[{"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:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,119,0,25,[9,64,91,116,141,168,195,220,241,264,291,318,338,359,382,405,433,455,479,504,523,541,570,593,617],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":42,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100644985","clonal-hematopoiesis-chemotherapy-and-radiation-effects-study-100644985",false,"NCT07675967","Clonal Hematopoiesis Chemotherapy and Radiation Effects Study","CH CARE","Inclusion Criteria:\n\n* Participants to be included in this study include the following:\n* Adults age \\>18 years\n* Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers)\n* Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer).\n* Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.\n\nExclusion Criteria:\n\n* Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure\n* Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer)\n* Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.","ALL","18 Years",{"count":20,"type":21},5000,"ESTIMATED","OBSERVATIONAL","The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers.\n\nThe study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs).\n\nUltimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"Lung Cancer (Diagnosis)","Osteochondroma","Spitz Nevus","Solid Cancers","Breast Cancer","Gastric (Stomach) Cancer","Colorectal (Colon or Rectal) Cancer","Sarcoma","Ovarian Adenocarcinoma","Uterine Adenocarcinoma","Endometrial Adenocarcinoma","Esophageal Adenocarcinoma","Head and Neck Cancer","Therapy-Related Acute Myeloid Leukemia","Therapy-Related MDS","Clonal Hematopoiesis of Indeterminate Potential (CHIP)","Clonal Cytopenia of Undetermined Significance",[43,44,45,46,47,48,49,50],"Adult cancer survivors","Precursor Lesions","clonal hematopoiesis","chemotherapy","radiation","therapy-related myeloid neoplasms","CCUS","clonal hematopoiesis of indeterminate potential","RECRUITING","2026-06-29",{"date":54,"type":55},"2026-06-30","ACTUAL",{"date":57,"type":55},"2025-04-04",{"date":59,"type":21},"2035-03-31",{"name":61,"class":62},"Dana-Farber Cancer Institute","OTHER",1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":71,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100531670","cv-care-cardiovascular-care-in-pc-patients-100531670","NCT06202820","CV CARE: CardioVascular Care in PC Patients","CV CARE: CardioVascular Care of Androgen Related Effects in Prostate Cancer Patients","Inclusion Criteria:\n\n* Participants must have a histologic diagnosis of prostate adenocarcinoma. Participants with any stage of prostate cancer are eligible, as long as treatment with at least 24 weeks of ADT is recommended by their treating physician.\n* Participants must have been prescribed a plan for treatment with at least 24 weeks of ADT, and can have received up to 12 weeks of ADT therapy.\n* Participants must be willing to participate in two CV CARE visits at weeks 12 and 24 after ADT initiation.\n* Participants must be willing to have their follow up visits for ADT management at DFCI Longwood site.\n* Participants must be willing to undergo lab and blood pressure assessments, which can include local labs and home blood pressure checks if they wish to do virtual visits for follow up care.\n* Participants can have pre-existing CVD and\u002For CV risk factors, but this is not a requirement for inclusion.\n* Participants receiving combination treatment with an androgen receptor signaling inhibitory, some examples being (abiraterone acetate, enzalutamide, darolutamide, apalutamide, or bicalutamide), immunotherapy (pembrolizumab), or PARP inhibitor (olaparib, rucaparib) are eligible.\n* Age ≥18 years.\n* Life expectancy of greater than 6 months.\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 24 weeks due to complicated comorbidities that necessitate close collaboration between the participant and their cardiologist.\n* Participants who have already been on ADT therapy for more than 12 weeks are ineligible due to their treatment cycle being incompatible with the quality improvement initiative's trial design. ADT therapy is defined as either a GnRH agonist or antagonist.\n* Participants receiving combination treatment with ADT and chemotherapy (docetaxel, cabazitaxel, carboplatin), radioligand therapy (radium-223, 177PSMA-lutetium-617), or treatment on a clinical trial are not eligible due to potential for more intensive symptom management that may be required for optimal support of their cancer-directed treatment.\n* Participants actively included in therapeutic clinical trials are not eligible due to their greater time constraints.","MALE",{"count":73,"type":21},180,"INTERVENTIONAL",[76],"NA","This research is being done to test a program to assess and manage reversible cardiovascular (CV) risk factors in participants with prostate cancer starting androgen deprivation therapy (ADT), with the goal of integrating a standardized method into Dana-Farber Cancer Institute clinics for all such participants.\n\nThe name of the intervention used in this research study is:\n\nCV Care (cardiovascular risk assessment and management program)",[79,80],"Prostate Cancer","Cardiovascular Diseases",[79,80,82],"Cardiovascular Risk","2026-06-24",{"date":52,"type":55},{"date":86,"type":55},"2024-01-18",{"date":88,"type":21},"2027-06-30",{"name":61,"class":62},2,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":74,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":90},"100644369","breast-and-cervical-cancer-stigma-in-rwanda-100644369","NCT07663006","Breast and Cervical Cancer Stigma in Rwanda","Assessing Breast and Cervical Cancer Stigma and Piloting a Mitigating Intervention in Rwanda","Aim 1 Inclusion and Exclusion Criteria Aim 1 Interviews and Surveys\n\nIndividual interviews and surveys:\n\nPotential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Patients with pathologically confirmed breast or cervical cancer\n* Patients receiving treatment at BCCOE during the study period\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInterpersonal interviews and surveys:\n\nCaregivers of the potential patients will be identified from the potential patients. Potential patients will be identified by the clinical team from physical and electronic registries of patients. Potential participants will be screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Caregiver (including spouses, children, family members or other individuals as designated by patients) of patients with pathologically confirmed breast or cervical cancer who are actively receiving treatment at BCCOE during the study period\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInstitutional Focus group:\n\nAn official participation letter will be sent from BL2TH to leaders of the preselected facilities. Interested participants will be encouraged to contact the study team. Potential participants will be invited by their hospital\u002Fcenter leadership and screened for eligibility by the study research assistant.\n\nInclusion Criteria\n\n* Healthcare Worker\n* Working in a preselected health center, district hospital, provincial hospital in the Northern Province\n* Age 18 or older\n* Ability to provide informed consent\n* Ability to participate in interview or surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nInstitutional surveys:\n\nFormal participation invitation will be sent to the Rwanda Medical and Dental Council, National Council of Nurses and Midwives, and the Rwanda Allied Health Professions Council. Potential participants will be screened for eligibility electronically and informed consent obtained electronically.\n\nInclusion Criteria\n\n* Healthcare Worker\n* Registered with relevant professional organization in Rwanda\n* Age 18 or older\n* Ability to provide informed consent\n* Ability to participate in surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nAim 2 Inclusion and Exclusion Criteria Aim 2 Intervention pilot (patient, caregivers and community health workers)\n\nPatient and Caregiver Pilot:\n\nInclusion Criteria\n\n* Patients with pathologically confirmed breast cancer who are actively receiving curative-intent treatment at BCCOE during the study period and a designated caregiver\n* Patients getting systemic neoadjuvant chemotherapy who are expected in the clinic on a 3-week cycle\n* Patients who have at least 4 cycles of therapy remaining\n* Age 18 and over\n* Ability to provide informed consent\n* Ability to participate in pilot, interview, and surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation.\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women Note: Determination of ability to consent will be made by trained study staff prior to enrollment\n\nCommunity Health Worker Pilot:\n\nInclusion Criteria\n\n* Community Health Worker registered with relevant healthcare facilities in Northern Rwanda\n* Age 18 or older\n* Willing to engage in activities related to breast and cervical cancer and to support survivors\n* Ability to provide informed consent\n* Ability to participate in pilot, interview, and surveys in English or Kinyarwanda\n\nExclusion Criteria\n\n* Unwilling or Unable to consent to participation\n* Unable to comprehend study language (Kinyarwanda or English)\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women","FEMALE",{"count":100,"type":21},1116,[76],"This study aims to assess breast and cervical cancer stigma and pilot a multi-modal intervention to mitigate stigma among patients, caregivers, and community health workers in Rwanda. The elements include resilience training (patient), support group (caregivers), or exposure to survivors by video and in-person (patient, caregivers, and community health workers), and educational curriculum (community health workers).",[29,104],"Cervical Cancer",[29,104,106],"Cancer Stigma","NOT_YET_RECRUITING","2026-06-22",{"date":110,"type":55},"2026-06-23",{"date":112,"type":21},"2026-11-01",{"date":114,"type":21},"2029-12-01",{"name":61,"class":62},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":74,"phases":125,"briefSummary":127,"conditions":128,"keywords":133,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":90},"100495068","phase-2-preoperative-pembrolizumab-and-chemotherapy-in-resectable-recurrent-hnscc-100495068","NCT05726370","Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC","A Phase 2 Study of Preoperative Pembrolizumab and Chemotherapy Followed by Adjuvant Pembrolizumab in Resectable Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed locoregionally recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC in a previously irradiated field, defined as \\>50% of the presurgical tumor volume having prior radiation dose of \\>45 Gy as determined by the treating radiation oncologist (including primary sites, such as oral cavity, oropharynx, larynx or hypopharynx carcinoma).\n* Participants must be a candidate for curative intent surgery.\n* Participants must have documented time of ≥ 6 months from completion of prior curative intent treatment for HNSCC (surgery and\u002For radiation therapy with\u002Fwithout platinum chemotherapy or cetuximab targeted therapy) to diagnosis of local or locoregional recurrence or a second primary in a previously irradiated field.\n* Participants must be willing to undergo a mandatory pre-treatment biopsy and willing to provide blood and tissue from the pre-treatment biopsy and at the time of surgery. Exceptions may be made after discussion with sponsor if it is not medically feasible to obtain a pre-treatment biopsy or is in the best interest of the patient. Archival tissue may be collected in this situation. Participants will be offered the opportunity to volunteer for optional biopsies at the time of recurrence of disease.\n* Participants may have any smoking history (no restrictions)\n* Participants may have any Human Papilloma Virus (HPV) status of the tumor. Patients with oropharyngeal cancer are required to undergo HPV testing with p16 immunohistochemistry and\u002For confirmatory HPV PCR or ISH testing\n* Age ≥18 years\n* ECOG performance status 0 or 1 (Karnofsky ≥70%, see Appendix A)\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)\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.\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* Because pembrolizumab and chemotherapy can 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.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  * a. Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR\n  * b. A WOCBP who agrees to follow the contraceptive guidance in Appendix B during the treatment period and for at least 180 days after the last dose of study treatment.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Sinonasal, nasopharyngeal or cutaneous primary site of squamous cell carcinoma of the head and neck\n* Has known distant metastatic disease. Those with known brain metastases should be excluded from this clinical trial, because of the poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic\n* Has had chemotherapy or radiotherapy for HNSCC in curative intent setting within 6 months prior to entering the study.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has a history of allergic reactions to agents used in study\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Has not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to study registration (see Appendix B). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because pembrolizumab and chemotherapy agents have 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 pembrolizumab and chemotherapy, breastfeeding should be discontinued if the mother is treated on this protocol.",{"count":124,"type":21},28,[126],"PHASE2","This research study is evaluating effectiveness and safety of a combination of immunotherapy drug, pembrolizumab, with chemotherapy, as a possible treatment before and after surgery for squamous cell carcinoma of the head and neck (HNSCC). The combination of pembrolizumab and chemotherapy will be given prior to your surgery, while immunotherapy pembrolizumab will be continued for approximately 1 year after surgery.\n\nThe names of the study drugs involved in this research study are:\n\n* pembrolizumab (a type of immunotherapy)\n* docetaxel (a type of chemotherapy)\n* cisplatin (a type of chemotherapy)\n* carboplatin (a type of chemotherapy)",[129,37,130,131,132],"Head and Neck Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Second Primary Squamous Cell Carcinoma of the Head and Neck",[129,37,130,131,132],"2026-06-21",{"date":110,"type":55},{"date":137,"type":55},"2023-05-20",{"date":139,"type":21},"2030-05-20",{"name":61,"class":62},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":74,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100337626","phase-2-resolve-abemaciclib--letrozole---metformin-or-gedatolisib-in-endometrial-cancer-100337626","NCT03675893","RESOLVE: Abemaciclib + Letrozole +\u002F- Metformin or Gedatolisib in Endometrial Cancer","RESOLVE: A Multi-Cohort Phase 2 Study of Letrozole\u002FAbemaciclib Alone and in Combination With Metformin and Gedatolisib","Inclusion Criteria:\n\n* Participants must have cytologically or histologically confirmed endometrial cancer that is recurrent or metastatic and\u002For resistant to standard therapies, or for which no standard therapy is available. Participants enrolled in the second stage of Cohort 1A, or into Cohort 3, 6 and 7, must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component\n* Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA-certified laboratory.\n* Participants must have measurable disease, 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) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.\n* Age ≥ 18 years\n* ECOG performance status of 0 or 1\n* Participants must have normal organ and bone marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin \\\u003C\u002F= 2.0 times ULN and direct bilirubin within normal limits are permitted.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3× institutional ULN\n  * Creatinine ≤ 1.5 × institutional ULN, OR\n  * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n* For cohorts 6 and 7, patients must not have remaining ovarian function to be included. Women who have ovarian function are eligible but must be placed on hormonal suppression.\n* The effects of the study agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of study agent. Contraceptive methods may include an intrauterine device (IUD) or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. A negative serum pregnancy test is required for study entry from women of childbearing potential.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to swallow and retain oral medication.\n* Participants can have received an unlimited number of prior therapies.\n* Participants must have archival tissue available for analysis in the form of a formalin-fixed paraffin embedded (FFPE) block or unstained slides. Note: confirmation of availability of archival tissue is the only requirement for eligibility, archival tissue does not need to be received by the study team prior to enrollment\n* For Cohorts 6 and 7, participants must have HbA1c ≤6.4% and fasting plasma glucose (FPG) ≤140 mg\u002FdL.\n* For Cohort 6 and 7, patients must have wildtype TP53 as assessed either by immunohistochemistry or any CLIA-certified next-generation sequencing assay.\n* For Cohort 7, patients must have received prior CDK4\u002F6 inhibitor therapy and developed disease progression as deemed by the investigator. Patients who have stopped CDK4\u002F6 inhibitor therapy because of intolerance are ineligible.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication. Previous hormonal therapy, including prior letrozole, is allowed and there is no required washout period for hormonal therapy.\n* Participants who have had tyrosine kinase inhibitor (TKI) therapy within 5 half-lives of study entry.\n* Participants who have had radiation therapy within 2 weeks of the first dose of study medication.\n* Participants who have received previous treatment with CDK4\u002F6 inhibitors, including but not limited to previous abemaciclib therapy. For Cohort 7, patients must have received prior treatment with CDK4\u002F6 inhibitors.\n* Participants who are currently receiving metformin therapy (if enrolling to Cohort 3).\n* Participants who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents that the participant will be administered.\n* Participants who at the time of study enrollment are known to require concomitant therapy with moderate or strong CYP3A4 inducers, or strong inhibitors of CYP3A4. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment on trial. Participants are eligible for study entry if an appropriate substitution is made prior to the first dose of study medication.\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* Use of known QT-prolonging drugs during screening or expected requirement for use during study therapy.\n* Participants with histories or evidence of cardiovascular risk including any of the following: acute coronary syndromes (i.e. myocardial infarction or angina), coronary angioplasty, or stenting within 6 months prior to study enrollment.\n* Pregnant women are excluded from this study because the study agents are anti-cancer agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding must be discontinued if the mother is treated on trial.\n* Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 5 years prior to study enrollment, or individuals who are deemed by the treating investigator to be at low risk for disease recurrence. Additionally, individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal or squamous cell carcinomas of the skin, and breast or cervical carcinomas in situ.\n* Known HIV-positive participants are ineligible because of the increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Participants with a history of uncontrolled hypertension despite optimal medical management, defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 90 mmHg.\n* For Cohorts 6 and 7: Inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF\\>480 msec (determined by mean of triplicate ECGs at screening).\n* For Cohorts 6 and 7, participants with type 1 diabetes or uncontrolled type 2 diabetes.\n* For Cohorts 6 and 7, participants who have previously received any PI3K pathway inhibitors are ineligible. Up to 10 patients in Cohort 6 and up to 10 patients in Cohort 7 may have received prior mTOR inhibitor therapy such as everolimus.",{"count":149,"type":21},110,[126],"This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer.\n\nThe drugs involved in this study are:\n\n* Abemaciclib (also known as Verzenio™)\n* Letrozole (also known as Femara®)\n* Metformin (also known as Glucophage®)\n* Gedatolisib (also known as PF-05212384)",[153],"Endometrial Cancer",[153,155,156,157,158,159],"CDK4\u002F6","ER+","Estrogen Receptor","PI3K","PAM","2026-06-18",{"date":108,"type":55},{"date":163,"type":55},"2018-12-24",{"date":165,"type":21},"2031-08-01",{"name":61,"class":62},3,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":175,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":74,"phases":179,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":167},"100644347","bridging-adolescent-and-young-adult-sarcoma-survivors-with-personalized-oncology-exercise-service-aya-one-a-pilot-intervention-100644347","NCT07662239","Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention","AYA-ONE","Inclusion Criteria:\n\n* Diagnosed with a bone or soft tissue sarcoma\n* Age 15-39 at time of diagnosis\n* Age 15 and older at time of enrollment\n* Age 15-17 at time of enrollment, with assent from participant and consent from parent\u002Flegal guardian\n* Established patient of the DFCI Sarcoma Center or Jimmy Fund\n* Able to read and understand English (to complete required questionnaires and participate in training\u002Fcoaching)\n* Individuals who are not yet adults (teenagers) if they assent and their parents\u002Flegal guardians' consent to participation.\n\nExclusion Criteria:\n\n* Unstable cardiovascular disease in the last 6 months\n* Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, untreated substance use disorder, severe personality disorder)\n* Pregnant\n* Currently participating in physical or occupational therapy\n* Presence of medical conditions or medications that would prohibit participation in an exercise program\n* Meeting exercise guidelines of 150 minutes of moderate intensity\u002F75 minutes of vigorous intensity physical activity per week plus consistent strength training (at least once per week) over the past 3 months. Assessed via Godin Leisure Time Questionnaire by study staff.\n* Adults unable to consent","15 Years","39 Years",{"count":178,"type":21},40,[76],"This study will evaluate strategies to improve physical function and promote exercise and physical activity in adolescents and young adults (AYAs) with sarcoma. The study will assess the feasibility of a standardized triage system for referring AYAs with sarcoma to appropriate exercise and rehabilitation services, and will also examine changes in physical function and health-related quality of life before and after a 12-week personalized exercise program.",[32,182,183],"Bone Sarcoma","Soft Tissue Sarcoma (STS)",[185,186,187],"sarcoma","bone sarcoma","soft tissue sarcoma","2026-06-16",{"date":110,"type":55},{"date":191,"type":21},"2026-08-01",{"date":193,"type":21},"2027-02-01",{"name":61,"class":62},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":74,"phases":205,"briefSummary":206,"conditions":207,"keywords":211,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":90},"100588091","bolster-learning-new-skills-to-thrive-100588091","NCT06936878","BOLSTER: Learning New Skills to Thrive","BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers","BOLSTER","Participant Inclusion Criteria:\n\n* Age ≥18 years\n* Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient\n* Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)\n* Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)\n* Plans to receive ongoing cancer treatment\n* Has a family caregiver or friend (hereafter designated family caregiver) willing to participate\n* Able to speak and read English or Spanish (self-report)\n* Are willing to be audio-recorded\n* Have the cognitive\u002Fphysical ability to participate in a 60-minute interview\n\nFamily or Caregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Identified by a patient (as defined above) as a family or friend who is involved in their care.\n* Willing to participate in study visits\n* Willing to be audio recorded\n\nParticipant Exclusion Criteria:\n\n* Has cognitive impairments (as determined by the patient's oncologist)\n* Planning to enroll in hospice\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n\nFamily or Caregiver Exclusion Criteria:\n\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners",{"count":204,"type":21},600,[76],"This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.",[208,209,210],"Gastrointestinal Cancer","Gynecologic Cancer","Advanced Cancer",[208,209,210,212,213],"Advanced Gastrointestinal Cancer","Advanced Gynecologic Cancer",{"date":160,"type":55},{"date":216,"type":55},"2025-05-12",{"date":218,"type":21},"2028-07-31",{"name":61,"class":62},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":74,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":90},"100438230","phase-2-scalp-cooling-in-mbc-100438230","NCT04986579","Scalp Cooling in MBC","Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2\n* Participant is ≥ 18 years old.\n* Hair present at baseline.\n* One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:\n\n  * Sacituzumab govitecan (IMMU-132) 10 mg\u002Fkg administered intravenously on days 1 and 8 of each 21-day cycle\n  * Trastuzumab deruxtecan 5.4 mg\u002Fkg administered intravenously once every 3 weeks\n  * Eribulin 1.4 mg\u002Fm2 administered intravenously on days 1 and 8 of each 21-day cycle\n* The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.\n\nExclusion Criteria:\n\n* Known hematological malignancies (i.e. leukemia or lymphoma)\n* Known scalp metastases.\n* Baseline alopecia (defined CTCAE 5.0 grade \\> 0, see Appendix B)\n* Subjects with cold agglutinin disease or cold urticaria.\n* Subjects who are scheduled for bone marrow ablation chemotherapy.\n* Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and\u002F or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator.\n* Subjects who have lichen planus or lupus.\n* Participants who are receiving any additional anti-cancer agents",{"count":228,"type":21},120,[126],"This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.\n\nThe name of the study intervention involved in this study is:\n\n* Paxman Scalp Cooling System",[232,233],"Metastatic Breast Cancer","Chemotherapy-induced Alopecia",[232,233],{"date":160,"type":55},{"date":237,"type":55},"2021-10-07",{"date":239,"type":21},"2030-06-01",{"name":61,"class":62},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":74,"phases":249,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":63},"100557855","pilot-randomized-controlled-trial-of-a-collaborative-agenda-setting-intervention-casi-for-patients-with-ovarian-cancer-100557855","NCT06543537","Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer","Participant Inclusion Criteria:\n\n* At least 18 years old\n* Able to speak, understand, and respond to questions written in English\n* Willing to be audio recorded\n* Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)\n* Be under the care of a participating clinician dyad\n* Be scheduled for chemotherapy during the recruitment period\n* Be signed up or willing to sign up for Patient Gateway\n\nCaregiver Inclusion Criteria:\n\n* At least 18 years old\n* Able to speak, understand, and respond to questions written in English\n* Willing to be audio recorded\n* Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care\n\nClinician Inclusion Criteria:\n\n* Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant\n* Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting\n\nParticipant Exclusion Criteria:\n\n* Age of \\\u003C18 years\n* Unable to consent",{"count":248,"type":21},112,[76],"This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians.\n\nThe name of the intervention in this research study is:\n\n-Collaborative Agenda-Setting Intervention (CASI)",[252,253,254],"Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma",[252,253,254],"2026-06-15",{"date":258,"type":55},"2026-06-17",{"date":260,"type":55},"2025-01-17",{"date":262,"type":21},"2027-04-30",{"name":61,"class":62},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":74,"phases":274,"briefSummary":276,"conditions":277,"keywords":283,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":90},"100540795","phase-1-intraperitoneal-cytokine-induced-memory-like-ciml-natural-killer-nk-cells-in-recurrent-ovarian-cancer-100540795","NCT06321484","Intraperitoneal Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cells in Recurrent Ovarian Cancer","A Phase 1b Study of Cytokine-Induced Memory Like (CIML) Natural Killer (NK) Cell Therapy in Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed recurrent epithelial ovarian cancer. Eligible histologies include high grade serous, high grade endometrioid and clear cell ovarian carcinoma.\n* Participants must have measurable cancer defined by RECIST 1.1 criteria.\n* Patients must have received at least 1 lines of prior systemic therapy and be deemed platinum resistant\u002Fintolerant by their treating oncologist. Patients with germline or somatic BRCA1 or BRCA2 mutations must have received prior PARP inhibitor therapy as maintenance or treatment. Prior receipt of immune checkpoint blockade is allowed if grade 3 or higher toxicities were not experienced.\n* Age ≥18 years and \\\u003C85 years old.\n* ECOG performance status of 0 or 1.\n* Participants must meet the following organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * Platelets ≥75,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤3 x institutional ULN\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  * Serum creatinine ≤ 2.0 mg\u002FdL OR glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73 m2\n  * Oxygen saturation: ≥ 90% on room air\n  * Left ventricular ejection fraction (cardiac function) ≥ 40%\n  * No laboratory evidence of ongoing hemolysis in opinion of 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 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* Physician assessment indicating the patient would be able to tolerate undergoing a brief procedure for placement of an intraperitoneal port for NK cell infusion.\n* Ability to understand and the willingness to sign a written informed consent document.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason and because CIML NK cells and IL-2 may 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.\n\nExclusion Criteria:\n\n* Participants who have had anti-tumor chemotherapy or other investigational agents within two weeks prior to NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 6 weeks prior, or those who have not recovered from adverse events due to agents administered more than two weeks prior.\n* Participants with a bowel obstruction within the last 3 months or high risk for bowel obstruction (in the opinion of the investigator) or current need for parenteral nutrition or dependence on intravenous fluids.\n* Participants who are receiving any other investigational agents.\n* Solid organ transplant (allograft) recipients.\n* Participants with known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of the first dose of study treatment with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for \\> 1 year after treatment with curative intent.\n* History of severe or anaphylactic allergic reactions attributed to compounds of similar chemical or biologic composition to CIML NK cells or IL-2 or any of the other agents used in study.\n* For patients with prior exposure to check point inhibitor therapy, those with a prior history of immune-related toxicity during immune therapy that resulted in permanent discontinuation of therapy (as recommended per product label or consensus guidelines) OR any immune-related toxicity requiring intensive or prolonged immunosuppression to manage (with the exception of endocrinopathy that is well-controlled on replacement hormones) are excluded.\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 (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[Wegener's granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g., GuillainBarre syndrome and myasthenia gravis). Patients with Hashimoto thyroiditis are eligible.\n* Systemic corticosteroid therapy (\\> 10 mg of prednisone or equivalent dose of systemic steroids for at least 4 weeks prior to NK cell infusion).\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* 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 fludarabine\u002Fcyclophosphamide 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 in the setting of marrow suppression. Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Receipt of a live vaccine within 30 days of start of study treatment. During eligibility confirmation the study team is requested to confirm that according to the planned NK cell dosing schedule, the washout period should be completed.\n* Anaphylactic reactions to murine-based antibody therapy or iron dextran as the CIML NK cell product contains similar reagents at end of manufacturing\u002Finfusion.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.","85 Years",{"count":273,"type":21},18,[275],"PHASE1","The goal of this research study is to evaluate the safety and effectiveness of the use of cytokine-induced memory-like (CIML) natural killer (NK) cell therapy in recurrent, high grade ovarian cancer (HGOC).\n\nNames of the study therapies involved in this study are:\n\nCIML NK (cellular therapy) Interleukin-2 (IL-2)",[278,279,252,254,280,281,282],"Platinum-resistant Ovarian Cancer","Recurrent Ovary Cancer","Ovarian Carcinoma, Recurrent","Endometroid Ovarian Carcinoma","Clear Cell Ovarian Carcinoma",[284,279,252,254,280,281,282],"Platinum-Resistant Ovarian Cancer",{"date":188,"type":55},{"date":287,"type":55},"2024-10-09",{"date":289,"type":21},"2031-10-31",{"name":61,"class":62},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":74,"phases":300,"briefSummary":301,"conditions":302,"keywords":309,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":90},"100526733","phase-1-preemptive-ciml-nk-cell-therapy-after-hematopoietic-stem-cell-transplantation-100526733","NCT06138587","Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation","Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I\u002FIb Clinical Trial","Inclusion Criteria for Trial Enrollment:\n\n* Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS\u002FMPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant. Patients at high risk for post-transplant relapse include:\n\n  * De novo AML diagnosed at or after age 60, except CBF AML\n  * De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow)\n  * Secondary AML\n  * AML with 5 - \\> 10% blasts at the time of transplant who are judged by their treating clinician and study PI to have no benefit from additional pre-transplant chemotherapy\n  * Any AML transplanted in CR2 or greater\n  * TP53-mutated MDS or AML\n  * Therapy-related MDS or AML\n  * MDS with monosomy 7\n  * MDS with \\>= 5% blasts at the time of transplant\n  * MDS\u002FMPN or CMML\n* Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT):\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  * Serum creatinine \\\u003C\u002F= 2.0mg\u002FdL\n  * O2 saturation: ≥90% on room air\n  * LVEF \\>40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO (per FACT standards should be performed within 6 weeks of stem cell infusion), then there is no need to repeat it. Otherwise, an ECHO will need to be repeated.\n* Adult patients (age ≥ 18) eligible for and planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis. All eligibility criteria and workups for undergoing SOC allogeneic SCT for the recipient and donor will be based on institutional standards and SOPs.\n* For patients with AML, the disease must meet criteria for CR\u002FCri according to 2017 ELN guidelines, or have 5-10% blasts at the time of the transplant and in the judgement of their primary BMT clinician and study PI to have no benefit from additional pre-transplant chemotherapy. For patients with MDS or MDS\u002FMPN, the blast percentage on the bone marrow aspirate and biopsy must be less than 10%.\n* The same related donor is available to provide a non-mobilized apheresis product after the stem-cell donation.\n* ECOG performance status \\\u003C= 2 (Karnofsky \\>= 60%, see Appendix C).\n* Negative pregnancy test for women of childbearing age\n* The effects of CIML NK cells combined with 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, for the duration of study participation, and 4 months after IL-2 dose administration.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria Trial Enrollment:\n\n* Adult participants who are eligible for and who would be expected to have a greater benefit from myeloablative conditioning in their SOC allo HSCT as judged by their treating physician\n* Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.\n* Extramedullary leukemia involving sanctuary sites not readily accessible to immune surveillance, such as CNS or testis. Other sites of extramedullary relapse (e.g., leukemia cutis, granulocytic sarcoma) are acceptable.\n* The planned use of sirolimus for GVHD prophylaxis would result in exclusion of the patient from the study. Consideration of the addition of sirolimus to the GVHD prophylaxis regimen within the first 100 days after transplant must be reviewed with the study PI.\n* Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion.\n* Prior history of solid organ (allograft) transplantation\n* Prior history of allergic reactions to cellular products\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\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 patients are excluded due to the potential for interaction between antiretroviral therapy as well as the risk for lethal infection in the context of marrow-suppressive therapy.\n* Patients with active and uncontrolled Hepatitis B or C are ineligible due to the high risk of treatment-related hepatotoxicity after cellular 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 allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study. 3. Diagnosed with MGUS or smoldering myeloma, and\u002For treated for multiple myeloma or plasmacytoma as long as attainment of complete remission by IMWG criteria following therapy.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion 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  * 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., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria to Receive CIML NK Infusion:\n\n* Systemic steroid therapy (oral or IV) on the day of NK cell infusion\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\n* Participants who have had other investigational agents within 4 weeks prior to CIML NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior. Therapy with BCR-ABL inhibitors must be stopped at least 2 weeks before CIML NK cell infusion and may not be resumed during the DLT period. The use of tocilizumab for cytokine release syndrome after stem cell infusion does not exclude patients, but the use of steroids for the treatment of CRS excludes patients if they are still on steroids by the day of planned NK cell infusion.\n* Systemic steroid use of \\>10mg\u002Fday of prednisone equivalent is an exclusion criteria unless there is a plan for dose to be tapered below this limit within 4 weeks prior to NK cell infusion.\n\nPatients must be off systemic steroid therapy on the day of planned NK cell infusion.\n\n-The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay who do not receive a desensitization protocol prior to and during stem cell transplant, or else who do receive a desensitization protocol and have detectable DSAs +1 day after stem cell infusion.\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 48 hours to enable inclusion criteria to be met.\n\nHowever, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder are in agreement with proceeding.",{"count":299,"type":21},15,[275],"The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.\n\nNames of the study therapies involved in this study are:\n\n* CIML NK cells intravenous infusion (cellular therapy)\n* Subcutaneous Interleukin-2 (recombinant, human glycoprotein)",[303,304,305,306,307,308],"Acute Myeloid Leukemia","Leukemia","Leukemia, Myeloid","Myelodysplastic Syndromes","Myeloproliferative Neoplasm","Myeloproliferative Disorders",[303,304,305,310,311],"Myelodysplastic Syndrome","MDS and Myeloproliferative Neoplasm Overlap Syndrome",{"date":258,"type":55},{"date":314,"type":55},"2024-01-24",{"date":316,"type":21},"2027-11-30",{"name":61,"class":62},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":324,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":74,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":90},"100364402","phase-1-a-phase-1-trial-of-ciml-nk-cell-infusion-for-myeloid-disease-relapse-after-hematopoietic-cell-transplantation-100364402","NCT04024761","A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation","1. Inclusion Criteria:\n\n   1.1 Relapse or post-transplant persistence of AML, MDS (including JMML) or MPN (CMML, myelofibrosis or MDS\u002FMPN). Disease relapse or persistence will be defined as any measurable disease by morphology, flow-cytometry, validated tests for minimal residual disease or disease-defining mutations in the bone marrow, or non-immune privileged extramedullary sites.\n\n   1.2 Persistence of disease within 4 weeks before planned NK cell infusion and at least 2 weeks after completion of immune suppression taper as long as it is \\> 2 months after stem cell transplantation for both adult and pediatric patients. If 2 weeks after completion of the immune suppression taper is still within 2 months of the most recent stem cell transplant, then chemotherapy with Fludarabine\u002FCyclophosphamide would need to start no earlier than at least 2 months after the transplant. For adults, disease persistence after a second transplant is allowed as long as the most recent transplant was a haploidentical or HLA matched stem cell transplant. In the pediatric cohort, disease persistence or recurrence after a second transplant is allowed as long as the most recent transplant was a haploidentical or matched related donor SCT.\n\n   1.3 Available original donor (same donor as used for the most recent haploidentical or HLA matched stem cell transplant for adults, or for the most recent matched related donor or related haploidentical donor for pediatrics) that is willing and eligible for non-mobilized collection.\n\n   1.4 Age ≥12 years.\n\n   1.5 ECOG performance status ≤2. For For patients in the pediatric cohort, this corresponds to a Lansky (patients \\\u003C16 years) or Karnofsky (≥16years) performance status of ≥50.\n\n   1.6 T cell chimerism ≥20% donor-derived within the 4 weeks prior to cell infusion.\n\n   1.7 Patient with ≤80% bone marrow involvement within 4 weeks prior to cell infusion. Medications like hydroxyurea, decitabine or cytarabine are allowed to control rising blasts between study enrollment and cell infusion.\n\n   1.8 No systemic corticosteroid therapy for GVHD (≤ 5mg of prednisone or equivalent dose of systemic steroids for non-GVHD, non-autoimmune indications are allowed) for at least 4 weeks prior to cell infusion. Patients on systemic GVHD prophylaxis medications such as tacrolimus or sirolimus need to be off these medications for at least 4 weeks prior to cell infusion.\n\n   1.9 No other systemic medications\u002Ftreatments (e.g. ECP) for GVHD for at least 4 weeks prior to cell infusion.\n\n   1.10 Ability of the patient or legal guardian to understand and the willingness to sign a written informed consent document.\n\n   1.11 Adequate organ function within 2 weeks of NK cell infusion as defined below:\n   * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C3 x ULN)\n   * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n   * Serum creatinine ≤2.0mg\u002FdL\n   * O2 saturation: ≥90% on room air\n   * LVEF \\>40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO, then there is no need to repeat it. Otherwise, an ECHO will need to be repeated within 2 weeks of NK cell infusion.\n\n   1.12 Negative pregnancy test for women of childbearing potential only.\n\n   1.13 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, for the duration of study participation, and 4 months after the last IL-2 dose administration.\n2. Exclusion Criteria:\n\n2.1 Extramedullary relapse involving immuno-privileged sites (e.g. CNS, testes, eyes). Other sites of extramedullary relapse (e.g. leukemia cutis, granulocytic sarcoma) are acceptable.\n\n2.2 Participants who have had investigational agents within 4 weeks prior to cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior or standard chemotherapy administered more than 14 days ago. Use of hydroxyurea, hypomethylating agents, low-dose cytarabine or venetoclax to control counts within 4 weeks prior to cell infusion is permitted with study PI approval but would need to be stopped 1 day prior to administration of Fludarabine and Cyclophosphamide preceding the NK cell infusion (provided that there are no ongoing AEs attributed to these agents that would preclude start of lymphodepletion in the view of the investigator). Patients on standard of care FLT-3, IDH1, and IDH2 inhibitors can stay on this treatment. Therapy with BCR-ABL inhibitors or bcl-2 inhibitors must be stopped 2 weeks before NK cell infusion and may be resumed after the end of the DLT period.\n\n2.3 Prior history of Donor Lymphocyte Infusion (DLI) within 8 weeks of CIML NK infusion. DLI that was given before this time period and that did not result in any GVHD requiring systemic treatment is not an exclusion criterion.\n\n2.4 Prior history of severe (grade 3 or 4) acute GVHD, or ongoing active GVHD requiring systemic treatment.\n\n2.5 Solid organ transplant recipient. Prior allogeneic HLA matched or mismatched stem cell transplant is allowed in the pediatric cohort. Prior HLA matched related donor or HLA matched unrelated donor stem cell transplant is allowed in the adult cohort.\n\n2.6 History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.\n\n2.7 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 (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\n2.8 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\n2.9 Patients who develop a critical illness prior to NK cell infusion that would contraindicate the administration of Fludarabine and Cyclophosphamide conditioning. Patients who recover from such illness may still be eligible, but this must be reviewed with the study PI. A repeat bone marrow examination may be required depending on the timing of recovery. Patients who become critically ill on the planned day of NK cell infusion are excluded if the NK cell infusion cannot be given within 48 hours of the planned day 0.\n\n2.10 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\n2.11 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\n2.12 Individuals with active uncontrolled hepatitis B or C, HIV, or HTLV-1 are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after HSCT.\n\n2.13 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.","12 Years",{"count":326,"type":21},50,[275],"This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.",[303,306,307,330],"Juvenile Myelomonocytic Leukemia",[304],{"date":258,"type":55},{"date":334,"type":55},"2019-08-31",{"date":336,"type":21},"2026-12-01",{"name":61,"class":62},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":74,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":167},"100294495","phase-1-sl-401-in-combination-with-azacitidine-or-azacitidinevenetoclax-in-acute-myeloid-leukemia-aml-high-risk-myelodysplastic-syndrome-mds-or-blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-100294495","NCT03113643","SL-401 in Combination With Azacitidine or Azacitidine\u002FVenetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\nHistologically confirmed diagnosis of acute myeloid leukemia (AML) \\[Cohort B\\] or myelodysplastic syndrome (MDS) \\[Cohort A\\] or BPDCN \\[Cohort C\\] per 2016 WHO criteria\n\nCD123 \u002F IL3RA expression on the subject's AML or MDS blasts or BPDCN cells determined locally within 3 months of first protocol treatment\n\nAge \\>= 18 years with relapsed or refractory AML (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with treatment-naïve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factors (see APPENDIX A for unfitness definitions) (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with MDS and \\> 10% myeloblasts in the bone marrow \\[Cohort A\\]\n\nOR\n\nAge \\>= 18 years with relapsed or refractory BPDCN (hydroxyurea is not considered a prior treatment regimen) \\[Cohort C\\]\n\nAdequate organ function as defined by:\n\nAlbumin \\> 3.2 g\u002FdL (in the absence of receipt of intravenous albumin in the previous 72 hours) Serum creatinine \\\u003C 1.5x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5x ULN Total bilirubin \\\u003C 1.5x ULN (if thought to be \\> 1.5x ULN due to Gilbert's disease or the patient's AML, must discuss with the PI) Creatine phosphokinase (CPK) \\\u003C 2.5x ULN Left ventricular ejection fraction \\> institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment\n\n\\[Cohorts B and C\\] WBC \\\u003C 20,000 \u002F uL on day of first therapy, cytoreduction may be achieved using hydroxyurea\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nAble to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment\n\nWomen of child-bearing potential must agree to use adequate contraception for the duration of study participation and for 2 months after completion of protocol treatment.\n\nMen treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 2 months after completion of protocol treatment.\n\nExclusion Criteria:\n\nPrior treatment with venetoclax \\[Cohorts B or C\\], unless it was last taken \\>2 months before protocol therapy\n\nDiagnosis of acute promyelocytic leukemia\n\nReceived treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment, except for intrathecal chemotherapy. Prior and concurrent hydroxyurea is permitted.\n\nHematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease\n\nActive CNS involvement by AML or BPDCN. Screening lumbar puncture (LP) required for patients with BPDCN. If history of treated CNS involvement, must have had two consecutive negative LPs since last CNS involvement, which may include the screening LP\n\nKnown positive status for HIV infection; known active hepatitis B or hepatitis C infection\n\nClinically significant cardiopulmonary disease including uncontrolled or NYHA class 3 or 4 congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within 6 months of first protocol treatment, or QTc \\> 480 ms\n\nPatients with known active advanced malignant solid tumors are excluded (except for basal or squamous skin cancers, or carcinomas in situ). Patients with additional hematologic malignancies that require treatment are excluded.\n\nPregnant women are excluded from this study because there is an unknown but potential risk for adverse events in the developing fetus with SL-401, azacitidine, and venetoclax (negative urine or serum pregnancy test required within 14 days of Cycle 1, Day 1). Because nursing infants have unknown potential for adverse events secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with SL-401, azacitidine, and venetoclax.\n\nPatients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. Patients with active infection are permitted to enroll provided that the infection is controlled\n\n\\[Cohorts B and C\\] Patients with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)\n\n\\[Cohorts B and C\\] Patients on strong CYP3A inducers within 7 days of first dose of study treatment.",{"count":346,"type":21},72,[275],"This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS.\n\nThe interventions involved in this study are:\n\n* SL-401\n* Azacitidine\n* Venetoclax",[303,310,350],"Blastic Plasmacytoid Dendritic Cell Neoplasm",[303,310,350,352],"BPDCN",{"date":258,"type":55},{"date":355,"type":55},"2017-06-26",{"date":357,"type":21},"2027-05-31",{"name":61,"class":62},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":365,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":74,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":63},"100266446","hereditary-risk-factors-for-thyroid-cancer-100266446","NCT02747888","Hereditary Risk Factors for Thyroid Cancer","Inclusion Criteria:\n\n* Individual pediatric patient with current or previous known or suspected thyroid cancer or nodule(s).\n* Individual adult patient with current or previous known or suspected thyroid cancer or nodule(s) if they come from a family with a high suspicion of hereditary cancer (as below).\n* Individuals from families with a high suspicion of hereditary thyroid cancer:\n\n  * Families with a current or previous diagnosis of a thyroid cancer\u002Fnodule occurring in childhood (\\\u003C18 years old).\n  * Families with a high suspicion of hereditary thyroid cancer\u002Fnodules other than above to include:\n\n    * Families with thyroid cancer in multiple individuals\n    * Families with thyroid cancer and a known genetic syndrome\n    * Families with thyroid cancer and a suspected genetic syndrome (e.g. multiple childhood cancers in the family, multiple primary cancers, multiple endocrinopathies, etc.)\n\nExclusion Criteria:\n\n* Individuals who are unable to give informed consent.\n* Individuals who are unable to complete study materials.",true,{"count":367,"type":21},250,[76],"Thyroid cancers can occur sporadically, but can also be found as tumors that cluster in families with other cancers or genetic syndromes. Researchers are studying thyroid cancer in children and families, with a particular interest in understanding genes and other factors that may put individuals at risk for developing thyroid cancer and thyroid nodules.\n\n* In this study, family and medical history information is collected alongside a blood or saliva sample for genetic studies.\n* Individuals with a past or present childhood thyroid cancer\u002Fnodule or a thyroid cancer suspected to be inherited in their family are invited to participate.",[371],"Thyroid Cancer",[373],"Thyroid","2026-06-09",{"date":376,"type":55},"2026-06-11",{"date":378,"type":55},"2016-03-01",{"date":380,"type":21},"2029-03-01",{"name":61,"class":62},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":74,"phases":390,"briefSummary":391,"conditions":392,"keywords":395,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":90},"100632410","phase-2-risk-adapted-therapy-in-hpv-positive-oropharyngeal-cancer-using-circulating-tumor-ct-hpv-dna-profiling-react-20-100632410","NCT07513324","Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed, stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging. Participants with HPV-associated disease of unknown primary (cT0) are eligible.\n\n  * Participants who undergo upfront surgery are permitted to enroll if their post-operative pathology necessitates that they receive adjuvant therapy.\n  * Participants who undergo upfront induction chemotherapy with platinum-based therapy are eligible if they have less than a complete clinical or radiologic response to induction as judged by the treating investigator(s).\n  * Participants with locoregionally recurrent disease are eligible if they completed definitive or curative-intent treatment and meet criteria 3.1, 6e below.\n* HPV status should be confirmed on tissue biopsy or cytologic sample by any of the following: (a) IHC staining for p16 with ≥70% expression, and\u002For (b) DNA testing (PCR or ISH) for high-risk subtypes 16, 18, 31, 33, or 35.\n* Tumor tissue available for PD-L1 CPS testing.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Intermediate or high-risk HPV+ disease defined by any one of the following:\n\n  * TTMV-HPV DNA score \\>200 at baseline and failure to clear by \\>95% by week 4-5 of treatment\n  * undetectable or low (≤200) TTMV-HPV DNA at baseline prior to treatment with clinical or pathologic T3-4 or N2-3 disease\n  * known HPV subtypes 18, 31, 33, or 35 (but excluding cT1-2N0 participants)\n  * known N3 disease or fixed neck nodes as judged by the treating investigator(s)\n  * any stage disease with known detectable TTMV-HPV DNA 6 weeks or onward from completion of definitive or curative-intent therapy without clinical or radiographic disease and with no additional intervening therapy administered.\n* Participants should have adequate organ and marrow function to receive adjuvant immunotherapy as outlined below:\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin ≥9.0g.\u002FdL or ≥5.6 mmol\u002FLa\n  * Creatinine OR Measured or calculated b creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n  * International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Participants or persons of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 72 hours prior to the start of therapy. Note: Contraception requirements should conform with CTFG guidelines. The pembrolizumab standard for use of highly effective contraceptive methods for POCBP is 120 days (5 half-lives) after the last dose. Abstaining from breastfeeding after study intervention is at least 5 half-lives or 120 days.\n\nExclusion Criteria:\n\n* Participants with AJCC 2017 8th edition stage IV (M1, metastatic) disease.\n* Pregnant or lactating women.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or another stimulatory or co-inhibitory T-cell receptor treatment.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of pembrolizumab.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days of first pembrolizumab dosing.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. Participants with a history of allogeneic tissue\u002Fsolid organ transplant are excluded.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of uncontrolled human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. Well-controlled typically includes a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening and achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n* Has a known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions: 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, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease is permitted if chance of recurrence is thought to be low (in discussion with the Sponsor-investigator).\n* ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\na Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n\nb Creatinine clearance (CrCl) should be calculated per institutional standard.",{"count":389,"type":21},116,[126],"The purpose of this study is to assess risk for HPV driven oropharyngeal cancers by using HPV blood tests and clinical features (such as tumor stage and smoking status) to determine appropriate treatment to improve survival outcomes in participants with stage I, II, or III, HPV-associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma,.",[393,394],"HPV-positive Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma",[396,397],"HPV-positive oropharyngeal squamous cell carcinoma","Oropharyngeal squamous cell carcinoma","2026-06-08",{"date":374,"type":55},{"date":401,"type":21},"2026-07-01",{"date":403,"type":21},"2030-01-01",{"name":61,"class":62},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":74,"phases":414,"briefSummary":415,"conditions":416,"keywords":421,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},"100510155","phase-2-belumosudil-for-bronchiolitis-obliterans-preventiontherapy-bebop-100510155","NCT05922761","BElumosudil for Bronchiolitis Obliterans Prevention\u002FTherapy (BEBOP)","An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria Cohort A:\n\n* Diagnosis of BOS after HCT using pulmonary function testing, per the NIH diagnostic criteria17 OR the Atypical BOS criteria33 3.1.2.1 NIH Diagnostic Criteria for BOS. All of the following must be met:\n\n  * FEV1\u002FVC \\\u003C 0.7 or \\\u003C5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity, or SVC, Slow Vital Capacity, whichever is greater)\n  * FEV1 \\\u003C75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \\>75% of predicted with albuterol, and the absolute decline for the corrected values should still remain ≥ 10% over 2 years.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage).\n  * One of the two supporting features of BOS:\n\n    * i - Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR\n    * ii - Evidence of air trapping by PFTs: RV (Residual Volume) \\> 120% of predicted or RV\u002FTLC elevated outside the 90% confidence interval (RV\u002FTotal Lung Capacity).\n* Atypical Criteria for BOS:\n\n  * FEV1 \\\u003C80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant. The remote comparator can be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility or the PFT assessment done prior to transplant.\n  * VC \\\u003C 80% of predicted.\n  * FEV1\u002FVC \\> 0.7.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage) or active non-infectious lung disease (such as interstitial lung disease) that explain spirometric changes or chest CT findings.\n\nInclusion Criteria for Cohort B:\n\n-Diagnosis of BOS-0p\n\n* Decline in FEV1 of 10% - 19% of predicted compared with pretransplant testing OR\n* Decline in predicted FEF25-75% (Forced Expiratory Flow between 25% and 75% of vital capacity) \\> 25%\n\nInclusion Criteria for Cohorts A and B:\n\n* Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and efficacy in pediatric patients have not yet been established. A protocol amendment to include pediatric patients will be considered once safety in pediatric patients is established.\n* ECOG performance status ≤2 (Karnofsky ≥ 60%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * WBC ≥ 3,000\u002FμL\n  * Absolute neutrophil count ≥ 1,500\u002F μL\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* No evidence of relapsed malignancy at the time of enrollment. Formal re-staging is not required for trial entry.\n* All females of childbearing potential must have a negative serum or urine pregnancy test \\\u003C 7 days before study drug administration.\n* The ability to understand and willingness to sign a written consent document.\n\nExclusion Criteria for Cohorts A and B:\n\n* Participants who have received prior therapy specifically for BOS. Therapy for cGVHD in the absence of BOS is permissible.\n* Prior exposure to belumosudil.\n* Participants who are receiving any other investigational immunosuppressive agents for cGVHD.\n* Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without signs or symptoms will not be interpreted as an active uncontrolled infection.\n* Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.",{"count":413,"type":21},45,[126],"The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).\n\nThe name of the study drugs involved in this study are:\n\n* Belumosudil (an immunotherapy)\n* Fluticasone (an intranasal corticosteroid)\n* Azithromycin (an antibiotic)\n* Montelukast (a leukotriene receptor antagonist)\n* Prednisone (a corticosteroid)",[417,418,419,420],"Bronchiolitis Obliterans Syndrome","Bronchiolitis Obliterans","Lung Diseases","Chronic Graft Versus Host Disease",[417,418,422,423,424,420],"Lung Disease","Allogeneic hematopoietic stem cell transplant","HSCT",{"date":426,"type":55},"2026-06-10",{"date":428,"type":55},"2024-05-31",{"date":430,"type":21},"2027-12-31",{"name":61,"class":62},6,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":74,"phases":442,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":452,"leadSponsor":454,"locationsCount":167},"100637549","phase-3-determination-2---isatuximab-iberdomide-bortezomib-and-dexamethasone-induction-followed-by-risk--and-response-adapted-consolidation-and-maintenance-therapy-in-transplant-eligible-patients-with-newly-diagnosed-multiple-myeloma-100637549","NCT07624513","Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n* N- NDMM based on IMWG criteria with clonal bone marrow plasma cells ≥10% or biopsy proven bony or extramedullary disease\u002Fplasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024) (See Appendix E)\n* \\- Age 18 - 75 years. (Patients aged 71-75 years who are deemed transplant-eligible by investigator may be enrolled after discussion with and approval from the Sponsor - Investigator)\n* \\- Eligible for HDM-ASCT, at time of registration per investigator's assessment, and willing to defer HDM-ASCT if in Cohort 1 or be randomized to HDM-ASCT vs. linvoseltamab if in Cohort 2 (Cohort assignment may not be known until after induction therapy)\n* \\- Bone marrow analysis with cytogenetic risk status established by fluorescence in situ hybridization (FISH) and NGS with TP53 by PlasmaSEQ at screening and positive identification of B-cell Clonality (ID) conducted by Adaptive Biotechnologies clonoSEQ® assay\n\n  * Qualified archival BMA may be submitted to Adaptive Biotechnologies clonoSEQ® assay.\n  * Results from a previously performed clonoSEQ® assay as standard of care may be acceptable if they meet the requirement of B-cell clonality ID.\n  * Previously performed BMA for FISH is acceptable if it can establish cytogenetic risk per Section 5.4.2 along with NGS for TP53 by PlasmaSEQ.\n  * Results must be within 1 year of screening and be representative of current NDMM. Results older than one year must be approved by the Sponsor-Investigator.\n* Measurable disease defined by at least one of the following:\n\n  * Serum protein electrophoresis (SPEP): Serum M protein ≥0.5 mg\u002FdL\n  * Urine protein electrophoresis (UPEP): Urine M protein ≥200 mg\u002F24 hours\n  * Serum free light chain (FLC) assay: involved FLC ≥10 mg\u002FdL (≥100 mg\u002FL) and abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65)\n* Screening laboratory evaluations meeting the following parameters:\n\n  * Absolute neutrophil count (ANC) ≥1,000 cells\u002FdL (1.0 × 10\\^9\u002FL). Growth factor support is not permitted within 10 days \\[14 days for pegfilgrastim\\], prior to registration\n  * Platelet count ≥ 75,000 cells\u002FdL (75 x 109\u002FL) without transfusions required during the 14 days prior to registration)\n  * Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3.0 x ULN\n  * Calculated creatinine clearance ≥30 mL\u002Fmin (See Appendix B)\n  * Hemoglobin ≥ 8.0 g\u002Fdl (red blood cell \\[RBC\\] transfusions are permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (see Appendix A)\n* Ability and willingness to complete HRQoL and PRO-CTCAE® assessments\n* Must be able to take antithrombotic prophylaxis\n* Sexually active IOCBP agree to use protocol-specified contraceptive methods, at least 28 days prior to starting study drug, while taking study drug, including interruptions in study drugs, and for at least 28 days after the last dose of iberdomide, 5 months after isatuximab, 6 months after linvoseltamab and bortezomib, or males (including those who have had a vasectomy), sexually active with IOCBP, agree to use protocol specified contraceptive methods while taking study drug, including interruptions in study drug and for at least 28 days after the last dose of iberdomide, 5 months after isatuximab, 6 months after linvoseltamab and bortezomib according the PPP (See Appendix G)\n* All patients (male and female with or without childbearing potential) agree to counseling according to the PPP and to abstain from donating blood products for at least 28 days after the last dose of iberdomide and semen or sperm while taking study drug and for at least 28 days after the last dose of iberdomide according to the PPP (See Appendix G) and for 3 months after the last dose of isatuximab, 6 months after the last dose of linvoseltamab and bortezomib\n* Both men and women of all races and ethnic groups are eligible for this trial.\n\nExclusion Criteria:\n\n* Prior therapy for MM. Patients may have received:\n\n  * Corticosteroids for management of MM not exceeding the equivalent of 160 mg of dexamethasone in a 2-week period and without change in dosing requirements within 7 days prior to registration\n  * Focal palliative radiation for the management of bone pain ≥ 7 days prior to registration\n  * Treatment for smoldering multiple myeloma (SMM) if the prior treatment was not an anti-CD38 or anti-BCMA-based therapy:\n  * Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity\n  * Resolution of symptoms of prior treatment to ≤ grade 1or baseline\n* Known intolerance to steroid therapy\n* Central nervous system (CNS) involvement of MM\n* History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition, CNS movement disorder, history of seizure within 12 months prior to enrollment\n* Peripheral neuropathy grade ≥3, or grade 2 with pain on clinical exam during screening period\n* Prior history of malignancies, other than MM, will be excluded unless the participant has been free of the disease for ≥ 3 years, except for the following non-invasive malignancies: basal or squamous cell skin carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (T1a or T1b using the TNM clinical staging system), or prostate cancer that is curative\n* Any medical or psychiatric illness that in the investigator's opinion would impose excessive risk or would adversely affect patient participation\n* Concurrent uncontrolled cardiovascular conditions (uncontrolled hypertension \\[HTN\\], uncontrolled arrhythmias, congestive heart failure \\[CHF\\], unstable angina, grade 3 thromboembolic event or myocardial infarction in the past 6 months)\n* Concurrent symptomatic amyloidosis or plasma cell leukemia\n* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)\n* Pregnant or breast feeding female or female who intends to become pregnant during the study\n* Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen \\[HepBSAg\\] or Hepatitis B core antibody \\[HepBcore Ab\\]) or hepatitis C (Hep C Ab), or acute hepatitis A; if any history of exposure to hepatitis B or C, then PCR should be negative\n* History of tuberculosis or systemic fungal disease\n* Concurrent active infection requiring therapeutic treatment\n* Lack of clonal identification by Adaptive Biotechnologies clonoSEQ® test","75 Years",{"count":441,"type":21},720,[443],"PHASE3","The purpose of the study is to determine the best treatment approach based on the risk profile of the cancer cells and on how the disease responds to treatment. This is a randomized research study evaluating treatment for transplant-eligible participants with newly diagnosed multiple myeloma. Induction therapy in this study includes the drugs isatuximab, iberdomide, bortezomib, and dexamethasone. After induction therapy, participants will receive consolidation and maintenance therapy that is adapted based on their risk profile and response to treatment.\n\nThe research study procedures include: screening for eligibility, study visits, blood and bone marrow tests, disease assessments, treatment with study drugs, and follow-up visits.\n\nIt is expected that about 720 participants will take part in this study.",[446],"Multiple Myeloma",[446],"2026-05-28",{"date":450,"type":55},"2026-06-03",{"date":398,"type":21},{"date":453,"type":21},"2038-03-01",{"name":61,"class":62},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":74,"phases":465,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":90},"100637076","phase-1-phase-1b2-isatuximab-iberdomide-bortezomib-dexamethasone-in-transplant-ineligibledeferred-newly-diagnosed-myeloma-100637076","NCT07601100","Phase 1b\u002F2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible\u002FDeferred Newly Diagnosed Myeloma","A Phase 1b\u002F2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant","IsaIberVD","Inclusion Criteria:\n\n* Male or female, 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n* NDMM based on IMWG criteria with clonal bone marrow plasma cells \\>10% or biopsy proven bony or extramedullary disease\u002Fplasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024). (See Appendix G)\n* Ineligible for ASCT as assessed by the treating physician or eligible but prefers and agrees to defer ASCT until after induction and maintenance therapy, upon progression or at a later time\n* Measurable disease defined as at least one of the following:\n\n  * Serum M-protein 0.5 g\u002FdL\n  * Urine M-protein 200 mg\u002F24 hours\n  * Serum FLC assay: involved FLC 10 mg\u002FdL (100 mg\u002FL) and an abnormal kappa to lambda FLC ratio (\\\u003C 0.26 or \\> 1.65)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix A)\n* Screening Laboratory evaluations with the following parameters:\n\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002FdL (1.0 x 109\u002FL)\n\n    \\--- Note: Growth factor support is not permitted within 10 days, \\[14 days for pegfilgrastim\\], prior to the screening hematologic test.\n  * Platelet count ≥ 75,000 cells\u002FdL (75 x 109\u002FL) (without transfusions required during the 3 days prior to the screening hematologic test)\n  * Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN\n  * Calculated creatinine clearance (CrCl) 30ml\u002Fmin (Appendix B)\n  * Hemoglobin ≥ 8.0 g\u002Fdl (red blood cell (RBC) transfusions are permitted)\n* Individuals of childbearing potential (IOCBP) must have 2 negative pregnancy tests before initiation of therapy, and agree to ongoing testing, based on the frequency outlined in the Pregnancy Prevention Plan (PPP) (See Appendix H)\n* Sexually active IOCBP agree to use protocol-specified contraceptive methods, at least 28 days prior to starting study drug, while taking study drug, including interruptions in study drugs, and for at least 28 days after the last dose of study drug or males sexually active with IOCBP, (including those who have had a vasectomy), agree to use protocol specified contraceptive methods while taking study drug, including interruptions in study drug and for at least 28 days after the last dose of iberdomide, 5 months after isatuximab and 6 months after bortezomib, according to the PPP (See Appendix H)\n* All patients (male and female with or without childbearing potential) agree to counseling according to the PPP and to abstain from donating blood products for at least 28 days after the last dose of iberdomide and abstain from donating semen or sperm while taking study drug and for at least 28 days after the last dose of iberdomide according to the PPP (See Appendix H) and for 5 months after the last dose of isatuximab and 6 months after the last dose of bortezomib\n* Must be able to take antithrombotic prophylaxis (See Section 5.9.1)\n\nExclusion Criteria:\n\n* Prior therapy for MM. Patients may have received:\n\n  * Corticosteroids for management of MM not to exceed equivalent of 160 mg of dexamethasone in a 2-week period and should be stable 7 days prior to the registration.\n  * Focal palliative radiation for the management of bone pain completed ≥ 7 days prior to registration\n  * Treatment for smoldering myeloma as long as the prior treatment did not include anti-CD38 therapy:\n\n    * Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity.\n    * Resolution of symptoms of prior treatment to ≤ grade 1 or baseline\n* Known intolerance to steroid therapy\n* Prior history of malignancies, other than MM, will be excluded unless the participant has been free of the disease for ≥ 3 years with the exception of the following non-invasive malignancies: basal or squamous cell skin carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (T1a or T1b using the Tumor, Node, Metastasis (TNM) clinical staging system), or prostate cancer that is curative\n* Central nervous system involvement with MM\n* Peripheral neuropathy grade 3, or grade 2 with pain on clinical exam during screening period\n* Any medical or psychiatric illness that in the investigator's opinion would impose excessive risk to the patient or would adversely affect participation\n* Concurrent uncontrolled cardiovascular conditions (uncontrolled hypertension, uncontrolled arrhythmias, congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction) in the past 6 months\n* Concurrent symptomatic amyloidosis or plasma cell leukemia\n* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)\n* Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen (HepBSAg) or Hepatitis B core antibody (HepBcore Ab) or C (Hep C Ab), or acute hepatitis A. If any history of exposure to hepatitis B or C, then PCR should be negative\n* Pregnant or breast feeding female or IOCBP who intend to become pregnant during the study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study",{"count":464,"type":21},88,[275,126],"This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant.\n\nThe names of the study drugs used in this research study are:\n\nisatuximab, iberdomide, bortezomib dexamethasone",[468],"Newly Diagnosed Multiple Myeloma",[470,471],"multiple myeloma","newly diagnosed multiple myeloma",{"date":473,"type":55},"2026-06-01",{"date":475,"type":21},"2026-06-26",{"date":477,"type":21},"2034-07-01",{"name":61,"class":62},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":365,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":74,"phases":486,"briefSummary":488,"conditions":489,"keywords":495,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":90},"100525527","early-phase-1-prospective-screening-for-pancreatic-ductal-adenocarcinoma-in-high-risk-individuals-100525527","NCT06122896","Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals","Inclusion Criteria:\n\nParticipants must meet any of the following:\n\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in STK11, and age ≥30 years.\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in CDKN2A, and age ≥40 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier).\n* Individuals with pathogenic\u002Flikely pathogenic germline variants in one of the other pancreatic cancer susceptibility genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53), and age ≥50 years (or 10 years younger than the earliest exocrine pancreatic cancer diagnosis in the family, whichever is earlier) AND\n\n  • Exocrine pancreatic cancer in ≥1 first- or second-degree relative from the same side of (or presumed to be from the same side of) the family as the identified pathogenic\u002Flikely pathogenic germline variant.\n* Individuals with pathogenic\u002Flikely pathogenic variants in PRSS1 AND a clinical phenotype consistent with hereditary pancreatitis, and age ≥40 years (or 20 years after onset of pancreatitis, whichever is earlier).\n* Individuals with familial pancreatic cancer including:\n\n  * Family history of exocrine pancreatic cancer in ≥2 first-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in 1 affected first-degree relative and 1 second-degree relative, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant, OR\n  * Family history of exocrine pancreatic cancer in ≥3 first- and\u002For second-degree relatives from the same side of the family, even in the absence of a known pathogenic\u002Flikely pathogenic germline variant.\n* Individuals who are undergoing clinically recommended pancreatic cancer surveillance.\n\nExclusion Criteria:\n\n* Individuals with active or prior pancreatic ductal adenocarcinoma diagnosis.\n* Individuals with any active metastatic cancer.\n* Individuals who are unable to give informed consent.\n* Individuals who are under the age of 18 (infants, children, teenagers).\n* Individuals unable to tolerate Magnetic Resonance Imaging\u002FMagnetic Resonance Cholangiopancreatography and Endoscopic Ultrasound.\n* Pregnant women are unlikely to be undergoing screening procedures and will not be considered eligible but can consent to the study at a later date.",{"count":20,"type":21},[487],"EARLY_PHASE1","The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.",[490,491,492,493,494],"Pancreatic Cancer","Pancreatic Ductal Adenocarcinoma","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Neoplasm",[490,491,492,493,494],"2026-05-27",{"date":498,"type":55},"2026-05-29",{"date":500,"type":55},"2023-11-21",{"date":502,"type":21},"2041-10-31",{"name":61,"class":62},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":365,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":74,"phases":512,"briefSummary":513,"conditions":514,"keywords":516,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":522,"locationsCount":63},"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":178,"type":21},[76],"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.",[515,304],"Blood Cancer",[515,304],"2026-05-26",{"date":448,"type":55},{"date":520,"type":55},"2024-12-09",{"date":88,"type":21},{"name":61,"class":62},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":4,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":74,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":540,"locationsCount":63},"100302615","phase-1-a-personalized-neoantigen-cancer-vaccine-in-treatment-nave-asymptomatic-patients-with-ighv-unmutated-cll-100302615","NCT03219450","A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.","A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide or Pembrolizumab in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia.","Inclusion Criteria:\n\n* Diagnosis of CLL as per IWCLL 2018 criteria\n* Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as \\\u003C 2% mutated compared to germline.\n* Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criteria; no present indication for treatment by iwCLL 2018 criteria; and in the opinion of the treating investigator be anticipated not to require CLL-directed treatment within the next 6 months.\n* Patient must have measurable disease (absolute lymphocyte count \\> 10K\u002FuL or total white blood cell count ≥ 20K\u002FuL of peripheral blood).\n* Patient must have had at least two other absolute lymphocyte counts (ALC) measured since diagnosis of CLL that are at least 2 weeks apart and at least 2 months prior to the one used for initial registration.\n* Age ≥ 18 years.\n* ECOG performance status 0 or 1\n* Participants must have normal organ and marrow function as defined below:\n\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal\n  * absolute neutrophil count ≥1000 cells\u002FμL\n* The effects of NeoVax and poly-ICLC on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent of HCG) before entry onto the trial and within 7 days prior to start of study medication. It is the investigators' responsibility to repeat the pregnancy test should start of treatment be delayed.\n* Female patients enrolled in the study, who are not free from menses for \\>2 years, post hysterectomy \u002F oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 4 weeks after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.\n* Patient is agreeable to allow tumor (from peripheral blood) and normal tissue (from saliva) samples to be submitted for complete exome and transcriptome sequencing.\n* Ability to understand and the willingness to sign a written informed consent document.\n* At least 7 immunizing peptides can be designed.\n* Continue to meet inclusion and exclusion criteria for Screening Registration.\n\nExclusion Criteria:\n\n* Prior therapy for CLL that met IW-CLL treatment criteria, including chemotherapy, targeted therapies (e.g. that antagonize B cell receptor signaling), or immunotherapy (including but not limited to monoclonal antibodies); or radiotherapy or hormonal therapy within the last 2 years of screening registration.\n* Participants who are receiving any other investigational agents.\n* Previous bone marrow or stem cell transplant\n* Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids. Previous history of corticosteroid use is acceptable. Use of corticosteroids after initial registration is acceptable if tapered at least one week before NeoVax administration.\n* Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks of any NeoVax administration.\n* History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases.\n* Participants who have never received the tetanus vaccine.\n* Active, known, or suspected autoimmune disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatment.\n* Uncontrolled autoimmune cytopenia.\n* No lymph node \\> 5 cm by CT scan (measured as long axis).\n* Del(17p) by fluorescence in situ hybridization in ≥ 10% of CLL cells analyzed\n* Any documented transformation of CLL (i.e. Richter's Syndrome).\n* Lymphocyte doubling time (LDT) \\\u003C 6 months in patients with WBC \\> 30,000\u002FuL. Factors contributing to lymphocytosis other than CLL (e.g. infections) should be excluded when calculating the LDT1.\n* Serum immunoglobulin level \\\u003C400 mg\u002FdL or currently requiring chronic intravenous immunoglobulin G (IVIG)\n* Known chronic infections with HIV, hepatitis B or C (see Study Calendar in Section 10 for screening assays).\n* Has received prior therapy with an anti-PD1, anti PD-L1, or anti PD-L2 agent.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.\n* Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of AEs.\n* Pregnant women are excluded from this study because personalized neoantigen peptides and poly-ICLC are agents with unknown risks to the developing fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with personalized neoantigen peptides and poly-ICLC, nursing women are excluded from this study.\n* Individuals with history of an invasive malignancy are ineligible except for the following circumstances: a) individuals with a history of invasive malignancy are eligible if they have been disease -free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix and basal cell or squamous cell carcinoma of the skin; c) individuals with prostate cancer managed with active surveillance that is not expected to limit their survival to \\\u003C10 years.\n* Participants with known CNS involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to poly-ICLC.\n* HIV-positive participants on combination antiretroviral therapy are ineligible because assessment of immunologic endpoints may be confounded by HIV-induced alterations in patient immune status and function. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated",{"count":299,"type":21},[275],"This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL)\n\nThe names of the study interventions involved in this study are:\n\n* Personalized NeoAntigen Vaccine\n* Poly-ICLC\n* Cyclophosphamide\n* Pembrolizumab",[534],"Lymphocytic Leukemia",[304,534],{"date":448,"type":55},{"date":538,"type":55},"2021-08-18",{"date":218,"type":21},{"name":61,"class":62},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":365,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":74,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":63},"100628909","phase-2-ph-2-elacestrant-in-er-positive-uterine-sarcomas-100628909","NCT07467772","Ph 2 Elacestrant in ER Positive Uterine Sarcomas","A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas","Inclusion Criteria:\n\nParticipant must have histologically confirmed uterine sarcoma of one of the following subtypes: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa.\n\nTumor must have moderate to strong immunohistochemical expression in ≥75% of tumor cells of estrogen receptor (ER) as assessed by institutional pathology review.\n\nParticipants must have locally advanced or metastatic disease that is not amenable to surgery.\n\nParticipants must have measurable disease, 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) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n\nAge ≥18 years at the time of consent\n\nECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n\nParticipants must have adequate organ and marrow function as defined below:\n\nHemoglobin ≥ 8.0 g\u002FdL\n\nabsolute neutrophil count ≥1,000\u002FmcL\n\nplatelets ≥100,000\u002FmcL\n\ntotal bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n\nAST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)\n\nglomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2\n\nHuman immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nFor participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nParticipants 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\nParticipants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\nParticipants must be disease-free of prior invasive malignancies for \\> 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, participants must not be receiving other specific treatment for that cancer.\n\nParticipants should have completed prior treatment for their cancer: chemotherapy or radiotherapy must have been completed for greater than 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n\nParticipants should have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n\nParticipants 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\nParticipants must have a QTc interval length of below 450 msec. QTc will be calculated via the Fridericia's formula.\n\nParticipant must be willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nParticipant must be able to swallow and maintain pills.\n\nAbility to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and\u002For family member available will also be eligible.\n\nWomen of childbearing age, women who are made postmenopausal through use of GNRH agonists must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of elacestrant if the risk of conception exists.\n\nAdequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and\u002For partner.\n\nHighly Effective Non-Hormonal Contraception\n\nMethods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly effective forms of contraception.\n\nThe following non-hormonal methods of contraception are acceptable:\n\n* True abstinence when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner.\n\nOR Effective Non-Hormonal Contraception\n\nAlternatively, two of the following effective forms of contraception may be used instead:\n\nPlacement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being15used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire.\n\n* Condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* The use of barrier contraceptives should always be supplemented with the use of spermicide. Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.\n\nIt should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\nPremenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:\n\n* Age \\> 60 years; or\n* Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; or\n* Documented Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n\nWomen must be postmenopausal, which is defined as any of the following:\n\n* Age ≥ 60 years\n* Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH, and estradiol in the postmenopausal range per local normal range\n* Premenopausal women must be on GnRH agonist prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n* Status-post bilateral oophorectomy - After adequate healing post-surgery\n\nExclusion Criteria:\n\nParticipants who are receiving any other investigational agents.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant.\n\nRapidly progressive, symptomatic, visceral spread of disease placing participant at risk of\n\nlife- threatening complications in the short term.\n\nParticipants with uncontrolled intercurrent illness, including but not limited to active infection, uncontrolled diabetes, cardiac disease, hypertension or conditions that in the opinion of the investigator would compromise participant safety or study participation\n\nParticipants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nTreatment with strong CYP3A inducers\u002Finhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced. See Appendix B for a list of medications that are CYP3A inducers\u002Finhibitors.\n\nFemale participants who are pregnant or nursing.",{"count":549,"type":21},30,[126],"This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is:\n\n-Elacestrant (a type of selective estrogen receptor degrader)",[553,554,555,556,557,558,559,560,561],"Uterine Sarcoma","Uterine Leiomyosarcoma","Endometrial Stromal Sarcoma","ESS","Perivascular Epithelioid Cell Tumors","Uterine Adenosarcoma","Uterine PEComa","Estrogen Receptor Positive Tumor","uLMS","2026-05-21",{"date":564,"type":55},"2026-05-22",{"date":566,"type":55},"2026-03-25",{"date":568,"type":21},"2028-04",{"name":61,"class":62},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":74,"phases":580,"briefSummary":581,"conditions":582,"keywords":585,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":63},"100626377","phase-2-ph-2-pemigatinib-in-sdh-deficient-gist-100626377","NCT07434843","PH 2 Pemigatinib in SDH-deficient GIST","PEMIGIST: Phase 2 Study of Pemigatinib (INCB054828) in the Treatment of Patients With Advanced SDH-deficient Gastrointestinal Stromal Tumor (GIST)","PEMIGIST","Inclusion Criteria:\n\n* Participant must have histologically confirmed SDH-deficient GIST. Participants must have locally advanced or metastatic disease that is not amenable to surgery.\n* Participants must have measurable disease, 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) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n* Participants must have radiographically documented progressive disease prior to study enrollment as per investigator assessment.\n* Age ≥18 years\n* ECOG performance status ≤2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Hemoglobin \\> 8 g\u002FdL. Patients with a hemoglobin of 7.5-8.0 g\u002FdL may be eligible if the value is chronic, there is no clinical evidence of active bleeding, and eligibility is confirmed upon review and approval of the Sponsor-Investigator\n  * Absolute neutrophil count ≥1,000\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)\n  * glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 (using the CDK-EPI formula see Appendix B)\n* Human immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) 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 treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants must be disease-free of prior invasive malignancies for \\> 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, participants must not be receiving other specific treatment for that cancer.\n* Participants should have completed prior treatment for their cancer: chemotherapy or radiotherapy must have been completed for greater than 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n* Participants should have recovered from adverse events due to prior anti-cancer therapy (i.e.,have residual toxicities \\> Grade 1) with the exception of alopecia.\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* Participants must have a QTc interval length of below 450 msec. QTc will be calculated via the Fridericia's formula.\n* Participant is willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Participant must be able to swallow and maintain pills.\n* Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days of initial dose of pemigatinib (INCB054828), and again within 7 days prior to treatment on day 1. If screening occurs within 7 days of day 1, only one regnancy test is required.\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and\u002For family member available will also be eligible.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pemigatinib (INCB054828).\n* Concomitant administration with sensitive substrates\u002Fnarrow therapeutic index drugs of CYP3A4, P-gp BCRP, MATE1, and MATE2K, and strong inhibitors and inducers of CYP3A4 should be avoided. Use caution with strong inhibitors and inducers of P-gp. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product. (See Appendix C Participant Drug Information Handout and Wallet Card).\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Women of childbearing potential unwilling or unable to perform contraception from screening until 4 months after completion of pemigatinib administration\n* Men unwilling or unable to perform contraception from screening to until 4 months after completion of pemigatinib administration.\n* Participants previously treated with a FGFR inhibitor.\n* History of hypovitaminosis D requiring supraphysiologic doses (e.g., 50,000 UI\u002Fweekly or above). Vitamin D supplements are allowed.\n* Participants with calcium and phosphate levels exceeding the upper limit of normal (ULN) despite medical intervention within 2 weeks prior to the first dose of pemigatinib.\n* Current evidence of corneal or retinal abnormalities that may increase eye toxicity, including but not limited to:\n\n  * Currently suffering from central serous retinopathy (CSR) or retinal vein occlusion (RVO), or with relevant history\n  * Active wet age-related macular degeneration (wAMD)\n  * Diabetic retinopathy with macular edema\n  * Uncontrollable glaucoma\n  * Keratopathy, such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration\n* Treatment with any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.\n* Participants with a history of soft tissue calcifications on imaging that are associated with documented abnormalities in calcium or phosphate levels except for soft tissue calcification due to aging, previous injury or other disease",{"count":579,"type":21},24,[126],"The purpose of this study is to determine how effective the drug pemigatinib is as a treatment option for advanced succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors(GIST). This study will also assess the side effects associated with pemigatinib and evaluate its tolerability.\n\nThe name of the study drug involved in this study is:\n\n• Pemigatinib (INCB054828)",[583,584],"SDH Gene Mutation","Gastrointestinal Stromal Tumor",[584,586],"Advanced SDH-deficient Gastrointestinal Stromal Tumor",{"date":564,"type":55},{"date":589,"type":55},"2026-05-19",{"date":591,"type":21},"2029-04-01",{"name":61,"class":62},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":74,"phases":602,"briefSummary":603,"conditions":604,"keywords":609,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":63},"100456579","video-education-with-result-dependent-disclosure-100456579","NCT05225428","Video Education With Result Dependent dIsclosure","VERDI","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma\n* Ability to understand spoken or written English or Spanish in a healthcare context\n* Ability to understand and the willingness to sign a written informed consent document\n* Black or Latinx (qualitative assessment study only)\n\nExclusion Criteria:\n\n* Prior cancer genetic testing\n* Prior germline genetic testing\n* Active hematologic malignancy (e.g. chronic lymphocytic leukemia)\n* Currently pregnant\n* Currently incarcerated",{"count":601,"type":21},1020,[76],"The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.",[605,29,252,490,79,606,607,608,32],"Genetic Testing","Colorectal Cancer","Renal Cancer","Melanoma",[605,29,252,490,79,606,607,608,32],"2026-05-20",{"date":564,"type":55},{"date":613,"type":55},"2022-08-04",{"date":615,"type":21},"2026-10-01",{"name":61,"class":62},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":98,"minAge":18,"maxAge":4,"enrollmentInfo":624,"targetDuration":4,"studyType":74,"phases":626,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":641},"100636185","adjuvant-endocrine-therapy-adherence-intervention-pilot-in-rwanda-100636185","NCT07562399","Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda","Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda","Inclusion Criteria:\n\n* Female patients\n* Age 18 or older\n* Pathologic confirmation of ER-positive breast cancer\n* Clinical or radiographic confirmation of disease localized to the breast and regional lymph nodes\n* Within 6-36 months of starting AET\n* Have a cellphone capable of receiving text messages.\n* Are currently receiving AET at Butaro or satellite clinics.\n\nExclusion Criteria:\n\n* Unwilling\u002FUnable to participate\n* Unable to comprehend study languages (English or Kinyarwanda)\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Pregnant women",{"count":625,"type":21},224,[76],"This study aims to evaluate a multi-modal intervention designed to improve adherence to adjuvant endocrine therapy (AET) among patients with ER-positive breast cancer in Rwanda. The intervention includes educational, behavioral, and reminder components, and will be assessed for feasibility and impact on medication adherence.",[629,29],"Medication Adherence",[631,632,633],"breast cancer","medication adherence","ER-positive breast cancer","2026-05-18",{"date":610,"type":55},{"date":637,"type":21},"2026-09-20",{"date":639,"type":21},"2028-12-31",{"name":61,"class":62},4,""]