[{"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:":556},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,80,0,25,[9,43,65,87,109,129,151,176,200,219,241,264,283,307,332,352,376,401,424,443,461,483,501,522,539],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100496608","ending-tobacco-use-through-interactive-tailored-messaging-for-cambodian-people-living-with-hivaids-100496608",false,"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.","ALL","18 Years",{"count":21,"type":22},800,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Smoking Cessation","HIV","RECRUITING","2026-08-11",{"date":33,"type":34},"2026-08-13","ACTUAL",{"date":36,"type":34},"2023-01-11",{"date":38,"type":22},"2027-09-30",{"name":40,"class":41},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",3,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100650950","libre-del-cigarrillo-development-of-an-mhealth-smoking-cessation-app-to-extend-reach-of-a-validated-smoking-cessation-intervention-for-spanish-speaking-smokers-100650950","NCT07754448","Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers","Inclusion Criteria:\n\n* Self-identify as Hispanic\u002FLatinx.\n* 18+ Years of age.\n* Monolingual Spanish-speaking, or bilingual Spanish-English and prefer educational health materials in Spanish.\n* Have been smoking at least 5 cigarettes per week over the past year\n* Not currently enrolled in a face-to-face or virtual smoking cessation program.\n\nExclusion Criteria:\n\n* A household member enrolled in the study.\n* Prior participation in the LDC randomized controlled trial.\n* Prior use of the NCI SmokefreeTXT program.",true,{"count":51,"type":22},120,[25],"Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program.",[28],"NOT_YET_RECRUITING","2026-08-04",{"date":58,"type":34},"2026-08-10",{"date":60,"type":22},"2026-08",{"date":62,"type":22},"2028-02",{"name":40,"class":41},1,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"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. Molecular relapse or Mixed chimerism or treated relapse in remission may be allowed on case by case basis but needs discussion with the study Chair\u002FPI\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":51,"type":22},[74],"PHASE2","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.",[77],"Chronic Graft-versus-host Disease (cGVHD)","2026-08-03",{"date":80,"type":34},"2026-08-05",{"date":82,"type":34},"2024-12-23",{"date":84,"type":22},"2028-12",{"name":40,"class":41},6,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":94,"minAge":19,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":64},"100646764","phase-2-evaluation-and-outcomes-of-savi-scout-md-for-localized-breast-surgery-100646764","NCT07686250","Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery","Clinical Evaluation and Outcomes of Multi-signal SAVI Scout (Scout MD) Localized Breast Conserving Surgery","Inclusion Criteria:\n\n* Adult females who are 18 years of age or older at time of signing informed consent will be eligible.\n* Must have ability to comprehend and the willingness to sign written informed consent for study participation.\n* Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.\n\nExclusion Criteria:\n\n* Patients undergoing mastectomy for resection of the targeted lesion.\n* Planned excision of multiple separate sites in the ipsilateral breast.\n* Inability to undergo surgery at Moffitt Cancer Center.","FEMALE",{"count":96,"type":22},37,[74],"The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.",[100],"Breast Cancer","2026-07-29",{"date":103,"type":34},"2026-07-30",{"date":105,"type":22},"2026-07",{"date":107,"type":22},"2028-07",{"name":40,"class":41},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":64},"100590125","phase-1-study-investigating-intravesical-hdac-inhibition-to-improve-response-to-immuno-oncology-agents-100590125","NCT06963346","Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents","HERO Trial: Phase I Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents in Localized Bladder Cancer","Inclusion Criteria:\n\n* Patients must have histologically confirmed MIBC (T2-T4a, N0, M0 per American Joint Commission on Cancer \\[AJCC\\]) pure or mixed histology urothelial carcinoma.\n* Patients must be ineligible for cisplatin-based chemotherapy due to any of the following: Creatinine clearance (CrCl) \\\u003C 60 mL\u002Fmin by the Cockcroft-Gault formula; Hearing impaired ≥ Grade 2 by CTCAE criteria; Neuropathy ≥ Grade 2 by CTCAE criteria; Heart failure NYHA ≥ III; ECOG ≥ 2.\n* Patients must be medically fit for TURBT and radical cystectomy (RC\n* Age ≥ 18 years\n* Body weight \\>30 kg\n* Ability to understand and willingness to sign IRB-approved informed consent.\n* Willing to provide tumor tissue, blood, and urine samples for research.\n* ECOG performance status 0 or 1 (Karnofsky ≥80%).\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants must have adequate organ and marrow function as defined below: Hemoglobin ≥ 9.0 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1500\u002FmcL; Platelet count ≥100,000\u002FmcL; Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN); total bilirubin must be \\\u003C 3 x ULN for patients with Gilberts syndrome; AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal; Measured creatinine CL \\>40 mL\u002Fmin or Calculated creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥120 days after the last dose of durvalumab.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Patient must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Patients with active or prior documented autoimmune disease within the past 2 years prior to Screening or other immunosuppressive agent within 14 days of study treatment. NOTE: Patients with well controlled type 1 diabetes mellitus, vitiligo, Graves' disease, Hashimoto's disease, eczema, lichen simplex chronicus, or psoriasis not requiring systemic treatment (within the past 2 years prior to Screening) are not excluded.\n* Patients who have concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma. Patients with history of non-invasive (Ta, T1, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.\n* Patients who have another malignancy that could interfere with the evaluation of safety or efficacy of the study drugs. Patients with a prior malignancy will be allowed without Principal Investigator approval in the following circumstances: Not currently active and diagnosed at least 5 years prior to the date of registration; Non-invasive diseases such as low risk cervical cancer or any cancer in situ; Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no chemotherapy was indicated (e.g. low\u002Fintermediate risk prostate cancer, etc.). Patients with other malignancies not meeting these criteria must be discussed prior to registration.\n* Patients who have received any prior immune checkpoint inhibitor (i.e. anti-KIR, anti-PD-1, anti- PD-L1, (including durvalumab) anti-CTLA4 or other).\n* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury or specific anti-cancer treatment ≤ 4 weeks prior to starting study drug, or patients who have had placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury.\n* Patients who have clinically significant cardiac diseases deemed not fit for radical cystectomy, including any of the following: History or presence of serious uncontrolled ventricular arrhythmias; Clinically significant resting bradycardia; Any of the following within 3 months prior to starting study drug: severe\u002Funstable angina, Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA); Uncontrolled hypertension defined by a SBP ≥ 180 mm Hg and\u002For DBP ≥ 100 mm Hg, with or without anti-hypertensive medication(s).\n* Patients who have history of chronic active liver disease or evidence of acute or chronic Hepatitis B Virus (HBV) or Hepatitis C (HCV).\n* Patients who have known diagnosis of human immunodeficiency virus (HIV) infection. Testing is not required in absence of clinical suspicion.\n* Patients who have known diagnosis of any condition (e.g. post-hematopoietic or solid organ transplant, pneumonitis, inflammatory bowel disease, etc.) that requires chronic immunosuppressive therapy which cannot be stopped for the duration of the clinical trial. Usage of non-steroidal anti-inflammatory medications (NSAIDS) for the treatment of osteoarthritis and uric acid synthesis inhibitors for the treatment of gout are permitted.\n* Patients with any serious and\u002For uncontrolled concurrent medical conditions.\n* Patients who have used any live viral vaccine for prevention of infectious diseases within 4 weeks prior to study drug(s). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID vaccination is allowed.\n* Patients unwilling or unable to comply with the protocol.\n* Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Patients who participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial throughout the duration of this study.\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference.\n* Patients with local symptoms from bladder cancer, (e.g. gross hematuria, dysuria, etc.) who are deemed to be unable to complete the treatment protocol per PI.\n* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.",{"count":117,"type":22},12,[119],"PHASE1","In this study, we aim to evaluate the safety and efficacy of neoadjuvant combination using intravesical romidepsin and durvalumab in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC).",[122],"Bladder Cancer",{"date":103,"type":34},{"date":125,"type":34},"2025-06-24",{"date":127,"type":22},"2028-04",{"name":40,"class":41},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"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":137,"type":22},318,[74],"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.",[141],"Non-small Cell Lung Cancer",[143],"Justice",{"date":103,"type":34},{"date":146,"type":34},"2025-06-13",{"date":148,"type":22},"2030-01",{"name":40,"class":41},7,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100648719","phase-1-domatinostat-with-sirolimus-for-relapsed-refractory-sarcoma-and-osteosarcoma-100648719","NCT07725380","Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma","Open-Label, Cohort-Sequential Dose-Escalation and Dose-Confirmation Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of Domatinostat in Combination With Sirolimus in Adolescents and Adults With Relapsed, Refractory Sarcoma and Osteosarcoma","Inclusion Criteria:\n\n* Age ≥12 and ≤40 years.\n* Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).\n* At least one prior standard systemic therapy regimen.\n* Not candidates for available therapies known to provide survival benefit.\n* Karnofsky\u002FLansky performance score ≥60.\n* Life expectancy ≥16 weeks.\n* Adequate organ function: ANC ≥1,000\u002FmcL, Platelets ≥100,000\u002FuL, Hemoglobin ≥8 g\u002FdL, Adequate hepatic and renal function.\n* Ability to swallow tablets.\n* Negative pregnancy test for females of childbearing potential.\n* Agreement to use effective contraception.\n* Ability to provide informed consent\u002Fassent.\n\nExclusion Criteria:\n\n* Receiving another investigational agent.\n* Receiving concurrent anticancer therapy.\n* Known hypersensitivity to domatinostat or sirolimus.\n* Bone marrow-only disease.\n* CNS metastatic disease.\n* Major surgery within 2 weeks prior to treatment.\n* Active malignancy within the previous 3 years (with protocol-specified exceptions).\n* History of solid organ transplantation.\n* Significant recent cardiac disease.\n* Concurrent prohibited CYP3A4\u002FP-gp interacting medications.\n* Uncontrolled infection or other serious uncontrolled illness.\n* Pregnancy or breastfeeding.\n* HIV infection on antiretroviral therapy.\n* Weight \\\u003C40 kg.\n* Inability to comply with study requirements.","12 Years","40 Years",{"count":161,"type":22},74,[119,74],"This is a multicenter, open-label, Phase 1\u002F2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.",[165,166],"Sarcoma","Osteosarcoma","2026-07-21",{"date":169,"type":34},"2026-07-24",{"date":171,"type":34},"2026-07-15",{"date":173,"type":22},"2031-08",{"name":40,"class":41},4,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":94,"minAge":19,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":175},"100445477","early-phase-1-using-aspirin-to-improve-immunological-features-of-ovarian-tumors-100445477","NCT05080946","Using Aspirin to Improve Immunological Features of Ovarian Tumors","Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors","Inclusion Criteria:\n\n* Participants that are greater than or equal to 18 years of age\n* For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French\n* Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2\u002F3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable.\n* Treatment naïve for this cancer diagnosis\n* Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +\u002F- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. \\[Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.\\]\n* Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2\n* Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available.\n* If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement\n* Willing and able to swallow pills without difficulty\n* Un-transfused platelet count \\> 100,000 cells\u002FμL\n* Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log\u002Fdiary)\n* Absolute neutrophil count \\> 1.5 x 109 cells\u002FL\n* Hemoglobin \\> 9.0 g\u002FdL, may use transfusions and the value can be post-transfusion\n* Estimated creatinine clearance of \\> 30 mL\u002Fmin, calculated using the formula Cockcroft-Gault \\[(140-age) x Mass (kg)\u002F(72 x creatinine mg\u002FdL)\\] x 0.85 for female\n* No severe hepatic impairment defined as AST or ALT elevation \\\u003C 2.5 x institutional ULN, unless liver metastasis is present \\\u003C 5 x ULN\n\nExclusion Criteria:\n\n* Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment\n* History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant \\[serious or significant\\] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions).\n* History of hypertensive crisis and\u002F or uncontrolled HTN, systolic blood pressure \\> 150 mmHg; diastolic blood pressure \\> 90mmHg. Participants must have blood pressure \\\u003C 150\u002F90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study.\n* Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated\n* History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study\n* Uncontrolled erosive esophagitis requiring 2 or more treatments\n* Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer\n* Autoimmune disorder requiring systemic therapy\n* Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days.\n* Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy)\n* History of bariatric surgery\n* Currently pregnant at the Screening visit or planning on becoming pregnant during the study period\n* Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication.\n* Metabolism CYP2C9, known G6PD deficient patients",{"count":184,"type":22},100,[186],"EARLY_PHASE1","The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma",[189,190,191],"Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer","2026-07-09",{"date":194,"type":34},"2026-07-10",{"date":196,"type":34},"2021-11-02",{"date":198,"type":22},"2026-12",{"name":40,"class":41},{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":216,"leadSponsor":218,"locationsCount":64},"100646073","phase-2-trial-of-therapies-with-it-cdc1s-combined-w-it-trastuzamab-for-her-or-it-nivolumab-for-her--bc-lmd-100646073","NCT07694986","Trial of Therapies With IT cDC1s Combined w\u002F IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD","Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of BC by ASCO\u002FCAP guidelines (Wolff et al, 2018), or radiographically definite LMD from BC.\n* Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; \\[Chamberlain et al., 2017\\] OR characteristic radiographic abnormalities of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion.\n* Patients must have an ECOG performance scale of ≤2.\n* Proton cranial spinal RT OR cranial spinal RT using IMRT are the preferred modalities of RT to treat LMD if possible, before study. At least WBRT is required for participation.\n* Coincident brain or spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable brain metastases are eligible to participate.\n* Stereotactic radiosurgery (SRS) and\u002For prior radiotherapy is permitted ≥2 weeks before the initial dendritic cell (DC) vaccine dose. A follow-up brain MRI should be obtained before the DC vaccine to determine the stability of the lesions. An interval of at least 2 weeks after the end of brain radiation or surgical resection of brain lesions or cytotoxic, targeted, immune, or investigational agent is required.\n* Must be ≥18 years of age on the day of signing the consent.\n* Life expectancy of ≥8 weeks.\n* Demonstrate adequate organ function as defined in Table 5. All screening labs should be performed within 14 days of treatment initiation.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Corticosteroids at doses equivalent to ≤4 mg of dexamethasone daily or equivalent for symptom control are acceptable. This should be minimized when possible.\n* If the disease has progressed on current treatment before consent, patients may continue current systemic cancer therapies by PI discretion see Section 7.7.5 (Systemic Therapies Allowed) and Section 5.2, 1 and 2 (Exclusion Criteria).\n* Patients with systemic disease are eligible and will be managed as detailed in Section 7.7.5.\n* Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once a month during treatment.\n* Contraception: Highly effective contraception for both male and female subjects throughout the study, and for the following specified durations after the last treatment administration as follows: highly effective contraception must be used by males for at least 90 days after the last treatment administration, if the risk of conception exists, to cover the spermatogenesis Cycle, and at least 5 months after the last dose of nivolumab or 7 months after the last dose of trastuzumab for females.\n* The patient has an Ommaya reservoir or equivalent device that allows routine access to CSF and administration of DC1s.\n* Patient must be able to tolerate MRIs of brain with contrast for routine disease assessments.\n\nExclusion Criteria:\n\n* Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However, all other treatments to control systemic disease or bulk CNS disease will be eligible, provided the therapy is not a Phase I agent, an agent that significantly and unequivocally penetrates the CSF (eg, high-dose methotrexate, thiotepa, high-dose ara-C) by PI discretion. H \\& P section: Patients may continue on IV trastuzumab, fam-trastuzumab deruxtecan-nxki, pertuzumab, tucatinib, or other HER2-directed, hormonal, or other therapeutic agents if controlling systemic disease and leptomeningeal metastases developed while on these therapies. In addition, at time of systemic progression, patients may start additional agents at the discretion of the treating physician according to criteria in Section 6.7.1. and not start on new systemic therapies until LMD disease assessment.\n* Use of any immunotherapy within the last 4 weeks.\n* Unable or unwilling to have a contrast-enhanced brain MRI.\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n* Has an active infection requiring systemic therapy which in the investigator's opinion will increase the risk to the patient.\n* Had major surgical procedure, or significant traumatic injury within 2 weeks. Ommaya placement is allowed.\n* Patients with shunts are excluded from the study (including but not limited to ventriculoperitoneal and ventriculoatrial shunts).\n* History of an intracranial thrombosis or thrombi extending up to the skull base. The choice of modality is at the investigator or provider's discretion.\n* Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1, 2 antibodies). Testing is not mandatory.\n* Has known active or chronic hepatitis B (HBV) or hepatitis C virus (HCV). Testing is not mandatory.\n* ORGAN TRANSPLANTATION: Prior organ transplantation including allogenic stem-cell transplantation.\n* Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n* Has received a live vaccine within 30 days before the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed. Current COVID vaccines are not live vaccines.",{"count":208,"type":22},30,[74],"The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), in combination with trastuzumab or nivolumab to confirm the highest dose of the study treatment that can be given safely to participants with Breast Cancer (BC) with Leptomeningeal Disease (LMD).",[100,212],"Leptomeningeal Disease","2026-07-06",{"date":194,"type":34},{"date":60,"type":22},{"date":217,"type":22},"2030-08",{"name":40,"class":41},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":226,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"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":228,"type":22},15,[119],"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.",[232],"Metastatic Ewing Sarcoma","2026-07-02",{"date":213,"type":34},{"date":236,"type":34},"2026-02-05",{"date":238,"type":22},"2030-10",{"name":40,"class":41},17,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":18,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":228},"100570020","phase-2-digoxin-medulloblastoma-study-100570020","NCT06701812","Digoxin Medulloblastoma Study","Evaluation of Digoxin for Relapsed Non-WNT, Non-SHH Medulloblastoma","Inclusion Criteria:\n\n* Patients must be age \\>12 months and \\\u003C30 years at the time of enrollment.\n* Patients must have relapsed non-WNT, non-SHH medulloblastoma confirmed by a CAP\u002FCLIA certified assay (such as nanostring or methylation) performed on tissue from diagnosis or relapse.\n* Patients must have received at least one prior course of chemotherapy for their medulloblastoma. They must also have received irradiation.\n* Prior therapy: Therapy may not have been received more recently than the timeframes defined below: Craniospinal radiotherapy: At least 3 months have elapsed since prior craniospinal radiotherapy (at doses ≥ 18 Gy). Local radiotherapy: At least 3 months since prior local radiotherapy to primary tumor. Focal radiotherapy: At least 2 weeks since prior focal radiotherapy to symptomatic metastatic sites. Myelosuppressive chemotherapy and\u002For immunotherapy and\u002For biologics: More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas), immunotherapy, or biologics. Hematopoietic growth factor: Seven days must have elapsed since the completion of therapy with colony-stimulating factors (e.g., filgrastim \\[G-CSF\\], sargramostim \\[GM-CSF\\], or erythropoietin), or platelet-stimulating agents.\n* Patients must have recovered from any surgical procedures such as biopsy, with neurological stability for \\> 7 days.\n* Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on MRI (ie, largest tumor diameter and its largest perpendicular). The size of a measurable lesion at baseline should be at least 2 times the thickness of the slices showing the tumor (adding the interslice gap).\n* Patients must have a Lansky or Karnofsky performance status score of ≥ 50%. Use Karnofsky for patients \\> 16 years of age and Lansky for patients \\\u003C 16 years of age. Patients who are unable to ambulate but who are functional in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.\n* Patients must have normal organ and marrow function.\n* Patient has no evidence of Wolff-Parkinson-White syndrome or high-grade AV block (form of second-degree heart block) on screening ECG.\n* Patient has no evidence of hypertrophic obstructive cardiomyopathy on screening echo.\n* Any patient that reports recent palpitations (within the last month), or concerning findings on echo or ECG must be evaluated and cleared for treatment with digoxin by a cardiologist prior to enrollment. Study PI should be contacted for additional questions\u002Fconcerns regarding these patients.\n* Patients receiving concurrent dexamethasone are eligible, provided dosage is stable or decreasing for ≥7 days prior to study enrollment.\n* Patients must have a stable neurologic status for ≥7 days prior to study enrollment. If a patient experiences neurologic decline following enrollment but prior to day 1 of cycle 1, they should be reassessed for eligibility.\n* Pregnancy: Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Female patients who are lactating must agree to stop breastfeeding.\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.\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* Participants who are receiving concurrent anticancer or any other investigational agents are ineligible.\n* Participants taking digoxin for any reason during treatment for initial diagnosis of medulloblastoma or relapse are ineligible. Exposure to digoxin therapy prior to initial diagnosis of medulloblastoma is allowed.\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to digoxin are ineligible.\n* Patients with serious or inadequately controlled cardiac arrhythmias, including baseline ectopy, ventricular tachycardia, frequent premature ventricular contractions (PVCs), or symptomatic sinus bradycardia are excluded from the study.\n* Patients taking medications that are known to interfere with digoxin metabolism are ineligible.\n* Participants with uncontrolled intercurrent illness, concurrent clinically significant unrelated systemic illness (e.g. serious infection) or significant cardiac, pulmonary, hepatic, or other organ dysfunction that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results are ineligible.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements are ineligible.\n* Pregnant women or women unwilling to stop breastfeeding are excluded from this study because it is unknown how pregnant women with recurrent medulloblastoma will metabolize and tolerate digoxin. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with digoxin in this setting.\n* Participants who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.","12 Months","30 Years",{"count":251,"type":22},23,[74],"The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients.",[255,256],"Medulloblastoma","Medulloblastoma, Non-WNT\u002FNon-SHH",{"date":258,"type":34},"2026-07-07",{"date":260,"type":34},"2026-01-15",{"date":262,"type":22},"2027-02",{"name":40,"class":41},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":64},"100580146","phase-2-phase-ii-study-of-systemic-screening-in-pathologic-node-positive-breast-cancer-100580146","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).",{"count":51,"type":22},[74],"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.",[100,275],"Node-positive Breast Cancer","2026-06-30",{"date":233,"type":34},{"date":279,"type":34},"2025-02-24",{"date":281,"type":22},"2026-10",{"name":40,"class":41},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":297,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":64},"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":291,"type":22},36,[119],"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).",[295,296],"Merkel Cell Carcinoma","Cutaneous Squamous Cell Carcinoma",[298],"Skin Cancer","2026-06-24",{"date":301,"type":34},"2026-06-25",{"date":303,"type":34},"2021-10-22",{"date":305,"type":22},"2028-03",{"name":40,"class":41},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":64},"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":291,"type":22},[119,74],"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).",[318],"Melanoma",[320,321,322,323],"Mucosal melanoma","Uveal melanoma","Cutaneous acral melanoma","Cutaneous non-acral melanoma","2026-06-23",{"date":326,"type":34},"2026-06-26",{"date":328,"type":34},"2025-12-03",{"date":330,"type":22},"2030-05",{"name":40,"class":41},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":94,"minAge":19,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":349,"leadSponsor":351,"locationsCount":64},"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.",{"count":341,"type":22},20,[25],"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.",[100],"2026-06-04",{"date":347,"type":34},"2026-06-10",{"date":60,"type":22},{"date":350,"type":22},"2027-04",{"name":40,"class":41},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":375},"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":359,"type":22},125,"OBSERVATIONAL","This study will evaluate obesity-mediated mechanisms of pancreatic carcinogenesis in minority populations.",[363],"Pancreatic Cancer",[365,366,367],"pancreas","biomarkers","health disparities","2026-05-21",{"date":370,"type":34},"2026-05-26",{"date":372,"type":34},"2023-02-22",{"date":198,"type":22},{"name":40,"class":41},2,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":49,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":64},"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",{"count":384,"type":22},600,[25],"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.",[28,388],"Alcohol Use",[390,391,392,393],"Mindfulness-based intervention","Cancer survivors","Smoking cessation","Alcohol use","2026-05-15",{"date":396,"type":34},"2026-05-18",{"date":394,"type":34},{"date":399,"type":22},"2029-12",{"name":40,"class":41},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":422,"leadSponsor":423,"locationsCount":64},"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":409,"type":22},24,[119],"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.",[413],"Peritoneal Carcinomatosis",[415,416,417,418],"Appendiceal cancer","Peritoneal disease","Colorectal cancer","Pressurized Intraperitoneal Aerosolized Chemotherapy","2026-05-14",{"date":394,"type":34},{"date":60,"type":22},{"date":305,"type":22},{"name":40,"class":41},{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":431,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":64},"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":117,"type":22},[74],"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.",[436],"Metastatic Castration-resistant Prostate Cancer",{"date":394,"type":34},{"date":439,"type":34},"2026-03-03",{"date":441,"type":22},"2027-09",{"name":40,"class":41},{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":23,"phases":451,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":375},"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":450,"type":22},156,[452],"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.",[100],{"date":394,"type":34},{"date":457,"type":34},"2026-02-25",{"date":459,"type":22},"2030-02",{"name":40,"class":41},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":476,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":375},"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":469,"type":22},170,[74],"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.",[473,474,475],"Triple Negative Breast Cancer","HER2-positive Breast Cancer","Hormone Receptor-positive Breast Cancer",[477],"Stage IV Breast Cancer",{"date":396,"type":34},{"date":480,"type":34},"2021-12-21",{"date":281,"type":22},{"name":40,"class":41},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":500,"locationsCount":64},"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":490,"type":22},26,[25],"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).",[363],"2026-05-05",{"date":496,"type":34},"2026-05-06",{"date":498,"type":34},"2024-02-09",{"date":60,"type":22},{"name":40,"class":41},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":64},"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":509,"type":22},38,[119],"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).",[513],"Cutaneous T Cell Lymphoma","2026-03-31",{"date":516,"type":34},"2026-04-01",{"date":518,"type":34},"2025-08-27",{"date":520,"type":22},"2028-06",{"name":40,"class":41},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":360,"phases":4,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":538,"locationsCount":64},"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":184,"type":22},"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.",[532,533],"Small Lymphocytic Lymphoma (SLL)","Chronic Lymphocytic Leukemia (CLL)",{"date":516,"type":34},{"date":536,"type":34},"2025-07-17",{"date":520,"type":22},{"name":40,"class":41},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":42},"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":240,"type":22},[74],"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).",[549],"Cutaneous Sarcoma",{"date":516,"type":34},{"date":552,"type":34},"2025-06-20",{"date":554,"type":22},"2030-07",{"name":40,"class":41},""]