[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dana-Farber Cancer Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":664},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,121,0,25,[9,52,82,103,128,151,173,199,256,288,319,337,361,384,409,434,457,476,499,521,544,566,591,620,641],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100635114","acupuncture-and-exercise-for-ev-pembro-induced-peripheral-neuropathy-100635114",false,"NCT07548476","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)","ACE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosed with pathologically proven urothelial cancer (UC)\n* Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th cycle\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks\n* Deemed acceptable for exercise by their treating provider\n* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek, as assessed by the Godin Leisure-Time Exercise Questionnaire\n* Willing to adhere to all study-related procedures, including randomization to either treatment group\n* Referrals to physical therapy are allowed during the study if necessary\n* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.\n* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of investigational regimen will be eligible.\n\nExclusion Criteria:\n\n* History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect\n* Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions\n* Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)\n* Receiving more than 10mg prednisone daily for any condition\n* History of bleeding diathesis (von Willebrand disease, hemophilia A\u002FB)\n* Known history of seizure disorder or taking antiepileptic drugs\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n\nInvestigators will not include the following special populations:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C 18 years)\n* Pregnant women\n* Prisoners","ALL","18 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).\n\nThe names of the two study groups in this research study are:\n\n* Acupuncture + Virtual Exercise (AVE)\n* Virtual Exercise Only (VE)",[28,29,30,31,32,33],"Metastatic Bladder Cancer","Peripheral Neuropathy","Advanced Urothelial Cancer","Metastatic Urothelial Cancer","Bladder Cancer","Urothelial Cancer",[35,36,37,38],"Enfortumab Vedotin-Induced Neuropathy","Pembrolizumab-Induced Neuropathy","mUC","UC","RECRUITING","2026-08-19",{"date":42,"type":43},"2026-08-20","ACTUAL",{"date":45,"type":22},"2026-08",{"date":47,"type":22},"2028-08",{"name":49,"class":50},"Dana-Farber Cancer Institute","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100649516","phase-2-rectify-1-neoadjuvant-botensilimab--balstilimab-in-msspmmr-early-rectal-cancer-100649516","NCT07735624","RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS\u002FpMMR Early Rectal Cancer","A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable \u002F Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)","RECTIFY-1","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017).\n* The tumor must confirmed to be MSS\u002FMMRp by local testing.\n* The tumor must be evaluable by endoscopy.\n* Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.\n* Age ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of botensilimab with balstilimab in participants \\\u003C 18 years of age, children are excluded from this study.\n* Measurable rectal primary on baseline imaging by MRI. The tumor must be definitively at least T1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function defined as the following laboratory values within 7 days of Cycle 1 Day 1 (C1D1):\n\n  * Neutrophils ≥ 1500\u002FμL (Must be stable and off any growth factor within 4 weeks of first study treatment administration).\n  * Platelets ≥ 50× 103\u002FμL.\n  * Hemoglobin ≥ 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration).\n  * Creatinine clearance ≥ 30 mL\u002Fmin as measured or calculated per local institutional standards.\n  * Aspartate aminotransferase\u002Falanine aminotransferase ≤ 1.5 × upper limit of normal (ULN).\n  * Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN).\n* All participants must undergo multidisciplinary evaluation by a qualified colorectal surgeon, medical oncologist, and radiation oncologist to discuss treatment options for rectal cancer.\n\n  * Per the treating surgeon, the patient must be a candidate for both TES and\u002For TME for rectal cancer.\n  * Per the treating medical oncologist, the patient must be a candidate for standard chemotherapy for rectal cancer.\n  * Per the treating radiation oncologist, the patient must be a candidate for standard radiation\u002Fchemoradiotherapy for rectal cancer.\n* The effects of botensilimab with balstilimab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men enrolled in this study must agree to use highly effective contraceptive measures (See Section 3.4) starting with the Screening Visit through 90 days after the last dose of study treatment. See section 3.4 for more detailed information on contraception requirements.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Tumor is MSI-H\u002FMMRd per any local testing.\n* Known TMB \\>20mut\u002FMb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.\n* Received prior anti-CTLA-4 or anti-PD-1\u002FPD-L1 therapy and\u002For other experimental immunologic agents.\n* Partial or complete bowel obstruction within the last 3 months, signs\u002Fsymptoms of bowel obstruction, or known radiologic evidence of impending obstruction.\n* Uncontrolled irritable bowel syndrome with predominant diarrhea (IBS-D) and\u002For other uncontrolled, chronic diarrhea syndromes.\n* Presence of rectal cancer metastases.\n* Stigmata of hepatic decompensation including a history of variceal bleeding, a history of ascites related to hepatic cirrhosis, or severe portal hypertension.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, i.e., patients with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the patient has no evidence of disease. Patients with history of prior early-stage basal\u002Fsquamous cell skin cancer, low-risk prostate cancer eligible for active surveillance, or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible.\n* Treatment with one of the following classes of drugs within the delineated time window prior to C1D1:\n\n  * Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.\n  * Investigational monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.\n  * Small molecule\u002Ftyrosine kinase inhibitors within 2 weeks or less than 5 circulating half- lives of investigational drug.\n* Prior therapy for rectal cancer.\n* Prior pelvic radiation therapy.\n* Prior treatment for rectal cancer.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.\n* History of allogeneic organ transplant.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n* History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* Uncontrolled infection with HIV and\u002For active infection with opportunistic pathogens. Patients stable on antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n* Known to be positive for HBV surface antigen, or any other positive test for HBV indicating acute or chronic\u002Flatent infection. HBV testing is required for study entry.\n* Known active HCV as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry.\n* History of untreated TB and\u002For positive quantiferon\u002FTspot test without previous tuberculosis prophylaxis, or untreated active infection with Mycobacterium tuberculosis. Testing must be negative for study entry.\n* Active or known prior infection with nontuberculous mycobacteria.",{"count":61,"type":22},16,[63],"PHASE2","This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) \u002F mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.",[66,67,68],"Early Rectal Cancer","Stage I Rectal Cancer","Microsatellite Stable Rectal Carcinoma",[70,71,68,72],"Early rectal cancer","Non-operative management","stage I rectal cancer","2026-08-17",{"date":75,"type":43},"2026-08-18",{"date":77,"type":22},"2026-09",{"date":79,"type":22},"2032-12-31",{"name":49,"class":50},3,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100559823","phase-1-elranatamab-in-patients-with-relapsed-or-refractory-al-amyloidosis-100559823","NCT06569147","Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis","A Phase I\u002FII, Open Label, Study to Evaluate Safety, Tolerability and Efficacy of Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis","Inclusion Criteria:\n\n* Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles).\n* Participants must have progression of light chain disease, defined as dFLC \\>20mg\u002FL.\n* For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg\u002FL; Abnormal level of FLC with an abnormal κ\u002Fλ ratio (except in participants with CKD stage 3 or higher where a rise of lambda FLC to an abnormal level and of at least 50% over the nadir with a normal κ\u002Fλ ratio is acceptable); A serum M spike measuring ≥ 0.5 g\u002FdL\n* Age ≥ 18 years\n* ECOG performance status ≤2 or Karnofsky ≥60%\n* Participants must meet the following organ and marrow function as defined below: Absolute leukocyte count ≥3,000\u002FmcL , Absolute neutrophil count ≥1,000\u002FmcL, Absolute platelet count ≥75,000\u002FmcL , Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN, Creatinine: Calculated clearance ≥30 mL\u002Fmin using Cockcault-Groft equation\n* Participants who received belantamab mafodotin are eligible if discontinued due to intolerance or adverse event.\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* AL Amyloidosis Cardiac stage I, II or IIIa disease based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging in participants with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar et al., 2013).\n* The effects of elranatamab on the developing human fetus are unknown. Based on the mechanism of action, elranatamab may cause fetal harm when administered to a pregnant woman and therefore should not be used during pregnancy. 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 and until 90 days since the last dose of elranatamab. 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 90 days after completion of elranatamab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willingness to undergo study procedures, including bone marrow biopsies as detailed in the schedule of events.\n* Participants should have received prior treatment with Daratumumab + CyBorD.\n\nExclusion Criteria:\n\n* Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.\n* Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents for this condition.\n* Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).\n* History of allergic reactions to elranatamab.\n* Participants with an active malignancy (including lymphoma) with the following exceptions: adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer; adequately treated stage I cancer from which the patient is currently in remission and has been for over 2 years; low-risk prostate cancer with a Gleason score \\\u003C 7 and prostate specific antigen \\\u003C 10ng\u002FmL; other localized, indolent and\u002For low risk cancer may be permitted\n* Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or 4 months following discontinuation of elranatamab, whichever is longer. Pregnant women are excluded from this study because elranatamab is an 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 elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.\n* Have any other medical, social or psychological factors that could affect the participant's safety or ability to consent personally or comply with study procedures.\n* Participants meeting criteria for active MM based on presence of CRAB criteria (a ratio of involved versus uninvolved FLC over 100 is allowed in the absence of CRAB criteria).\n* Participants with active clinically significant autoimmune diseases.\n* Participants seropositive for the human immunodeficiency virus (HIV).\n* Severe, uncontrolled orthostatic hypotension resulting in syncopal\u002Fpre-syncopal events despite optimized medical management (e.g., midodrine, pyridostigmine) and in the absence of volume depletion.\n* Plan for autologous stem cell transplant during the first 6 months of protocol therapy.\n* History of acute coronary syndrome or uncontrolled ventricular arrhythmias within 3 months prior to screening.\n* Evidence of LV systolic dysfunction as defined by LVEF is \\\u003C 30% by echocardiogram at Screening per site cardiology interpretation.\n* Presence of severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area \\\u003C 1.0 cm2) or severe congenital heart disease.\n* Have history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not placed.\n* QT corrected by Fridericia (QTcF) is \\> 550 msec on Screening ECG unless they have a PPM\u002FICD implanted.\n* Screening EKG showing acute myocardial ischemia or active conduction system abnormalities with the exception of any of the following: First degree atrioventricular block; Second degree atrioventricular block Type 1 (Mobitz Type 1\u002FWenckebach type); Right or left bundle branch block (e.g., Left Bundle Branch Block, Right Bundle Branch Block, Left Anterior Fascicular Block, or Left Posterior Fascicular Block); Atrial fibrillation with a controlled ventricular rate; Bifascicular block assessed as benign by the Investigator\n* Major surgery that required general anesthesia within 4 weeks of randomization or is planning major surgery during the study.\n* NYHA class IV symptoms or participants with acute decompensation of congestive heart failure.\n* Transplant eligible participants who have not undergone transplant are not eligible.",{"count":90,"type":22},49,[92,63],"PHASE1","This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.",[95],"AL Amyloidosis",{"date":40,"type":43},{"date":98,"type":43},"2024-11-01",{"date":100,"type":22},"2029-07-01",{"name":49,"class":50},5,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100534468","phase-2-pd-l1-t-hank-nai-il-15sa-and-cetuximab-for-recurrent-metastatic-hnscc-100534468","NCT06239220","PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC","A Phase 2 Trial of PD-L1 t-haNK, NAI IL-15 Superagonist (Anktiva), and Cetuximab for Immunotherapy-treated Patients With Recurrent, Metastatic HNSCC (QUILT-505)","Inclusion Criteria:\n\n* Participants must have an existing histologically confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) with evidence of recurrent, metastatic (R\u002FM) or locoregionally advanced, incurable or unresectable disease from any mucosal subsite including oral cavity, oropharynx, larynx, hypopharynx, nasal cavity, and the paranasal sinuses.\n* Participants must have at least one RECIST v1.1 measurable lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.\n* Must have had at least 1, but no more than 2, prior lines of prior systemic therapy for R\u002FM HNSCC; one of these lines should have included anti-PD-1\u002FL1 therapy.\n\n  * a.Platinum-based therapy as part of definitive\u002Fadjuvant or curative-intent treatment can count as 1 prior line of therapy if the subject progressed within 6 months of receiving therapy.\n  * b. At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (2 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE v5 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or peripheral neuropathy).\n* Be ≥18 years of age on the day of signing informed consent.\n* Must provide prior documentation on tumor PD-L1 expression status and HPV status (for oropharyngeal cancer cases), if available from the medical record.\n* Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).\n* Participants must have adequate organ and marrow function as defined below (within 14 days prior to study registration):\n\n  * a. ANC ≥1,000\u002FmcL\n  * b. Hemoglobin ≥9 g\u002FdL\n  * c. Platelets ≥100,000\u002FmcL\n  * d. Total bilirubin ≤ upper limit of normal (ULN)\n  * e. AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN (or ≤1.5x institutional ULN if concomitant with alkaline phosphatase \\>2.5x institutional ULN) or ≤5x ULN for those with liver metastases\n  * g. Serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above 1.5x ULN\n* Baseline tumor measurements must be documented from imaging within 28 days prior to study registration.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects should not become pregnant or nurse a baby during the study and through 120 days after the last dose of study drugs. Male subjects should use a condom as a contraceptive during the study and through 120 days after the last dose of study drugs.\n\nSperm donation is discouraged for up to 6 months after the last dose of study drug.\n\n-Be willing and able to provide written informed consent for the trial.\n\nExclusion Criteria\n\n* Have been previously treated with 3 or more lines of systemic therapy for R\u002FM HNSCC.\n* Have received radiation therapy (RT) within 10 days of starting protocol therapy.\n* Solid organ transplant (allograft) recipients.\n* Participant has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging and off systemic steroids for at least 3 weeks prior to study registration) and have no evidence of new or enlarging brain metastases.\n* A history of significant autoimmune disease as judged by the treating investigator and on active therapy including prednisone ≥10 mg daily dose equivalent of corticosteroids.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection; evidence of symptomatic congestive heart failure, unstable angina pectoris, stroke, or ventricular arrhythmia within 6 months of enrollment.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions might include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Any known positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). Patients with HIV are eligible if their plasma HIV viral load is undetectable at baseline on antiretroviral therapy.\n* Subjects who are 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 120 days after the last dose of trial treatment. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.",{"count":7,"type":22},[63],"The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), NAI (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer.\n\nThe names of the therapies involved in this study are:\n\n* PD-L1 t-haNK cell therapy (a NK cell therapy infusion)\n* NAI (a type of recombinant human superagonist)\n* Cetuximab (a type of antibody)",[114,115,116,117,118,119],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Recurrent Head and Neck Cancer","Metastatic Head-and-neck Squamous-cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma",[114,115,116,117,118,119],{"date":75,"type":43},{"date":123,"type":43},"2024-02-16",{"date":125,"type":22},"2027-03-31",{"name":49,"class":50},2,{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":143,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":51},"100531621","exercise-for-gut-microbiome-in-patients-with-young-onset-colorectal-cancer-undergoing-chemotherapy-the-courage-trial-100531621","NCT06202183","Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial","Inclusion Criteria:\n\n* Patient diagnosed with early-stage or metastatic colon or rectal cancer\n* Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included\n* No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)\n* No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks\n* On or planning chemotherapy\n* Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week\n* Medical clearance to perform exercise intervention and testing by their treating oncologist\n* No uncontrolled medical conditions that could be exacerbated with exercise\n* Ability to communicate and complete written forms in English\n* Ability to understand and the willingness to sign informed consent prior to any study-related procedures\n* Willing to travel to DFCI for necessary data collection\n\nExclusion Criteria:\n\n* Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.\n* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.\n* Patients actively on a weigh loss diet and\u002For actively taking weight loss drugs. This could effect gut microbiome.\n* Patient with other active malignancies (excluding basal cell carcinoma).\n* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.","50 Years",{"count":136,"type":22},84,[25],"This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer.\n\nThe names of the study groups involved in this study are:\n\n* Exercise\n* Waitlist Control",[140,141,142],"Colorectal Cancer","Metastatic Colon Cancer","Metastatic Colorectal Cancer",[140,141,142,144],"Early Stage Colorectal Cancer",{"date":40,"type":43},{"date":147,"type":43},"2024-07-22",{"date":149,"type":22},"2028-07-31",{"name":49,"class":50},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100431055","phase-2-atempt-20-adjuvant-t-dm1-vs-th-100431055","NCT04893109","ATEMPT 2.0: Adjuvant T-DM1 vs TH","A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)","Inclusion Criteria:\n\n* Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.\n\n  * If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined to be negative, for the patient to be considered node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H\\&E or immunohistochemistry (IHC) will be considered node-negative.\n  * Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.\n  * Patients who have an area of a T1aN0, ER+ (defined as \\>10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.\n* HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. NOTE: HER-2 status must be confirmed to be positive by central review by NeoGenomics prior to patient starting protocol therapy. Patients previously having had HER2 immunohistochemical testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status.\n\nNOTE: DCIS components will not be counted in the determination of HER2 status\n\n* ER\u002FPR determination is required. ER and PR assays should be performed by immunohistochemical methods according to the local institution standard protocol.\n* Bilateral breast cancers that individually meet eligibility criteria are allowed.\n* Patients with multifocal or multicentric disease are eligible, as long as each tumor individually meets eligibility criteria. Central confirmation is needed for any site of disease that is tested to be HER2-positive by local testing (unless testing was previously done by NeoGenomics).\n* Patients with a history of ipsilateral DCIS are eligible if they were treated with wide excision alone, without radiation therapy, or treated with a mastectomy for this current breast cancer. Patients with a history of contralateral DCIS are not eligible.\n* ≤ 90 days between the planned treatment start date and the patient's most recent breast surgery for this breast cancer\n* ≥ 18 years of age with any menopausal status.\n* ECOG Performance Status 0 or 1\n* All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy), with either a sentinel node biopsy or axillary dissection\n\n  * All margins should be clear of invasive cancer or DCIS (i.e. no tumor on ink). The local pathologist must document negative margins of resection in the pathology report. If all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed. Likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed.\n* Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. Radiation to the conserved breast is required.\n* Patients may have received up to 4 weeks of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this cancer. Patients cannot receive adjuvant hormonal therapy during protocol treatment for the first 12 weeks.\n* Prior oophorectomy for cancer prevention is allowed.\n* Patients who have undergone partial breast radiation (duration ≤ 14 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy. Patients who have undergone whole breast radiation are not eligible.\n* Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤ 2 weeks) are eligible. Patients must have discontinued the investigational agent at least 14 days before participation.\n* Adequate bone marrow function:\n\n  * ANC ≥ 1000\u002Fmm3,\n  * Hemoglobin ≥ 9 g\u002Fdl\n  * Platelets ≥ 100,000\u002Fmm3\n* Adequate hepatic function:\n\n  * Total bilirubin ≤ 1.2mg\u002FdL\n  * AST and ALT ≤ 1.5x Institutional ULN\n  * For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. Serum alkaline phosphatase should be ≤ 1.5x Institutional ULN.\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n* Premenopausal patients must have a negative serum or urine pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.\n* Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception by the patient and\u002For partner. Contraceptive use must be continued for the duration of the study treatment and for 7 months after the last dose of study treatment. Hormonal birth control methods are not permitted.\n* Patients should have tumor tissue available, and a tissue block of sufficient size to make 15 slides, which must be sent to DFCI for correlative research. If a tissue block is unavailable, sites may send one H\\&E-stained slide and 15 unstained sections of paraffin-embedded tissue on uncharged slides. Slide sections should be 4-5 microns in thickness. It is also acceptable to submit 2 cores from a block of invasive tissue using a 1.2 mm diameter coring tool. If tumor is not available, the investigator must document why tissue is not available in the patient medical record, and that efforts have been made to obtain tissue.\n* Willing and able to sign informed consent\n* Must be able to read and understand English in order to participate in the quality of life surveys. If patient does not read and understand English, the patient is still eligible, but cannot participate in the quality of life surveys.\n\nExclusion Criteria:\n\n* Any of the following due to teratogenic potential of the study drugs:\n\n  * Pregnant women\n  * Nursing women\n  * Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).\n  * Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).\n* Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations\u002Fnodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)\n* Patients with a history of previous invasive breast cancer.\n* History of prior chemotherapy in the past 5 years.\n* History of paclitaxel therapy\n* Patients with active liver disease, for example due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy.\n  * Individuals with the following cancer are eligible regardless of when they were diagnosed and treated: cervical cancer in situ, and non-melanoma cancer of the skin.\n* Intercurrent illness including, but not limited to: ongoing or active, unresolved systemic infection, renal failure requiring dialysis, active cardiac disease, prior myocardial infarction (asymptomatic changes on EKG suggestive of old MI is not an exclusion), history of CHF, current use of any therapy specifically for CHF, uncontrolled hypertension, significant psychiatric illness, or other conditions that in the opinion of the investigator limit compliance with study requirements.",{"count":159,"type":22},500,[63],"This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery.\n\nThe name of the study drugs involved are:\n\n* Trastuzumab-emtansine (T-DM1, Kadcyla)\n* Trastuzumab SC (Herceptin Hylecta)\n* Paclitaxel",[163,164],"Breast Cancer","HER2-positive Breast Cancer",[163,164],{"date":40,"type":43},{"date":168,"type":43},"2021-06-16",{"date":170,"type":22},"2029-05-01",{"name":49,"class":50},53,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":190,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":51},"100610438","phase-2-all-backbone-in-ayas-100610438","NCT07227584","ALL Backbone in AYAs","Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)","Inclusion Criteria:\n\n3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.\n\n* Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.\n\n  o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.\n* Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:\n* Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).\n* IT chemotherapy.\n* Emergent radiation therapy or leukapheresis for life threatening complications.\n* One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction).\n\n3.1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin \\\u003C1.4 mg\u002FdL (total bilirubin \\\u003C 1.4 mg\u002FdL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, 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.\n\n3.1.6 Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPhiladelphia chromosome-positive \u002F BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. \\[FISH\u002FPCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology\\]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.\n\n3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.\n\n3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.","51 Years",{"count":182,"type":22},67,[63],"The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).\n\nThe names of the study drugs involved in this study are:\n\n* blinatumomab (a type of immunotherapy drug)\n* cyclophosphamide (a type of chemotherapy drug)\n* cytarabine (a type of antineoplastic agent)\n* dexamethasone (a type of synthetic glucocorticoid)\n* doxorubicin (a type of antineoplastic agent)\n* etoposide (a type of antineoplastic agent)\n* mercaptopurine (a type of antineoplastic agent)\n* methotrexate (a type of chemotherapy drug)\n* pegaspargase (a type of antineoplastic agent)\n* vincristine (a type of antineoplastic agent)",[186,187,188,189],"Acute Lymphoblastic Leukemia","Philadelphia Chromosome-Negative Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia (ALL)","Leukemia",[186,191,188,189],"Philadelphia Chromosome-Negative lymphoblastic leukemia","2026-08-14",{"date":73,"type":43},{"date":195,"type":43},"2026-04-03",{"date":197,"type":22},"2035-07-31",{"name":49,"class":50},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":206,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":207,"targetDuration":209,"studyType":210,"phases":4,"briefSummary":211,"conditions":212,"keywords":244,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":51},"100474891","inadvance-surveillance-prevention-and-interception-in-a-population-at-risk-for-cancer-100474891","NCT05463796","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer","InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer","Inclusion Criteria:\n\n* Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):\n\n  1-Hereditary risk for cancer including\n  * Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes\n  * Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)\n  * Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)\n  * Hereditary Cancer Prediction Model-based elevated cancer risk\n  * Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\\&N cancer for example), etc.\n* Exposed High Risk including\n\n  * Childhood cancer survivors with treatment exposures associated with increased risk of cancer\n  * Adult cancer survivors with treatment exposures associated with increased risk of cancer\n  * Documented high level exposure to group 1 IARC carcinogens\n  * Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \\>50, Smoking history of \\>15 pack years, First-degree relative history of lung cancer or COPD\n  * alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis\n* Precursor Lesions including\n\n  * Breast: ductal\u002Flobular carcinoma in situ (CIS) and atypical hyperplasia\n  * GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia\u002Fadenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis\n  * GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia\u002Fcarcinoma in situ,\n  * Lung: Adenomatous hyperplasia\n  * H\\&N: high-risk oral precancerous diseases\n  * Skin: Class II melanocytic lesions. Squamous dysplasia\n  * Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas\n  * Thoracic: Lung nodules detected on screening CT that prompt further follow-up\n  * GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia\n  * Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.\n* FAMILY MEMBERS or healthy individuals\n\nExclusion Criteria:\n\nThere are no exclusion criteria for the study.\n\nNote: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.",true,{"count":208,"type":22},5000,"20 Years","OBSERVATIONAL","This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.\n\n* The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.\n* The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.",[213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243],"Cancer Risk","Cancer Predisposition Syndrome","Hereditary Cancer Prediction","Childhood Cancer Survivors","Adult Cancer Survivors","IARC Carcinogens","Smoking History","Lung Cancer","Ductal\u002FLobular Carcinoma","Barrett Esophagus","Pancreatic Precursor Lesions","Colonic Dysplasia\u002FAdenomata","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Steatohepatitis","Cirrhosis","High Grade Prostatic Epithelial Neoplasia","High-grade Bladder Urothelial Dysplasia\u002FCarcinoma in Situ","Adenomatous Hyperplasia","High-risk Oral Precancerous Diseases","Melanocytic Lesion, Adult","Hematologic Malignancy","Lung; Node","Serous Tubal Intraepithelial Carcinoma","Endometrial Intraepithelial Neoplasia","Cervical and Endocervical Carcinoma in Situ","Vulvar Intraepithelial Neoplasia","Nephrogenic Rests","Benign Bone Lesions With Risk of Malignant Degeneration","Giant Cell Tumor","Osteochondroma","Spitz Nevus",[245,246,247,248],"Hereditary Risk for Cancer","Childhood cancer survivors","Adult cancer survivors","Precursor Lesions","2026-08-13",{"date":73,"type":43},{"date":252,"type":43},"2023-04-25",{"date":254,"type":22},"2031-03-25",{"name":49,"class":50},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":127},"100625734","phase-4-cosibelimab-for-cscc-in-patients-with-kidney-transplant-or-hematologic-malignancy-100625734","NCT07426484","Cosibelimab for CSCC in Patients With Kidney Transplant or Hematologic Malignancy","A Phase IV Master Protocol of Cosibelimab in Special Populations With Advanced Cutaneous Squamous Cell Carcinoma (CosiMaster)","Inclusion Criteria:\n\n* COHORT A: Participant must have a history of kidney transplant (at least 6 months prior to enrollment). (A history of more than one kidney transplantation is permitted.)\n* COHORT B: Participant must have a diagnosis of a hematologic malignancy, including chronic myeloproliferative neoplasm (CMN) or an indolent non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM).\n* Examples of indolent non-Hodgkin's lymphomas (NHL), including but not limited to:\n\n  * Chronic lymphocytic leukemia (CLL)\n  * Small cell lymphocytic lymphoma (SLL)\n  * Follicular lymphoma (FL)\n  * Lymphoplasmacytic lymphoma\n  * Waldenström macroglobulinemia\n  * Marginal zone lymphoma\n  * Mantle cell lymphoma, indolent variety\n  * Cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome)\n* Examples of chronic myeloproliferative neoplasms (CMN), including but not limited to:\n\n  * Chronic myelogenous leukemia (CML)\n  * Polycythemia vera (PV)\n  * Primary myelofibrosis\n  * Essential thrombocythemia (ET)\n  * Chronic neutrophilic leukemia\n  * Chronic eosinophilic leukemia\n* Examples of myeloma, including but not limited to:\n\n  * Multiple myeloma (MM)\n  * Smoldering myeloma\n* Participants must have histologically or cytologically confirmed diagnosis of cutaneous squamous cell carcinoma (CSCC).\n* Note: Mixed histology is acceptable (e.g. basosquamous, squamous cell carcinoma with adnexal differentiation), and other histologic variants (sarcomatoid carcinoma, spindle cell carcinoma, poorly differentiated carcinoma with squamous features).\n* Participant must have CSCC that is not amenable to surgery or radiation therapy, or recurrent despite prior surgery or radiation therapy, including locally advanced unresectable CSCC for which local therapy (surgery and\u002For radiation therapy) is not recommended. This includes CSCC occurring in patients who are not surgical candidates due to comorbidities and patients who refuse surgery (due to concerns about morbidity, disfigurement, etc).\n* Participants must have measurable disease as per PET Response Criteria in Solid Tumors version\n* (PERCIST 1.0),46 defined as any tumor (of any size) whose SUV lean (SUL) peak is greater than 1.5 times the mean SUL in the liver + 2 times its standard deviation. Mean SUL in the liver is measured in a 3-cm diameter spherical volume of interest (VOI), which is a measurement of the SUV background.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of cosibelimab in participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status 0-2 (see Appendix A for definitions of this and Karnofsky Performance Status).\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1.0 K\u002FmcL\n  * Platelets ≥30 K\u002FmcL\n  * Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome, who must have total bilirubin \\\u003C 3.0 mg\u002FdL\n  * AST(SGOT) ≤ 2.5 × institutional ULN\n  * ALT(SGPT) ≤ 2.5 × institutional ULN\n  * Adequate renal function, defined as defined as estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\n  * Serum creatinine ≤ 3.0 x institutional ULN or ≤ 3.0 x baseline (grade ≤ 2 per CTCAE)\n* Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* PD-1 and PD-L1 immune checkpoint antibodies are classified as pregnancy class D. For this reason, and because other therapeutic agents used in this trial are potentially teratogenic, women of child-bearing potential (WOCBP) 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, and 120 days after completion of cosibelimab administration. 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 120 days after completion of cosibelimab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior treatment within the past 12 months with any of the following classes of drugs: anti-PD-1 inhibitors, anti-PD-L1 inhibitors, or anti-CTLA-4 inhibitors.\n* Prior treatment within the past 6 months with CAR-T cell therapies, other cellular therapies, or multiagent cytotoxic chemotherapy regimens (e.g. R-CHOP). (Bispecific antibodies and EGFR- targeted therapies are permitted without a washout period.)\n* Participants who have adverse events due to prior anti-cancer therapy not recovered to Grade 1 or less, with the exception of alopecia, sensory neuropathy, and cytopenias.\n* Active autoimmune disease that is currently requiring systemic steroid treatment with prednisone \\>10mg daily (or equivalent), anti-CD20 antibodies, intravenous immunoglobulin (IVIG) or JAK inhibitors (ruxolitinib, tofacitinib, upadacitinib, etc).\n* Severe interstitial lung disease (ILD), or a history of pneumonitis that has required oral or IV steroids in the past 5 years.\n* Participants who are receiving any other investigational agents for cancer within 2 weeks of study enrollment.\n* Participants who have uncontrolled, symptomatic infections, or infections requiring systemic antibiotics (prophylactic antimicrobials are permitted).\n* Participants who have uncontrolled or unstable brain metastases (or other CNS metastases) for whom systemic steroids are required. These patients are excluded because steroids may interfere with the effectiveness of immune checkpoint therapy.\n* Uncontrolled or significant cardiovascular disease.\n* Current need for dialysis (hemodialysis or peritoneal dialysis).\n* History of stem cell transplant or bone marrow transplant\n* Psychiatric illness or social situation that would preclude study compliance.\n* Pregnant and breastfeeding women are excluded from this study because cosibelimab is classified as pregnancy class D 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 cosibelimab, breastfeeding should be discontinued if the mother is treated with cosibelimab.\n* Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the study drug are excluded.\n* COHORT A ONLY:\n\n  * History of organ transplant other than kidney, including a heart, lung, or liver transplant, etc, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.\n  * History of severe allergic reaction attributed to sirolimus or everolimus, or other absolute contraindication to mTOR inhibitor, as determined by the treating physician.\n* COHORT B ONLY: History of any solid organ transplant, with the exception of cornea transplantation. Cornea transplant is allowed if participant is not taking systemic immunosuppressive medication expressly for the purpose of corneal allograft.",{"count":264,"type":22},80,[266],"PHASE4","This is study is to evaluate the safety and efficacy of cosibelimab in special populations with advanced cutaneous squamous cell carcinoma (CSCC).\n\nThe name of the drug involved in this research study is:\n\n-cosibelimab (a type of an anti-PD-L1 antibody)",[269,270],"Cutaneous Squamous Cell Carcinoma","Skin Cancer",[272,269,270,273,274,275,276,277,278,279],"Advanced Cutaneous Squamous Cell Carcinoma","Kidney Transplant Recipient","Chronic lymphocytic leukemia (CLL)","Myeloma","Waldenstrom macroglobulinemia","Solid Organ Transplant Recipient","Immunosuppressed","Lymphoma","2026-08-10",{"date":282,"type":43},"2026-08-11",{"date":284,"type":43},"2026-04-23",{"date":286,"type":22},"2032-12-15",{"name":49,"class":50},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":296,"minAge":19,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":307,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":51},"100630031","supporting-health-including-endocrine-treatment-for-long-duration-100630031","NCT07482384","Supporting Health Including Endocrine Treatment for Long Duration","Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention","SHIELD","Inclusion criteria\n\nParticipants will be eligible if they meet the following eligibility criteria:\n\n* Female\n* Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer\n* Premenopausal\n* In active treatment (including long-term endocrine therapy) at the time of enrollment\n* Able to speak, understand and read English\n* Access to a US-based mobile phone number\n* Cognitively able to complete study requirements\n* Ability to access medical records from treating hospital (DFCI)\n* Willing to provide cell phone number and\u002For email address and willing to receive email, mobile push notifications, and\u002For text messages from the study team\n\nExclusion criteria\n\nParticipants will be ineligible if they meet any of the following criteria:\n\n* Individuals under age 18 or over age 50 at initial breast cancer diagnosis\n* Stage IV or metastatic breast cancer\n* Pregnant patients\n* Individuals who do not have a US mobile phone number\n* Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.","FEMALE","49 Years",{"count":299,"type":22},30,[25],"This research is being done to pilot an intervention which aims to test a new web- and mobile application (\"app\")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.",[163,303,304,305,306],"Breast Cancer - Female","Breast Carcinoma","ER Positive Breast Cancer","PR-Positive Breast Cancer",[308,309,310,311,294],"Breast cancer","Breast cancer female","Breast carcinoma","ER+","2026-08-06",{"date":280,"type":43},{"date":315,"type":43},"2026-08-04",{"date":317,"type":22},"2027-05",{"name":49,"class":50},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":51},"100518097","preliminary-efficacy-of-different-exercise-training-during-immunotherapy-in-patients-with-lung-cancer-the-enhance-trial-100518097","NCT06026111","Preliminary Efficacy of Different Exercise Training During Immunotherapy in Patients With Lung Cancer: The ENHANCE Trial","ENHANCE","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically diagnosed with non-small cell lung cancer (NSCLC).\n* Having been receiving immunotherapy for at least one month with a plan to continue for at least 12 weeks prospectively at the time of recruitment.\n* Medical clearance to perform exercise intervention and testing by their treating oncologist.\n* No uncontrolled medical conditions that could be exacerbated with exercise (e.g., uncontrolled hypertension or diabetes).\n* Ability to communicate and complete written forms in English.\n* Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month.\n* Ability to understand and the willingness to sign informed consent prior to any study-related procedures.\n* Willing to travel to DFCI for necessary data collection.\n\nExclusion Criteria:\n\n* Participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes.\n* Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.\n* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.\n* Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study.",{"count":299,"type":22},[25],"The purpose of this study is to examine the feasibility and effects of 12-week exercise training at different intensities among individuals with advanced lung cancer receiving immune checkpoint inhibitors.\n\nThe names of the study interventions involved in this study are:\n\n* High-intensity interval training (HIIT)\n* Moderate-intensity continuous training (MICT)\n* Usual care (UC)",[220],[220],{"date":280,"type":43},{"date":333,"type":43},"2024-02-01",{"date":335,"type":22},"2028-12-31",{"name":49,"class":50},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":353,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":51},"100549871","phase-2-the-sappho-study-sequential-therapy-with-curative-intent-in-de-novo-her2-metastatic-breast-cancer-100549871","NCT06439693","The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer","A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study","Inclusion criteria:\n\n* Participants must have histologically or cytologically confirmed unresectable locally advanced or metastatic invasive breast carcinoma. Patients must have stage IV breast carcinoma at diagnosis (i.e., de novo metastatic) with unequivocal evidence of metastasis on imaging.\n* Diagnosis of HER2-positive invasive breast carcinoma and 3+ by immunohistochemistry on both breast and metastatic biopsies, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines. HER2 status must be determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory (central testing not required). Patients with HER2 1+ or 2+ disease which is HER2 FISH positive are not eligible to enroll.\n* No prior systemic therapy for invasive breast cancer, aside from first-line trastuzumab\u002Fpertuzumab\u002Ftaxane (THP) within 6 weeks from treatment start. Prior endocrine therapy for non-invasive breast carcinoma or non-cancerous lesions is allowed if it has been completed at least 5 years prior to study entry.\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, T-DM1 and tucatinib in Participants \\<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* Left ventricular ejection fraction (LVEF) ≥50%, as assessed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) documented within 12 weeks prior to first dose of study treatment, or within 12 weeks before starting THP for patients who start metastatic therapy prior to study entry.\n* Participants must meet the following organ and marrow function as defined below within 28 days prior to registration:\n\n  * Hgb ≥9.0 g\u002FdL\n  * Absolute Neutrophil Count ≥ 1,000 \u002Fmm3\n  * Platelets ≥100,000\u002Fmm3\n  * Total bilirubin ≤ 1.5 x ULN (institutional) or direct bilirubin within normal limits in patients with a history of Gilbert\\'s syndrome.\n  * AST and ALT ≤ 2.5 x ULN (institutional) or ≤ 5 x ULN for participants with documented liver metastases\n  * Serum creatinine ≤ 1.5 x ULN (institutional) OR calculated GFR ≥60mL\u002Fmin\n* Participants with concurrent human immunodeficiency virus (HIV) infection are eligible provided the following criteria are met:\n\n  * CD4+ T-cell (CD4+) counts \\> 350 cells\u002FuL\n  * No history of AIDS-defining opportunistic infection within 12 months prior to enrollments\n  * Any medication used in an ART regimen must have no known interaction with the agents used in the study treatment regimen.\n* Participants with active or chronic Hepatitis B or C are eligible provided they meet the liver function criteria described in 3.1.7 and are not on a medication with a known liver function criteria described in 3.1.7 and are not on a medication with a known interaction with the agents used in the study treatment regimen. The following guidance applies:\n\n  * patients with chronic HBV infection with active disease who meet the FDA criteria for anti-HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n  * patients with a history of HCV infection should have completed curative antiviral treatment. HCV viral load must be below the limit of quantification.\n  * patients who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* Participants with brain metastases identified at diagnosis or at time of screening are eligible if the following criteria are met:\n\n  * Known, untreated brain metastases must undergo definitive local therapy - as determined by treating physician - prior to study entry.\n  * Treated brain metastases must be clinically stable since treatment. Restaging brain MRI is not required to deem eligibility if local therapy was given within 28 days from first dose of study treatment. Patients are eligible if time from local therapy and first dose of study treatment is:\n\n    * 7 days for stereotactic radiosurgery (SRS);\n    * 14 days for whole-brain radiation therapy (WBRT);\n    * 28 days for surgical resection.\n  * Patients who have already started THP prior to study entry and have brain metastasis detected at screening MRI are eligible after completion of definitive local therapy- as determined by treating physician. Systemic treatment can be interrupted as determined by the treating physician and after discussion with the Sponsor Investigator.\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 (i.e., adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer).\n* This study involves agents that have known genotoxic, mutagenic and teratogenic effects. 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 7 months after completion of study therapy.\n* Women of childbearing potential must have had a negative pregnancy test within 14 days of registration. Childbearing potential is defined as: those who have not been surgically sterilized and\u002For have had a menstrual period in the past 12 months or who have been on ovarian suppression in the past year.\n* Ability to understand and the willingness to sign a written informed consent document indicating awareness of the investigational nature and the risks of this study\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion criteria:\n\n* Prior history of invasive breast carcinoma\n* Treatment with any other investigational agents for this condition.\n* Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery during the study.\n* Extracranial palliative radiotherapy within 7 days prior to enrollment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab, pertuzumab, paclitaxel, trastuzumab deruxtecan, trastuzumab emtansine, tucatinib.\n* Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV).\n* Subjects must not have any of the following:\n\n  * Any untreated brain lesion on screening MRI, unless approved by the Sponsor Investigator\n  * Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \\>2 mg of dexamethasone (or equivalent).\n  * Known or concurrent leptomeningeal disease on screening MRI\n  * Poorly controlled (\\>1\u002Fweek) generalized or complex partial seizures\n* History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Sponsor-Investigator.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* History of other lung disease, such as:\n\n  * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrolment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion etc.).\n  * Any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  * Prior pneumonectomy.\n* Active or uncontrolled clinically serious infection\n* Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications\n* Have ongoing ≥ Grade 2 diarrhea of any etiology\n* Participants receiving any medications or substances that are inhibitors or inducers of CYP2C8 and\u002For CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference.\n* Pregnant women are excluded from this study because of potential for teratogenic or abortifacient effects of study drugs. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued prior to enrollment.",{"count":345,"type":22},72,[63],"The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.\n\nThe names of the study drugs involved in this study are:\n\n* Paclitaxel (a type of anti-microtubule agent)\n* Docetaxel (a type of anti-microtubule agent)\n* Nab-Paclitaxel (a type of anti-microtubule agent)\n* Trastuzumab (a type of IgG1 kappa monoclonal antibody)\n* Pertuzumab (a type of monoclonal antibody)\n* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)\n* Tucatinib (Tyrosine Kinase HER2 Inhibitor)\n* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)",[349,163,350,351,164,352],"Breast Cancer Female","Breast Cancer Metastatic","Estrogen Receptor-positive Breast Cancer","Stage IV Breast Cancer",[163,349,350,354,164,352],"Estrogen Receptor-Positive Breast Cancer",{"date":312,"type":43},{"date":357,"type":43},"2024-08-08",{"date":359,"type":22},"2033-03-30",{"name":49,"class":50},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":51},"100624623","precise-exercise-regimen-for-cancer-care-percc-a-pilot-study-100624623","NCT07412041","Precise Exercise Regimen for Cancer Care (PERCC): A Pilot Study","PERCC","Inclusion Criteria:\n\n* Age ≥18 years at time of diagnosis; due to the rarity of the disease in those \\\u003C18 years, this age bracket will not be included.\n* Histologically diagnosed with stage II or III non-small cell lung cancer (NSCLC) and has not started lung cancer treatment.\n* Patient's treatment plan is to receive neoadjuvant therapy (defined as chemotherapy, chemotherapy and immunotherapy, or chemotherapy and radiation therapy) followed by surgical treatment. Patients will be enrolled at least three weeks prior to receiving their first neoadjuvant treatment.\n* Ability to follow directions and complete questionnaires in English and\u002For Spanish.\n* Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.\n* Willing to travel to DFCI for necessary data collection.\n\nExclusion Criteria:\n\n* Patients who are morbidly obese (BMI\\>40 kg\u002Fm2) or Anorexic (BMI\\\u003C17 kg\u002Fm2).\n* Unstable comorbidities that contraindicate participation in exercise program compliance. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because part of this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded. Study staff will identify untreated or unmanaged conditions when screening and treating MDs must provide clearance prior to patient enrollment.\n* Patients with alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer).\n* Patients scheduled to receive single modality cancer treatment (unimodal therapy), scheduled surgery within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started.\n* Patients who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.\n* Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.",{"count":21,"type":22},[25],"The purpose of this study is to test the feasibility of the Precise Exercise Regimen for Cancer Care (PERCC) exercise program in participants with stage II-III primary lung cancer.",[372,220,373,374],"Stage II Lung Cancer","Non-small Cell Lung Cancer","NSCLC",[372,220,373,374],"2026-08-03",{"date":378,"type":43},"2026-08-05",{"date":380,"type":43},"2026-01-22",{"date":382,"type":22},"2028-03-30",{"name":49,"class":50},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":391,"minAge":19,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":399,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":81},"100498072","phase-2-recoverpc-relugolix-vs-gnrh-agonist-in-quality-of-life-100498072","NCT05765500","RecoverPC: Relugolix vs GnRH Agonist in Quality of Life","RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer","Inclusion Criteria:\n\n* Participants must have a histologic diagnosis of prostate adenocarcinoma.\n* Participants must be eligible for treatment with 6 months of ADT with leuprolide depot or relugolix without additional systemic therapies other than first generation androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).\n* Participants cannot have received prior GnRH agonist or antagonist therapy.\n* Patients must have testosterone level \\> 200 ng\u002FmL prior to initiation of ADT.\n* Age ≥18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Life expectancy of greater than 12 months\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes ≥3,000\u002FmcL\n  * absolute neutrophil count ≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome\n  * AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN\n  * creatinine ≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥50 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2 (see Appendix B).\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 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 known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of relugolix and leuprolide on the developing human fetus are unknown. For this reason and because GnRH agents are known to be teratogenic, 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 relugolix or leuprolide depot administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.\n* Participants who have prior or planned concurrent treatment with second generation AR targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide).\n* Participants who are receiving any other investigational agents.\n* Patients with brain metastases will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide depot or relugolix.\n* Participants with uncontrolled intercurrent illness.\n* Participant is unable to swallow pills.","MALE",{"count":393,"type":22},110,[63],"This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label.\n\nThe names of the study drugs involved in this study are:\n\n* Leuprolide (type of ADT)\n* Relugolix (type of ADT)",[397,398],"Prostate Cancer","Prostatic Neoplasms",[397,400],"Prostate Neoplasms","2026-07-29",{"date":403,"type":43},"2026-07-30",{"date":405,"type":43},"2024-02-12",{"date":407,"type":22},"2028-01-01",{"name":49,"class":50},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":391,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":423,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":51},"100464420","exercise-to-enhance-cardiovascular-health-among-black-prostate-cancer-patients-with-androgen-deprivation-therapy-100464420","NCT05327465","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy","Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy: POWER Trial","Inclusion Criteria:\n\n* Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.\n* Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease\n* Histologically diagnosed of localized or metastatic prostate cancer\n* Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \\[LHRH\\] agonist\u002Fantagonist and\u002For androgen receptor \\[AR\\] agonist\u002Fantagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment\n* Self-identify as Black\n* Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist\n* Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases\n* Speak English and\u002For Spanish\n* Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Willing to travel to DFCI for necessary data collection\n* Ability to communicate and complete written forms in English and\u002For Spanish\n\nExclusion Criteria:\n\n* Are not receiving ADT (i.e., LHRH agonist\u002Fantagonist and\u002For AR agonist\u002Fantagonist)\n* Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise\n* Are not English or Spanish speaking\n* Patients with secondary diagnosis (with the exception of basal cell carcinoma)\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n* Unable to travel to DFCI for necessary data collection\n* May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.",{"count":417,"type":22},62,[25],"The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.\n\nParticipants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.",[421,397,422],"Androgen Deprivation Therapy","Prostate Cancer Metastatic",[424,425,422,426],"Androgen deprivation therapy","Localized Prostate Cancer","Exercise","2026-07-28",{"date":401,"type":43},{"date":430,"type":43},"2022-08-11",{"date":432,"type":22},"2027-05-31",{"name":49,"class":50},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":449,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":127},"100649672","bridge-sic-efficacy-trial-100649672","NCT07735442","BRIDGE-SIC Efficacy Trial","Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication (BRIDGE-SIC)","Inclusion Criteria:\n\n* DFCI Patients, defined as patients who have a DFCI medical record number.\n* Admitted to an inpatient solid tumor medical oncology service at BWH (including beds that are considered to be DFCI beds within BWH)\n* Age ≥ 18 years\n* Mortality prediction ≥ 25%\n* Admitted on a Sunday after 4pm through Friday at 4pm. These time restrictions are necessary for the workflow of this pragmatic pilot trial, as the intervention requires a staff member to send intervention emails during the work week but within \\\u003C= approximately 18 hours of admission. Accordingly, we will not enroll patients during holiday time periods (e.g., for a Monday holiday, enrollment would start on Monday at 4pm instead of Sunday at 4pm) or on days where staff absences (e.g., illness) preclude enrollment.\n\nExclusion Criteria:\n\n• Patients with elective inpatient admissions (typically for planned administration of chemotherapy or other treatments)",{"count":442,"type":22},600,[25],"This is a pragmatic, prospective, randomized clinical trial to test the effectiveness of large language model (LLM)-generated serious illness conversation (SIC) summaries delivered to patients' inpatient and outpatient clinicians at the time of hospital admission on the primary outcome of days in the hospital in the next 90 days.",[446],"Cancer",[448],"Cancer (Solid Tumor)","NOT_YET_RECRUITING","2026-07-24",{"date":403,"type":43},{"date":453,"type":22},"2026-07-31",{"date":455,"type":22},"2028-06-30",{"name":49,"class":50},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":51},"100365992","a-pilot-of-a-microdevice-for-in-situ-candidate-drug-screening-in-cutaneous-lesions-of-t-cell-lymphoma-100365992","NCT04045470","A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma","Inclusion Criteria:\n\n* Participants must have clinical diagnosis of cutaneous T-cell lymphoma or peripheral T-cell lymphoma with cutaneous involvement supported by histological evaluation of skin lesions.\n* Participants must have measurable cutaneous disease, based on the modified Severity Weighted Assessment Tool (mSWAT; definition provided in appendix E). Skin lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Two lesions are amenable to placement of multiple devices in terms of lesion size and location, as assessed by dermatologist (minimum diameter of 1.5 cm).\n* Patient must have the following minimum washout period from previous treatments and cannot be on any systemic therapy at the time of implantation.\n\n  * 2 week from topical therapies of lesional skin selected for implantation\n  * 2 weeks from retinoids, interferons, vorinostat, romidepsin, therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteoids are allowed)\n  * 4 weeks from phototherapy\n  * 5 half-lives for systemic cytotoxic anticancer agents, monoclonal antibodies, and investigational therapy\n  * 12 weeks from local radiation therapy of lesional skin selected for implantation\n  * 15 weeks from systemic immunotherapy targeting PD-1\u002FPD-L1\n* Age minimum of age 18.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Participants will undergo laboratory testing within 28 days prior to the procedure. Participants must have marrow function as defined below:\n\n  * absolute neutrophil count ≥500\u002FmcL\n  * platelets ≥50,000\u002FmcL\n* Participants must be evaluated by a dermatologist or medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. Systemic therapy will be mandatory for cohort 2\u002Fexpansion cohort, not for cohort 1. Systemic therapy may be initiated anytime within 4 weeks of MD removal.\n* Patients must be deemed medically stable to undergo percutaneous procedures by their treating cutaneous oncologist.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patients must be willing to undergo research-related genetic and transcriptomic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.\n* Patient is considered to have capacity to properly follow instructions at home for the care of device(s) that will each have an attached thin guidewire protruding through the skin and fixed in place (see Appendix B).\n\nExclusion Criteria:\n\n* Positive serum pregnancy test at screening visit.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who will receive standard of care systemic therapy are not allowed to start any new skin directed therapy (e.g. topical steroids, radiation, phototherapy) concurrent with first systemic therapy initiated after device implantation and retrieval. Should a patient clinically progress on first systemic therapy and require a change in treatment, skin directed therapies may be introduced.\n* Patients unable to undergo treatment wash-out period due to rapidly progressive disease requiring immediate systemic therapy",{"count":21,"type":22},[25],"This research is being done to study the safety of implanting and retrieving a microdevice that releases up to 19 drugs directly within a cancerous lesion as a possible tool to evaluate the effectiveness of several approved cancer drugs against cutaneous T cell lymphoma and peripheral T cell lymphoma",[467,468],"Cutaneous T Cell Lymphoma","Peripheral T Cell Lymphoma",[467,468],{"date":471,"type":43},"2026-07-27",{"date":473,"type":43},"2019-12-11",{"date":149,"type":22},{"name":49,"class":50},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":490,"overallStatus":449,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":127},"100649179","listen-aphasia-pilot-study-100649179","NCT07732140","Listen Aphasia Pilot Study","LISTEN: Supporting Communication in Patients With Tumor-Related Aphasia","LISTEN","Inclusion Criteria:\n\nPatient inclusion criteria are as follows:\n\n* A histologically or cytologically confirmed primary or secondary brain tumor with expected ongoing deterioration in language as determined by their oncologist\n* Mild-to-moderate aphasia or other acquired communication disorder as determined by their oncologist or speech-language pathologist\n* ECOG Performance Status of ≤2 or Karnofsky Performance Status ≥60\n* Expected overall survival of \\>6 months\n* Ability to understand and the willingness to sign a written consent form\n* Age ≥18 years\n* Willingness to participate in study interviews and be recorded for the study (for monitoring of study fidelity)\n* Cancer survivors will also be included\n\nCare-partner inclusion criteria are as follows:\n\n* Identified by their patient as someone who is integral to their care\n* Age ≥18 years\n* Ability to understand and the willingness to sign a written consent form\n* Willingness to participate in study interviews and be recorded for the study (monitoring of study fidelity)\n\nExclusion Criteria:\n\nPatient exclusion criteria are as follows:\n\n* Unable to read or respond to questions in English\n* Severe dysarthria as determined by their oncologist\n* Aphasia that is moderate-to-sever enough that the patient cannot consent without a proxy\n* Expected survival of ≤ 6 months\n* Severe cognitive impairment as determined by their oncologist\n\nCare-partner exclusion criteria are as follows:\n\n-Unable to read or respond to questions in English",{"count":264,"type":22},[25],"This is a feasibility and pilot study to refine and test LISTEN, an AI-based augmentative and alternative communication (AAC) smartphone app, integrated into the patient's personal electronic device, to augment and facilitate communication in patients with tumor-related aphasia (TRA) and their care partners. The study will assess the feasibility and acceptability of LISTEN in patients with TRA and their care partners.",[488,489],"Aphasia","Malignant Brain Tumor",[491,489],"Tumor-Related Aphasia (TRA)","2026-07-23",{"date":427,"type":43},{"date":495,"type":22},"2027-01",{"date":497,"type":22},"2030-12",{"name":49,"class":50},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":509,"conditions":510,"keywords":514,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":127},"100527826","phase-1-ciml-nk-cells-with-venetoclax-for-aml-100527826","NCT06152809","CIML NK Cells With Venetoclax for AML","A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML","Inclusion Criteria for Trial Enrollment (Screening Visit #1):\n\n* Diagnosis of acute myeloid leukemia (AML)\n* Age ≥ 18 years old\n* At time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle of HMA (azacitidine or decitabine) + venetoclax. Patients can have received other lines of therapy prior to HMA + venetoclax therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \\> 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-host disease.\n* Presence of molecular risk factors for relapse with continued HMA + venetoclax therapy as defined by any of the following present at the time of diagnosis or start of HMA + venetoclax therapy (these do not need to be present at the time the screening BM biopsy):\n\n  * 2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)\u002FDEK::NUP214; t(v;11q23.3)\u002FKMT2A-rearranged; t(9;22)(q34.1;q11.2)\u002FBCR::ABL1; t(8;16)(p11.2;p13.3)\u002FKAT6A::CREBBP; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\u002F GATA2, MECOM(EVI1), t(3q26.2;v)\u002FMECOM(EVI1)-rearranged; -5 or del(5q); -7; Complex karyotype, monosomal karyotype\n  * 2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n  * Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD\u002FTKD\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n  * left ventricular ejection fraction ≥ 40%\n* Negative pregnancy test for women of childbearing potential only.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry 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 and until 4 months after the last IL-2 dose administration.\n* Participants with current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* 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* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* Subjects must be able to swallow pills.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator (demonstration of hemolysis should include a haptoglobin level that is below assay).\n\nExclusion Criteria for Trial Enrollment (Screening visit #1)\n\n* Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy\n* Persisting Grade \\> 1 non hematologic toxicity related to prior therapy; however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n* Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease disease requiring any steroids \\>\\> the equivalent dose of 10 mg of prednisone or other immunosuppressive therapies at the time of this screening visit (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after conditioning therapy.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.\n* History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.\n* Participants who are receiving any other investigational agents for this condition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior history of Grade 2 or higher hemolytic anemia (≥ 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* Patient was eligible for protocol per section 3.1.\n* Repeat bone marrow biopsy at this time shows a complete remission (CR) or complete remission with incomplete count recovery (CRi) or morphologic leukemia free state (MLFS) (\\\u003C 5% blasts) but with presence of measurable residual disease (MRD+). MRD can be determined by either flow cytometry, next generation sequencing or PCR. Patients with only persistent DNMTA, TET2 or ASXL1 mutations will not qualify as MRD+ as these DTA mutations without other comutations are associated with clonal hematopoiesis. OR\n* Repeat bone marrow biopsy at this time shows 5-19% residual myeloblasts in the bone marrow by either bone marrow aspirate or core biopsy.\n* Confirmed haploidentical or fully HLA-matched related donor that is willing and eligible for non-mobilized collection.\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following laboratory and organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* Negative pregnancy test for women of childbearing potential only.\n* Subjects must be able to swallow pills.\n\nExclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* No live vaccines within the last 6 months.\n* No ongoing or active infections.\n* Moderate\u002Fstrong inhibitors of CYP3A except of antifungal medications (such as posaconazole, voriconazole) which the patient is on and the dose of venetoclax has already been adjusted. These are excluded as moderate\u002Fstrong inhibitors of CYP3A induce higher drug levels of venetoclax which in turns carry the risk of CIML NK cell elimination.\n* The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay in subjects who do not receive a desensitization protocol prior to and during stem cell transplant.\n\nCriteria to Receive Lymphodepletion on Day -5\n\n* Adequate organ function within 24 hours of lymphodepletion as defined below:\n\n  * Direct bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST (SGOT)\u002FALT (SGPT): ≤ 3 x institutional ULN\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with lymphodepletion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months\n\nCriteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n* No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No systemic steroid therapy (oral or IV) of \\> 10mg prednisone or equivalent dose of other steroid agent on the day of NK cell infusion\n\nIf any of the above criteria are noted at these time points, please discuss with PI the benefits\u002Frisks of proceeding with the CIML infusion and document rationale for course of action taken in study regulatory binder. However, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder agree with proceeding.\n\nIf inclusion\u002Fexclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 24 hours to enable inclusion criteria to be met.\n\nCriteria to Receive Venetoclax\n\n* Adequate organ function within 24 hours of venetoclax initiation as defined below:\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with venetoclax administration, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe ongoing tumor lysis syndrome)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months",{"count":507,"type":22},10,[92],"The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML).\n\nNames of the study therapies involved in this study are:\n\n* Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion\n* CIML NK (a cellular therapy)\n* IL-2 (a recombinant, human glycoprotein)\n* Venetoclax (a selective inhibitor of BCL-2 protein)",[511,512,189,513],"Acute Myeloid Leukemia","Acute Myeloid Leukemia Recurrent","Leukemia, Myeloid",[511,512,189,513],{"date":450,"type":43},{"date":517,"type":43},"2024-02-20",{"date":519,"type":22},"2027-11-30",{"name":49,"class":50},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":391,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":449,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":4},"100649047","reduce-heat-a-randomized-trial-of-wearable-thermal-devices-for-adt-induced-hot-flashes-100649047","NCT07729150","Reduce HEAT: A Randomized Trial of Wearable Thermal Devices for ADT-Induced Hot Flashes","Reduce Hot flashEs AssociaTed With ADT (Reduce HEAT) - a Prospective Randomized Clinical Trial of a Wearable Thermal Device for Patients With Prostate Cancer on ADT With Bothersome Vasomotor Symptoms","Reduce HEAT","Inclusion Criteria:\n\n* Patients with a clinical or pathologic confirmed diagnosis of prostate cancer\n* Patients must be undergoing treatment with standard androgen deprivation therapy (i.e., GnRH agonist or antagonist) for ≥ 4 weeks. Patients must remain on ADT for the duration of the study (12 weeks); they may receive treatment with an androgen receptor pathway inhibitor (ARPI), radioligand therapy, or immunotherapy combined with ADT.\n* Patients must report bothersome hot flash symptoms (defined as ≥ 28 hot flashes per week, perceived to be at least moderately bothersome to the patient), during a period of at least 30 days prior to entering the study.\n* Age ≥18 years.\n* ECOG performance status ≤ 2\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Pregnant and nursing women are excluded as prostate cancer is a disease of men.\n* Participants with a concurrent diagnosis, including separate malignancy, that may limit life expectancy \\\u003C 6 months.\n* Systemic antineoplastic therapy besides approved ARPI, radioligand therapy, and immunotherapy - enrollment in a clinical trial that is using SOC therapeutic options in these categories is allowed.",{"count":530,"type":22},66,[25],"This is a prospective, randomized, non-pharmacologic interventional trial evaluating the effectiveness of the Embr Wave wearable thermal device in reducing hot flash burden in men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will be randomized 1:1 to immediate (12 weeks) versus delayed (after 6 weeks) use of the Embr Wave device. The study aims to determine whether the device reduces vasomotor symptoms using a number of patient-reported outcomes",[397,534,535],"Hot Flashes","Vasomotor Symptoms",[397,534,535],"2026-07-22",{"date":471,"type":43},{"date":540,"type":22},"2026-10-01",{"date":542,"type":22},"2028-06-01",{"name":49,"class":50},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":18,"minAge":551,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":127},"100552094","developing-restful-environments-and-management-strategies-for-pediatric-stem-cell-transplant-patients-100552094","NCT06468618","Developing Restful Environments and Management Strategies for Pediatric Stem Cell Transplant Patients","DREAMS","Inclusion Criteria:\n\n* Patient aged 9-17 years.\n* Patient scheduled to receive a stem cell transplant at Boston Children's Hospital.\n* English speaking child and primary caregiver (parent\u002Fguardian).\n\nExclusion Criteria:\n\n-Primary team declines permission to approach.","9 Years","17 Years",{"count":507,"type":22},[25],"Pediatric patients undergoing stem cell transplant (SCT) are hospitalized for extended periods and are at high risk for sleep disturbances. In order to begin to address the environmental issues that SCT recipients face during inpatient hospitalizations, investigators will conduct a single arm pilot study of a program entitled 'Developing Restful Environments and Management Strategies' (DREAMS). The program will provide children receiving SCT and families with information and a kit that includes tools which may support sleep and circadian health during an inpatient hospitalization.",[557,558],"Stem Cell Transplant Complications","Sleep Disturbance","2026-07-21",{"date":537,"type":43},{"date":562,"type":43},"2024-08-06",{"date":564,"type":22},"2027-08",{"name":49,"class":50},{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":23,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":449,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":127},"100647878","phase-2-zanzalintinib-in-unresectable-and-progressive-mpggs-100647878","NCT07714551","Zanzalintinib in Unresectable and Progressive MPGGs","A Phase 2 Clinical Trial of Zanzalintinib in Patients With Unresectable and Progressive Metastatic Pheochromocytoma or Paraganglioma (MPPGs)","Inclusion Criteria:\n\n* Age ≥ 18 years. As no dosing or adverse event data are currently available in participants \\\u003C 18 years of age, children and adolescents are excluded from this study.\n* Documentation of Disease\n\n  * Histologic Documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.\n  * Stage: Advanced (metastatic or unresectable primary) disease\n  * Tumor Site: Histologically-proven pheochromocytoma or paraganglioma\n  * Radiographic Evaluation: Radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration.\n* Measurable disease\n\n  * Lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 1 cm with CT or MRI (or ≥ 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly non-measurable including: leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung.\n* Prior Treatment\n\n  * Prior treatment with other somatostatin analog, chemotherapy, radiotherapy (including peptide radionuclide receptor therapy \\[PRRT\\]), or surgery is permitted.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Organ and marrow function and laboratory values as follows within 4 days prior to the first dose of zanzalintinib:\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3without colony stimulating factor support\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Bilirubin ≤ 1.5 the upper limit of normal (ULN). For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg\u002FdL\n  * Serum albumin ≥ 2.8 g\u002Fdl\n  * Serum creatinine ≤ 1.5 ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin. For creatinine clearance estimation, the Cockcroft and Gault equation should be used:\n\nMale: CrCl (mL\u002Fmin) = (140 - age) × wt (kg) \u002F (serum creatinine × 72) Female: Multiply above result by 0.85\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 ULN\n* Lipase \\\u003C 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis\n* Urine protein\u002Fcreatinine ratio (UPCR) ≤ 1\n* Serum phosphorus, calcium, potassium ≥ LLN and magnesium ≥ 1.2 mg\u002FdL\n\n  * Capable of understanding and complying with the protocol requirements and has signed the informed consent document.\n  * Sexually active patients (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).\n  * Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post-menopause is defined as amenorrhea ≥ 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.\n\nExclusion Criteria:\n\n* Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas\u002F mitomycin C within 6 weeks before the first dose of study treatment.\n* Prior treatment with zanzalintinib\n* Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Received radionuclide treatment (i.e. I 131 meta-iodo- benzyl guanidine) within 6 months of the first dose of study treatment\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment.\n* Receipt of any other type of investigational agent within 28 days before the first dose of study treatment.\n* The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia, fatigue, and other non-clinically significant AEs.\n* Prothrombin time (PT)\u002F International Normalized Ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 the laboratory ULN within 7 days before the first dose of study treatment.\n* The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (≤ 81 mg\u002Fday), , prophylactic low molecular weight heparin (LMWH), and or specified direct Fxa inhibitors rivaroxaban, edoxaban, or apixabanare permitted in subjects without known brain metastases.\n* Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to first dose of study treatment, whichever is longer.\n* The subject requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Note: Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment. Note: Base of skull lesions without definitive evidence of dural or brain parenchymal involvement are allowed.\n* The subject has experienced any of the following: clinically significant gastrointestinal bleeding within 6 months before the first dose of study treatment hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment\n\n  ·any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n* Radiographic evidence of cavitating pulmonary lesion(s)\n* Tumor invading or encasing \\> 180 degrees any major blood vessels\n* Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of zanzalintinib.\n\n  ·Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n* Cardiovascular disorders including\n\n  * Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening\n  * Concurrent uncontrolled hypertension defined as sustained BP \\> 150 mm Hg systolic, or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\n  * Any history of congenital long QT syndrome\n  * Any of the following within 6 months before the first dose of study treatment:\n  * unstable angina pectoris\n  * clinically-significant cardiac arrhythmias\n  * stroke (including TIA, or other ischemic event)\n  * myocardial infarction\n  * thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)\n* Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\n\nAny of the following within 28 days before the first dose of study treatment\n\n* intra-abdominal tumor\u002Fmetastases invading GI mucosa\n* known gastric or esophageal varices, ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks\n* active peptic ulcer disease; patients must be completely recovered\n* acute flare of inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis; patients must be completely recovered from these conditions\n* malabsorption syndrome\n\nAny of the following within 6 months before the first dose of study treatment:\n\n* abdominal fistula\n* gastrointestinal perforation\n* bowel obstruction or gastric outlet obstruction\n* intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with zanzalintinib even if the abscess occurred more than 6 months before the first dose of study treatment.\n* Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy\n\n  -Other clinically significant disorders such as:\n* Active infection requiring systemic treatment within 28 days before the first dose of study treatment.\n* Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness except for subjects meeting all of the following criteria: (1) on stable anti-retroviral therapy; (2) CD4+ T cell count ≥ 200\u002FµL; and (3) an undetectable viral load. Note: HIV testing will be performed at screening if and as required by local regulation. Note: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to initiation of study treatment. Anti-retroviral therapies (ART) must have been received for at least 4 weeks prior to the first dose. Note: CD4+ T cell counts, and viral load are monitored per standard of care by the local health care provider. Serious non-healing wound\u002Fulcer\u002Fbone fracture within 28 days before the first dose of study treatment\n\n  * History of organ transplant\n  * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment\n  * Major surgery within 12 weeks before the first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment. Minor surgery within 28 days before the first dose of study treatment with complete wound healing at least 10 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n  * Unable to swallow tablets\n  * A corrected QT interval calculated by the Fridericia formula (QTcF) \\>500 ms within 28 days before first dose of study treatment. Three ECGs must be performed. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard.\n  * Pregnant or breastfeeding.\n  * A previously identified allergy or hypersensitivity to components of the study treatment formulation.\n  * Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n  * Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer or cured in situ cervical carcinoma\n  * Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the patient inappropriate for entry into this study.\n  * Moderate to severe hepatic impairment (Child-Pugh B or C).\n  * Requirement for hemodialysis or peritoneal dialysis.\n\nInclusion of Women and Minorities\n\nBoth men and women of all races and ethnic groups are eligible for this trial.\n\nNIH policy requires that women and members of minority groups and their subpopulations be included in all NIH-supported biomedical and behavioral research projects involving NIH-defined clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the funding Institute \\& Center (IC) Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances designated by the Director, NIH, upon the recommendation of an IC Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. Please see http:\u002F\u002Fgrants.nih.gov\u002Fgrants\u002Ffunding\u002Fphs398\u002Fphs398.pdf.",{"count":574,"type":22},14,[63],"This study is to examine the effects of oral daily zanzalintinib in participants with unresectable, progressive metastatic pheochromocytoma or paraganglioma.",[578,579],"Pheochromocytoma","Paraganglioma",[578,579,581,582],"Metastatic pheochromocytoma or paraganglioma","Unresectable, progressive advanced pheochromocytoma\u002Fparaganglioma","2026-07-17",{"date":585,"type":43},"2026-07-20",{"date":587,"type":22},"2027-01-09",{"date":589,"type":22},"2032-01-01",{"name":49,"class":50},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":296,"minAge":599,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":608,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":619},"100480377","telehealth-resistance-exercise-intervention-to-preserve-dose-intensity-and-vitality-in-elder-breast-cancer-patients-100480377","NCT05535192","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients","TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)","THRIVE-65","Inclusion Criteria:\n\n* Women age \\>=65\n* Diagnosed with stage I-III invasive breast cancer\n* BMI between 18-50 kg\u002Fm2\n* Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent\n* If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents\u002Fdoses according to patient response (e.g.; I-SPY trials)\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks (with or without assistive device)\n* Ability to provide written informed consent.\n* Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters.\n\nExclusion Criteria:\n\n* Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD\n* Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year\n* Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year\n* Presence of medical conditions or medications that would prohibit participation in an exercise program\n* Current use of weight-loss medication\n* Documented history of alcohol or substance abuse within the past 12 months\n* History of dementia","65 Years",{"count":601,"type":22},270,[25],"This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.",[163,605,349,606,607],"Stage III Breast Cancer","Stage I Breast Cancer","Stage II Breast Cancer",[163,605,607,606,609,610,611],"Exercise Intervention","Nutrition Intervention","Supportive Care","2026-07-16",{"date":583,"type":43},{"date":615,"type":43},"2023-03-20",{"date":617,"type":22},"2028-02-01",{"name":49,"class":50},4,{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":624,"acronym":625,"eligibilityCriteria":626,"healthyVolunteers":206,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":23,"phases":629,"briefSummary":630,"conditions":631,"keywords":633,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":51},"100552147","driving-inclusivity-validity-and-equity-in-research-through-strategic-engagement-diverse-100552147","NCT06469307","Driving Inclusivity, Validity, and Equity in Research Through Strategic Engagement (DIVERSE)","DIVERSE","CAB Participant Inclusion Criteria:\n\n* Age 18 or older\n* English speaking\n* Ability to understand and willingness to provide oral consent\n* DFCI patient who are in remission from a blood cancer \\>1 year will be preferred.\n\nCAB Participant Exclusion Criteria:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C18 years old)\n* Prisoners.\n* Unwilling\u002Funable to agree to maintaining the confidentiality of reviews and clinical trial materials, as outlined in Section 9.1\n* Note 1: Patients and non-patient community members who are pregnant are eligible. This is a non-interventional study that meets the definition of minimal risk and poses no greater risk to pregnant individuals or fetuses. Pregnancy status will not be assessed.\n* Note 2: English fluency is necessary as protocols being reviewed are written in English and cannot be feasibly translated to other languages within the time period necessary to complete timely reviews.\n\nInvestigator Participant Inclusion Criteria:\n\n* Age 18 older\n* English Speaking\n* Site or Principal investigator\n* Not a member of the research team",{"count":628,"type":22},40,[25],"The purpose of this research study is to enhance inclusion and diversity in clinical trial enrollment by training participants to perform and provide feedback through a community-based protocol review process, called DIVERSE.",[632,189],"Blood Cancer",[632,189],"2026-07-15",{"date":612,"type":43},{"date":637,"type":43},"2024-12-09",{"date":639,"type":22},"2028-01-30",{"name":49,"class":50},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":18,"minAge":648,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":656,"overallStatus":449,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":659,"startDateStruct":660,"completionDateStruct":661,"leadSponsor":663,"locationsCount":51},"100525128","integrated-smartphone-technology-to-alleviate-malignant-pain-i-stamp-testing-100525128","NCT06117709","Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP) Testing","Integrated Smartphone Technology to Alleviate Malignant Pain (I-STAMP): Development, Usability, and Acceptability Testing","Inclusion Criteria for Participants (Activities 1a, 2a, 3a):\n\n* Age ≥ 21 years\n* Current or previous diagnosis of advanced cancer\n* Current or previous experience with cancer pain\n\nExclusion Criteria for Participants (Activities 1a, 2a, 3a):\n\n* Inability to understand, speak, or read English\n* Any condition that would impede the patient's ability to complete study procedures such as visual impairment or significant cognitive impairment as determined by the participant's treating provider.","21 Years",{"count":650,"type":22},73,[25],"The purpose of the study is to evaluate if the smartphone app, I-STAMP (Integrated Smartphone Technology to Alleviate Malignant Pain), helps participants with cancer pain manage symptoms and keep track of medications.",[654,655],"Advanced Cancer","Pain",[654,657,658],"Pain management","Opioid pain management",{"date":612,"type":43},{"date":45,"type":22},{"date":662,"type":22},"2026-11-30",{"name":49,"class":50},""]