disease, or clinically significant atrial or ventricular rhythm abnormality are excluded unless they undergo a cardiac stress test and cardiology clearance examination and are determined to be low or acceptable risk.\n* Participants with either a primary immunodeficiency disorder (i.e., severe combined immunodeficiency syndrome) or acquired immunodeficiency disorders (such as HIV\u002FAIDS).\n* Pregnant women are excluded from this study because the agents used in this study have 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 CD40L-augmented TIL or the other agents in the study, breastfeeding should be discontinued if the mother is enrolled in the study.\n* Participants taking systemic steroid therapy (other than replacement therapy or prednisone equivalent of ≤10mg daily) or therapy with any immunosuppressive medications such as mycophenolate mofetil (MMF). Participants who require more than 10mg of prednisone or equivalent other steroid therapy should taper their steroid therapy to 10 mg prednisone 1 week prior to planned first interventional drug therapy (lymphodepleting therapy). Participants who are on baseline replacement therapy or prednisone equivalent of ≤10mg daily and require stress doses of steroid therapy will be allowed to receive stress dose steroids during the trial interventions. Participants who require dapsone for pneumocystis pneumonia (PCP) prophylaxis during TIL therapy are eligible.\n* Participants who have a history of severe immediate hypersensitivity reaction to the study agents including cyclophosphamide, fludarabine, or IL-2 or any of their constituents.\n* Participants with a left ventricular ejection fraction (LVEF) ≤ 45% or New York Heart Association (NYHA) functional classification \\> 1.\n* Forced expiratory volume (FEV1) ≤ 60% of predicted value and DLCO (corrected) \\\u003C 60% of predicted value. Participants who underwent pulmonary function testing within 6 months of screening may omit PFTs if they demonstrate stable cardiopulmonary status.\n* Participants who, in the opinion of the Investigator, have a medical condition that would subject the patient to prohibitive risk by participation in this study, or who may be unable to safely complete tumor harvest, lymphodepletion regimen, TIL infusion, or aldesleukin administration.\n* Participants with active infections requiring antibiotics.\n* Participants with active autoimmune diseases currently requiring systemic treatment with immunosuppressive doses of corticosteroids (\\>10 mg of prednisone-equivalent daily dosing), immunosuppressive biologic agents, or disease modifying antirheumatic drug agents (DMARDs).\n* Patients who received prior live cell therapy are excluded, unless express written permission is provided by the clinical PI.",{"count":75,"type":21},[77,24],"This is a phase I\u002FII clinical trial of a single dose of CD40L-augmented TIL administered in patients with advanced melanoma (Cohort 1: Cutaneous acral melanoma, cutaneous non-acral melanoma, (n=26); Cohort 2: Mucosal melanoma, uveal melanoma, (n=10)). Patients will undergo an excision of a readily accessible tumor for preparation of TIL. Eligible patients with progressive disease after standard of care therapy will undergo lymphodepletion with cyclophosphamide and fludarabine followed by CD40L-augmented TIL and standard of care bolus dose interleukin-2 (short-course IL-2).",[102],"Melanoma",[104,105,106,107],"Mucosal melanoma","Uveal melanoma","Cutaneous acral melanoma","Cutaneous non-acral melanoma","2026-06-23",{"date":60,"type":33},{"date":111,"type":33},"2025-12-03",{"date":113,"type":21},"2030-05",{"name":39,"class":40},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":123,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":41},"100643253","prehabilitation-intervention-to-modify-eating-for-breast-cancer-patients-prime-100643253","NCT07638150","PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)","PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study","PRIME","Inclusion Criteria:\n\n* Newly diagnosed stage I-III breast cancer.\n* Treatment-naïve; no neoadjuvant therapy planned.\n* Surgery scheduled at Moffitt in 1-2 months.\n* Post-menopausal.\n* BMI 28-35 kg\u002Fm².\n* NCI Fruit \\& Vegetable Screener \\\u003C5 servings\u002Fday.\n* Willing to consume only study-provided meals.\n\nExclusion Criteria:\n\n* Stage IV\u002Fmetastatic disease.\n* Prior cancer.\n* Surgery scheduled sooner than 4-5 weeks.\n* NCI FVS ≥5 servings\u002Fday.\n* Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.","FEMALE",{"count":125,"type":21},20,[53],"This single-arm pilot study evaluates the feasibility and acceptability of a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery. All meals are provided to participants. Secondary aims include assessing changes in body composition, metabolic biomarkers, inflammation, gut microbiome composition, patient-reported outcomes, and clinician-reported surgical recovery metrics.",[27],"NOT_YET_RECRUITING","2026-06-04",{"date":132,"type":33},"2026-06-10",{"date":134,"type":21},"2026-08",{"date":136,"type":21},"2027-04",{"name":39,"class":40},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100492057","evaluating-obesity-mediated-mechanisms-of-pancreatic-carcinogenesis-in-minority-populations-100492057","NCT05687188","Evaluating Obesity-Mediated Mechanisms of Pancreatic Carcinogenesis in Minority Populations","Inclusion Criteria:\n\n* Adults 18 years of age or older at time of signing informed consent\n* Patients who self-report as African American, Non-Hispanic White\n* Patients who present to the gastrointestinal (GI) clinic, surgery, or endoscopy at a participating Florida Pancreas Collaborative (FPC) site or the University of Mississippi Medical Center (UMMC) with a clinical suspicion or diagnosis of a pancreatic tumor.\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Has no suspicion or diagnosis of a pancreatic cancer or tumor\n* Self-reported race\u002Fethnicity other than African American or Non-Hispanic White.",{"count":145,"type":21},125,"OBSERVATIONAL","This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.",[149],"Pancreatic Cancer",[151,152,153],"pancreas","biomarkers","health disparities","2026-05-21",{"date":156,"type":33},"2026-05-26",{"date":158,"type":33},"2023-02-22",{"date":160,"type":21},"2026-12",{"name":39,"class":40},2,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":188,"locationsCount":41},"100627361","testing-an-mbi-for-smoking-cessation-and-alcohol-use-among-cancer-survivors-100627361","NCT07447635","Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors","Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention","Inclusion Criteria:\n\n* ≥18 years old\n* History of a cancer diagnosis at any point in lifetime\n* Smoked ≥1 cigarette\u002Fday in past month\n* At least one binge drinking episode in past month or exceeds weekly drinking limits\n* Motivated to quit smoking and modify alcohol use in next 30 days\n* Valid home address in Florida\n* English-speaking, reading, and writing ability\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Active psychotic disorder\n* History of severe alcohol withdrawal\n* Current use of tobacco cessation medication or other treatments to quit smoking\n* End-of-life or hospice care\n* Household member already enrolled",true,{"count":172,"type":21},600,[53],"This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.",[56,176],"Alcohol Use",[178,179,180,181],"Mindfulness-based intervention","Cancer survivors","Smoking cessation","Alcohol use","2026-05-15",{"date":184,"type":33},"2026-05-18",{"date":182,"type":33},{"date":187,"type":21},"2029-12",{"name":39,"class":40},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":196,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100629540","phase-2-phase-2a-study-of-high-dose-testosterone-followed-by-radioligand-therapy-in-mcrpc-100629540","NCT07476001","Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC","A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed prostate cancer that has progressed to mCRPC with no grade 2 or above cancer related symptoms.\n* Participants need to have either PSA or imaging progression at castrate level of serum testosterone (i.e. \\\u003C50ng\u002Fdl). The definition of PSA progression and the definitions of imaging progression on measurable or non-measurable lesions will be based on the prostate cancer working group 3 (PCWG3) criteria. Patients with symptomatic oligo progression (1-3 sites), the symptoms need to be improved to grade 1 or less with palliative local therapy prior to study enrollment.\n* Participants need to have a positive PSMA PET scan and deem eligible for PSMA-617.\n* Allowable prior therapies: Prior treatment with one line of ARPI. Patients need to be on ARPI for at least 4 weeks to be considered one line of therapy. Prior treatment with sipuleucel-T for mCRPC. Prior treatment with docetaxel in the castration sensitive setting.\n* ECOG performance status 0-1.\n* Participants must have adequate organ and marrow functions.\n* Participants 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* Participants with h\u002Fo myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.\n* Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of enzalutamide or docetaxel administration.\n* Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* Metastatic prostate cancer with known epidural, liver or brain metastases.\n* No history of cord compression.\n* Treatment with radiation within 30 days prior to the first dose of Tc400.\n* Receiving any other investigation agents. Prior treatment with investigation agents need to have a washout period of 4 weeks prior to enrollment.\n* Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, delayed healing of wounds, ulcers, or bone fractures, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","MALE",{"count":198,"type":21},12,[24],"The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.",[202],"Metastatic Castration-resistant Prostate Cancer","2026-05-14",{"date":182,"type":33},{"date":206,"type":33},"2026-03-03",{"date":208,"type":21},"2027-09",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":231,"locationsCount":41},"100630399","phase-1-safety-and-efficacy-of-pipac-using-single-agent-mitomycin-in-solid-tumors-100630399","NCT07487168","Safety and Efficacy of PIPAC Using Single Agent Mitomycin in Solid Tumors","Phase 1 Single Center Study to Evaluate Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Single Agent Mitomycin C (MMC) in Peritoneal Carcinomatosis (PC) From Solid Gastrointestinal Malignancies (sGI-PC) in Palliative Setting","Inclusion Criteria:\n\n* Participants must have histologically confirmed peritoneal disease from colorectal, small bowel, or high grade appendiceal adenocarcinoma. High grade appendiceal cancers include moderate or poorly differentiated mucinous or non-mucinous adenocarcinoma, signet ring cell adenocarcinoma, or goblet cell adenocarcinoma. This can be established by image guided biopsy, diagnostic laparoscopy, or previous surgery.\n* Patients must be ineligible for CRS\u002FHIPEC through one of the following criteria: a) PCI score ≥16. b) Inability to achieve complete cytoreduction due to extent of disease. c) Significant small bowel involvement precluding a complete CRS. d) Unresectable disease in porta hepatis, pelvic side wall or other critical structure. e) Patients who decline invasive cytoreduction.\n* Participants must be 18 years of age or older.\n* Participants must have completed at least 4 months of first-line systemic therapy (5-FU based approach with or without biologic therapy).\n* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below: a) absolute neutrophil count ≥1500\u002FmcL. b) platelets ≥100,000\u002FmcL. c) total bilirubin ≤ institutional upper limit of normal (ULN). d) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN. e) creatinine ≤ 1.5 institutional ULN. or f) glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification (see Appendix C).\n\nTo be eligible for this trial, participants should be class 2B or better.\n\n* MMC is a known teratogen, for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration. For women of child-bearing potential a negative urine pregnancy test is required on the morning of surgery.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have received targeted therapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for VEGF inhibitors, nitrosoureas or mitomycin C) prior to entering the study.\n* Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1), except for alopecia and chemotherapy induced peripheral neuropathy \\\u003C 2.\n* Patients with extensive metastatic liver disease (\\>50% liver volume) are excluded from the trial as are patients with brain metastases. Patients with non-peritoneal metastatic disease are otherwise eligible provided they meet the survival expectations of \\>6 months.\n* Patients with brain metastases are excluded\n* Patients with bowel obstruction or need for nutritional support (i.e., TPN or tube feeds).\n* Participants who are receiving any other investigational agents or enrolled on other research protocols that may interfere with compliance with requirements of the study.\n* History of allergic reactions or poor tolerance attributed to compounds of similar chemical or biologic composition to MMC, fluoropyrimidines, or anesthesia medications.\n* Participants with uncontrolled intercurrent illnesses.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because MMC is an antibiotic alkylating antineoplastic agent 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 MMC, breastfeeding should be discontinued if the mother is treated with MMC.\n* Inability to safely perform laparoscopy due to previously noted adhesions or extensive prior surgery which the treating surgeon feels would exclude safe abdominal access.\n* Life expectancy less than 6 months.\n* Patients with history of thromboembolic complications that cannot discontinue for the perioperative duration.",{"count":218,"type":21},24,[77],"This single-center, Phase 1 dose-escalation study will evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of pressurized intraperitoneal aerosol chemotherapy with mitomycin C (PIPAC-MMC) for patients with unresectable peritoneal carcinomatosis from gastrointestinal primaries (colorectal, high-grade appendiceal, or small bowel). Up to three PIPAC procedures are planned at 8-week intervals while patients continue 5-fluorouracil\u002Fleucovorin (5-FU\u002FLV) between procedures. The trial uses a Bayesian optimal interval (BOIN) design to determine dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD). Pharmacokinetics (PK), pharmacodynamics (PD), and quality of life (QoL) will be assessed.",[222],"Peritoneal Carcinomatosis",[224,225,226,227],"Appendiceal cancer","Peritoneal disease","Colorectal cancer","Pressurized Intraperitoneal Aerosolized Chemotherapy",{"date":182,"type":33},{"date":134,"type":21},{"date":89,"type":21},{"name":39,"class":40},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":162},"100620413","phase-3-phase-iii-trial-of-brain-mri-surveillance-in-stage-iv-breast-cancer-100620413","NCT07357298","Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status\n* Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+\u002FHER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.\n* HR+ will be defined as ER and\u002For PR \\> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO \u002F CAP Guidelines41. Triple negative will be classified as ER and PR \\\u003C10% and HER2-.\n* Age ≥ 18\n* Life expectancy ≥ 6 months\n* Eastern Cooperative Oncology Group performance status ≤ 2\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of brain metastases or leptomeningeal disease\n* History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \\> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI\n* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment\n* Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)\n* Contraindication towards MRI with contrast\n* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\\u003C30 ml\u002Fmin)",{"count":239,"type":21},156,[241],"PHASE3","This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.",[27],{"date":182,"type":33},{"date":246,"type":33},"2026-02-25",{"date":248,"type":21},"2030-02",{"name":39,"class":40},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":257,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100607860","phase-1-metastatic-ewings-trial-testing-schedule-enhancement-to-improve-outcomes-100607860","NCT07194044","Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes","METTSEO","Inclusion Criteria:\n\n* Patients must be \\>1 year of age. There is no upper age limit.\n* Patients, in the opinion of the enrolling investigator, must be healthy enough to tolerate protocol therapy.\n* Patients must have a new histologic diagnosis of either: widely metastatic Ewing sarcoma or metastatic CIC-rearranged sarcoma.\n* Patients must have sufficient tissue submitted (flash frozen tissue, FFPE block, or up to 10 unstained FFPE slides) for correlative testing. This may be from a primary or metastatic site.\n* Patients must not have received any prior systemic therapy with the exception that they may have started an initial cycle of vincristine\u002Fdoxorubicin\u002Fcyclophosphamide (VDC) prior to enrollment, i.e. VDC may have been given, but not ifosfamide\u002Fetoposide (IE).\n* Adequate organ function.\n* Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.\n* All patients and\u002For their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.\n\nExclusion Criteria:\n\n* Patients with localized disease or lung only metastases for Ewing sarcoma or localized disease for CIC-rearranged sarcomas.\n* Patients with central nervous system (CNS) tumors (primary or metastatic) are not eligible.\n* Patients who are receiving any other investigational agents for their cancer.\n* Patients with a history of cancer that was treated with myelosuppressive chemotherapy or radiation therapy.\n* Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer.\n* Patients are ineligible if they have uncontrolled intercurrent illness.\n* Pregnancy or Breast Feeding: Pregnant or breast-feeding women will not be entered on this study, because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to starting protocol therapy.\n* Patients who are considered unable to comply with the safety monitoring requirements of the study are not eligible.","1 Year",{"count":259,"type":21},15,[77],"This single arm study is designed to demonstrate the feasibility of a radically different approach for an exceptionally high-risk subset of MES with widely metastatic disease (WMES). We incorporate the use of evolutionary principles that apply to species and population dynamics as related to adaptation and extinction to populations of cancer cells that similarly adapt and that we are attempting to make extinct, resulting in a cure for the patient. Such principles include an initial intense first strike to deplete the bulk of the cancer cells, followed by a series of sequential second strikes towards eliminating residual, resistant populations, followed by a prolonged period of maintenance chemotherapy to eliminate any remnant cells, using agents generally regarded to be active against newly diagnosed ES.",[263],"Metastatic Ewing Sarcoma",{"date":182,"type":33},{"date":266,"type":33},"2026-02-05",{"date":268,"type":21},"2030-10",{"name":39,"class":40},17,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":286,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":162},"100448132","phase-2-study-of-screening-brain-mris-in-stage-iv-breast-cancer-100448132","NCT05115474","Study of Screening Brain MRIs in Stage IV Breast Cancer","Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status\n* Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+\u002FHER2- patients\n* Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients\n* Age ≥ 18\n* Life expectancy ≥ 6 months\n* Eastern Cooperative Oncology Group performance status 0 to 2\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of brain metastases or leptomeningeal disease\n* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years\n* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment\n* Indications warranting brain MRI for other neurologic conditions at time of study entry\n* Contraindication towards MRI imaging with contrast\n* Chronic kidney disease stage IV or V or end stage renal disease",{"count":279,"type":21},170,[24],"The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.",[283,284,285],"Triple Negative Breast Cancer","HER2-positive Breast Cancer","Hormone Receptor-positive Breast Cancer",[287],"Stage IV Breast Cancer",{"date":184,"type":33},{"date":290,"type":33},"2021-12-21",{"date":37,"type":21},{"name":39,"class":40},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":66},"100585975","creation-of-an-infrastructure-to-support-delivery-of-mhealth-interventions-for-cancer-patients-100585975","NCT06909357","Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients","Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida","Project mFLi","Inclusion Criteria:\n\n* ≥18 years of age.\n* ≥100 lifetime cigarettes.\n* English-speaking.\n* Report smoking ≥ 1 cigarette in past 30 days.\n* Working smartphone.\n\nExclusion Criteria:\n\n* Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.\n* Currently pregnant or breastfeeding.",{"count":302,"type":21},90,[53],"Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.",[56],"2026-05-12",{"date":203,"type":33},{"date":309,"type":33},"2025-03-28",{"date":311,"type":21},"2027-02",{"name":39,"class":40},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":330,"locationsCount":41},"100548666","remote-exercise-and-nutritional-prehabilitation-for-pancreatic-cancer-100548666","NCT06423963","Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer","Inclusion Criteria:\n\n* Age 18 years or older\n* Biopsy-proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Undergoing neoadjuvant chemotherapy with treatment plan including chemoradiation therapy and surgical resection\n* Ability to read and speak English\n\nExclusion Criteria:\n\n* Regular engagement in RT (2x\u002Fweek targeting all major muscle groups)\n* Screen failure for exercise safety based on PAR-Q\n* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease\n* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT\n* Numeric pain rating scale greater than or equal to a 7 out of 10\n* Myopathic or rheumatologic disease that impacts physical function",{"count":320,"type":21},26,[53],"The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition \"prehabilitation\" program for patients preparing for pancreatic cancer resection (removal).",[149],"2026-05-05",{"date":326,"type":33},"2026-05-06",{"date":328,"type":33},"2024-02-09",{"date":134,"type":21},{"name":39,"class":40},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100566836","phase-2-ruxolitinib-vs-prednisone-as-first-line-therapy-for-cgvhd-needing-systemic-therapy-100566836","NCT06660355","Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy","Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Karnofsky performance status ≥60%.\n* Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed.\n* No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.\n* Able to take oral medications.\n* Participants must have adequate organ and marrow function as defined below:\n\n  1. absolute neutrophil count ≥1,000\u002FmcL\n  2. platelets ≥30,000\u002FmcL\n  3. Hemoglobin ≥ 7 g\u002FdL\n  4. Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH\n\n  d. AST(SGOT)\u002FALT(SGPT) ≤5 × institutional ULN unless attributable to GVH e. creatinine clearance ≥30 ml\u002Fmin\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD).\n* Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded.\n* Relapse malignancy post- transplant.\n* Active hepatitis B, hepatitis C and HIV will be excluded.\n* Any uncontrolled infection at the time if enrollment will be excluded.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib.\n* Current or history of active Tuberculosis.",{"count":20,"type":21},[24],"Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.",[342],"Chronic Graft-versus-host Disease (cGVHD)","2026-04-07",{"date":345,"type":33},"2026-04-08",{"date":347,"type":33},"2024-12-23",{"date":349,"type":21},"2028-12",{"name":39,"class":40},5,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":351},"100573407","phase-2-prospective-trial-assessing-real-world-outcomes-response-to-pembro-in-black-patients-w-nsclc-100573407","NCT06745882","Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w\u002F NSCLC","Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent\u002Fassent.\n* Must be ≥ 18 years of age on day of signing informed consent.\n* Be Black \u002F African American per self-report.\n* Have an ECOG performance status of 0- 2.\n* Have histologically or cytologically confirmed, advanced\u002Fmetastatic NSCLC.\n* Be treatment naïve in the advanced\u002Fmetastatic\u002Frecurrent disease setting.\n* No known EGFR\u002FALK\u002FROS1 tumor mutations. Liquid biopsies are acceptable.\n* Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and\u002For neoadjuvant and\u002For adjuvant immunotherapy and\u002For consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible.\n* Be planned\u002Feligible to receive first-line therapy in the advanced\u002Fmetastatic setting.\n* Have testing status for PDL1 tissue status.\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n* Adequate organ function.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n* Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.\n\nCohorts 1, 2a and b: Exclusion Criteria:\n\n* Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard\u002Ftreating provider.\n* History of allogenic tissue\u002Fsolid organ transplant.\n\nCohort 2a and b Only: Exclusion Criteria:\n\n* Received prior treatment chemotherapy and\u002For immune checkpoint inhibitor therapy in the advanced\u002Fmetastatic setting for lung cancer.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses\n\n  ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg\u002Fday prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.\n* Has active autoimmune disease that has required active systemic treatment in the past 2 years \\[i.e., with use of disease modifying agents, corticosteroids in doses greater than 10 mg of prednisone daily (or equivalent) or immunosuppressive drugs\\]. 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.\n* Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, that would substantially increase the risk of incurring adverse events (AEs) from the study medications, that would interfere with the subject's participation for the full duration of the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has received a live vaccine within 30 days of planned start of study therapy.\n\nCohorts 1, 2a and b: Exclusion Criteria:\n\n* Has received an investigational agent or has used an investigational device within 3 weeks prior to study intervention administration.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has known untreated central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have completed radiation therapy (where applicable), are clinically stable and have not required steroid treatment at ≥ 10 mg of prednisone for at least 3 days prior to the first dose of study intervention.\n* Severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients or has a known sensitivity as applicable to carboplatin, cisplatin, taxane or pemetrexed.",{"count":360,"type":21},318,[24],"This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced\u002Fmetastatic NSCLC without known EGFR\u002FALK\u002FROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.",[364],"Non-small Cell Lung Cancer",[366],"Justice","2026-04-01",{"date":369,"type":33},"2026-04-02",{"date":371,"type":33},"2025-06-13",{"date":373,"type":21},"2030-01",{"name":39,"class":40},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":41},"100596624","phase-1-ropeginterferon-in-patients-wcutaneous-t-cell-lymphoma-ctcl-100596624","NCT07047885","Ropeginterferon in Patients w\u002FCutaneous T-Cell Lymphoma (CTCL)","A Phase I\u002FIB Study of Ropeginterferon in Patients With Cutaneous T-Cell Lymphoma (CTCL)","Inclusion Criteria:\n\n* Diagnosed with cutaneous T-cell lymphoma, stage IA-IIIB CTCL according to WHO-EORTC classification, specifically the following subtypes: Mycosis Fungoides (MF); Sézary Syndrome (SS); Lymphomatoid Papulosis (LyP) or other rare CTCL variants per WHO-EORTC classification, provided the investigator determines the disease course warrants systemic treatment.\n* A) For Stage IA-IB: Must have failed at least two prior lines of skin-directed therapy, where \"failed\" is defined as any of the following: a. Inadequate response (persistent clinically significant lesions or symptoms), b. Unacceptable toxicity, or c. Disease progression. Such patients require a systemic approach because of symptomatic, refractory, or recalcitrant disease. B) For Stage IIA-IIIB: Must have a documented less-than-complete response to phototherapy, extracorporeal photopheresis (ECP), or total skin electron beam therapy (TSET), or have failed disease after ≥2 lines of topical therapy (using the same definition of \"failed\" as above.\n* Patients are allowed to continue phototherapy or ECP at their prior schedule or a less frequent schedule. Topical therapy, phototherapy, and ECP are allowed if the patient has been on a stable dose of topical therapy or schedule of the phototherapy or ECP. Patients are not allowed to start new skin-directed therapies or escalate the frequency of the prior skin-directed therapy schedule while on the study.\n* Male or female, aged 18 years or older.\n* There is no evidence of large cell transformation on the skin biopsy at the screening visit.\n* Ability to take subcutaneous injection medication and be willing to adhere to the P1101 q2week injection regimen.\n* Minimum wash-out period of 3 weeks between the last dose of prior systemic therapy (other anti-cancer therapy aside from ECP or phototherapy) and the first dose of P1101.\n* Women of childbearing potential (WCBP) must have a negative serum beta-HCG pregnancy test within 7 days of receiving study medication. An WOCP is considered a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months. For WOCP and female partners of male subjects, reliable contraception methods must be used throughout the duration of treatment up to at least 8 weeks after the last dose of study drug has been administered.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Acceptable Hematologic Parameters\n* Thyroid-stimulating hormone (TSH) within institutional normal limits OR well-controlled on thyroid replacement.\n* Lipid Panel: a. No severe hypertriglyceridemia (e.g., triglycerides \\\u003C 400-500 mg\u002FdL, or medically manageable per investigator discretion). b. No uncontrolled hypercholesterolemia that is unresponsive to standard lipid lowering agents.\n* Renal Function: Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin using a CKD EPI.\n* AST\u002FALT \\\u003C 3 x upper limit of normal (ULN), and total bilirubin \\\u003C 2 x ULN (unless due to Gilbert's syndrome).\n\nExclusion Criteria:\n\n* Large cell transformation at screening visit.\n* Child-Pugh B or C hepatic impairment of any etiology.\n* Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3.\n* Treatment with another investigational drug or other systemic drug within 3 weeks. Concomitant administration of radiotherapy or systemic anti-cancer therapy, including but not restricted to chemotherapy, biological agents, or immunotherapy. Concurrent use of systemic steroids is allowed in patients with erythroderma who have been on corticosteroids to avoid possible rebound flare of the disease, adrenal insufficiency, or unnecessary suffering. Concomitant phototherapy or extracorporeal photopheresis (ECP) are also allowed.\n* Severe or unstable cardiovascular disease (uncontrolled hypertension, heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina, or recent stroke or myocardial infarction.\n* Active, uncontrolled HIV, detectable HBV, or active HCV infection. The patients who are stable on anti-retroviral therapy or suppressed on HBV\u002FHCV therapy are allowed in the study.\n* Active, uncontrolled ophthalmic disorders such as severe retinopathy, uncontrolled glaucoma, or advanced proliferative retinopathy.\n* History of or active serious or uncontrolled autoimmune disease, or patients on systemic immunosuppressants or history of systemic immunosuppressants for autoimmune disease.\n* History of solid organ or stem cell transplantation recipients who are at heightened risk for immunologic complications on interferons.\n* Known hypersensitivity to interferons.\n* Baseline QTcF \\> 470 ms.\n* No active, serious infection requiring systemic antimicrobial therapy at screening.\n* Pregnant or breastfeeding women are excluded.",{"count":383,"type":21},38,[77],"This is a single-center, phase I\u002FIB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at least two prior lines of skin-directed therapy (Stage IA-IB) or have less than a complete response to phototherapy or extracorporeal photopheresis (ECP) or total skin electron beam therapy (TSET), or stable\u002Fprogressive disease after at least two lines of topical therapy (Stage IIA-IIIB).",[387],"Cutaneous T Cell Lymphoma","2026-03-31",{"date":367,"type":33},{"date":391,"type":33},"2025-08-27",{"date":393,"type":21},"2028-06",{"name":39,"class":40},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":412,"locationsCount":41},"100595280","predictors-of-health-related-qol-in-adults-with-cll-or-small-lymphocytic-lymphoma-100595280","NCT07030400","Predictors of Health-Related QOL in Adults With CLL or Small Lymphocytic Lymphoma","Predictors of Health-Related Quality of Life in Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","Inclusion Criteria:\n\n* All patients with pathology-confirmed diagnoses of CLL who are within seven days of starting treatment with a BTKi +\u002F- an anti-CD 20 monoclonal antibody or BCL2i with Obinutuzumab treatment will be included.\n* Subjects must be able to read and speak English or Spanish at the 8th grade level.\n\nExclusion Criteria:\n\n* Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.",{"count":403,"type":21},100,"The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.",[406,407],"Small Lymphocytic Lymphoma (SLL)","Chronic Lymphocytic Leukemia (CLL)",{"date":367,"type":33},{"date":410,"type":33},"2025-07-17",{"date":393,"type":21},{"name":39,"class":40},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":66},"100593502","phase-2-pembrolizumab-for-advanced-cutaneous-sarcomas-not-including-angiosarcoma-100593502","NCT07007273","Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of soft tissue sarcoma, not including angiosarcoma, will be enrolled on study. The primary tumor site must be deemed to be cutaneous or dermal in the opinion of the treating investigator (note the primary tumor site does NOT need to be present at the time of screening, i.e., may have been previously resected but recurred and\u002For metastasized).\n* Participants must have metastatic or advanced disease which could include recurrent, unresectable or multifocal lesions or in which resection would result in unacceptable morbidity per the treating investigator.\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Archival tumor tissue sample or newly obtained \\[core, punch, incisional, or excisional\\] biopsy of a tumor lesion not previously irradiated is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n* Prior oncologic therapy is allowable but not required. Must be at least 4 weeks since prior systemic anti-cancer therapy including investigational agents prior to start of study treatment. For prior tyrosine kinase inhibitor therapy, 3 drug half-lives may instead be used for this criterion (if shorter). Must be at least 2 weeks since prior radiotherapy prior to start of study treatment.\n* Have an ECOG performance status ≤ 1.\n* Participants must have adequate organ and marrow function as defined in the protocol.\n* HIV-infected participants must have well-controlled HIV on ART.\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.\n* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n* Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system- (CNS-) directed therapy shows no evidence of progression for at least 4 weeks by repeat imaging, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy.\n* Participants with a prior or concurrent malignancy are eligible for this trial if the malignancy is not progressing and has not required therapy in the past 3 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n* Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1), with the exception of alopecia or participants who have ≤Grade 2 neuropathy.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of other vaccine types is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid)\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.",{"count":270,"type":21},[24],"This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and\u002For gender. Approximately N=17 patients are planned to be enrolled. Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).",[423],"Cutaneous Sarcoma",{"date":367,"type":33},{"date":426,"type":33},"2025-06-20",{"date":428,"type":21},"2030-07",{"name":39,"class":40},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":162},"100566837","phase-2-bcl2i-clag-m-in-rr-acute-myeloid-leukemia-100566837","NCT06660368","BCL2i CLAG-M in R\u002FR Acute Myeloid Leukemia","A Prospective, Multicenter, Randomized, Open-Label, Phase II Study of Salvage BCL2i Plus CLAG-M in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.\n* Adults aged ≥18 years - 80 years.\n* Patients with documented refractory or relapsed AML: Refractory disease is defined as failure to achieve CR (i.e., \\\u003C5% blasts in BM or blood) with or without normal restoration of hematopoiesis (Cri) after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction). Relapse: Recurrence of disease after achieving remission, meeting one or more of the following criteria: ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease.\n* Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if \\> 3 months from venetoclax exposure), and\u002For 1 cycle of induction chemotherapy.\n* Extramedullary AML with marrow involvement is allowed as long as concurrent medullary AML is present.\n* ECOG performance status ≤ 2.\n* Participants must have adequate organ function as defined within the protocol.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not mandatory.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and have an undetectable HCV viral load. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Testing is not mandatory.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 4 months after completion of study drug administration.\n\nExclusion Criteria:\n\n* Venetoclax-refractory disease or recent venetoclax exposure \\\u003C 3 months prior to first dose of study therapy.\n* Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG\u002FFLAG\u002FMEC\u002FCLIA\u002FHAM, etc.).\n* Allogeneic stem cell transplant in the past 3 months.\n* Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea.\n* Known history of prior TP53 mutation (results from any myeloid mutation panel are not required for screening eligibility).\n* Active CNS involvement by AML.\n* WBC count ≥25k at the time study treatment begins.\n* Uncontrolled intercurrent systemic illness that would limit compliance.\n* Concurrent malignancy in addition to AML that requires active treatment with some exceptions.\n* Immunosuppressive therapy in the past 14 days except for prednisone at ≤ 10 mg\u002Fday or equivalent AND no active or uncontrolled graft-versus-host disease (GvHD).\n* Participants who have not recovered from adverse events (Aes) due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1), with the exception of alopecia.\n* Participants who are receiving any other investigational agents.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with active heart disease that limits the use of mitoxantrone or recent (\\\u003C6 months) history of an acute cardiovascular event (STEMI, NSTEMI).\n* Pregnant women are excluded from this study because venetoclax, cladribine, and cytarabine are agents 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 these drugs, breastfeeding should be discontinued.","80 Years",{"count":439,"type":21},52,[24],"This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R\u002FR) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.",[443],"Relapsed or Refractory Acute Myeloid Leukemia (AML)",{"date":367,"type":33},{"date":446,"type":33},"2024-11-26",{"date":448,"type":21},"2027-11",{"name":39,"class":40},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":464,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":41},"100558650","phase-2-ph-ii-study-of-enfortumab-vedotin-in-patients-with-advanced-or-metastatic-crc-or-hcc-100558650","NCT06553885","Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC","A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed CRC or HCC that is metastatic or unresectable and have progressive disease or intolerance after standard front-line therapies as defined below:\n\nParticipants with CRC (cohort 1): Participants must have had progressive disease or intolerance after at least 2 but no more than 3 prior lines of systemic therapy in advanced or metastatic setting. Prior lines of therapy should include fluoropyrimidine (5-fluorouracil or capecitabine), oxaliplatin, and irinotecan with or without anti EGFR antibody for RAS\u002FRAF wild-type CRC or bevacizumab unless contraindicated. For patients with microsatellite instability high (MSI-H) CRC, previous lines of therapy should include a PD-1\u002FPD-L1 immune checkpoint inhibitor in additional to the chemotherapy agents mentioned above. Adjuvant chemotherapy with radiographic progression greater than 12 months after the last dose is not considered as a line of therapy.\n\nParticipants with HCC (cohort 2): Participants must have had progressive disease or intolerance after at least 1 but no more than 2 prior lines of systemic therapy in advanced or metastatic setting. Prior lines of therapy should include a PD-1\u002FPD-L1 immune checkpoint inhibitor or a multikinase inhibitor, which was administered either alone or in combination.\n\n* Participants must have measurable disease according to RECIST v1.1. Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable.\n* Participants must have had progression or recurrence of CRC or HCC during or following receipt of most recent therapy.\n* Legally an adult according to local regulation at the time of signing informed consent, and minimum age of 18 years\n* ECOG performance status ≤1\n* Participants must have adequate organ and marrow function as defined below:\n\n  1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n  2. Platelet count ≥100 × 109\u002FL\n  3. Hemoglobin ≥9 g\u002FdL\n  4. Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease\n  5. Creatinine clearance (CrCl) ≥30 mL\u002Fmin as estimated per institutional standards\n  6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN or ≤ 5 x ULN for subjects with liver metastases\n  7. Liver function status should be Child-Pugh (CP) Class A.\n* Tumor tissue samples must be available for submission prior to study treatment.\n* Participants must have an anticipated life expectancy of ≥3 months as assessed by the investigator.\n* The effects of enfortumab vedotin on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 4 months after the last dose. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Radiotherapy or major surgery or chemotherapy, biologics, investigational agents, and\u002For immunotherapy that is not completed 2 weeks prior to first dose of study drug.\n* Ongoing sensory or motor neuropathy Grade ≥2. Ongoing clinically significant toxicity (Grade 2 or higher) associated with prior treatment (including systemic therapy, radiotherapy or surgery).\n* Active central nervous system (CNS) metastases. Participants with treated CNS metastases are permitted on study if all the following are true: i. CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis ii. If requiring steroid treatment for CNS metastases, the patient is on a stable dose ≤20 mg\u002Fday of prednisone or equivalent for at least 2 weeks iii. Participant does not have leptomeningeal disease\n* Prior enrollment in an enfortumab vedotin study or prior treatment with other MMAE-based ADCs.\n* 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. Participants with nonmelanoma skin cancer, 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 carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.\n* Patients with a positive hepatitis B surface antigen and\u002For antihepatitis B core antibody. Patients with a negative polymerase chain reaction (PCR) assay (HBV DNA is less than 10 IU\u002Fml) are permitted with appropriate antiviral prophylaxis.\n* Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Patients who have been treated for hepatitis C infection are permitted if they have negative HCV RNA test (less than 15 IU\u002Fml) and have documented sustained virologic response of ≥12 weeks.\n* 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 enfortumab vedotin.\n* Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20)\n* Participants with active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.\n* Participants with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7-8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n* Participants with uncontrolled tumor-related bone pain or impending spinal cord compression, uncontrolled intercurrent illness, psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.\n* Pregnant women are excluded from this study because enfortumab vedotin is an antibody-drug conjugate agent 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 enfortumab vedotin. Breastfeeding should be discontinued if the mother is treated with EV, and for 3 weeks after the last dose.",{"count":458,"type":21},40,[24],"This study is a multi-indication, open-label, single-treatment arm, parallel-cohort phase II study of enfortumab vedotin in adult participants with advanced or metastatic colorectal cancer (CRC) or hepatocellular carcinoma (HCC) who have been previously treated with one or more lines of systemic therapy.",[462,463],"Metastatic Colorectal Cancer","Hepatocellular Carcinoma",[465,466,467,468,469],"Nectin-4","Antibody-drug conjugate","Enfortumab","Colorectal","Hepatocellular carcinoma",{"date":367,"type":33},{"date":472,"type":33},"2025-04-01",{"date":474,"type":21},"2029-09",{"name":39,"class":40},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":41},"100559151","working-through-outreach-navigation-and-digital-enabled-referral-and-recruitment-strategies-act-wonders-100559151","NCT06560398","Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)","ACT WONDER²S","Inclusion Criteria:\n\n* Community residents: Community residents may engage with various intervention components deployed in the intervention priority zones.\n* Community Physicians: may engage with various intervention components deployed in the intervention priority zones if they 1) practice medicine in one of the geographic priority zones.\n* Cancer Center Physicians: may engage with various intervention components if they 1) practice medicine at Moffitt.\n* Clinical Research Coordinators (CRC): may engage with various intervention components if they 1) work as a CRC at Moffitt and 2) coordinate\u002Fpre-screen patients for at least 1 therapeutic clinical trial at Moffitt.\n* Cancer Center Patients: may engage with various intervention components if they have an address that maps to an intervention priority zone and 2) are newly registered patients or new existing patients (NEPs).\n\nExclusion Criteria:\n\n* Community residents, Community Physicians, Cancer Center Physicians, Clinical Research Coordinators, and Moffitt patients who do not meet the inclusion criteria.",{"count":484,"type":21},7649,[53],"The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.",[488],"Cancer",{"date":367,"type":33},{"date":491,"type":33},"2024-09-18",{"date":493,"type":21},"2026-09-01",{"name":39,"class":40},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":162},"100554321","support-through-remote-observation-and-nutrition-guidance-program-for-individuals-with-gastroesophageal-cancer-100554321","NCT06497569","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)","Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)\n* Participants must plan to initiate chemotherapy and\u002For radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt\n* Participants must be able to speak and read Spanish and\u002For English\n* Participants must be able to provide informed consent\n\nExclusion Criteria:\n\n* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)\n* Use of feeding tubes at the time of study enrollment",{"count":503,"type":21},80,[53],"The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.",[507],"GastroEsophageal Cancer",[509],"Nutrition Support",{"date":367,"type":33},{"date":512,"type":33},"2024-07-26",{"date":514,"type":21},"2027-06",{"name":39,"class":40},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":41},"100549540","early-phase-1-personalized-dendritic-cell-vaccine-pilot-for-high-risk-tnbc-after-neoadjuvant-therapy-100549540","NCT06435351","Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy","Precision DC: Personalized Neoantigen Dendritic Cell Vaccine Pilot Trial for High Risk Triple Negative Breast Cancer After Neoadjuvant Therapy","Inclusion Criteria:\n\n* Patient has stage II-III ER\u002FPR less than or equal to 10% HER2 negative by FISH and\u002For IHC breast cancer treated with standard of care neoadjuvant systemic chemotherapy and surgical resection with significant residual breast tumor (equivalent to RCB II or III) disease.\n* Patient has sufficient residual viable primary breast tumor or ipsilateral breast axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome sequencing.\n* Patient is 18 years of age or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patients must have adequate organ and marrow function.\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 without radiologic evidence of active metastatic disease and who are within 18 months of their last dose curative intent chemotherapy and\u002For radiotherapy (whichever is later) for the purposes of study enrollment.\n* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with known active locally advanced unresectable or metastatic cancer.\n* Patients with significant uncontrolled intercurrent illness or autoimmune disease requiring systemic immunosuppressants that would be deemed unsuitable to participate in the study by the Principal Investigator (PI).\n* Patients who have a medical issue in the opinion of the treating physician and\u002For PI that would make them unsuitable for pheresis.\n* Patients who are currently receiving any other investigational agents.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study.",{"count":524,"type":21},16,[526],"EARLY_PHASE1","This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.",[27,283],{"date":367,"type":33},{"date":531,"type":33},"2024-06-12",{"date":533,"type":21},"2029-05",{"name":39,"class":40},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":554},"100541271","phase-1-avapritinib-with-decitabine-in-patients-with-sm-ahn-100541271","NCT06327685","Avapritinib With Decitabine in Patients With SM-AHN","A Phase 1 Study of Avapritinib in Combination With Decitabine in Patients With Systemic Mastocytosis With an Associated Hematologic Neoplasm (SM-AHN)","Inclusion Criteria:\n\n* Diagnosis of SM-AHN defined by World Health Organization 2022 criteria.\n* ECOG 0-3\n* Ability to understand and the willingness to sign a written informed consent.\n* Ability to adhere to study visit schedule and other protocol requirements.\n* Willing to receive blood products as deemed clinically necessary.\n* Adequate organ and marrow function as defined by the protocol.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should undergo a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of decitabine and 6 weeks after the last dose of avapritinib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study or in the 6 months after last dose of decitabine or 6 weeks after last dose of avapritinib she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.\n\nExclusion Criteria:\n\n* History of decitabine use with documented disease progression of AHN by 2006 IWG MDS response criteria while on decitabine.\n* History of avapritinib use with documented progression of mastocytosis while on avapritinib per m-IWG-MRT-ECNM criteria.\n* History of treatment with decitabine in combination with avapritinib.\n* Use of azacitidine within 4 weeks of first dose of study drug.\n* Diagnosis of AML defined as presence of ≥ 20% myeloblasts in the peripheral blood or bone marrow or presence of a myeloid sarcoma.\n* Patients who are receiving any other investigational agents or are participating in another interventional study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacytidine, decitabine, cedazuridine, avapritinib, propylene glycol, mannitol (only for patients receiving azacytidine).\n* History of intracranial hemorrhage or need for full anticoagulation with warfarin, direct oral anticoagulant, or treatment dose low molecular weight heparin (LMWH), or any condition that, in the investigator's opinion, would put the patient at an increased risk for spontaneous, unprovoked hemorrhage such as: I) Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within one year of the first dose of study drug II) Presence of a vascular aneurysm in the brain III) Known intracranial arteriovenous malformation (AVM).\n* Patient has a history of a seizure disorder (eg, epilepsy) or requirement for antiseizure medication.\n* Patient has a QT interval corrected using Fridericia's formula (QTcF) \\> 480 msec.\n* Previous allogeneic hematopoietic stem cell transplant within 6 months prior to enrollment, active graft versus host disease (GVHD), or requiring transplant related immunosuppression.\n* Patients receiving any medications or substances that are strong or moderate CYP3A inhibitors or strong or moderate CYP3A inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because, based on the mechanism of action and data from animal reproduction studies, in utero exposure to avapritinib may cause fetal harm.\n* Women who are breast feeding.\n* Patient is unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.\n* Patient has a primary brain malignancy or metastases to the brain.\n* Patient has had a major surgical procedure within 14 days of the first dose of study drug. Surgical procedures such as central venous catheter placement, bone marrow (BM) biopsy, and feeding tube placement are considered minor surgical procedures.\n* Patient has eosinophilia and known positivity for the FIP1L1-PGDFRA fusion, unless the patient has demonstrated relapse or progressive disease (PD) on prior imatinib therapy. Patients with eosinophilia (\\> 1.5 × 109\u002FL), who do not have a detectable KIT D816 mutation, must be tested for a PDGFRA fusion mutation by fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR).\n* Patient is participating in another interventional clinical study.",{"count":543,"type":21},34,[77],"Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) is a challenging disease to treat. Targeted KIT inhibitors have been approved for this indication based on their ability to control the mastocytosis portion of the disease, but patients frequently experience progression of the concomitant myeloid malignancy (i.e. the AHN). Using a combination approach to treat both aspects of the disease has the potential to provide enhanced disease control; however, overlapping toxicity is a concern. In this study, investigators aim to study the safety and tolerability of combined avapritinib and decitabine for the treatment of SM-AHN.",[547],"Systemic Mastocytosis With an Associated Hematologic Neoplasm",{"date":367,"type":33},{"date":550,"type":33},"2024-03-13",{"date":552,"type":21},"2027-03",{"name":39,"class":40},7,""]