[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Roswell Park Cancer Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":544},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,40,63,83,104,125,147,169,186,205,229,247,267,288,307,330,349,368,403,425,444,467,486,504,522],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100645055","phase-1-phase-i-trial-of-pacritinib-in-combination-with-venetoclax-and-azacitidine-for-the-treatment-of-accelerated-and-blast-phase-myeloproliferative-neoplasms-100645055",false,"NCT07679334","Phase I Trial of Pacritinib in Combination With Venetoclax and Azacitidine for the Treatment of Accelerated and Blast Phase Myeloproliferative Neoplasms","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Subjects must have accelerated phase MPN as defined by 10-19% blasts or blast phase MPN (AML) as defined by ≥ 20% blasts in the blood or bone marrow by manual aspirate differential, immunohistochemistry staining, or flow cytometry, with a documented prior diagnosis of essential thrombocythemia (ET), polycythemia vera (PV), or primary myelofibrosis (PMF), The absence of a spleen, lack of splenomegaly, or history of splenic irradiation is not exclusionary.\n* Subjects with blast phase MPN must be newly diagnosed\u002Funtreated (no prior blast reduction therapy for blast phase disease except for hydroxyurea and\u002For a JAK inhibitor; treatment of a prior accelerated phase is allowed). Prior treatment with a hypomethylating agent (with or without a JAK inhibitor) is allowed for accelerated phase MPN. Prior treatment with any JAK inhibitor (including pacritinib) is allowed for any phase of disease (chronic, accelerated, or blast); however, must not have discontinued pacritinib due to toxicity. If a participant previously required dose reduction during pacritinib therapy and tolerated it well, then may enroll into a cohort utilizing that dose level or lower.\n* WBC \\\u003C 25 x 109\u002FL prior to treatment initiation- subjects with WBC ≥ 25 x 109\u002FL may still be eligible after receiving cytoreduction measures such as hydroxyurea and\u002For leukapheresis if WBC becomes \\\u003C 25 x 109\u002FL prior to treatment initiation. Cytoreduction with hydroxyurea and\u002For leukapheresis is allowed prior to treatment. Hydroxyurea must be discontinued ≥ 12 hours prior to treatment initiation.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration:\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) unless considered to be due to Gilbert's Syndrome, hemolysis, or leukemic organ involvement. Total bilirubin WBC \\\u003C 25 x 109\u002FL prior to treatment initiation- subjects with WBC ≥ 25 x 109\u002FL may still be eligible after receiving cytoreduction measures such as hydroxyurea and\u002For leukapheresis if WBC becomes \\\u003C 25 x 109\u002FL prior to treatment initiation. Cytoreduction with hydroxyurea and\u002For leukapheresis is allowed prior to treatment. Hydroxyurea must be discontinued ≥ 12 hours prior to treatment initiation.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration:\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) unless considered to be due to Gilbert's Syndrome, hemolysis, or leukemic organ involvement. Total bilirubin must be \\\u003C 3 x upper limit normal in subjects with Gilbert's Syndrome, hemolysis, or leukemic organ involvement.\n* Aspartate aminotransferase (AST): ≤ 3 x ULN (≤ 5 x ULN if considered to be due to myelofibrosis or leukemic organ involvement).\n* Alanine aminotransferase (ALT): ≤ 3 x ULN (≤ 5 x ULN if considered to be due to myelofibrosis or leukemic organ involvement).\n* Creatinine clearance: ≥ 30 mL\u002Fmin by Cockcroft-gault formula or measured by 24-hour urine collection.\n* Participants of child-bearing potential must agree to use highly effective contraceptive methods prior to study entry. 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\nExclusion Criteria:\n\n* Diagnosis of de novo AML, acute promyelocytic leukemia, or accelerated or blast phase MPN without a documented prior diagnosis of ET, PV, or PMF.\n* Known CNS leukemia involvement. NOTE: Subjects with clinical suspicion or signs of neurologic deficit should undergo a screening lumbar puncture prior to enrollment to confirm lack of CNS leukemia.\n* Previous treatment with BCL-2\u002FBCL-X inhibitors (including venetoclax and navitoclax).\n* Prior allogeneic stem cell transplantation for blast phase disease. Prior allogeneic stem cell transplantation for chronic and accelerated phase MPN is allowed. Subjects must not have received transplant within 60 days. Cannot be receiving immunosuppression therapy, with the exception of prednisone ≤10mg\u002Fd (or equivalent), for the treatment or prophylaxis of GVHD. If the subject has been on immunosuppressant treatment or prophylaxis for GVHD, the treatment must have been discontinued at least 14 days prior to study treatment and there must be no evidence of Grade ≥ 2 GVHD.\n* Treatment with moderate or strong CYP3A4 inhibitors or strong CYP3A4 inducers within five half-lives or 14 days, whichever is shorter, prior to the initiation of study treatment.\n\nTreatment with chemotherapy, wide-field radiation, or biologic therapy, with the exception of hydroxyurea as above, and all trans-retinoic acid given initially for presumed APML, within 14 days of study entry. Prior JAK inhibitor (other than pacritinib) must be held for five half-lives prior to study entry. Administration of steroids to prevent withdrawal symptoms is allowed.\n\n* Treatment with investigational drug within five half-lives or 14 days, whichever is shorter, prior to study entry.\n* Baseline prolonged QTc of \\> 480 msec. QTc measured by Fridericia's formula (QTc=QT\u002F\\[RR1\u002F3\\]) based on the mean of triplicate reads. Repeat EKGs after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria.\n* Grade ≥2 bleeding event within the previous 3 months. Treatment with anticoagulation or antiplatelet agents (except for aspirin at dosages ≤100 mg per day or prophylactic doses of enoxaparin or heparin) within five half-lives or 7 days, whichever is shorter.\n* Any GI or metabolic condition that could interfere with absorption of oral medication.\n* Known severe (Child-Turcotte-Pugh class C) hepatic cirrhosis. Testing not required.\n* Pre-existing uncontrolled pathology such as heart failure (congestive\u002Fischemic, NYHA classes III and IV), clinically significant abnormalities on a 12-lead electrocardiogram, significant pulmonary disease, severe\u002Funstable arrhythmias\u002Fangina pectoris\u002Fhypertension, acute or chronic pancreatitis, etc. Acute myocardial infarction or stroke within 6 months of study entry.\n* Known active HIV, Hepatitis B, or Hepatitis C infection; testing not required.\n* Active uncontrolled or severe systemic infection. Enrollment is possible after control of infection, at discretion of the treating physician.\n* History of another active malignancy in the previous 2 years, with the exception of:\n\nadequately treated in situ carcinoma of the cervix, breast, prostate; basal cell carcinoma pf the skin or localized squamous cell carcinoma of the skin.\n\n* Pregnant or nursing female participants","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial studies the side effects and best dose of pacritinib when given together with venetoclax and azacitidine in treating patients with accelerated and blast phase myeloproliferative neoplasms (MPN-AP\u002FBP). Pacritinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving pacritinib together with venetoclax and azacitidine may be safe, tolerable, and\u002For effective in treating patients with MPN-AP\u002FBP",[26],"Myeloproliferative Neoplasm","NOT_YET_RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":33,"type":20},"2026-08-01",{"date":35,"type":20},"2029-08-01",{"name":37,"class":38},"Roswell Park Cancer Institute","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100577469","virtual-reality-for-symptom-management-in-patients-undergoing-hematopoietic-stem-cell-transplantation-100577469","NCT06798701","Virtual Reality for Symptom Management in Patients Undergoing Hematopoietic Stem Cell Transplantation","Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) admitted to Roswell Park on 5 North for planned hematopoietic stem cell transplantation (HSCT)\n* Must be alert and oriented (Glascow Coma Scale of 15, Nursing Universal Flowsheet) and able to consent to participate in the study\n* Expected to be admitted to Roswell Park inpatient unit for ≥ 1 week\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\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* 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 patients\n* Incarcerated patients\n* Patients who are unwilling or unable to follow protocol requirements\n* Individuals that are prone to motion sickness, nausea, dizziness, history of seizure, potential for seizure, history of delirium, at risk for confusion, etc\n* Participants with audio and\u002For visual impairments that would preclude them from using a VR device",{"count":48,"type":20},28,[50],"NA","This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact\u002Ftouch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.",[53,54],"Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm","RECRUITING","2026-06-29",{"date":28,"type":31},{"date":59,"type":31},"2025-03-14",{"date":61,"type":20},"2026-08-14",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100520335","phase-1-pkpd-of-vaping-thc-containing-liquids-vs-smoked-cannabis-100520335","NCT06055231","PK\u002FPD of Vaping THC-containing Liquids vs. Smoked Cannabis","A Randomized Within-Subject Cross-Over Study to Compare Short-Term PK\u002FPD Effects of Vaping THC-containing Liquids vs. Smoked Cannabis","Inclusion Criteria:\n\n* Age \\>= 21 years of age\n* Report concurrent use of commercial (medical or recreational) smoked cannabis and THC vaping cartridges for at least 3 months prior to enrollment\n* Report smoking cannabis and THC- vaping liquid use at the potency level of the study product at least weekly (4x\u002Fmonth)\n* Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products\u002Fprocedures\n* Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#:NCE-STHC-1) and semi -quantitative urinary tetrahydrocannabinol-carboxylic acid (THCA) rapid test (NarcoCheck® THC PreDosage) during baseline testing, prior to receiving any study-related products\n* Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* • Illegal or non-prescription drug use within the past 90 days. As detected by NacroCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product\n\n  * Report 2 or more drinking occasions\u002Fweek with 4 or more drinks\u002Foccasion\n  * Report of daily nicotine use\n  * Current or prior diagnosis of any psychotic disorders\n  * Current or prior diagnosis of chronic heart conditions\n  * Current or prior diagnosis of any respiratory condition\n  * Pregnant or currently trying to become pregnant (females)\n  * Detection level 4-5 (\\>300 ng\u002FmL) from a semi-quantitative urinary THCA rapid test (NarcoCheck® THC PreDosage)\n  * Unwilling or unable to follow protocol requirements\n  * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation",true,"21 Years",{"count":73,"type":20},40,[23],"We will conduct a randomized, within-subjects clinical study to compare short-term pharmacokinetic (PK) and pharmacodynamic (PD) effects of Δ9-tetrahydrocannabinol (THC) vaping liquids vs. smoked cannabis containing 6 equivalent standard THC units (5 mg THC=1 Standard THC Unit (STU)) in healthy community members who are current users of both products. While smoking cannabis remains the most common mode of THC use among adults and youth, alternative modes of delivery, such as Electronic Vaping Products (EVPs), are becoming increasingly popular for the delivery of cannabinoids. Declining cannabis risk perceptions, increasing normalization of cannabis, greater legal access and availability to cannabis, ease of administration, and ability to conceal vaped THC use have likely contributed to increasing prevalence of use throughout the population across all age groups. Comparing vaping THC containing liquids with smoking cannabis can serve as an important benchmark for evaluating the delivery and effects of THC vaping products and, their relative safety",[77],"Cigarette Smoking-Related Carcinoma",{"date":28,"type":31},{"date":33,"type":20},{"date":81,"type":20},"2027-09-15",{"name":37,"class":38},{"id":84,"slug":85,"hasResults":12,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":70,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":39},"100635525","home-based-respiratory-muscle-training-and-aerobic-exercise-programs-to-improve-lung-health-in-current-and-former-cigarette-smokers-100635525","NCT07553819","Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers","Effects of Respiratory Muscle Training and Aerobic Exercise on Lung Health in Smokers: A Pilot Parallel-Group Study for Lung Cancer Prevention","Inclusion Criteria:\n\n* Age ≥ 50 years old\n* Current smoker with a ≥ 20-pack-years history\n* Former smoker within the past 15 years, with a history of ≥ 20 pack-years (CT scan cohort only)\n* Participant must be able to speak, read and comprehend English language\n* Cognitively capable of following direction and performing the intervention\n* Understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Any previous lung cancer diagnoses and or undergoing treatment for any cancer\n* Recent pneumonia, bronchitis, or other inflammatory conditions in the lungs, including but limited to chronic obstructive pulmonary disease (COPD) and\u002For asthma exacerbation within the previous 6 months\n* Have uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention","50 Years",{"count":92,"type":20},200,[50],"This clinical trial studies whether home-based respiratory muscle training (RMT) and aerobic exercise (AE) programs can be used to improve lung health in current and former cigarette smokers. Lung cancer, the leading cause of cancer death, is overwhelmingly caused by exposure to cigarette smoke. Research suggests that daily activity reduces lung cancer risk in current and former smokers. However, current and former smokers are generally not active and new approaches to improve lung health are needed. During the home-based RMT program, participants use a handheld device to complete breathing exercise sessions consisting of breathing in and out against adjustable resistance. During the home-based AE program, participants complete aerobic exercises using a stationary bike working at a moderate workload against adjustable resistance. The home-based RMT and AE programs may be effective ways to strengthen the breathing muscles, which may improve lung health in current and former cigarette smokers.",[96],"Lung Carcinoma","2026-06-18",{"date":99,"type":31},"2026-06-22",{"date":33,"type":20},{"date":102,"type":20},"2029-05-01",{"name":37,"class":38},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":39},"100630562","phase-1-gb-5267-for-the-treatment-platinum-resistant-ovarian-peritoneal-or-fallopian-tube-cancer-100630562","NCT07489287","GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer","A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety and Tolerability of GB-5267, an IL-18 Armored CAR T Cell Product Targeting MUC16, in Patients With Platinum-Resistant Ovarian Cancer","Inclusion Criteria:\n\n* At least 18 years of age\n* Patients must have epithelial ovarian, peritoneal, or fallopian tube cancer that is confirmed by histology or cytology, with a histopathological diagnosis of serous, clear cell, endometrioid, mucinous carcinoma, or carcinosarcoma.\n* Must have platinum-resistant disease, defined as:\n\n  1. Progression of disease within 6 months of last platinum-based chemotherapy, OR\n  2. Patients who have an intolerance for further platinum-based therapy.\n* CA125 \\> 2 x ULN as assessed at the local lab by a 501(k) cleared test at Screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Must have evaluable disease or measurable disease defined as:\n\n  a. Measurable lesion as per RECIST v1.1 criteria\n* Adequate hematological function, including:\n\n  1. Absolute neutrophil count (ANC) \\> 1,000\u002Fmm3\n  2. Platelet count \\> 50,000\u002Fmm3\n  3. Hemoglobin \\> 8.5 g\u002FdL\n* Adequate renal function, including estimated creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault) or directly measured with a 24-hour urine collection test.\n* Adequate liver function, including:\n\n  1. Total bilirubin \\\u003C 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin \\\u003C 3 x ULN\n  2. Aspartate and alanine aminotransferase (AST and ALT) \\\u003C 3 x ULN; \\\u003C 5 x ULN if there is liver involvement by the tumor.\n* Life expectancy of at least 3 months without treatment.\n* Participant must be willing to undergo core or excisional biopsy of a tumor lesion\n\n  1. A pretreatment biopsy must be obtained following completion of screening procedures and at least 7 days prior to the cell infusion.\n  2. An on-treatment biopsy must be performed on Day 28 (±5 days) after infusion.\n  3. An end-of-treatment biopsy must be performed within 10 days of disease progression or any other reason for discontinuation.\n* Individuals of child-bearing potential (ICBP), defined as a sexually mature individual who has not undergone a hysterectomy, bilateral oophorectomy, or tubal ligation, or who has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months,\n\n  1. Must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test, as verified by the Investigator, at Screening and Baseline.\n  2. Must agree to abstain from breastfeeding during study participation and for at least 1 year post-GB-5267 infusion.\n  3. Must agree to use effective methods of contraception during sexual contact that has the possibility of resulting in pregnancy without interruption from the time of infusion until at least 1 year post GB-5267 infusion.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Coagulation Abnormalities and Hemorrhage:\n\n  1. Recent significant bleeding, defined as a history of Grade ≥2 hemorrhage within 30 days before Screening.\n  2. Coagulation parameters (assessed at Screening):\n\n     * Activated partial thromboplastin time (aPTT) \\>1.5 × ULN. Exception: Participants on therapeutic heparin may be allowed if aPTT is between 1.5 and 2.5 × ULN.\n     * International Normalized Ratio (INR) \\>1.5. Exception: Participants on warfarin are allowed if INR is between 2.0 and 3.0 on two consecutive measurements taken 1-4 days apart.\n  3. Anticoagulant use: Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes is excluded. Prophylactic anticoagulation (e.g., low-molecular-weight heparin \\[LMWH\\] 40 mg\u002Fday) or use of anticoagulants for venous access device patency is permitted if the participant has been on a stable dose for ≥4 weeks without bleeding complications.\n\n     2\\. History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to Screening, including cerebrovascular accident (CVA) \u002F stroke, transient ischemic attack (TIA), or subarachnoid hemorrhage.\n* Known history or presence of clinically relevant CNS pathology (e.g., untreated or active brain metastases, epilepsy requiring ongoing treatment, stroke or subarachnoid hemorrhage within 3 months, severe neurodegenerative disorders, or psychosis).\n* Active or clinically significant autoimmune disease requiring systemic immunosuppression (e.g., \\>10 mg\u002Fday prednisone equivalent or other immunosuppressants) within the past 6 months.\n\nException: Patients with stable, well-controlled autoimmune conditions, including but not limited to:\n\n* Type 1 Diabetes Mellitus on stable insulin therapy\n* Hypothyroidism managed with hormone replacement\n* Vitiligo\n* Resolved childhood asthma\n* Patients on low-dose immunosuppressants (≤10 mg\u002Fday prednisone equivalent) without recent exacerbations\n* Other non-systemic autoimmune conditions deemed low risk at the Principal Investigator's (PI) discretion\n\n  * Any treatment-related immune-mediated AEs from previous immunotherapy that have not resolved to baseline or Grade ≤1 at least 3 months prior to enrollment.\n  * Ongoing systemic bacterial, viral, or fungal infection not improving despite appropriate antimicrobial therapy, or requiring intravenous (IV) antimicrobials at Screening. Participants receiving prophylactic antimicrobials are eligible if there is no active infection.\n  * Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ (e.g., cervix, breast).\n  * Need for urgent intervention due to tumor mass effects (e.g., bowel obstruction or major vascular compression) that would preclude protocol compliance.\n  * Cardiac-Related Exclusions:\n\n    1. History of Class III or IV congestive heart failure, non-ischemic cardiomyopathy, unstable or poorly controlled angina, or peripheral arterial disease event within 6 months prior to enrollment.\n    2. Echocardiogram or multigated acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \\\u003C40%.\n    3. Previous myocardial infarction within 1 year prior to Screening.\n    4. Clinically significant arrhythmia (e.g., second- or third-degree AV block, paroxysmal atrial fibrillation requiring active treatment, or prior pacemaker\u002Fdefibrillator placement).\n    5. Any history of myocarditis.\n    6. Signs or symptoms of active angina, arrhythmia, or heart failure. Moderate-to-severe valvular disease not surgically corrected is also excluded.\n    7. Baseline plasma troponin above institutional ULN. Exception: Minimally elevated troponin-T is permitted if cleared by a cardiologist.\n    8. Inadequately controlled hypertension (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg).\n    9. Known history of hypertensive crisis or hypertensive encephalopathy.\n    10. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair, recent peripheral arterial thrombosis) within 6 months prior to enrollment.\n    11. Pericardial involvement in the primary ovarian malignancy.\n  * Pulmonary and Third-Space Fluid:\n\n    1. Oxygen saturation \\\u003C92% on room air.\n    2. Known history or evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis within the past 5 years.\n    3. Clinically significant third-space fluid (pericardial, pleural, or peritoneal) requiring recurrent drainage, or fluid drained for symptom management within 28 days prior to Screening.\n  * Any serious, uncontrolled medical condition (e.g., cirrhotic liver disease, recent significant trauma, or severe psychiatric illness) that, in the opinion of the Investigator, could compromise participant safety or the interpretation of study data.\n  * Prior or Concurrent Therapies:\n\n    1. Treatment with any previous anti-MUC16 therapy.\n    2. Prior allogenic stem cell transplant.\n    3. Receipt of any cellular or gene therapy.\n    4. Prohibited medications relative to leukapheresis or study treatment:\n\n       1. Steroids: Therapeutic doses (\\>10 mg\u002Fday prednisone equivalent) within 72 hours prior to leukapheresis\u002FGB-5267 infusion; physiologic replacement doses and topical\u002Finhaled steroids are allowed.\n       2. Immunosuppressants: Any non-steroidal immunosuppressive medications (e.g., cyclosporine, biologic TNF inhibitors) within 2 weeks prior to leukapheresis.\n       3. Antiproliferative therapies: Within 2 weeks prior to leukapheresis.\n       4. Radiation therapy: Within 2 weeks prior to leukapheresis.\n  * Live Vaccine Administration:\n\n    1. Receipt of a live vaccine within 30 days prior to enrollment.\n\n       * Infectious Disease (HIV, Hepatitis):\n    2. Active or inadequately controlled hepatitis A, B, or C infection:\n\n       1. Hepatitis A: Positive anti-HAV IgM excludes participation; positive anti-HAV IgG alone is allowed.\n       2. Hepatitis B: Vaccinated individuals (positive HBsAb only) are eligible. Past exposure (HBcAb positive) is permitted if the participant has undetectable HBV DNA for ≥6 months and is on or has completed antiviral prophylaxis.\n       3. Hepatitis C: Participants with positive anti-HCV antibody must have undetectable HCV RNA (PCR) for ≥6 months.\n       4. Participants who are hepatitis antibody-positive but DNA\u002FRNA-negative (e.g., due to recent IVIG) may be allowed at Investigator discretion",{"count":112,"type":20},18,[23],"This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.",[116],"Platinum-resistant Ovarian Cancer",[118],"Ovarian Cancer",{"date":99,"type":31},{"date":121,"type":20},"2026-07-15",{"date":123,"type":20},"2030-01-15",{"name":37,"class":38},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":39},"100594314","phase-2-gt103-in-combination-with-pembrolizumab-for-the-treatment-of-advanced-or-metastatic-stk11-mutant-non-small-cell-lung-cancer-100594314","NCT07017829","GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer","A Phase II Trial of GT103 in Combination With Pembrolizumab in STK11 Mutant Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at the time of study treatment initiation.\n* Have pathologically confirmed diagnosis of STK11 mutant NSCLC. STK11 mutation will be based on subject's local clinically accredited laboratory testing (Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified) using deoxyribonucleic acid (DNA) sequencing test.\n* Must have progressed on a pembrolizumab containing regimen and eligible for continuing pembrolizumab post-progression as determined by treating physician. Other anti-PD-1 or anti-PD-L1 checkpoint inhibitors may also be used in place of pembrolizumab\n\n  \\_Adequate bone marrow and organ function as defined by the following lab values:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL.\n* Platelets ≥ 100 x 10\\^9\u002FL.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Estimated glomerular filtration rate (GFR) (measured or calculated with Cockroft and Gault formula) \\> 45mL\u002Fmin.\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN) (ALT and AST ≤ 5 x ULN is acceptable if liver metastases are present).\n* Total bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin ≤ 3 x ULN with direct bilirubin within normal range.\n* Troponin-I ≤ ULN and B-type natriuretic peptide test (BNP) \\\u003C 200 pg\u002FmL.\n* Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) (institutional limit).\n* Patients must have measurable disease as defined in Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n* Participant agrees to provide blood samples at the start of treatment and at multiple times during the study. Participant agrees to provide tumor biopsy tissue or have adequate archival formalin-fixed paraffin-embedded (FFPE) tissue available.\n\nExclusion Criteria:\n\n* Receipt of anticancer chemotherapy within 4 weeks before the first administration of study drug.\n* Prior radiotherapy or gamma knife within 2 weeks of study treatment for non-brain metastasis. Subjects must have recovered from all radiation related toxicities.\n* Active\u002Funtreated brain metastasis. Whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug. Previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy.\n* Leptomeningeal involvement regardless of treatment status.\n* Tumor with oncogenic mutation based on standard of care broad genomic profiling in EGFR, ALK, ROS1, RET, MET, or NTRK genes.\n* History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before the first administration of study drug.\n* Currently receiving or has received systemic corticosteroids within 4 weeks prior to starting study drug for management of brain metastases, or who have not fully recovered from side effects of such treatment. Steroids for endocrine replacement or receipt of short-course of steroids during the preceding 4 week period as supportive medication such as for drug allergy, anti-emetic, etc. is allowed.\n* Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery.\n* Has known immunosuppressive disease (e.g., HIV, AIDS or other immune depressing disease). Testing is not mandatory.\n* Active, clinically serious infections or other serious uncontrolled medical conditions.\n* Patient has known hypersensitivity to the components of the study drugs or any analogs.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:\n\n  * Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease.\n  * History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline.\n  * Uncontrolled hypertension (systolic blood pressure \\[SBP\\] \\> 160\u002Fdiastolic blood pressure \\[DBP\\] \\> 100 despite medical intervention).\n  * History of myocarditis of any etiology.\n  * History of ventricular arrhythmias.\n* Patients diagnosed with an invasive cancer within 2 years prior to starting protocol therapy with the following exceptions: non-melanoma skin cancers, in-situ cancers, and prostate cancer Gleason ≤ 6 (under surveillance or treated), early-stage node-negative estrogen receptor positive (ER+)\u002Fprogesterone receptor positive (PR+) breast cancer with Oncotype Dx score \\\u003C 25 not taking adjuvant hormonal therapy.\n* Pregnant or nursing female participants.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.\n* Unwilling or unable to follow protocol requirements.",{"count":48,"type":20},[134],"PHASE2","This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). GT103 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. GT103 targets the tumor cell-protein complement factor H found on some cancer cells and may provide specific anti-tumor activity that may help block the formation of growths that may become cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving GT103 in combination with pembrolizumab may kill more cancer cells and improve outcomes in patients with advanced or metastatic STK11 mutant non-small cell lung cancer.",[137,138,139,140],"Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8",{"date":99,"type":31},{"date":143,"type":31},"2026-04-01",{"date":145,"type":20},"2028-12-01",{"name":37,"class":38},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":39},"100588612","phase-2-photoimmunotherapy-with-asp-1929-and-cemiplimab-for-the-treatment-of-refractory-inoperable-and-metastatic-stage-iiib-iv-non-small-cell-lung-cancer-100588612","NCT06943664","Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer","Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Subjects with histologically or cytologically confirmed stage IIIB-IV NSCLC\n* Subjects lacking actionable genetic mutations must have been previously treated with (a) anti-PD-1\u002FPD-L1 therapy; and (b) platinum-based chemotherapy, either as combination or sequentially for metastatic disease and have progressed on or after therapy. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy or who are unable to receive it are eligible to enroll based on progression after anti-PD-1\u002FPD-L1 therapy alone\n* NSCLC with known actionable genomic alteration (e.g., EGFR, ALK, ROS1, BRAF) must have received all approved targeted therapies and have progressed (data capture not necessary for ALK, ROS1, BRAF)\n* Subjects have at least two lesions of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* At least one site of disease accessible to photoimmunotherapy. Thus, the therapeutic 690-nm laser light can be administered via insertion of optical fiber\u002Fs in the target tumor for interstitial photoimmunotherapy (I-PIT), or target tumors can be illuminated with external beam photoimmunotherapy (EB-PIT)\n* Absolute neutrophil count: ≥ 1,000\u002FµL\n* Platelets: ≥ 100,000\u002FµL\n* Total bilirubin: ≤ institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 x institutional ULN\n* Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n* Patient has not received a transfusion within 2 weeks prior to screening\n* Female patients of childbearing potential must have a negative pregnancy test at screening and must be willing to use 2 methods of highly effective birth control while on study or be surgically sterile, or abstain from heterosexual sexual activity for the course of the study through 120 days after the last dose of anti-PD1 treatment. 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 must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of anti-PD1 treatment\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedures\n\nExclusion Criteria:\n\n* Has received an investigational agent within 30 days prior to initial treatment or less than 4 half-lives of a previous drug\n* Had a major surgery, (e.g., requiring general anesthesia) within 4 weeks before the first dose of study treatment or, will not have fully recovered from surgery prior to the first dose\n* Patients who received chemotherapy or chemoimmunotherapy within 21 days or those who have not recovered from reversible adverse events prior to the scheduled surgery and interstitial or intraoperative PIT\n* The participants received high dose or curative radiotherapy to the target tumor\u002Fs within 30 days prior to the planned I-PIT or EB-PIT\n* Toxicity related to prior anticancer therapy that has not returned to grade ≤ 1 or baseline levels (except for alopecia, vitiligo, grade ≤ 2 peripheral neuropathy, and endocrinopathies that are stable on hormone replacement, which may be grade 2)\n* History of immune-related adverse events (irAEs) from prior anticancer therapy leading to permanent treatment discontinuation\n* History of solid organ or hematologic stem cell transplantation\n* Prolonged corrected QT interval by Fredericia (QTcF) \\> 470 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (e.g., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate or abnormalities in conduction or morphology of electrocardiogram \\[ECG\\] \\[e.g., complete left bundle branch block, third- or second-degree heart block, PR interval \\> 250 msec\\]). Note: Participants with cardiac pacemakers who are clinically stable are eligible\n* Clinically significant cardiovascular disease, including any of the following within 6 months prior to signature of informed consent:\n\n  * Myocardial infarction, severe or unstable angina, or coronary artery bypass surgery\n  * Clinically significant arrhythmias (e.g., ventricular arrhythmias or atrial fibrillation with uncontrolled heart rate)\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] class III\u002FIV)\n  * Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event\n  * Myocarditis\n* Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures\n* Patients with untreated or symptomatically unstable treated brain metastases or history of leptomeningeal disease 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. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management\n* Known history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Exceptions include past or resolved hepatitis B (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of hepatitis B virus surface antigen \\[HBsAg\\]) and patients positive for hepatitis C (hepatitis C virus \\[HCV\\]) antibody if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). HIV testing is not required in absence of clinical suspicion of HIV\n* History of, or active autoimmune disorder, requiring systemic steroids or immunosuppressive agents. Exceptions allowed: Patients with autoimmune dermatologic conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo, eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal supplementation\n\n  * Use of immunosuppressant drugs such as steroids, azathioprine, tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment (exception allowed is use of steroids as hormone replacement therapy or as supportive medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)\n* History of significant (≥ grade 3) cetuximab infusion reactions\n* Evidence of interstitial lung disease or current active, noninfectious pneumonitis\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included\n  * Patients with celiac disease controlled by diet alone\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* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive ASP-1929\n* Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive the experimental PIT or immunotherapy\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements",{"count":155,"type":20},27,[134],"This phase II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.",[159,138,160,161,162,140],"Lung Non-Small Cell Carcinoma","Refractory Lung Non-Small Cell Carcinoma","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8",{"date":99,"type":31},{"date":165,"type":20},"2026-08-15",{"date":167,"type":20},"2028-05-01",{"name":37,"class":38},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":185,"locationsCount":39},"100579650","phase-2-psilocybin-with-psychotherapy-for-improving-chronic-pain-in-cancer-patients-requiring-opioids-100579650","NCT06827054","Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids","Low-Dose Psilocybin Therapy for Palliative Care Patients With Chronic Cancer Pain Requiring Opioids","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years old\n* Diagnosis of active cancer, any stage\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Estimated prognosis of ≥ 3 months at the time of enrollment, determined by participant's primary oncologist or palliative physician\n* Diagnosis of moderate to severe pain (reported average pain score ≥ 4 on the 11-point Numerical Rating Scale) that is chronic (≥ 3 months) and secondary to cancer or cancer treatment\n* Pain regimen has been escalated to opioid therapy\n\n  * Participants must be on stable pain regimen for at least one month prior, with no intention to adjust pain regimen during the study period\n* Participants must be ≥ 4 weeks beyond treatments\u002Fprocedures that, in the opinion of the study physician, would significantly affect outcomes related to pain and physical function (e.g., surgery or radiation). Participants may otherwise receive cancer-directed treatment throughout the study period\n* Have no known procedures\u002Ftreatments scheduled in advance that would prohibit patient from completing or significantly delaying completion of the study\n\n  * The participant has no vacations or plans to be out of town during their study enrollment\n* Participants must not plan for additional treatments\u002Fprocedures that, in the opinion of the study physician, would significantly affect outcomes related to pain and physical function (e.g., surgery or radiation) for ≥ 4 weeks following psilocybin treatment initiation. Participants may otherwise receive cancer-directed treatment throughout the study period\n* No use of other illicit substances (excluding cannabis) within the past year based on self-report at screening and routine urine toxicology screen\n* Participants must be able to read, write, and speak English\n* Participants must be able to swallow pills\n* Agree to refrain from using any unprescribed psychoactive drugs, including alcoholic beverages, ≤ 24 hours of before each psilocybin administration. Exceptions include:\n\n  * Daily use of caffeine or nicotine\n  * Prescribed benzodiazepine medications and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for ≥ 6 weeks prior to screening\n* Participants using cannabis, including legal cannabis, for any purpose must agree to refrain from use beginning at two weeks before dosing and one week following completion of dosing (7-8 weeks total, dependent on frequency of prior use)\n\n  * Participants will not be withdrawn from the trial for a positive cannabis result during the initial screening drug test. However, participants who test positive for cannabis at the second drug test on visit 10 will be withdrawn from the trial\n* Participants must agree to be driven home after each experimental session and not drive or operate heavy machinery ≤ 16 hours of ingesting psilocybin\n* Participants must provide an emergency contact (relative, spouse, close friend, or other support person) willing and able to be reached by the investigators if the participant is unreachable by study staff or in an emergency\n* The participant agrees to take part in all study procedures, including the assessments, psychological evaluations, and dosing day requirements\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participants who are pregnant or breast-feeding\n* Participants of childbearing potential who decline to use a highly effective dual contraceptive method for the duration of the study\n* Participants with a condition impairing oral intake or digestive absorption\n* Cognitive impairment as defined by Montreal Cognitive Assessment (MOCA) score \\\u003C 23\n* Medical conditions or serious abnormalities of complete blood count, chemistries, or electrocardiography (ECG) that in the opinion of the study physician would preclude safe participation in the trial. Some examples include: congestive heart failure, valvular heart disease, recent acute myocardial infarction or evidence of ischemia, clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (e.g. corrected QT interval using Fridericia's Correction Formula \\[QTcF\\] interval \\> 450 in males and \\> 470 in females), uncontrolled hypertension (systolic blood pressure \\[BP\\] ≥ 140 or diastolic BP ≥ 90 on three separate occasions), congenital long QT syndrome, renal dysfunction (i.e. creatinine clearance \\[CrCl\\] \\\u003C 40 mL\u002Fmin), liver cirrhosis or hepatic dysfunction (indicated by gamma-glutamyltransferase \\[GGT\\], aspartate aminotransferase \\[AST\\], or alanine aminotransferase \\[ALT\\] \\> 3 x ULN \\[upper limit of norm\\] or total bilirubin \\[bili\\] \\> 3.0 mg\u002Fdl, or Child Pugh over class C), paraneoplastic syndrome, respiratory failure, dementia, delirium, known cerebral aneurysm, seizure disorder, stroke\u002Ftransient ischemic attack (TIA) in past year, cancer with known central nervous system (CNS) involvement, previously treated brain metastasis, or other major CNS disease\n* Participants who have a personal history of, or a current diagnosis of the following: primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder\n* Participants who have an ongoing substance use disorder (defined as active in the past year)\n* Participants with first-degree relatives with schizophrenia or bipolar disorder may be eligible depending on their age and personal and family psychiatric history. The decision will be made by the principal investigator and study psychiatrist or on-call psychiatric provider based on risk assessment\n* Active suicidal behavior (interrupted or aborted attempt; preparatory acts) as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) connotating either passive or active suicidal intent; OR one of the following:\n\n  * History of suicide attempt(s) within the past year (≤ 365 days)\n  * Have any suicidal ideation or thoughts, in the opinion of the study physician or principal investigator (PI), that presents a serious risk of suicidal or self-injurious behavior\n* Any contraindications to undergoing an fMRI scan, including having metal implants or metal fragments in the body\n* Participants who have hypersensitivity to the ingredients of the IMP (Investigational Medicinal Product) listed below:\n\n  * Indol alkaloids including psilocybin and psilocin\n  * Constituents of Psilocybe cubensis including protein, fats, carbohydrates, ergosterols, beta-glucan, and polyphenols\n  * Hydroxypropyl methylcellulose (HPMC) capsules\n* Participants who are taking medications with significant potential to interact with study medications will be exclusionary if they cannot be tapered. The taper interval will be at least five times the half-life. These medications include the following:\n\n  * Selective serotonin reuptake inhibitors (SSRIs)\n  * Serotonin and norepinephrine reuptake inhibitors (SNRIs)\n  * Tricyclic antidepressants (TCAs)\n  * Efavirenz\n  * Serotonin-acting dietary supplements (i.e., 5-hydroxy-tryptophan or St. John's wort)\n  * Centrally acting serotonergic agents (e.g., monoamine oxidase \\[MAO\\] inhibitors)\n  * Antipsychotics for a psychiatric disorder (e.g., first and second generation)\n\n    * Antipsychotics that are utilized for nausea, insomnia, or other non-psychiatric condition will be permitted, but patients will be asked to refrain from use 8 hours prior to dosing sessions\n  * Mood stabilizers (e.g., lithium, valproic acid)\n  * Aldehyde dehydrogenase inhibitors (e.g., disulfiram)\n  * Significant inhibitors of UGT 1A9 or UGT 1A10\n* Use of serotonergic hallucinogens (e.g., psilocybin, lysergic acid diethylamine \\[LSD\\]) within the past 12 months or significant lifetime use (\\> 25 uses)\n* Those with a history of prior violent and\u002For drug-related felonies\n* Those currently incarcerated will be excluded\n* Unwilling or unable to follow protocol requirements\n* Any social circumstance which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug","75 Years",{"count":19,"type":20},[134],"This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's \"total pain\", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.",[53,54],{"date":99,"type":31},{"date":165,"type":20},{"date":184,"type":20},"2027-05-05",{"name":37,"class":38},{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":39},"100541757","early-phase-1-evaluating-the-delivery-and-effects-of-thc-vaping-liquids-in-the-bloodstream-100541757","NCT06334016","Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream","Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC: A Double-Blind, Placebo-Controlled, Randomized Within-Subject Crossover Study","Inclusion Criteria:\n\n* Age ≥ 21 years of age; (self-reported on screening, verified at study visit).\n* Report use of commercial THC vaping cartridges for at least 3 months prior to enrollment; (self-reported).\n* Experience with THC potency at or above the study product AND experience with chasing THC with nicotine (at least monthly); (self-reported).\n* Report use of THC vaping liquids at least weekly (4x\u002Fmonth); (self-reported).\n* Daily use of nicotine vaping products containing 5% nicotine for at least 3 months prior to enrollment; (self-reported).\n* Report of not currently trying to become pregnant (females). Women of childbearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products\u002Fprocedures.\n* Willing to complete a THC saliva test to check for recent use (NarcoCheck Ref#: NCE-STHC-1), semi-quantitative urinary THCA rapid test (NarcoCheck® THC Pre Dosage), and an illicit drug urine test (NarcoCheck® Évolutive®) during baseline testing, prior to receiving any study-related products.\n* Negative THC saliva test (NarcoCheck Ref#: NCE-S-THC-1), detection level 1-3 on urinary THCA rapid test (NarcoCheck® THC PreDosage), and illicit drug screen negative for all drugs except THC (NarcoCheck® Évolutive®).\n* Willing to abstain from nicotine use for 8 hours prior to each study session and abstain from cannabis use 7 days prior to each session.\n* Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Detection level 4-5 (\\> 300 ng\u002FmL) on urinary THCA rapid test (NarcoCheck® THC PreDosage Ref#: DOA-M03-9B) and a positive result on THC saliva test (NarcoCheck Ref#: NCE-S-THC-1).\n* Illegal or non-prescription drug use within the past 90 days. As detected by NarcoCheck® Évolutive® (detection in human urine of the 12 most currently abused drugs) at the first session and prior to receiving any study product. THC use detected by NarcoCheck® Évolutive® is permitted\n* Illegal or non-prescription drug use\u002Falcohol substance use disorder (SUD) within the past year; (self-reported).\n* Report 2 or more drinking occasions\u002Fweek with 4 or more drinks\u002Foccasion; (self-reported).\n* Report of daily cigarette use; (self-reported).\n* Current or prior diagnosis of schizophrenia, bipolar disorder, or other severe psychotic mental illness; (self-reported).\n* Current or prior diagnosis of myocardial infarction, arrhythmia, or congestive heart failure (self-reported).\n* Current or prior cancer diagnosis.\n* Pregnant, currently trying to become pregnant, or breastfeeding (females); (self-reported; pregnancy validated on study visit by urine test).\n* Regular use of medications that contain nicotine, induce CYP2A6, stimulants, or sympatholytics (e.g., beta-blockers); (self-reported).\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for participation.\n* The following special populations will be excluded:\n\n  * Cognitively impaired adults\u002Fadults with impaired decision-making capacity\n  * Individuals who are not yet adults (infants, children, teenagers)\n  * Pregnant women\n  * Prisoners\n* No children or person under the age of 21 will be involved in the study. While those under 21 may use cannabis smoked or vaping products, the legal age of purchasing and using those products in New York State is 21. The current legal age to purchase and use tobacco products in New York State (NYS) is 21. Thus, our provision of study product to adults aged 21 and older is in line with current NYS law.",{"count":194,"type":20},60,[196],"EARLY_PHASE1","This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.",[199],"Cannabis Dependence",{"date":99,"type":31},{"date":121,"type":20},{"date":203,"type":20},"2028-03-01",{"name":37,"class":38},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":212,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":39},"100539573","phase-1-bipolar-androgen-therapy-to-restore-sensitivity-to-androgen-deprivation-therapy-for-patients-with-metastatic-castration-resistant-prostate-cancer-100539573","NCT06305598","Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer","Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Histologically confirmed carcinoma of the prostate\n* Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist)\n* Documented castrate level of blood testosterone (\\\u003C 50 ng\u002FdL)\n* Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) (by prostate specific antigen \\[PSA\\] criteria or radiographically)\n* Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available)\n* Absolute neutrophil count: ≥1,200\u002FµL\n* Platelets: ≥ 100,000\u002FµL\n* Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): ≤ 3 × institutional ULN\n* Creatinine clearance (CrCl) \\> 50 mL\u002Fmin (Cockcroft-Gault equation)\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\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* Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted)\n* Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)\n* Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C\n* Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule\n* Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation\n* Hematocrit \\> 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines)\n* Evidence of serious and\u002For unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study\n* Known allergy to testosterone cypionate or any of its excipients\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug","MALE",{"count":214,"type":20},14,[23],"This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.",[218,219,220],"Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","2026-06-09",{"date":223,"type":31},"2026-06-10",{"date":225,"type":31},"2024-12-19",{"date":227,"type":20},"2029-12-15",{"name":37,"class":38},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":176,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":244,"leadSponsor":246,"locationsCount":39},"100591213","electrotherapy-stimulation-together-with-life-coaching-for-the-support-of-burnout-symptoms-in-healthcare-workers-100591213","NCT06977503","Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers","A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)","Inclusion Criteria:\n\n* Age 21 ≤ and ≤ 75 years old\n* Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)\n* Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey\n* Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.)\n* Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 12 corresponding to the initial, midpoint, and final assessments\n* Ability to use the CES daily for an hour each day\n\n  * Although the device is water-resistant, participants must agree to not use the device in the bath or shower\n* Ability to read and write in English\n* Participant has access to a computer with internet access and an email address\n\n  * Ability to attend three (3) virtual 60-minute group life coaching sessions, via Zoom\n  * Ability to complete three (3) 10-15-minute pre-recorded video assignments, which will be distributed via email (each assignment will be due by the end of the week that they are distributed)\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus\n* Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker \u002F implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator \\[AICD\\]), cochlear implant, or any implanted electrical devices that cannot be shut off\n* Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.\n* Any self-reported medical or psychiatric condition which in the PI or study physician's opinion deems the participant an unsuitable candidate to participate in this trial.\n* Unwilling or unable to follow protocol requirements",{"count":73,"type":20},[50],"This clinical trial evaluates the effect of life coaching together with Cranial Electrotherapy Stimulation (CES) as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. The device is attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the CES device, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.",[240],"Psychiatric Disorder","2026-06-08",{"date":221,"type":31},{"date":33,"type":20},{"date":245,"type":20},"2027-10-15",{"name":37,"class":38},{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":39},"100583060","phase-1-genetically-engineered-cells-cd83-car-t-cells-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100583060","NCT06871410","Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Karnofsky performance status score ≥ 70%.\n* Relapsed or refractory AML based upon ELN 2022 criteria.\n* Creatinine clearance: ≥ 40 mL\u002Fmin (Cockroft-Gault).\n* Total bilirubin: ≤ 2mg\u002FdL except for patients with Gilbert's syndrome, hemolysis, or related to disease.\n* Aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C 3.0 x upper limit of normal (ULN).\n* Left ventricular (LV) ejection fraction: \\> 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia.\n* Oxygen (O2) saturation: ≥ 92% on room air without needs for supplemental O2.\n* Absolute lymphocyte count: ≥ 0.2 x 10\\^9\u002FL, HCT of ≥ 27% and platelets of ≥ 20 x 10\\^9\u002FL. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.\n* Life expectancy ≥12 weeks from the time of enrollment, per clinical judgment.\n* Negative serum pregnancy test in females of child-bearing potential (FOCBP). FOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n* If history of allogeneic HCT, must have completed transplant at least 3 months prior, be off immunosuppression, including ruxolitinib, at least 2 weeks prior to apheresis, and have no evidence of GVHD requiring treatment at enrollment.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 12 months following 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* Participants must be considered preliminarily eligible for an allogeneic hematopoietic cell transplantation, with potential donors identified per a transplant and cellular therapy consult at Roswell Park Comprehensive Cancer Center.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Concomitant systemic glucocorticoid use at a dose equivalent to \\> 10 mg daily prednisone at the time of apheresis and\u002For within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.\n* Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British \\[FAB\\] classification).\n* Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.\n* Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.\n* Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and\u002For targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n* Ongoing uncontrolled serious infection, pulmonary disease or psycho\u002Fsocial concerns.\n* HIV seropositivity or active hepatitis B or C infection within (defined by positive polymerase chain reaction \\[PCR\\]) 4 weeks of enrollment.\n* Other active malignancy within 2 years of study entry, except for basal cell cancer of skin, cervical cancer treated surgically with curative intent or localized prostate cancer managed with observational approach.\n* Active grade II-IV acute GVHD in patients with relapsed AML after HCT requiring treatment.\n* Prior solid organ transplant.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* Pregnant or nursing female participants.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.",{"count":255,"type":20},26,[23],"This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \\[CAR\\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory AML.",[259,260],"Recurrent Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia",{"date":223,"type":31},{"date":263,"type":31},"2026-03-02",{"date":265,"type":20},"2028-04-01",{"name":37,"class":38},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":39},"100609416","phase-1-pegcetacoplan-in-combination-with-modified-folfirinox-for-the-treatment-of-metastatic-pancreatic-ductal-adenocarcinoma-100609416","NCT07214298","Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma","A Phase I\u002FII Study of Complement Inhibition in Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic PDAC\n* Age ≥ 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Absolute neutrophil count ≥ 1,500\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Estimated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault equation)\n* Albumin ≥ 3 g\u002FdL\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present\n* All patients must either have available archival tumor tissue or undergo new tumor biopsy (if presence of a lesion that can be safely biopsied) before treatment initiation for correlative studies\n* Willing and able to self-administer pegcetacoplan (administration by caregiver will be allowed)\n* Willing to receive vaccination against Neisseria meningitidis and Streptococcus pneumoniae if not already vaccinated\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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\n  * Women of child-bearing potential taking part in this study should continue the use of birth control for 6 months after the last study treatment, and should not donate eggs during that timeframe\n  * Male participants taking part in this study should continue the use of birth control for 3 months after the last study treatment, and should not donate sperm during that timeframe\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Previous chemotherapy for PDAC. Gemcitabine-based post- or pre-operative therapy is allowed provided that the last dose and or surgical resection was at least 6 months prior to the documentation of metastatic disease, whichever occurred last\n* Toxicities from prior treatment grade \\> 1 with the exemption of alopecia and fatigue\n* Refractory ascites or pleural effusion (requiring para- or thoracentesis weekly or more frequently or use of indwelling catheter for palliation)\n* Untreated bowel or gastric outlet obstruction; patients with ≤ 6 weeks from such an event who are adequately palliated are allowed to participate\n* Participants with known untreated brain metastases will 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* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with major arterial thromboembolism (ATE) (coronary, cerebral, extremity or splanchnic) or venous thromboembolism (VTE) (pulmonary embolism or deep venous thrombosis) within 6 months from initiation of study treatment are not eligible for participation\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug",{"count":275,"type":20},35,[23,134],"This phase I\u002FII trial tests the effect of pegcetacoplan in combination with oxaliplatin, irinotecan, leucovorin, and fluorouracil (mFOLFIRINOX) in treating patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). Pegcetacoplan works by targeting the immune complement process, a part of the immune system that defends against bacteria and may limit tumor progression and improve the immune system's response against tumor cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Leucovorin is a drug used to lessen the toxic effects of substances that block the action of folic acid. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Fluorouracil stops cells from making DNA and it may kill tumor cells. It is a type of antimetabolite. Giving pegcetacoplan in combination with mFOLFIRINOX may be safe, tolerable, and\u002For effecting in treating patients with metastatic PDAC. This trial also evaluates the effect of pegcetacoplan on the incidence of major thrombotic events and the resulting complications. Thrombosis is a common complication in patients with PDAC. Thrombosis occurs when blood clots block veins or arteries. Complications of thrombosis, such as stroke or heart attack, can be life-threatening. Giving pegcetacoplan may help prevent blood clots from forming and decrease the risk of major thrombotic events.",[279,280],"Metastatic Pancreatic Ductal Adenocarcinoma","Stage IV Pancreatic Cancer AJCC v8","2026-06-04",{"date":241,"type":31},{"date":284,"type":31},"2026-02-16",{"date":286,"type":20},"2028-10-01",{"name":37,"class":38},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":39},"100585002","a-financial-intervention-financial-compass-to-identify-and-address-financial-hardship-among-head-and-neck-cancer-patients-financial-compass-trial-100585002","NCT06896695","A Financial Intervention (Financial Compass) to Identify and Address Financial Hardship Among Head and Neck Cancer Patients, Financial Compass Trial","Financial Compass: A Pilot Feasibility Study of a Novel Intervention to Identify and Address Financial Hardship Among Cancer Patients","Inclusion Criteria:\n\n* They have been diagnosed with head and neck cancer\n* Screen positive for financial hardship on the validated Comprehensive Score for Financial Toxicity (COST) measure\n* Are able to participate in English or Spanish\n\nExclusion Criteria:\n\n* Adults unable to complete the process of informed consent\n* Adults whose primary language is not English or Spanish\n* Individuals who are not yet adults (i.e., infants, children, teenagers)\n* Unwilling or unable to follow protocol requirements",{"count":296,"type":20},50,[50],"This clinical trial compares the effect a financial intervention, called Financial Compass, to usual care in identifying and addressing financial hardship in patients with head and neck cancer. Previous research has shown that head and neck cancer patients experiencing financial hardship have decreased overall and cancer specific survival. Using a financial intervention, Financial Compass, may be more effective than usual care in identifying and addressing financial hardship in patients with head and neck cancer.",[300],"Head and Neck Carcinoma",{"date":241,"type":31},{"date":303,"type":31},"2025-09-23",{"date":305,"type":20},"2027-02-25",{"name":37,"class":38},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":39},"100539723","phase-1-fluorescence-image-guided-surgery-followed-by-intraoperative-photodynamic-therapy-for-improving-local-tumor-control-in-patients-with-locally-advanced-or-recurrent-colorectal-cancer-100539723","NCT06307548","Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer","Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I\u002FII","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Patients with locally advanced or recurrent colorectal cancer undergoing surgery\n* Amenable to diagnostic CT and MR imaging\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Pregnant or nursing female participants\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive the fluorescence-guided surgery with intraoperative PDT\n* Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds\n* Patients who are not cleared to undergo surgery\n* Patients with any acute hepatitis or chronic liver dysfunction with baseline elevated liver function tests (i.e. Aspartate transaminase (AST)\u002Falanine transaminase (ALT) ≥ 2.5 x upper limit of normal \\[ULN\\]) will be excluded from the study\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug and\u002For procedure",{"count":315,"type":20},21,[23,134],"\\*As of June 2026- Phase I has been completed and we are now in Phase II. This phase I\u002FII trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer.",[319,320,321],"Locally Advanced Colorectal Carcinoma","Recurrent Colorectal Carcinoma","Stage III Colorectal Cancer","2026-06-03",{"date":324,"type":31},"2026-06-05",{"date":326,"type":31},"2024-07-30",{"date":328,"type":20},"2027-06-01",{"name":37,"class":38},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":39},"100606952","pilot-study-of-line-field-confocal-optical-coherence-tomography-for-detection-of-mohs-micrographic-surgery-margins-of-basal-cell-carcinomas-100606952","NCT07182240","Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.\n* Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.\n* The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.\n\nExclusion Criteria:\n\n* Known or reported allergy to mineral oil, the optical agent used during imaging.\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* . Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.\n* Unwilling or unable to follow protocol requirements",{"count":194,"type":20},[50],"To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).",[340],"Basal Cell Carcinoma","2026-05-28",{"date":343,"type":31},"2026-06-01",{"date":345,"type":31},"2025-12-22",{"date":347,"type":20},"2027-06-22",{"name":37,"class":38},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":39},"100600791","influence-of-authorized-smokeless-tobacco-product-modified-risk-claims-i-consumer-product-demand-100600791","NCT07102082","Influence of Authorized Smokeless Tobacco Product Modified Risk Claims I: Consumer Product Demand","Ifluence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effect","Inclusion Criteria:\n\n* Residing in one of the 8 counties of Western New York (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming).\n* Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year.\n* Open to trying a non-combusted oral tobacco product.\n* Have access to a device (ie: computer\u002Ftablet\u002Fsmartphone) with internet capabilities to participate in an online survey study.\n* Have the ability to read, write, and communicate in English.\n* Participant must understand the investigational nature of this study and an Independent Ethics Committee\u002FInstitutional Review Board approved information sheet prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Plan to quit smoking in the next 30 days.\n* Use of smokeless tobacco at least weekly in the last 6 months.\n* Lifetime use (that is, ever used at any time prior to the study) of Copenhagen or General Snus.\n* Unwilling or unable to follow protocol requirements.\n* Pregnant or planning to become pregnant (by self report)",{"count":357,"type":20},160,[50],"To explore consumer responses to the announcement and implementation of new modified risk claims for Copenhagen and General Snus (brands of smokeless tobacco (ST) products) using a series of complementary and innovative research activities and methods.",[361],"Smoking Behaviors",{"date":343,"type":31},{"date":364,"type":31},"2025-09-25",{"date":366,"type":20},"2027-09-30",{"name":37,"class":38},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":375,"minAge":17,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":21,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},"100457017","phase-2-pembrolizumab-combined-with-bevacizumab-with-or-without-agonist-anti-cd40-cdx-1140-for-the-treatment-of-patients-with-recurrent-ovarian-cancer-100457017","NCT05231122","Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer","Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years of age.\n* Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of treatment, and BRCA status must be known.\n\nNeoadjuvant + adjuvant is considered one line.\n\n* Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance.\n* Participants may have received a prior anti-PD1\u002Fanti-PDL1 therapy or bevacizumab, these will not be considered a separate line of therapy.\n* Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.\n* Hormonal therapy for OC (e.g. Tamoxifen, aromatase inhibitors etc.) will not count as a separate line of prior therapy.\n\n  * Anticipated lifespan greater than 6 months.\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.\n  * All residual toxicity related to prior anti-cancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must be resolved to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n  * Absolute neutrophil count (ANC): \\>= 1,500 \u002FmcL.\n  * Platelets: \\>= 100,000 \u002F mcL.\n  * Hemoglobin: \\>= 8 g\u002FdL or 5.0 mmol\u002FL transfusion allowed with adequate bone marrow function\n  * Creatinine clearance \\>= 50 mL\u002Fmin.\n  * Total bilirubin: =\\\u003C 2 X upper limit of normal (ULN) except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin =\\\u003C 3 mg\u002FdL.\n  * Aspartate aminotransferase (AST) ( serum glutamic-oxaloacetic transaminase \\[SGOT\\] ) and alanine aminotransferase (ALT) ( serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases.\n  * Albumin: \\> 2.5 mg\u002FdL.\n  * International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (APTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n  * Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 7 days prior to the first dose of investigational product and after 3 cycles of treatment(prior to cycle 4-day 1: mandatory only if available) and, at the end of treatment (optional). Participants for whom newly obtained samples cannot be provided at baseline (e.g., inaccessible or subject safety concern), may submit an archived specimen, only upon agreement from the Prinicipal Investigator, if available).\n  * A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year). Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n  * Participant (or legal representative) must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Primary platinum-refractory patients are excluded\n* Has a nonepithelial cancer (germ cell tumors, sex cord-stromal tumors), borderline tumors, mucinous or seromucinous that is predominately mucinous, malignant Brenner's tumor, carcinosarcoma or undifferentiated carcinoma.\n* Receipt of any antibody targeting T cell checkpoint or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Has received prior systemic anticancer therapy (including investigational agents or maintenance therapy) within 28 days prior to the planned start of study treatment.\n\nHormonal therapy is allowed until the time of randomization\n\n* Progression on prior immune checkpoint blockade therapy.\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks prior to the first dose of study treatment.\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* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Known or prior malignancy requiring active treatment in the past 2 years. Exception: basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases. Patients with brain metastases identified at screening may be rescreened after the lesion(s) have been appropriately treated; patients with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before administration of study drugs, and treated lesions should demonstrate no new growth on the re-screening scan.\n* History of (non-infectious) pneumonitis or has current pneumonitis, including grade 1 (asymptomatic; clinical or diagnostic observations only; intervention not indicated) pneumonitis.\n* History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\n* Prior therapy with any anti-CD40 antibody.\n* Hypersensitivity to bevacizumab, pembrolizumab, or any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months.\n* Has an acute infection requiring systemic therapy\n* Known immunodeficiency or active human immunodeficiency virus (HIV)\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA)and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has an active infection requiring systemic therapy\n* Known immunodeficiency or active HIV\n* Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.\n\nInvestigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n* Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.\n* Subject has a serious, non-healing wound, ulcer, or bone fracture.\n* Subject has a clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension \\\u003C 150\u002F90 mmHg (may be rescreened after adequate control)\n  * Myocardial infarction or unstable angina within 6 months prior to enrollment\n  * New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* New onset on thromboembolic event or hemorrhage within 6 weeks prior to randomization\n* Subject has organ allografts.\n* Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or require parenteral hydration and\u002For nutrition.\n* Pregnant or nursing female participants.\n* Known active alcohol or drug abuse.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.","FEMALE",{"count":377,"type":20},80,[134],"This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolong survival, and improve quality of life in patients with ovarian cancer.",[381,382,383,384,385,386,387,388,389,390,391,392,393,394,395],"Ovarian Clear Cell Adenocarcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Fallopian Tube Endometrioid Adenocarcinoma","Recurrent Fallopian Tube Serous Adenocarcinoma","Recurrent Ovarian Carcinoma","Recurrent Ovarian Clear Cell Adenocarcinoma","Recurrent Ovarian Endometrioid Adenocarcinoma","Recurrent Ovarian Serous Adenocarcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Primary Peritoneal Clear Cell Adenocarcinoma","Recurrent Primary Peritoneal Endometrioid Adenocarcinoma","Recurrent Primary Peritoneal Serous Adenocarcinoma",{"date":343,"type":31},{"date":398,"type":31},"2024-03-12",{"date":400,"type":20},"2027-03-15",{"name":37,"class":38},2,{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":21,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":39},"100582909","new-york-better-breathing-study-100582909","NCT06869447","New York Better Breathing Study","Lung Cancer Better Breathing Study","Inclusion Criteria:\n\n* Age ≥ 18 years of age.\n* Able to speak, read and comprehend the English language\n* Self-identify as non-Hispanic Black or White.\n* Are \\\u003C 24 months of histologically confirmed invasive, non-metastatic, lung cancer diagnosis.\n* Have received surgical treatment (primarily stage I, II and III) and have completed all cancer treatments (surgery, chemotherapy, radiation).\n* Willing to provide biospecimen samples for the study (blood) which will be collected in the comfort of the patient's home by a mobile phlebotomy group.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Participant has in situ (stage 0) or metastatic (stage IV) disease at study entry.\n* Has contraindications for respiratory muscle training (e.g., recent pulmonary embolism, aortic aneurysm, current pneumothorax).\n* Is actively engaging in a structured exercise program and\u002For meeting exercise guidelines.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study.",{"count":411,"type":20},100,[50],"This clinical trial evaluates the effects of whether breathing exercises at home can reduce symptoms and help stage I-III lung cancer survivors stay active. Over 70% of lung cancer survivors have trouble breathing, feel tired, and have lower levels of fitness. This is often because their breathing muscles are weaker after surgery. Many survivors find it hard to exercise, which affects their quality of life and overall survival. A training program to strengthen these muscles might reduce breathing problems, lower fatigue, and improve quality of life. Staying active could also help boost the immune system to fight cancer. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Participating in a home-based RMT intervention may reduce symptoms from cancer or treatment in lung cancer survivors.",[415,416,417,139],"Localized Lung Carcinoma","Stage I Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8","2026-05-27",{"date":341,"type":31},{"date":421,"type":31},"2026-04-20",{"date":423,"type":20},"2028-04-15",{"name":37,"class":38},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":39},"100531612","phase-2-temozolomide-and-survivin-long-peptide-vaccine-survaxm-for-the-treatment-of-patients-with-progressing-metastatic-neuroendocrine-carcinomas-100531612","NCT06202066","Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Carcinomas","A Phase II Study of Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) in Patients With Progressing Metastatic Neuroendocrine Carcinomas (NECs)","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Have a Karnofsky performance status ≥ 80 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (i.e. the patient must be able to care for himself\u002F herself with occasional help from others)\n* Measurable, pathologically confirmed diagnosis of neuroendocrine tumor of gastrointestinal, pancreatic, or thoracic origin with ki67\\>20% (well-differentiated G3 NETs) or neuroendocrine carcinoma of any origin excluding small cell lung carcinoma\n* Patients must have documented radiographic progression, determined as clinically significant by the treating provider, within the last twelve months on two CT or MRI scans performed at least four weeks apart per RECIST v1.1 criteria. In the case of retreatment, progression may be defined by the treating provider (e.g., clinical, radiographic, biochemical)\n* Patients must have failed at least one prior systemic therapy\n* Patients who have been on somatostatin analogues (SSA) may continue to take SSA while on study treatment\n* Archival neuroendocrine tumor tissue must test positive for survivin presence by clinical immunohistochemistry prior to study enrollment\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Platelets ≥ 100 x 10\\^9\u002FL (obtained within 14 days prior to enrollment)\n* Hemoglobin (Hgb) \\> 9g\u002FdL (obtained within 14 days prior to enrollment)\n* Plasma total bilirubin: ≤ 1.5 x upper limit of normal (ULN) (obtained within 14 days prior to enrollment)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 x ULN (obtained within 14 days prior to enrollment)\n* Creatinine clearance ≥ 60 mL\u002Fmin (per Cockroft-Gault equation) (obtained within 14 days prior to enrollment)\n* Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight \\[LMW\\] heparin) must meet the following criteria:\n\n  * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices, which carries a significant risk of bleeding in investigator's opinion)\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. 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* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients who have received temozolomide in the advanced disease setting either alone or as part of a combination therapy will be excluded if they progressed while on it\n* Has received prior treatment with SurVaxM\n* Received an investigational agent within 30 days prior to enrollment\n* Participants who have received checkpoint inhibitors within 3 months prior to study enrollment or, those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, bradycardia, tachycardia or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements and, which in the treating physicians' opinion would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety\n* Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study\n* Known history of an autoimmune disorder\n* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness or other serious medical illness\n* Systemic corticosteroid therapy \\> 2mg of dexamethasone or equivalent per day at study entry\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Patients with Hepatitis B or Hepatitis C may be included if there are adequately controlled viral titers and no drug-drug interactions, testing not required",{"count":194,"type":20},[134],"This phase IIa trial compares the safety and effect of temozolomide combined with survivin long peptide vaccine (SurVaxM) to temozolomide alone in patients with neuroendocrine tumors (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and is growing, spreading or getting worse (progressing). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Survivin, a protein, is expressed in 50% of patients that have neuroendocrine tumors and, is associated with poor outcomes. SVN53-67\u002FM57-KLH peptide vaccine (SurVaxM) is a vaccine that has been shown to produce an immune system response against cancer cells that express a survivin and may block the growth of new tumor cells. Giving temozolomide with SurVaxM may kill more tumor cells in patients with progressing metastatic neuroendocrine tumors.",[436,437,54,438],"Digestive System Neuroendocrine Neoplasm","Lung Neuroendocrine Neoplasm","Pancreatic Neuroendocrine Neoplasm",{"date":341,"type":31},{"date":121,"type":20},{"date":442,"type":20},"2028-10-15",{"name":37,"class":38},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":39},"100499790","home-based-respiratory-muscle-training-for-minimizing-side-effects-in-patients-undergoing-treatment-for-cancer-100499790","NCT05787834","Home-based Respiratory Muscle Training for Minimizing Side Effects in Patients Undergoing Treatment for Cancer","Respiratory Muscle Training During Cancer Treatment: Effects on the Autonomic Nervous System and Cardiotoxicity","Inclusion Criteria:\n\n* Documented breast cancer and scheduled to receive adjuvant or neoadjuvant chemotherapy\n* Age \\>= 21 years old\n* Diagnosed with solid tumor (e.g., head and neck, thoracic, or breast cancer)\n* Scheduled to receive at least one dose of chemotherapy or immunotherapy or radiation\n* Treated at Roswell Park Comprehensive Cancer Center\n\nExclusion Criteria:\n\n* Presence of oral mucosal disease including oral mucositis, or oral candidiasis detected at baseline\n* Have uncontrolled intercurrent illness including, but not limited to, ongoing or active respiratory infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, heart failure or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention",{"count":452,"type":20},130,[50],"This clinical trial evaluates whether home-based respiratory muscle training is useful for minimizing side effects in patients undergoing treatment for cancer. Over-activation of the nervous system during breast cancer treatment can result in heart- and lung-related side effects which have the potential to reduce a patient's quality of life. Aerobic exercise can help prevent the development of these side effects. However, engaging in regular aerobic exercise may be difficult for breast cancer patients who are actively undergoing treatment. Respiratory muscle training (RMT) involves a series of breathing and other exercises that are performed to improve the function of the respiratory muscles through resistance and endurance training. Home-based RMT may represent a more feasible approach for reducing side effects in patients undergoing treatment for breast cancer.",[456,457,458],"Breast Carcinoma","Head and Neck Cancer","Lung Cancer","2026-05-26",{"date":461,"type":31},"2026-05-29",{"date":463,"type":31},"2023-10-16",{"date":465,"type":20},"2029-10-16",{"name":37,"class":38},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":475,"phases":4,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":39},"100626733","understanding-tobacco-and-cannabis-co-use-practices-initiation-escalation-and-maintenance-100626733","NCT07439471","Understanding Tobacco and Cannabis Co-Use Practices: Initiation, Escalation, and Maintenance","Inclusion Criteria:\n\n* \\* Adults aged 18 to 30 years old.\n\n  * Currently living in the Roswell Park catchment area.\n  * Able to speak, read, and write in English.\n  * Currently consuming cannabis at least weekly.\n\n    * Group 1: currently using cigarettes daily and not using nicotine vaping products more than one day per week.\n    * Group 2: currently using nicotine vaping products daily and not using cigarettes more than one day per week.\n\nExclusion Criteria:\n\n* \\* Unwilling or unable to follow protocol requirements.\n\n  * Individuals under the age of 18 or over 30.\n  * Individuals not meeting product consumption criteria for inclusion items 3 and 4.","30 Years",{"count":73,"type":20},"OBSERVATIONAL","This study evaluates histories among cannabis and tobacco co-users of their initiation, escalation, and maintenance of the co-use behavior.",[77],"2026-05-21",{"date":480,"type":31},"2026-05-22",{"date":482,"type":20},"2026-06-28",{"date":484,"type":20},"2027-03",{"name":37,"class":38},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":212,"minAge":17,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":21,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":499,"startDateStruct":500,"completionDateStruct":501,"leadSponsor":503,"locationsCount":39},"100598762","transperineal-micro-ultrasound-for-the-detection-of-prostate-cancer-during-biopsy-100598762","NCT07075705","Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy","Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer","Inclusion Criteria:\n\n* Men aged ≥ 18 years\n* Men scheduled for transrectal ultrasound guided prostate biopsy who have had a prebiopsy MRI. Therefore patients unable to have a prebiopsy MRI who have contraindications to MRI or unwilling to undergo MRI would be excluded\n* The participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board-approved written informed consent form before receiving any study-related procedure\n\nExclusion Criteria:\n\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation",{"count":494,"type":20},138,[50],"This clinical trial studies whether transperineal micro-ultrasound can be used to detect prostate cancer during biopsy. Transrectal ultrasound is often used during prostate biopsy. Transrectal ultrasound imaging is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Transrectal ultrasound is used to look for abnormalities in the rectum and nearby structures, including the prostate. The images are used to guide the prostate biopsy. Transperineal micro-ultrasound is completed by placing a probe over the skin between the scrotum and anus (perineum). It is a high-resolution ultrasound at 29 megahertz (MHz) (compared to traditional ultrasound at 6-9 MHz). This higher frequency allows for an improved spatial resolution. This improved spatial resolution is approximately the diameter of a prostatic duct, and therefore, may be able to visualize slight changes in the structure of prostatic ducts that are not possible with standard transrectal ultrasound. Transperineal micro-ultrasound may be more effective in detecting prostate cancer during biopsy.",[498],"Prostate Carcinoma",{"date":480,"type":31},{"date":121,"type":20},{"date":502,"type":20},"2027-01-15",{"name":37,"class":38},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":21,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":39},"100601180","influence-of-authorized-smokeless-tobacco-product-modified-risk-claims-ii-laboratory-assessment-of-sensory-and-subjective-effects-100601180","NCT07107139","Influence of Authorized Smokeless Tobacco Product Modified Risk Claims II: Laboratory Assessment of Sensory and Subjective Effects","Inclusion Criteria:\n\n* Age ≥ 21 years of age\n* Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)\n* Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year\n* Open to trying a non-combusted oral tobacco product\n* Have the ability to read, write, and communicate in English\n* Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and\u002For General Snus \\> $0\n* Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (\\\u003C8ppm)\n* Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Age ≥ 21 years of age\n* Residing in 8 counties of Western NY (Erie, Niagara, Cattaraugus, Chautauqua, Allegheny, Livingston, Genesee, Orleans, Wyoming)\n* Smoke cigarettes every day, at least 5 cigarettes per day, for at least 1 year\n* Open to trying a non-combusted oral tobacco product\n* Have the ability to read, write, and communicate in English\n* Have successfully completed our preliminary Auction study I-4008824 with a bid for Copenhagen and\u002For General Snus \\> $0\n* Willing to abstain smoking 8-10 hours prior to each laboratory session and complete breath CO test for verification (\\\u003C8ppm) .\n* Female participants must be amenable to taking a pregnancy test (urine) prior to beginning study procedures.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.",{"count":296,"type":20},[50],"This study seeks to measure the effects of smokeless tobacco product risk messages on sensory experiences and future intentions to use.",[514],"Smokeless Tobacco","2026-05-20",{"date":480,"type":31},{"date":518,"type":31},"2026-05-11",{"date":520,"type":20},"2027-05-01",{"name":37,"class":38},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":21,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":39},"100582445","phase-2-nemtabrutinib-and-pembrolizumab-for-the-treatment-of-richter-transformation-diffuse-large-b-cell-lymphoma-subtype-100582445","NCT06863402","Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype","Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study","Inclusion Criteria:\n\n* Patients with biopsy-proven Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL) from an antecedent or concurrently diagnosed chronic lymphocytic leukemia (CLL) and\u002For small lymphocytic lymphoma (SLL).\n* Be ineligible for frontline anthracycline-based chemoimmunotherapy (determined by treating investigator) OR have clinical evidence of disease progression after any prior treatment for RT-DLBCL.\n* Participants who have adverse events (AEs) due to previous anti-cancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤ grade 2 neuropathy are eligible.\n\n  * Note: Participants who have lingering cytopenias from prior anti-cancer therapy or progressive disease may be eligible at the discretion of the study principal investigator (PI), provided they meet all other study criteria.\n* Have measurable disease as determined by imaging (by positron-emission tomography \\[PET\\] and\u002For computed tomography \\[CT\\] scans), immunohistochemistry, and\u002For flow cytometry, as per the Cheson criteria.\n* Have the ability to swallow and retain oral medication.\n* Age 18 years and older on the day of signing informed consent.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Be free from other malignancy within 2 years prior to enrollment (with the exception of CLL\u002FSLL, low-risk and early stage \\[T1-T2a- Gleason score ≤ 6, and prostate-specific antigen \\[PSA\\] \\\u003C 10 ng\u002FmL\\] prostate cancer, or localized skin cancer that has undergone potentially curative therapy).\n* Absolute neutrophil count: ANC ≥ 500 cells\u002FµL (without G-CSF dose within the last 7 days prior to initiation of study treatment\n* Platelets: ≥ 25,000\u002FµL -not requiring transfusion within the last 3 days prior to initiation of study treatment). Patients on medications that increase bleeding risk (e.g. systemic anticoagulation, anti-platelet therapies, etc.) must have a platelet count ≥50,000 \u002FµL and have no history of major bleeding.\n* Hemoglobin: ≥ 7gm\u002FdL (transfusion support allowed).\n* Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \\> 1.5 x ULN.\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \\[SGPT\\]): ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).\n* Creatinine clearance (CrCl): ≥ 30 mL\u002Fmin (per Cockroft-Gault equation).\n* International normalized ratio (INR) (prothrombin \\[PT\\]\u002Factivated partial thromboplastin time \\[aPTT\\]): ≤ 1.5 x ULN, unless participant is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.\n* Patients with history of human immunodeficiency virus (HIV) infection are potentially eligible (after conferring with the PI) if they meet ALL of the following criteria:\n\n  * Must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 AND an HIV viral load below the detectable level as per locally available testing at the time of screening\n  * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  * Participants on anti-retroviral therapy (ART) must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study.\n  * The combination ART regimen must not contain any antiretroviral medications that interact with strong CYP3A4 inhibitors\u002Finducers\u002Fsubstrates (\\\u003Chttps:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers\\>). Participants receiving ART that are strong CYP3A4 inducers are not eligible to be included in the study.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\nNote: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests, including HBsAg and hepatitis B core antibodies (anti-HBc), are required for all participants.\n\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening (Participants must have completed curative anti-viral therapy at least 4 weeks prior to the first administration of the study treatment).\n* A person of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Participants of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Should a person of child-bearing potential become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).\n* Has received prior systemic anti-cancer therapy within 5 half-lives of last dose (or within 30 days for cellular therapy or investigational agents, or within 100 days post allogeneic hematopoietic stem cell transplantation and without any grade ≥ 2 graft versus host disease) prior to enrollment.\n* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed or messenger ribonucleic acid (mRNA) vaccines is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (daily dose exceeding 10 mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has severe hypersensitivity (≥ grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid 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 not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients with pathologically confirmed Hodgkin-like RT (RT-classical Hodgkin's lymphoma \\[cHL\\]).\n* Estimated life expectancy of \\\u003C 1 month as determined by the treating investigator.\n* Uncontrolled active illness including but not limited to heart failure, unstable ischemic heart disease, arrhythmia, psychiatric illness, acute renal failure, and any other conditions that would reasonably be expected to limit compliance with the study protocol.\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n* Corrected QT interval (QTc) prolongation (defined as a Fridericia's corrected QT \\[QTcF\\] \\> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats\u002Fmin).\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Unwilling or unable to follow protocol requirements.\n* Received any other investigational agent within 30 days prior to enrollment.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For multicentric Castleman's disease.\n* History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding.NOTE: Patients on active anti-coagulation, anti-platelet therapies, and other medications that may increase bleeding risks may be allowed on study, permitted that these potentially interacting drugs may be safely held in the setting of thrombocytopenia, and at the discretion of the treating investigator and with close monitoring.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogeneic tissue\u002Fsolid organ transplant. Note: Patients with prior allogeneic hematopoietic stem cell transplant or allogeneic cellular therapy are allowed, provided they meet they meet the washout period.\n* Use of medications that are strong CYP3A4 inhibitors or inducers or P-gp and\u002For BCRP substrates with a narrow therapeutic index within 14 days prior to first dose of study treatment or 5 half-lives of the given drug, whichever is longer",{"count":530,"type":20},32,[134],"This phase II trial tests how well nemtabrutinib in combination with pembrolizumab works in treating patients with Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as Richter transformation at abnormal levels. This may help keep cancer cells from growing and spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving nemtabrutinib in combination with pembrolizumab may kill more cancer cells in patients with RT-DLBCL.",[534,535,536],"Richter Syndrome","Diffuse Large B-Cell Lymphoma","Chronic Lymphocytic Leukemia","2026-05-19",{"date":515,"type":31},{"date":540,"type":20},"2026-06-15",{"date":542,"type":20},"2030-06-01",{"name":37,"class":38},""]