[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Memorial Sloan Kettering Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":629},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,318,0,25,[9,45,70,93,114,138,159,187,213,240,262,285,311,337,361,386,408,432,456,480,501,525,553,578,606],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":44},"100628287","phase-2-herizon-breast-a-ctdna-guided-adaptive-study-of-sequential-anti-her2-therapies-and-cns-prophylaxis-to-induce-long-term-remission-100628287",false,"NCT07459673","HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission","Inclusion Criteria:\n\n* Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.\n* Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.\n* HER2 IHC results of 3+.\n* Life expectancy of ≥12 weeks.\n* Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy.\n* Must have measurable disease per PERCIST 1.0.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study intervention.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 3 during the intervention period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  * A WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) within 72 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n  * Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of therapy.\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Criteria for known Hepatitis B and C positive subjects: Hepatitis B and C screening tests are required as per MSK policy but do not need to be repeated prior to study unless there is a known history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n* Participants who have active hepatitis B infection (defined as HBsAg positive and\u002For detectable HBV DNA) are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Participants should remain on anti-viral therapy throughout study intervention and follow MSK guidelines for HBV anti-viral therapy post completion of study intervention.\n* Participants with a history of HCV infection (defined as anti-HCV Ab positive and detectable HCV RNA) are eligible if HCV viral load is undetectable at screening.\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nTable 1 Adequate Organ Function Laboratory Values Hematological Absolute neutrophil count (ANC): ≥1500\u002FµL Platelets: ≥100 000\u002FµL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\nRenal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × ULN\n\nHepatic Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT)\n\nCoagulation\n\nInternational normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT):\n\n≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\nExclusion Criteria:\n\n* Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH\n* Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses \\>10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded.\n* Has known CNS metastases and\u002For leptomeningeal carcinomatosis.\n* Has a history or evidence of active pneumonitis or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has grade \\>=3 neuropathy of any etiology.\n* Has an active infection requiring antibiotics.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has an inability to swallow capsules or tablets.\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* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has significant cardiovascular impairment within 12 months of the first dose of study drug: such as NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n* Has a left ventricular ejection fraction (LVEF) below the institutional normal range of 50%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Known intolerance to any of the study drugs (or any of the excipients).\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.",[26,27,28],"Breast Cancer","HER2-positive Breast Cancer","Breast Cancer Stage IV",[30,27,28,31,32],"breast cancer","Memorial Sloan Kettering Cancer Center","25-258","RECRUITING","2026-08-19",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":37},"2026-03-04",{"date":41,"type":20},"2030-03-04",{"name":31,"class":43},"OTHER",7,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100623699","phase-2-a-study-of-obecabtagene-autoleucel-in-people-with-b-cell-acute-lymphoblastic-leukemia-100623699","NCT07400029","A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia","A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease","Inclusion Criteria:\n\n* Diagnosis of CD19+ B-cell ALL.\n\n  * Both Ph-negative and Ph-positive are allowed\n  * Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD.\n* Patients aged ≥ 40 years at time of screening A.\n* Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg\u002Fm2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen).\n* In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and\u002For molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD \\\u003C10\\^-4 will be eligible.\n* Patients may receive more than one course of upfront induction and\u002For consolidation, but must be in MRD- CR\u002FCRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial.\n\nFrontline regimens include but are not limited to:\n\n* HyperCVAD or mini-hyper-CVD\n* Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)\n* Inotuzumab or blinatumomab with or without chemotherapy\n* Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab\n\n  \\- Adequate organ function at time of screening A, including:\n* ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)\n* Serum creatinine \\\u003C2.0mg\u002FdL\n* SaO2 ≥92% on room air\n* Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening\n\n  * ECOG performance status 0-2\n  * CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.\n  * CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.\n  * Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Burkitt's leukemia or lymphoma\n* Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET\u002FCT scan (or CT with contrast if PET cannot be performed).\n* The following medications are excluded:\n\n  * Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.\n  * Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.\n  * Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.\n  * Blinatumomab must be discontinued 5 days before apheresis\n  * Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion\n* Blinatumomab may not be used as bridging therapy following apheresis\n* Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.","40 Years",{"count":54,"type":20},40,[23],"The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).",[58],"Acute Lymphoblastic Leukemia",[60,61,62],"Obecabtagene Autoleucel","B-cell","25-342",{"date":36,"type":37},{"date":65,"type":37},"2026-02-03",{"date":67,"type":20},"2029-02",{"name":31,"class":43},9,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":80,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100623036","registry-for-bone-metastases-100623036","NCT07391410","Registry for Bone Metastases","The International Bone Metastasis Registry","Inclusion Criteria:\n\n* Age ≥22 years\n* Biopsy-proven or clinically obvious metastatic bone disease . For purposes of this study, metastatic bone disease includes skeletal involvement from multiple myeloma.\n* Symptomatic bone lesion requiring intervention\n* This includes but is not limited to radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above\n\nExclusion Criteria:\n\n* Age \\\u003C22 years","22 Years",{"count":79,"type":20},500,"10 Years","OBSERVATIONAL","The purpose of this study is to learn more about symptomatic bone metastases. This study is an international patient registry of people with symptomatic bone metastases. A patient registry is a database - a collection of health information - about a group of people, and it is usually focused on a specific diagnosis or condition.",[84],"Bone Metastases",[86],"23-175",{"date":36,"type":37},{"date":89,"type":37},"2026-01-13",{"date":91,"type":20},"2031-01",{"name":31,"class":43},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":69},"100587507","phase-3-a-study-comparing-standard-treatments-in-people-with-non-muscle-invasive-bladder-cancer-nmibc-100587507","NCT06929286","A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)","COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial","Inclusion Criteria:\n\n* 21 years of age or older\n* Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of the participating treating urologists\n* One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed\n\n  °Any amount of maintenance BCG is allowed\n* In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment\n\n  * An intravesical agent can include BCG or any other NMIBC treatment\n  * Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence\u002Fsuspicion of recurrent disease (by urinary cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent.\n* In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than \"best usual care\"\n\nExclusion Criteria:\n\n* Opting for treatment with radical cystectomy\n* Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC\n* Prior exposure to nadofaragene firadenovec","21 Years",{"count":102,"type":20},125,[104],"PHASE3","The purpose of this study is to compare the effectiveness of different FDA-approved\u002FNCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).",[107],"Non-Muscle Invasive Bladder Cancer",{"date":36,"type":37},{"date":110,"type":37},"2025-04-11",{"date":112,"type":20},"2028-04",{"name":31,"class":43},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":44},"100484661","observational-study-of-bone-complications-in-people-with-post-menopausal-breast-cancer-who-have-stopped-treatment-with-denosumab-and-aromatase-inhibitors-100484661","NCT05590949","Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors","Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation","Inclusion Criteria:\n\n* Women with confirmed diagnosis of breast cancer\n* Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment\n* Received at least 2 doses of denosumab and then discontinued therapy\n* Discontinued AI prior to or within 6 months of last denosumab injection\n* Patients must be 18 years of age or olde\n\nExclusion Criteria:\n\n* Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;\n* Patients with history of insufficiency fracture.\n* Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab\n* Patients on chronic low-dose glucosteroids.","FEMALE",{"count":123,"type":20},100,"The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor\u002FAI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.",[26],[127,26,128,129,130,31],"Post-menopausal Breast Cancer","Denosumab","Aromatase","22-280","2026-08-18",{"date":36,"type":37},{"date":134,"type":37},"2022-10-18",{"date":136,"type":20},"2026-10-18",{"name":31,"class":43},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":121,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":44},"100652693","phase-2-a-study-of-romosozumab-in-people-with-breast-cancer-and-osteoporosis-100652693","NCT07776613","A Study of Romosozumab in People With Breast Cancer and Osteoporosis","A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)","Inclusion Criteria:\n\n* ≥18 years of age at the time of giving informed consent;\n* Patients diagnosed with hormone-receptor positive (ER\u002FPR \\>1%) metastatic breast cancer to bones on any endocrine therapy with or without targeted therapy (i.e. CDK 4\u002F6 inhibitors, PI3K inhibitors, anti-HER2-therapy);\n* Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must following:\n* osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;\n\nExclusion Criteria:\n\n* Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for metastatic bone disease;\n* 25 (OH) vitamin D levels \\\u003C 20 ng\u002FmL; Vitamin D repletion will be permitted and subjects will be be rescreened once 25 (OH) vitamin D level ³ 20 ng\u002FmL;\n* History of myocardial infarction or stroke within the preceding year;\n* Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (\\\u003C8.5 or \\>10.5 mg\u002FdL); Calcium repletion will be permitted and subjects will be be rescreened once values are within the institutional standard.\n* History of non-healed dental or oral surgery;\n* History of osteonecrosis of the jaw",{"count":7,"type":20},[23],"The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. The researchers will also look at bone breakdown (resorption) in participants and determine if romosozumab is a safe treatment for osteoporosis in people with MBC that has spread to the bones.",[26,149],"Metastatic Breast Cancer (MBC)",[151,152],"Romosozumab","26-191","2026-08-17",{"date":36,"type":37},{"date":153,"type":37},{"date":157,"type":20},"2028-08",{"name":31,"class":43},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":44},"100624850","phase-2-a-study-of-radiation-therapy-and-cemiplimab-with-or-without-fianlimab-in-people-with-bladder-cancer-100624850","NCT07414992","A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer","Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of informed consent\n* ECOG 0-1\n* Histologically confirmed diagnosis of urothelial carcinoma.\n\n  ° Variant histology is acceptable if there is a predominant urothelial component. Any neuroendocrine \u002F small cell components are excluded (Investigators are encouraged to discuss with study team and PI)\n* Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.\n\n  * Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.\n  * Clinically node-negative pelvis (cN0) on CT or MRI within 56 days: no pelvic lymph node ≥15 mm short-axis. Pelvic nodes 10-14 mm are permitted if not suspicious by GU radiology morphology; if deemed suspicious, biopsy or repeat imaging in 4-6 weeks must confirm cN0 prior to enrollment. PET may inform adjudication but is not required.\n* Patients declines cisplatin-based therapy or is ineligible for cisplatin-based therapy based on any of the following criteria:\n\n  * Estimated or calculated creatinine clearance ≥ 30ml\u002Fmin but \\\u003C 60 ml\u002Fmin\n  * Grade 2 or above audiometric hearing loss (per CTCAE v5.0)\n  * Grade 2 or above peripheral neuropathy (per CTCAE v5.0)\n* Availability of tumor specimen block or 20 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 20 slides available may be enrolled after discussion with the Principal Investigator.\n* Medically appropriate candidate for radical cystectomy, as per MSK Attending Urologic Oncologist\n* Life expectancy ≥ 12 weeks at randomization\n* Required initial laboratory values:\n\n  * Absolute neutrophil count ≥ 1.0 x 10\\^9\u002FL\n  * Platelets ≥ 100 x 10\\^9\u002FL\n  * Bilirubin ≤1.5 times the upper limit of normal (x ULN)\n  * AST and ALT ≤ 3 x ULN\n  * Partial thromboplastin time (PTT)\u002Fprothrombin time (PT) ≤1.5 x ULN or international normalized ratio (INR) \\\u003C 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.\n* For women of childbearing potential: agreement to remain abstinent (i.e., refrain from heterosexual intercourse) or use contraception, as defined below:\n\n  * Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period plus 6 months after the last dose of cemiplimab with or without fianlimab.\n  * Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, and copper intrauterine devices\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a woman with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n* Male subjects must be willing to use contraception during the study and until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease on standard staging CT and\u002For MR imaging\n* Evidence of nodal metastasis (cN+), defined as any pelvic node ≥15 mm short-axis on CT\u002FMRI or biopsy-proven nodal disease of any size.\n* Prior systemic chemotherapy or non-BCG immunotherapy (e.g., T cell co-stimulation or targeting of immune checkpoint pathways with anti-PD-1, anti-PD-L1, anti-LAG-3, anti-PD-L2, anti-CTLA-4, anti-CD137, IL-15 superagonist, or other medicines specifically targeting T cells other than prior IL-2 therapy) for the treatment of bladder cancer\n* Prior therapy with intravesical BCG within 6 weeks of treatment.\n* Prior pelvic RT\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Patients using immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study. It is recommended that patients do not receive systemic corticosteroids such as hydrocortisone, prednisone, prednisolone (Solu-Medrol®) or dexamethasone (Decadron®) at any time throughout the study except in the case of a life-threatening emergency and\u002For to treat an immune-mediated adverse event.\n\n  °Immunosuppressive doses (≥ 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement must be discontinued within 14 days of initiating neoadjuvant SBRT.\n* Received a live vaccine within 30 days of planned start of study medication.\n\n  * Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n  * Live vaccines are also prohibited during neoadjuvant therapy and for 90 days after completing neoadjuvant therapy.\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Unstable angina.\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* History of myocardial infarction within 6 months.\n* History of stroke within 6 months.\n* Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.\n* Major surgical procedure within 28 days prior to the study other than transurethral resection of bladder tumor.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Other prior malignancy active within the previous 2 years except for local or organ-confined early-stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n* Notes:\n\n  * Patients with known HIV who have controlled infection (undetectable viral and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n  * Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.\n* Participants with a history of myocarditis.\n* Troponin T (TnT) or troponin I (TnI) \\> 2x institutional ULN at baseline.\n\n  * TnT or Tnl levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN.\n  * If TnT or Tnl levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the judgement in the patient's best interest.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* WOCBP\\* must have a negative serum (beta-hCG) at screening.\n\n  * WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n\n    * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance.\n\nPregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.\n\n* Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence.\n* Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n  * All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n  * Pregnant or breastfeeding women.\n  * Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n* stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n* intrauterine device; intrauterine hormone-releasing system;\n* bilateral tubal occlusion\u002Fligation;\n* vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For\n* sexual abstinence\n* Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n* Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n\n  * Active infection requiring therapy.\n  * Subjects who are compulsorily detained for treatment of a psychiatric illness.\n  * History or current evidence of significant (CTCAE grade ≥ 2) local or systemic infection (e.g, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.",{"count":167,"type":20},44,[23],"The researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).",[171],"Bladder Urothelial Carcinoma",[173,174,175,176,177,178,179],"Cemiplimab","Fianlimab","Bladder cancer","Muscle-invasive bladder cancer","Cystectomy","Radiotherapy","25-328","NOT_YET_RECRUITING",{"date":131,"type":37},{"date":183,"type":20},"2026-09",{"date":185,"type":20},"2028-03",{"name":31,"class":43},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100455806","phase-4-a-study-comparing-music-therapy-and-cognitive-behavioral-therapy-for-anxiety-in-cancer-survivors-100455806","NCT05215353","A Study Comparing Music Therapy and Cognitive Behavioral Therapy for Anxiety in Cancer Survivors","Music Therapy vs. Cognitive-Behavioral Therapy for Cancer-related Anxiety (MELODY)","Inclusion Criteria:\n\n* English- or Spanish-speaking\n* 18 years or older\n* Prior cancer diagnosis of any type or stage\n* Free of oncological disease, or stable disease with no evidence of progression\n* Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)\n* Report anxiety symptoms lasting at least one month\n* Willing to adhere to all study-related procedures, including randomization to one of two treatment arms: MT or CBT\n* Access to Zoom and a quiet\u002Fprivate location\n\nInclusion Criteria for Advanced Cancer Sub-Study (N=50)\n\n* English-speaking\n* 18 years or older\n* Advanced cancer diagnosis: stage III or IV lung cancer; any stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer, or other stage IV gastrointestinal cancer; stage III or IV ovarian or fallopian tube cancers or other stage IV gynecologic cancer; stage IV breast cancer; stage III testicular cancer or any stage IV genitourinary cancer; stage IV sarcoma; stage IV melanoma; stage IV endocrine cancer; lymphoma, myeloma, or leukemia\n* Currently receiving oncological treatment or on active surveillance\n* Karnofsky performance score of ≥60\n* Score of ≥8 on the HADS anxiety subscale\n* Anxiety symptoms lasting for at least 1 month\n* Greater than 6-month expected survival as judged by the treating oncologist\n* Willing to adhere to all study procedures\n* Access to Zoom and a quiet\u002Fprivate location\n\nInclusion Criteria for group MT sub-study (N=18)\n\n* English-speaking\n* 18 years or older\n* Prior cancer diagnosis of any type or stage\n* Free of oncological disease, or stable disease with no evidence of progression\n* Score of ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)\n* Report anxiety symptoms lasting at least one month\n* Willing to adhere to all study-related procedures\n* Access to Zoom and a quiet\u002Fprivate location\n\nExclusion Criteria:\n\n* Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).\n* Active suicidal ideation, bipolar disorder, schizophrenia, or substance abuse\n* Score of ≥10 indicative of cognitive impairment on the Blessed Orientation-Memory-Concentration\n* Received a treatment course of seven or greater MT or CBT sessions for anxiety symptoms within the last six months\n* Unable to provide informed consent for themselves\n\nExclusion Criteria for Advanced Cancer Sub-Study\n\n* Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse\n* Score of ≥10 on Blessed Orientation-Memory-Concentration\n* Prior receipt of MT within the past six months\n* Plan to receive any form of psychotherapy in the coming 8 weeks\n* Initiation or change in anxiety medications within the past 4 weeks\n* Plan to initiate or change anxiety medications in the coming 8 weeks\n* Unable to provide informed consent for themselves\n\nExclusion Criteria for group MT sub-study\n\n* Completed active cancer treatment (e.g., surgery, radiation, chemotherapy) less than one month prior to enrollment (maintenance hormonal or targeted therapies are allowed).\n* Active suicidal ideation; bipolar disorder, schizophrenia, or substance abuse\n* Score of ≥10 on Blessed Orientation-Memory-Concentration\n* Prior receipt of MT within the past six months\n* Plan to receive any form of psychotherapy in the coming 8 weeks\n* Initiation or change in anxiety medications within the past 4 weeks\n* Unable to provide informed consent for themselves",{"count":195,"type":20},368,[197],"PHASE4","The researchers are doing this study to compare how music therapy and cognitive behavioral therapy, given virtually, may be able to reduce anxiety in people who have had cancer. In addition, this study will see if certain factors affect how well participants respond to music therapy or cognitive behavioral therapy. For example, the researchers will see if personal characteristics (like age, sex, race, and education) and ways of thinking (like expectations of therapy) may affect how well participants respond.",[200],"Survivorship",[202,203,204,205],"Music Therapy","Cognitive Behavioral Therapy","Anxiety","21-516",{"date":131,"type":37},{"date":208,"type":37},"2022-01-14",{"date":210,"type":20},"2027-01",{"name":31,"class":43},3,{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":121,"minAge":220,"maxAge":52,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":44},"100586418","phase-2-acupuncture-for-people-experiencing-period-loss-due-to-chemotherapy-100586418","NCT06915116","Acupuncture for People Experiencing Period Loss Due to Chemotherapy","Acupuncture for Adolescent and Young Adult Cancer Patients: (AcuAYA)","Inclusion Criteria:\n\n* English speaking woman between the ages of 15 and 40\n* History of stage I, II, or III cancer OR stage IV or unstaged hematologic malignancy (e.g. lymphoma, leukemia, myeloma) that is stable, as assessed by care team\n* Premenopausal status with regular menstruation at the time of diagnosis by patient report\n* Completed cytotoxic chemotherapy within the past year\n* Premenopausal status with regular menstruation at the time of diagnosis by patient report for females ages 18 or older\n* Report cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment.\n* Have reached menarche prior to therapy or during therapy for females between 15 and 17 years old\n* Patient meets at least one of the following:\n* Reports cessation of menses during or after chemotherapy and have not experienced menses recovery at the time of enrollment and has been without menses for at least 3 months 64 following the completion of cytotoxic chemotherapy; OR\n* Is receiving ovarian suppression therapy (e.g., leuprolide \\[Lupron\\] or goserelin \\[Zoladex\\]) or hormonal contraceptive drugs, regardless of menstrual status, and report persistent (≥3 months), moderate-to- severe menopause-related symptoms, defined as a score of ≥4 on a 0-10 scale for at least one MENQOL item during eligibility screening.\n* Willing to adhere to all study-related procedures, including randomization to one of the two possible arms: acupuncture and WLC\n\nExclusion Criteria:\n\n* Had been pregnant or lactating within 3 months prior to enrollment\n* History of hysterectomy or bilateral oophorectomy\n* Ongoing or planned radiation or surgery within 4 months from randomization\n* Use of acupuncture for menses recovery within 3 months of enrollment\n* Had been or will be receiving ovarian suppression medicine, such as leuprolide (Lupron) and goserelin (Zoladex), or hormonal contraception drugs within 3 months of enrollment or during the study period","15 Years",{"count":19,"type":20},[23],"The purpose of this study is to find out whether it is practical (feasible) to use acupuncture to treat period loss (amenorrhea) caused by chemotherapy treatment in people with cancer. The researchers will look at how many participants enroll and complete the study. The researchers will also study how treatment with acupuncture affects the amount of time for the menstrual cycle to return and symptoms and quality of life related to amenorrhea.",[225,226],"Cancer","Period Problem",[228,229,230,231,232],"Acupuncture","Stage I cancer","Stage II cancer","Stage III cancer","Period Loss Due to Chemotherapy","2026-08-14",{"date":153,"type":37},{"date":236,"type":37},"2025-03-31",{"date":238,"type":20},"2027-03-31",{"name":31,"class":43},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":247,"sex":16,"minAge":52,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":44},"100645529","a-study-of-lung-cancer-risk-100645529","NCT07701733","A Study of Lung Cancer Risk","ARISE: Assessing Lung Cancer Risk in Never-Smoking Women","Criteria:\n\n* Female at birth\n* Age 40-74 years\n* No smoking history\n\n  * Participants must be never-smokers, defined as having smoked \\\u003C100 cigarettes in their lifetime\n* Documentation of disease - case patients\n\n  o Case patients must have pathologically confirmed primary lung adenocarcinoma. New and prevalent cases will be eligible. Case patients with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment.\n* Criteria for control participants\n\n  * Control participants must have no personal history of lung cancer, symptoms suspicious for lung cancer, or suspicious pulmonary nodules. Participants recruited as controls and found on imaging to have lesions suspicious for lung cancer will be excluded from analysis and followed prospectively. Data regarding these participants will be reported in a sensitivity analysis. Additional control participants will be recruited to ensure balanced age- and race-matched enrollment by frequency matching. Control participants with a history of prior non-lung cancer will be eligible for the study unless actively being diagnosed or treated for another form of cancer at the time of enrollment.",true,"74 Years",{"count":79,"type":20},"The researchers are doing this study to learn more about factors that may increase the risk of lung cancer in people who have never smoked. This information may help predict which people who have never smoked may be more likely to get lung cancer.",[252],"Lung Cancer",[254],"26-239","2026-08-13",{"date":233,"type":37},{"date":258,"type":37},"2026-06-30",{"date":260,"type":20},"2029-06",{"name":31,"class":43},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100610087","phase-3-a-study-of-fludarabine-dosing-in-children-and-young-adults-with-b-cell-acute-lymphoblastic-leukemia-100610087","NCT07223021","A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia","Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)","Inclusion Criteria:\n\n* Patients with B-ALL and eligible to receive commercial tisagenlecleucel.\n* Patient's weight \\> 9 kg at time of lymphodepleting chemotherapy\n* Adequate organ function at time of LD is required and is defined:\n\n  * Hepatic: Serum bilirubin ≤ 2 mg\u002FdL, unless benign congenital hyperbilirubinemia\n  * Hepatic: AST and ALT \\\u003C 5x the upper limit of normal for age, unless thought to be leukemic disease-related\n  * Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml\u002Fmin\u002F1.73m\\^2. (based on Schwartz formula GFR (mL\u002Fmin\u002F1.73 m²) = (36.2 × Height in cm) \u002F Creatinine in mg\u002FdL\n  * Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening\n  * Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnofsky \\> 60% at treatment\n  * Age \\\u003C 16 years: Lansky ≥ 60% at treatment\n* Willing to participate as research subject and provide written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.\n\nExclusion Criteria:\n\n* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.\n* Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol\n* Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA etc.)\n* Patient\u002Fparent\u002Fguardian unable to give informed consent or unable to comply with the treatment protocol.\n* Pregnant or lactating women","1 Year",{"count":271,"type":20},65,[104],"The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.",[275],"B-cell Acute Lymphoblastic Leukemia",[277],"Fludarabine",{"date":153,"type":37},{"date":280,"type":37},"2025-10-20",{"date":282,"type":20},"2028-10",{"name":31,"class":43},5,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":44},"100601020","phase-1-a-study-of-teclistamab-and-mezigdomide-in-people-with-multiple-myeloma-100601020","NCT07105059","A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma","Teclistamab and Mezigdomide for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.\n2. Patients need to have measurable disease defined by one or more of the following:\n\n   1. Serum myeloma (M)-protein greater than or equal to 0.5 g\u002FdL (5 g\u002FL).\n   2. Urine M-protein greater or equal to 200 mg\u002F24 h.\n   3. Involved light chain (either kappa or lambda) \\>10 mg\u002FdL with an abnormal kappa: lambda ratio\n   4. Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.\n\n      Increase is defined as a 50% and at least 1 cm increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion.\n   5. A bone marrow biopsy demonstrating \\>30% infiltration of clonal plasma cells.\n3. Patients who have received prior BCMA-directed therapy \\> 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell \\[CAR T\\] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.\n4. Patients who have received bispecific antibodies \\>60 days prior with targets other than BCMA are eligible.\n5. Patients who have received allogeneic stem cell transplantation \\>6 months prior are eligible.\n6. Age ≥18 years.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. PS-2 is permitted if PS is due solely to bone pain.\n8. Fulfil the criteria for Adequate Organ System Function Based on Safety Assessments:\n\n   Hematologic:\n   * Hemoglobin ≥8 g\u002FdL (without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)\n   * Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF) before the screening and laboratory test\n   * Platelets ≥75 × 10\\^9\u002FL in participants in whom \\\u003C50% of bone marrow nucleated cells are plasma cells and ≥50×109 \u002FL in participants in whom ≥50% of bone marrow nucleated cells are plasma cells (without transfusion support or thrombopoietin receptor agonist within 7 days before the screening laboratory test)\n\n   Chemistry:\n   * Total bilirubin ≤2 × ULN; except in subjects with congenital bilirubinemia, such as Gilbert syndrome (in which case if total bilirubin is \\>2×ULN, then direct bilirubin ≤1.5×ULN is required)\n   * AST and ALT ≤2.5 × ULN\n   * eGFR ≥30 mL\u002Fmin Calculated by CKD-EPI formula adjusted for body surface area (BSA): (mL\u002Fmin\u002F1.73 m2) x BSA\u002F1.73)\n   * Serum calcium corrected for albumin ≤14 mg\u002FdL (≤3.5 mmol\u002FL) or free ionized calcium ≤6. mg\u002FdL (≤1.6 mmol\u002FL)\n9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1, with the exception of peripheral neuropathy attributable to bortezomib.\n10. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    ° Is not a woman of childbearing potential (WOCBP)\n\n    Nonchildbearing potential is defined as follows (by other than medical reasons):\n    * ≥45 years of age and has not had menses for \\>1 year\n    * Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n    * Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure OR\n    * Is a WOCBP and agrees to use two different contraceptive methods that are highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency , during the intervention period and for at least 6 months after the last dose of study intervention.\n    * WOCBP must have two negative serum or urine pregnancy tests with 10-14 days in between prior to treatment with mezigdomide. The latter must be within 15 days of starting mezigdomide. WOCBP must agree to use two highly effective methods of contraception (i.e. copper-containing intrauterine device, established use of oral, inserted, injected or implanted hormonal method of contraception, or male\u002Ffemale sterilization, etc.\n    * WOCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n\n    The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. Pregnancy prevention while on mezigdomide treatment is All WOCBP must agree and adhere to all testing and contraception requirements in the mezigdomide Global Pregnancy Prevention Plan (PPP). Duration of contraception for WOCBP must be in accordance with the mezigdomide Global PPP\n11. Male participants: Male participants are eligible to participate if they agree to the following: male participants must agree to practice complete abstinence or agree to use a condom during sexual contact with a pregnant partner or an WOCBP while taking mezigdomide, during dose interruptions, and for 28 days after the last dose of mezigdomide, even if they have undergone a successful vasectomy (ie, with documented azoospermia 90 days after the procedure). See mezigdomide Global PPP, Appendix 3. Male participants must agree not to donate sperm for the purpose of reproduction during this period.\n12. Signed and dated Informed Consent by study participant.\n13. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with a BCMA targeted bispecific antibody\n2. Prior treatment with mezigdomide\n3. Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.\n4. Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.\n5. Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited \\[i.e., ≤ 25% of bone marrow in field\\] radiation therapy during this period).\n6. Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed\n7. Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.\n8. Patients who received CAR T therapy within 90 days prior to study enrollment\n9. Patients with primary AL amyloidosis will be excluded.\n10. Participant must not have had major surgery ≤4 weeks prior to initiating study treatment.\n11. Evidence of active internal bleeding.\n12. Presence of active renal condition. Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfill criteria given\n13. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).\n14. Subject has active or prior history of malignancy, other than multiple myeloma, unless the subject has been free of the disease or medically stable for ≥ 2 years. The only allowed exceptions are the below listed malignancies treated within the last 24 months and that are considered cured:\n\n    * Non-muscle invasive bladder cancer\n    * Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment) The participant must not be receiving active therapy, other than hormonal therapy for this disease. Presence of low risk prostate cancer per NCCN on active surveillance is permitted.\n15. Evidence of cardiovascular risk including any of the following:\n\n    * Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.\n    * History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening\n    * Stroke, transient ischemic attack, or seizure within 6 months prior to randomization\n    * Class III or IV heart failure as defined by the New York Heart Association functional classification system.\n16. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or mezigdomide, or any of the components of the study treatment.\n17. Pregnant or lactating individual.\n18. Active infection requiring treatment.\n19. Participant has known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria:\n\n    1. Established antiretroviral therapy (ART) for at least 6 months and HIV viral load \\\u003C400 copies\u002FmL, and\n    2. CD4+ T-cell (CD4+) counts ≥350 cells\u002FμL, and\n    3. No history of acquired immunodeficiency s-defining opportunistic infections or other acquired immune deficiency syndrome (AIDS)-defining conditions within the last 12 months and\n    4. Not receiving highly active anti-retroviral therapy, and\n    5. Not receiving antiretroviral therapy that may interfere with study treatment\n20. Presence of hepatitis B surface antigen (HbsAg), or hepatitis B core antibody (HbcAb at Screening or within 3 months prior to first dose of study treatment). Note: Participants with positive Hepatitis B antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis B DNA test is obtained.\n21. Active Hepatitis C infection as measured by positive hepatitis C virus (HCV)-RNA testing. Subjects with a history of HCV antibody positivity must undergo HCV RNA testing. The result needs to be negative for trial eligibility.\n22. Any serious and\u002For unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n23. Administration of strong CYP3A modulators or proton-pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) within 2 weeks of starting study treatment.",{"count":293,"type":20},18,[295],"PHASE1","The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed\u002Frefractory multiple myeloma (MM).",[298],"Multiple Myeloma",[300,301,302,303,304],"Teclistamab","Mezigdomide","Relapsed or refractory multiple myeloma","24-393","MATRIX (Mezigdomide And Teclistamab to Relieve Immune eXhaustion)",{"date":153,"type":37},{"date":307,"type":37},"2025-08-08",{"date":309,"type":20},"2028-08-08",{"name":31,"class":43},{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},"100430915","phase-2-gemcitabine-and-oxaliplatin-chemotherapy-with-or-without-a-floxuridine-and-dexamethasone-pump-in-people-with-cholangiocarcinoma-that-cannot-be-removed-with-surgery-100430915","NCT04891289","Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery","A Randomized Phase II Study of Systemic Chemotherapy With or Without HAI FUDR\u002FDexamethasone in Patients With Unresectable Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* ECOG 0-1\n* Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (IHC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to randomization.\n* Clinical or radiographic evidence of metastatic disease confined to the liver. Note: presence of regional (porta hepatis) lymph node metastases will be allowed, provided they are amenable to resection. (Note: If peritoneal or other extrahepatic disease is found at time of pump placement, the pump will not be implanted. The patient will be removed from study, deemed nonevaluable and will not count toward the overall study accrual.)\n* Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.\n* Disease must be considered unresectable at the time of preoperative evaluation.\\*\n* Considered candidate for general anesthesia, abdominal exploration and hepatic artery pump placement.\n* Patients with chronic hepatitis and\u002For cirrhosis are eligible, but must be Child-Pugh class A.\n* WBC ≥ 2,000\u002FmcL , ANC ≥ 1000\u002FmcL\n* Platelet count ≥ 75,000\u002FmcL\n* Creatinine ≤ 1.8 mg\u002FdL\n* Total bilirubin \\\u003C 1.5 mg\u002FdL\n* Hgb \\> 7 g\u002FdL The % involvement of the liver will be determined by radiologists after review of imaging\n\nExclusion Criteria:\n\n* Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or post-operative biopsies that definitively diagnose IHC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.\n* Patients previously treated with systemic chemotherapy for IHC will be non-eligible.\n* Prior treatment with FUDR.\n* Prior external beam radiation therapy to the liver.\n* Prior ablative therapy to the liver.\n* Diagnosis of sclerosing cholangitis.\n* Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis; surgically related ascites does not exclude the patient).\n* Active infection within one week prior to HAI placement.\n* Pregnant or lactating women.\n* History of other malignancy within the past 3 years except with early stage\u002Flocalized cancer that was surgically resected or radiation treatment that would yield the same result as surgery within the past 3 years.\n* Life expectancy \\\u003C12 weeks.\n* Inability to comply with study and\u002For follow-up procedures.\n* History of peripheral neuropathy. There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.",{"count":319,"type":20},164,[23],"This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.",[323],"Intrahepatic Cholangiocarcinoma",[325,326,327,328,329],"Gemcitabine","Oxaliplatin","Floxuridine","Dexamethasone Pump","20-348",{"date":153,"type":37},{"date":332,"type":37},"2021-05-07",{"date":334,"type":20},"2027-05",{"name":31,"class":43},11,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":16,"minAge":344,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":44},"100651993","a-study-of-counseling-support-for-cancer-survivors-age-65-100651993","NCT07768449","A Study of Counseling Support for Cancer Survivors Age 65+","A Randomized Controlled Trial of Brief Behavioral Activation for Older Adult Cancer Survivors (BBA-OACs)","Inclusion Criteria:\n\n* As per self-report or medical record, ≥65 years old\n* As per self-report or medical record, has a history of cancer\n* As per medical record and\u002For self-report:\n\n  * currently with no evidence of disease (NED) AND\u002FOR\n  * 6 months or more post-treatment\n* Fluent in English or Spanish, as per self-reported fluency of \"well\" or \"very well\"\\*\n* As per self-report, able to communicate over video-conference and\u002For phone for sessions\n* Elevated score on the PHQ-9: ≥8 (N\u002FA for Training Case participants)\n* Received a Blessed Orientation-Memory-Concentration Scale (BOMC) score of ≤ 11 (N\u002FA for Training Case participants)\n\nExclusion Criteria:\n\n* As per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of \\> 0 on item 9 of the PHQ-9, they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale (CSSR) (MSK Standard) to determine level of risk;. Only those with active suicidal ideation will be excluded and referred to a higher level of care.\n* As per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.\n* As per self-report or medical record, currently taking antidepressant medication for \\\u003C 3 month\n* As per self-report, engagement in regular individual psychotherapeutic support that the participant is unable or unwilling to put on hold for the course of the study\n* \\[MSK patients only\\] As per medical record, patient has impaired decision-making capacity\n* Language verification: Prior to enrollment, patients will be asked the following two questions by research staff to verify English or Spanish fluency necessary for participation in the study:\n\n  1. How well do you speak English\u002F Spanish? (must respond \"Well\" or \"Very well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English or Spanish)","65 Years",{"count":346,"type":20},454,[348],"NA","The purpose of this study is to find out if a psychotherapy method called brief behavioral activation (BBA) can improve depression, anxiety, and overall well-being and encourage healthy lifestyle behaviors in English- and Spanish-speaking Older Adult Cancer Survivors (OACS). BBA is a therapeutic technique that guides people to set goals and engage in enjoyable or rewarding activities as a way of changing behavior and reducing symptoms of depression. In this study, BBA will be given by telephone or videoconference (remotely).",[351],"Cancer Survivors",[203,353],"26-200","2026-08-12",{"date":153,"type":37},{"date":357,"type":37},"2026-08-10",{"date":359,"type":20},"2030-08",{"name":31,"class":43},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":16,"minAge":368,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100651921","phase-2-a-study-of-cyclophosphamide-methotrexate-fluorouracil-cmf-for-people-with-breast-cancer-100651921","NCT07768436","A Study of Cyclophosphamide, Methotrexate, Fluorouracil (CMF) for People With Breast Cancer","STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70","Inclusion Criteria:\n\n* Patients must have histologically confirmed adenocarcinoma of the breast confirmed at MSK. The patient must have had diagnostic biopsy or completion of primary surgical management, within 3 months of enrollment. Results of HER-2\u002Fneu, estrogen receptor, and progesterone receptor are required for study entry.\n* Patients must be ≥ 70 years of age.\n* Patients must have ECOG performance status \\>2 (Karnofsky score of ≥ 60%).\n* Patients may have received hormonal therapy for the purpose of chemoprevention.\n* Adjuvant\u002Fneoadjuvant chemotherapy decision to treat based on the discretion of investigator\n* Cohort 1 only: Patients have any histology except Her 2 Neu positive in the adjuvant or neoadjuvant setting\n* Cohort 2 only: Patients have triple negative (ER- (10%) PR-Her 2 Neu -) in the neoadjuvant setting\n* Cohort 2 only: Patients have received at least 1 dose of carboplatin\u002Fpaclitaxel +\u002F- pembrolizumab in the neoadjuvant setting\n\nRequired Organ Function\n\nAdequate hematologic function defined as follows:\n\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n* Platelets ≥ 100,000 cells\u002Fmm3\n\nAdequate renal function defined as follows:\n\n° Creatinine clearance (CrCL) of \\>30 mL\u002Fmin by the Cockcroft-Gault formula:\n\nCrCl (mL\u002Fmin) = \\[(\\[140 - age(years)\\] x weight (kg))\u002F72 x creatinine (mg\u002FdL)\\] (x 0.85 for female patients)\n\nAdequate hepatic function defined as follows:\n\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* AST and ALT ≤3 x institutional ULN\n\n  * Patients or their Legally Authorized Representative must give written, informed consent indicating their understanding and willingness to participate in the study.\n\nExclusion Criteria:\n\n* Stage IV breast cancer\n* CARG score- high Frail 4 or more as assessed by CAIT\n* Her 2 Neu positive 3+\u002Famplified breast cancer\n* No prior chemotherapy within 1 year of study enrollment\n* Cohort 2 only: patients may not receive pembrolizumab during dd CMF treatment","70 Years",{"count":370,"type":20},76,[23],"The purpose of this study is to find out if it is practical (feasible) to give dose-dense CMF (cyclophosphamide, methotrexate, and fluorouracil) in two standard chemotherapy regimens in people with breast cancer, age 70 and older.",[374,26,375],"Adenocarcinoma of the Breast","Triple Negative Breast Cancer",[377,30,378,31,379],"adenocarcinoma of the breast","triple negative breast cancer","26-303",{"date":153,"type":37},{"date":382,"type":37},"2026-08-11",{"date":384,"type":20},"2030-08-11",{"name":31,"class":43},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":21,"phases":395,"briefSummary":396,"conditions":397,"keywords":399,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":44},"100448977","phase-1-study-of-2141-v11-in-people-with-non-muscle-invasive-bladder-cancer-that-did-not-respond-to-standard-treatment-100448977","NCT05126472","Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment","Phase I\u002FII Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody (2141-V11) in Subjects With Bladder Cancer","Inclusion Criteria:\n\nCohorts A and B Part 1\n\n* High-grade (HG) NMIBC (HG Ta, CIS, and\u002For T1) of urothelial histology that is unresponsive to adequate BCG therapy.\n* Stage, grade, and histology must be confirmed by the MSK Department of Pathology\n* Subjects with tumors of mixed urothelial\u002Fnon-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded\n* In those subjects with CIS, the CIS must be present on the tumor sample from the most recent cystoscopy\u002FTURBT\n* In this context, adequate BCG therapy is defined as at least one of the following:\n* At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy\n* At least five of six doses of an initial induction course plus at least two of six doses of a second induction course\n* Disease unresponsive to adequate BCG therapy is defined as the following. Suspected recurrence from suspicious cytology or cystoscopy, and later confirmed via TURBT, is acceptable:\n* Persistent or recurrent CIS alone or with recurrent Ta\u002FT1 disease (noninvasive papillary disease\u002Ftumor invades the subepithelial connective tissue) within 12 months of completion of adequate BCG therapy\n* Recurrent HG Ta\u002FT1 disease within 6 months of completion of adequate BCG therapy\n* HG T1 disease at the first evaluation following an induction BCG course\n\nCohort C:\n\n* Muslce invasive bladder cancer cT2-T4aN0-2 that has a predominant urothelial histology.\n* Stage, grade, and histology must be confirmed by the MSK Department of Pathology\n* Subjects with tumors of mixed urothelial\u002Fnon-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded\n\nCohort A and B Only:\n\n* In subjects with papillary tumors (Ta and T1), a complete TURBT must have been performed.\n\nThis is characterized by:\n\n* Attainment of a visually complete resection of all papillary tumors (Ta and T1)\n* Residual CIS not amenable to complete transurethral resection is acceptable\n* Receipt of restaging transurethral resection for any tumor with invasion into the lamina propria (HG T1) as part of standard care, with documented presence of uninvolved detrusor muscle.\n* Most recent cystoscopy\u002FTURBT must have been performed within 6 months of the first dose of trial treatment.\n* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy).\n* Have elected not to undergo or are considered ineligible for radical cystectomy, as determined by the treating surgeon. Reasons for ineligibility or refusal of radical cystectomy should be discussed with the subject as part of the informed consent process.\n* Ineligibility factors for radical cystectomy may include, but are not limited to:\n* Cardiovascular disease (e.g., recent acute coronary syndrome, arrhythmia, heart failure)\n* Chronic obstructive pulmonary disease that would preclude a safe surgical procedure, as determined by the treating surgeon\n* Poor performance status\n* Prior major abdominal and pelvic surgery that would preclude a safe surgical procedure, as determined by the treating surgeon\n\nCohort C Only:\n\n\\- Are willing to undergo a standard of care examination under anesthesia or cystoscopy within four weeks of scheduled radical cystetomy.\n\n* Patients must have received 3-4 cycles of neoadjuvant Enfortumab Vedotin and pembrolizumab\n* Age ≥18 years on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 \u002F Karnofsky performance status ≥60%, as assessed within 28 days prior to treatment initiation.\n* Required values for screening laboratory tests, performed within 28 days prior to treatment initiation:\n\nAbsolute neutrophil count (ANC) ≥1000\u002Fmm3\n\n* Platelets \\>75,000\u002Fmm3 without\n* Hemoglobin \\>8 g\u002FdL\n* Creatinine clearance \\>40 mL\u002Fmin for the dose-escalation phases, \\>25 mL\u002Fmin for the dose expansion phases (estimated GFR can also be used in place of creatinine clearance)\n* AST\u002FALT ≤3 times the institutional upper limit of normal (ULN)\n* Total bilirubin ≤1.5 times the institutional ULN\n\n  * Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n  * Female subjects will be considered of non-reproductive potential if any of the following:\n  * Postmenopausal \\[defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C45 years of age a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n  * Have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening\n  * Has a congenital or acquired condition that prevents childbearing\n  * Male and female subjects of childbearing potential must agree, if participating in sexual activity that could lead to pregnancy, to use of an adequate method of contraception from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of trial therapy. Subjects should be informed that taking the study medication(s) may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study.\n\n    o Male subjects will be considered of non-reproductive potential if they have azoospermia (whether due to vasectomy or an underlying medical condition). Female subjects will be considered of non-reproductive potential if as described above. Acceptable methods of contraception:\n  * Single method (one of the following is acceptable): intrauterine device, vasectomy of a female subject's male partner, or contraceptive rod implanted into the skin\n  * Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), or hormonal contraceptive \\[oral contraceptive pill (estrogen\u002Fprogestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\n  * Male subjects must agree not to donate sperm during and after the study\n  * Able to comply with the treatment schedule as determined by the participant and the licensed practitioner.\n\nCohort B Part 2\n\n* Subjects with BCG-naïve High-grade Ta NMIBC are eligible. BCG-naïve NMIBC is defined as patients with no prior BCG exposure or no BCG treatment within 2 years of trial start.\n\n  * Stage, grade, and histology must be confirmed by the MSK Department of Pathology\n  * Subjects with tumors of mixed urothelial\u002Fnon-urothelial histology may be included, but urothelial carcinoma must be the predominant histology; subjects with predominant or exclusively non-urothelial histology are excluded\n* A complete TURBT must have been performed, as characterized by:\n\n  o Attainment of a visually complete resection of all tumors\n* Most recent cystoscopy\u002FTURBT must have been performed within 60 days of the first dose of trial treatment\n* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 \u002F Karnofsky performance status ≥60%, as assessed within 28 days prior to treatment initiation\n* Required values for screening laboratory tests, performed within 28 days prior to treatment initiation:\n\n  o Absolute neutrophil count (ANC) ≥1000\u002Fmm3 independent of growth factor support\n\n  o Platelets \\>75,000\u002Fmm3 without receiving transfusion within 4 weeks prior to screening\n\n  o Hemoglobin \\>8 g\u002FdL without receiving transfusion within 4 weeks prior to screening\n\n  o Creatinine clearance (measured or calculated per institutional standard) \\>40mL\u002Fmin; estimated GFR can also be used in place of creatinine clearance\n\n  o AST\u002FALT ≤3 times the institutional upper limit of normal (ULN)\n\n  o Total bilirubin ≤1.5 times the institutional ULN (except for participants with Gilbert's Syndrome or of non-hepatic origin)\n* Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n\n  o Female subjects will be considered of non-reproductive potential if any of the following: oPostmenopausal \\[defined as at least 12 months with no menses without an alternative medical cause; in women \\\u003C45 years of age a high follicle stimulating hormone (FSH) level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\\] Have had a hysterectomy and\u002For bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation\u002Focclusion, at least 6 weeks prior to screening\n* Has a congenital or acquired condition that prevents childbearing\n* Male and female subjects of childbearing potential must agree, if participating in sexual activity that could lead to pregnancy, to use of an adequate method of contraception from the day of study medication initiation (or 14 days prior to the initiation of study medication for oral contraception) throughout the study period up to 120 days after the last dose of trial therapy. Subjects should be informed that taking the study medication(s) may involve unknown risks to the fetus (unborn baby) if pregnancy were to occur during the study.\n\n  * Male subjects will be considered of non-reproductive potential if they have azoospermia (whether due to vasectomy or an underlying medical condition). Female subjects will be considered of non-reproductive potential if as described above.\n  * Acceptable methods of contraception:\n* Single method (one of the following is acceptable): intrauterine device, vasectomy of a female subject's male partner, or contraceptive rod implanted into the skin\n* Combination method (requires use of two of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap\u002Fspermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), or hormonal contraceptive \\[oral contraceptive pill (estrogen\u002Fprogestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection\\]\n* Male subjects must agree not to donate sperm during and after the study\n* Willing and able to provide written informed consent\u002Fassent for the trial\n* Able to comply with the treatment schedule as determined by the participant and the licensed practitioner\n\nExclusion Criteria:\n\n(Cohort A and B) Part 1\n\n* History of or currently being treated for muscle-invasive (T2, T3, T4) locally-advanced non-resectable or metastatic urothelial carcinoma.\n* Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma.\n* Concurrent anti-cancer therapy, including investigational agents\n\nExceptions include:\n\n* Cohorts A and B Exceptions: Subjects on topical therapy (e.g. topical 5-\n* Cohort C Exceptions: Subjects on topical therapy (e.g. topical 5-fluorouracil) and Neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine)\n* Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy\u002FTURBT to starting trial treatment (a single dose of intravesical treatment given as part of the most recent cystoscopy\u002FTURBT, during the screening period, such as with chemotherapy as per local\u002Fregional practices, is acceptable).\n* Have received any other neoadjuvant treatment other than Enfortumab Vedotin and pembrolizumab for muscle invasive bladder cancer\n* Has had prior chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent.\n\n  °Subjects with Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception to this criterion and may qualify for the study\n* Major surgery or a wound that has not fully healed within 4 weeks prior to the first dose of trial treatment.\n\n  * If subject has undergone major surgery greater than 4 weeks prior, subject must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting trial therapy\n\n    * Refer to detail description for the rest of the Inclusion\u002FExclusion criteria",{"count":394,"type":20},115,[295,23],"The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment, and who will not have the standard surgical procedure to remove the bladder. The researchers will test different doses of 2141-V11 to see which dose is safest in people. The researchers will also do tests to see how the body absorbs, distributes, and gets rid of 2141-V11. This study is one of the first to test 2141-V11 in people, and the first to test 2141-V11 delivered through a catheter into the bladder.",[398],"Non-muscle Invasive Bladder Cancer",[400,401,325],"2141-V11","21-314",{"date":233,"type":37},{"date":404,"type":37},"2021-11-08",{"date":406,"type":20},"2027-11",{"name":31,"class":43},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":247,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":417,"conditions":418,"keywords":423,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100311460","a-study-of-blood-based-biomarkers-for-pancreas-adenocarcinoma-100311460","NCT03334708","A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma","Development of Biomarkers for the Early Detection, Surveillance and Monitoring of Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nCohort 1: Advanced Pancreatic Cancer Cohort Inclusion Criteria\n\n* Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution\n* Patient planning to receive systemic treatment\n* Hemoglobin \\> 8\n* ECOG performance status 0-2\n* A minimum age of 18 years old\n* Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).\n\nCohort 2: Operable Pancreatic Cancer Cohort Inclusion Criteria\n\n* Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution\n* Patient planned to undergo upfront resection\n* No pre-operative systemic therapy nor chemoradiation therapy planned\n* Hemoglobin \\> 8\n* ECOG performance status 0-2\n* A minimum age of 18 years old\n* Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).\n\nCohort 3: Acute Benign Pancreatic Pathology Control Inclusion Criteria\n\n* Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution\n* Hemoglobin \\> 8\n* ECOG performance status 0-2\n* A minimum age of 18 years old\n\nCohort 4: Chronic Benign Pancreatic Pathology Control Inclusion Criteria\n\n* Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution\n* Hemoglobin \\> 8\n* ECOG performance status 0-2\n* A minimum age of 18 years old\n\nCohort 5: IPMN Control Inclusion Criteria\n\n* Confirmed diagnosis of IPMN without high risk features by the enrolling institution\n* A minimum age of 18 years old\n\nCohort 6: Pancreatic Cyst Control Inclusion Criteria\n\n* Confirmed diagnosis of benign pancreatic cyst by the enrolling institution\n* A minimum age of 18 years old\n\nCohort 7: Healthy Control Inclusion Criteria\n\n* A minimum age of 18 years old\n\nExclusion Criteria:\n\nCohort 1: Advanced Pancreatic Cancer Cohort Exclusion Criteria\n\n* Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting\n* Active second malignancy, unless low grade malignancy\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 2: Operable Pancreatic Cancer Cohort Exclusion Criteria\n\n* Neoadjuvant chemotherapy or radiation therapy is planned\n* Active second malignancy, unless low grade malignancy\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 3: Acute Benign Pancreatic Pathology Control Exclusion Criteria\n\n* Active or prior malignancy, except prior non-melanoma skin cancer\n* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 4: Chronic Benign Pancreatic Pathology Control Exclusion Criteria\n\n* Active or prior malignancy, except prior non-melanoma skin cancer\n* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 5: IPMN Control Exclusion Criteria\n\n* IPMN with high risk features or planned resection\n* Active or prior malignancy, except prior non-melanoma skin cancer\n* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 6: Pancreatic Cyst Control Exclusion Criteria\n\n* Active or prior malignancy, except prior non-melanoma skin cancer\n* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures\n\nCohort 7: Healthy Control Exclusion Criteria\n\n* Active or prior malignancy, except prior non-melanoma skin cancer\n* Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer\n* Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures",{"count":416,"type":20},120,"The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.",[419,420,421,422],"Pancreatic Cancer","Pancreatic Diseases","Pancreatitis","Pancreatic Cyst",[424],"17-257",{"date":233,"type":37},{"date":427,"type":37},"2017-10-30",{"date":429,"type":20},"2026-10-30",{"name":31,"class":43},13,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":21,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":44},"100627876","study-of-a-support-program-for-quality-of-life-in-chinese-cancer-patients-and-survivors-100627876","NCT07454330","Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors","A Multicomponent Support Program to Enhance Quality of Life in Chinese Cancer Patients and Survivors (MSP-CCS): Pilot Optimization Trial and Implementation Outcomes","Inclusion Criteria:\n\n* Diagnosed with cancer (any type\u002Fstage) (per EMR for MSK patients or self-report for external participants) within the last 5 years\n* Age ≥ 18 years (per EMR for MSK patients or self-report for external participants)\n\nSelf-Report Criteria:\n\n* Of Chinese descent\n* Speaks Mandarin \"well\" or \"very well\"\n* Moderately low HRQOL (\\\u003C70 FACT-G score)4, 48\n* Resides in New York or New Jersey\n* Agrees to participate via telehealth (video or phone)\n* Agrees to be audio-recorded\n\nExclusion Criteria:\n\nSelf-Report Criteria:\n\n* Per PI determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. If a participant receives a score of \\> 0 on item 9 of the PHQ-9,5 they will be referred to study PI for further evaluation using the Columbia-Suicide Severity Rating Scale. They will be excluded from participation in this study if there is presence of suicidal risk, determined by affirmative response(s) on the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Too ill to participate determined by the question: \"Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?\"\n* Cognitive impairment (Montreal Cognitive Assessment 5 Minute - telephone version with a score \\\u003C 12)\n* Per consenting professional determination, unable to understand the informed consent procedure\n* Participation in study #14-076: Adaptation of Individual Meaning-Centered Psychotherapy for Chinese immigrant cancer patients)\n* Currently receiving\u002Fhave received psychotherapy\u002Fcounseling\u002Fpeer support within the last 6 months (patients being treated solely with psychotropic medications will not be excluded if they are not receiving psychotherapy\u002Fcounseling\u002Fpeer support)",{"count":440,"type":20},64,[348],"The purpose of this study is to evaluate different combinations of cancer education sessions, counseling sessions, and peer support meetings developed for Chinese cancer patients and survivors. The researchers will look at whether the combinations are practical and effective, and how they impact participants' quality of life.",[225,200],[445,446,447,448,449],"Chinese","Quality of Life","Patients","Survivors","26-025",{"date":255,"type":37},{"date":452,"type":37},"2026-02-27",{"date":454,"type":20},"2028-02",{"name":31,"class":43},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":247,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":21,"phases":464,"briefSummary":465,"conditions":466,"keywords":469,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":44},"100610246","descanso-a-mental-health-intervention-for-depression-insomnia-and-fatigue-symptoms-in-latino-people-with-cancer-100610246","NCT07225088","DESCANSO, a Mental Health Intervention for Depression, Insomnia, and Fatigue Symptoms in Latino People With Cancer","DESCANSO\u002FREST (Depresión\u002FDepressed Mood, Cansancio\u002FFatigue, and Sueño\u002FSleep): A Trial Assessing Feasibility and Acceptability of an Intervention for Depressed Mood, Insomnia, and Fatigue Symptoms in Latino Cancer Patients","Provider Eligibility Criteria:\n\nParticipant eligibility will be determined by a self-report screener. Inclusion Criteria Self-Report Criteria\n\n* Mental health provider\n* Treats Latino cancer patients and\u002For survivors\n* Has at least 3 years of clinical experience providing psychosocial services to cancer patients and\u002For survivors\n* Able to read Spanish determined by the question: \"Can you read in Spanish? Yes\u002FNo\"\n\nPatient Eligibility Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener.\n\nInclusion Criteria EMR Criteria\n\n* Documentation of Disease\n\n  o Pathologically confirmed solid tumor cancer (either most recent or new diagnosis)\n* Definition of Disease \\[or Measurable Disease\\]\n\n  o Diagnosed with stages I, II, or III\n* Prior Treatment\n\n  * Currently undergoing systemic therapy (chemotherapy, radiation therapy, and\u002For immunotherapy) or within the first year following completion of systemic therapy Self-Report Criteria\n  * Age ≥ 21 years\n  * Lives in mainland U.S. or Puerto Rico\n  * Identifies as Latino\u002Fa or Hispanic\n  * Reports Spanish as their preferred language\n  * Speaks Spanish \"Very well\" or \"Well\" as determined by the question: \"How well do you speak Spanish?\"\n  * Presence of fatigue and disturbed sleep determined by a score of ≥ 3 on the MD Anderson Symptom Inventory\n\nExclusion Criteria EMR Criteria\n\no In the judgment of the treating physician, protocol investigators, and\u002For study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For study participation\n\nSelf-Report Criteria\n\n* History of comorbidities within the last 12 months associated with fatigue and poor sleep, including hypothyroidism or abnormal thyroid function, sleep apnea, chronic obstructive pulmonary disease, neuromuscular disease, alcohol or drug abuse\n* Pregnant or lactating, women only\n* Presence of suicidal risk determined by any affirmative response on the Columbia-Suicide Severity Rating Scale",{"count":102,"type":20},[348],"The purpose of this study is to improve ways of providing mental health support to Spanish-speaking Latino participants who have cancer and experience depression, insomnia, and fatigue. Investigators will test a special mental health intervention called DESCANSO\u002FREST (Depresión\u002FDepressed Mood, Cansancio\u002FFatigue, and Sueño\u002FSleep). The intervention can be delivered through telehealth.",[467,468],"Solid Tumor","Solid Tumor, Adult",[467,470,471,472,31,473],"Solid Tumor Stage I","Solid Tumor Stage II","Solid Tumor Stage III","25-277",{"date":354,"type":37},{"date":476,"type":37},"2026-01-23",{"date":478,"type":20},"2029-04",{"name":31,"class":43},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":21,"phases":488,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":44},"100582432","phase-1-a-study-of-cd8-t-cell-imaging-during-treatment-in-people-with-non-small-cell-lung-cancer-100582432","NCT06863233","A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer","Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging","Inclusion Criteria:\n\n* Patient must be 18 years of age or older at the time of signing the informed consent.\n* Patient has a histologically confirmed diagnosis of metastatic non-small cell lung cancer\n* Patient is enrolled in the engineered TIL cell therapy protocol OBX115-23-01, but has not received the treatment yet.\n* Men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.\n* Patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Patient or legally authorized representative provided written authorization for use and disclosure of protected health information.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with a history of splenectomy or significant splenic dysfunction (e.g., as evidenced by splenomegaly or a history of recurrent infections due to impaired immune function)",{"count":284,"type":20},[295],"The purpose of this study to learn whether PET\u002FCT (positron emission tomography\u002Fcomputed tomography) scans using an imaging agent (radiotracer) called zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells",[252,491,492],"Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[252,491,492,31,494],"24-369",{"date":255,"type":37},{"date":497,"type":37},"2025-03-03",{"date":499,"type":20},"2028-03-03",{"name":31,"class":43},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":510,"briefSummary":511,"conditions":512,"keywords":515,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":44},"100517752","phase-1-a-study-of-crd3874-si-in-people-with-solid-tumors-100517752","NCT06021626","A Study of CRD3874-SI in People With Solid Tumors","A Phase I Trial of CRD3874-SI, a STING Agonist, in Patients With Advanced\u002FMetastatic Malignant Solid Tumors","Inclusion Criteria:\n\n* Male or female age ≥ 18 years at the time of informed consent.\n* Be capable, willing, and able to provide written informed consent.\n* Be willing to comply with clinical trial instructions and requirements, including tumor biopsies (if feasible and required per protocol).\n* Patients must have a locally advanced or metastatic cancer, a malignant solid tumor that has progressed on at least one line of systemic therapy or for which no standard treatment is available, the participant is intolerant to available treatment, or the participant declined standard of care systemic therapy.\n* In the dose escalation phase study patients with the following tumor types will be eligible: Of note patients who declined or were intolerable of standard of care systemic therapy will be considered in all dose expansion cohorts.\n* Head and neck squamous cell carcinoma (HNSCC)\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic HNSCC and must have received 1-2 prior lines of systemic anti-cancer therapy including a checkpoint inhibitor (patients treated initially with immune checkpoint blockade alone followed by the addition of other drugs in combination \\[i.e., cytotoxic chemotherapy or EGFR inhibitor\\], will be considered 1 line of therapy.\n* HPV positive (p16 IHC positive or HPV RNA ISH positive), PD-L1 CPS score high (≥1)\n* HPV negative (p16 IHC negative or HPV RNA ISH negative), PD-L1 CPS score high (≥1)\n* Adenoid cystic carcinoma (ACC)\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic ACC (cancers arising from non-salivery gland primary sites are eligible) and may have received none or up 2 prior lines of systemic anti-cancer therapy.\n* Merkel cell carcinoma (MCC)\n* Participants must have histologically or cytologically confirmed recurrent and or metastatic MCC and must have received at least one but no more than 3 prior lines of systemic anti-cancer therapy including a checkpoint inhibitor and may not have received prior chemotherapy for MCC.\n* Monotherapy alone\n* Radiation therapy\n* Patients will receive palliative radiation therapy to a tumor site if they have at least one other site of measureable disease that can be chosen as the target lesion to assess response to investigational therapy.\n* Sarcoma that has demonstrated clinical benefit or an objective response to immune checkpoint blockade or sarcoma subtypes that are considered immunogenic subtypes including but not limited to undifferentiated pleomorphic (UPS) or myxofibrosarcoma (MFS), angiosarcoma, alveolara soft part sarcoma, or undifferentiated sarcoma will be considered.\n* Melanoma\n* Uveal Melanoma\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic uveal melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including tebentafusp (if HLA-A 02:01+, unless patient declined or was deemed ineligible) and\u002For immune checkpoint inhibitor. Melphalan PHP will count as a line of therapy if give on its own. Unlimited partial hepatic directed therapy will be permitted.\n* Mucosal and Acral melanoma\n* Participants must have histologically or cytologically confirmed recurrent and\u002For metastatic mucosal or acral melanoma and received at least one but no more than two prior lines of systemic anti-cancer therapy including prior exposure to immune checkpoint inhibition. Patients treated with BRAF-MEK therapy may have up to 3 prior lines of therapy.\n* Non small cell lung cancer\n* Participants must have histologically or cytologically confirmed locally advanced\u002Fmetastatic non-small cell lung cancer with prior exposure to immune checkpoint inhibition and received at least one but no more than 2 prior lines of systemic anti-cancer therapy.\n* Participants must have histologically or cytologically confirmed locally advanced\u002Fmetastatic sarcoma and must have received at least one but no more than 2 prior lines of systemic anti-cancer therapy. Patients will receive palliative radiation therapy to a tumor site if they have at least one other site of measureable disease that can be chosen as the target lesion to assess response to investigational therapy\n* Adequate performance status: ECOG 0 or 1\u002FKPS 100-70%.\n* Life expectancy of at least three months after the first CRD3874 infusion, according to the Investigator's opinion\n* Presence of measurable disease per RECIST v1.1.Target lesion(s) must not be chosen from a previously irradiated field unless there has been radiographically and\u002For pathologically documented tumor progression in that lesion prior to enrollment.\n* In the dose expansion phase , participants must agree to have a pretreatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom the associated procedure would result in unacceptable risk, in the opinion of the Investigator, or patients who do not wish to have a biopsy, archival tissue (most recently procured sample where tissue is available) may be used instead, if available.\n* In the dose expansion phase , participants must agree to on-treatment tumor biopsy for research purposes. Participants in whom biopsy is technically not feasible or in whom would result in unacceptable risk, in the opinion of the Investigator, or patients who do not wish to have a biopsy- may be exempted from the biopsy requirement with discussion with the Principal Investigator .\n* Female subject of childbearing potential (defined as a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy or who has not been naturally postmenopausal for at least 24 consecutive months) should have a negative serum pregnancy testing at screening visit and within 72 hours prior to the first dose of study medication.\n* Adequate organ function determined within 14 days of treatment initiation, defined as follows:\n\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1,000\u002Fmm\\^3 (1.0 x 10\\^9\u002FL)\n  * Platelet count ≥ 100,000\u002Fmm3 (100 x 10\\^9 \u002FL)\n  * Serum bilirubin ≤ 1.2x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin level \\> 1.2x ULN\n  * Aspartate aminotransferase (AST) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases\n  * Alanine aminotransferase (ALT) ≤ 2.5x ULN OR ≤ 5x ULN for participants with liver metastases\n  * Albumin ≥ 2.5mg\u002FdL.\n  * Calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by Cockcroft-Gault formula or CKD-EPI 2021\n  * International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.\n  * Activated partial thromboplastin time (aPTT) ≤ 1.5x ULN unless participant is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants\n  * Left ventricular ejection fraction (LVEF) \\> 50%, as measured by echocardiogram (2D-ECHO) or multi-gated acquisition scan (MUGA)\n\nExclusion Criteria:\n\n* Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG), (NCI CTCAE v5.0 Grade ≥ 3)\n* Evidence of clinically significant immunosuppression such as the following:\n\n  * Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease\n  * Concurrent opportunistic infection\n  * Receiving systemic immunosuppressive therapy (\\> 2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within 7 days prior to enrollment. In the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid (equivalent to \\\u003C\u002F=10mg\u002Fday prednisone) use may be permitted at the discretion of the principal investigator.\n  * Current use of immunosuppressive medication, EXCEPT for the following:\n\nI. Intranasal, inhaled, ocular, topical steroids, or local steroid injection (e.g., intraarticular injection) II. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent III. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n\n* Prior organ transplantation, including allogenic stem-cell transplantation. Consideration will be given to allow patients with a history of autologous transplantation enroll if they are at least 5 years beyond the completion of the transplant pending discussion with the principal investigator.\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.\n* Systemic antibiotics received ≥ 7 days prior to the first dose of study drugs.\n* Uncontrolled medical condition including current active infection requiring systemic therapy or symptomatic congestive heart failure within 6 months that in the investigators opinion compromise the ability of the patient to complete all study related requirements safely\n* Inability to comply with protocol required procedures\n* Resting QTc interval by Friderica's formula ≥ 470 ms on a 12-lead electrocardiogram (ECG) for males and females\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment or 5 half-lives, if shorter.\n* Has had prior chemotherapy or targeted small molecule therapy within 3 weeks, anti-cancer monoclonal antibody (mAb) within 4 weeks or OR 5 half-lives, if shorter, or radiation therapy within 2 weeks prior to the first CRD3874 infusion prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Alopecia or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable\n  * Note: If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study therapy\n* Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment.\n* History of unstable or deteriorating cardiovascular disease within the previous 6 months prior to screening including but not limited to the following:\n\n  * Unstable angina or myocardial infarction\n  * CVA\u002Fstroke\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV\n  * Uncontrolled clinically significant arrhythmias.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Patients with previously treated brain metastases or carcinomatous meningitis may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.\n* Has received a live vaccine within 30 days of the planned start of study drug. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.\n* Patients known to be positive for active Hepatitis B (HBsAg reactive with detectable HBV DNA), or Hepatitis C (HCV RNA (qualitative) is detected)\n\n  1. Patients with chronic hepatitis B (positive HBsAg and\u002For HBcAb and negative HBV DNA by PCR) are eligible for this study if they are on suppressive anti-viral therapy and deemed safe by a gastroenterologist\n  2. Patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution will be considered eligible.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies) disease that is not controlled. Note HIV-positive patients will be considered eligible if:\n\n  * Established ART for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment\n  * CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL\n  * No opportunistic infection within the past 12 months\n  * Has a known history of active TB (Bacillus Tuberculosis)\n* Women who are pregnant or breastfeeding\n* Patients expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through three months after the last dose of study treatment(s).\n* Female participants of childbearing potential and male participants who are unwilling to use acceptable method(s) of effective contraception during study treatment and until six months for female and three months for males after the last dose of CRD3874-SI. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.\n\n(Note: Women not of childbearing potential are defined as: Any female who is postmenopausal \\[age \\> 55 years with cessation of menses for 12 or more months or less than 55 years but with no spontaneous menses for at least two years or less than 55 years and spontaneous menses within the past one year but currently amenorrheic (e.g., spontaneous or secondary to hysterectomy) and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \\> 40 IU\u002FL) or postmenopausal estradiol levels (\\\u003C 5 ng\u002FdL) or according to the definition of \"postmenopausal range\" for the laboratory involved\\] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.)\n\n* The presence of a concurrent active malignancy that in the opinion of the investigator could compromise the conduct of the study or interfere with determining the outcomes of the study objectives.\n* History of non-infectious colitis.",{"count":509,"type":20},81,[295],"This study will test the safety of a study drug called CRD3874-SI. The researchers will test different doses of CRD3874-SI to find the highest dose that causes few or mild side effects in participants. After the researchers find the highest safe dose of CRD3874-SI, they will test that dose in new groups of participants to help them learn more about the side effects of the study drug and find out whether CRD3874-SI is an effective treatment for for patients with advanced or metastatic malignant solid tumors including sarcoma and Merkel Cell Carcinoma. (MCC), Head and neck squamous cell carcinoma (HNSCC), Adenoid cycstic carcinoma (ACC), Uveal Melanoma, Muscosal and Acral melanoma, and Non small cell lung cancer. The researchers will also look at how the body absorbs, distributes, and gets rid of CRD3874-SI, and the how the body and immune system respond to CRD3874-SI.",[513,514],"Sarcoma","Merkel Cell Carcinoma",[516,517,518],"CRD3874-SI","23-169","Advanced\u002FMetastatic Malignant Solid Tumors",{"date":255,"type":37},{"date":521,"type":37},"2023-08-25",{"date":523,"type":20},"2029-08",{"name":31,"class":43},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":21,"phases":534,"briefSummary":535,"conditions":536,"keywords":541,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100481064","phase-2-a-study-of-decreasing-radiation-therapy-and-chemotherapy-in-people-with-head-and-neck-cancer-100481064","NCT05544136","A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer","A Pilot Study of Radiation De-Escalation for p16 Negative Oropharyngeal Cancer and p16-Negative or Positive Laryngeal and Hypopharyngeal Cancers","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of SCC of the head and neck (excluding nasopharynx, nasal cavity\u002Fparanasal sinus, oral cavity, salivary, thyroid, and cutaneous primary malignancies).\n\n  * Any unknown primary SCC of the head and neck with radiographically detectable gross nodes is allowed (core or excisional biopsy acceptable; if excisional biopsy is performed, there must be residual radiographically detectable nodal disease; FNA may be acceptable only with PI and\u002For co-PI approval)\n  * If the primary site is oropharynx or unknown primary, P16 IHC must be negative.\n  * If the primary site is hypopharynx or larynx, any P16 status is acceptable (positive, negative, or unknown). P16 IHC is strongly encouraged when possible.\n* Clinical stage T0-3 N1-2C M0 (AJCC 7th edition) without evidence of distant metastasis based on staging FDG PET\u002FCT.\n* 18 years of age or older.\n* Must not have received prior radiation therapy or chemotherapy for HNC.\n* Patients who have had their primary site tumor removed by surgery but still have residual grossly enlarged, radiographically detectable lymph nodes are eligible for this study.\n* Karnofsky Performance Status (KPS) ≥ 70.\n* CT or MRI of the Neck with and without contrast\n\n  o Note: A CT scan of the Neck and\u002For a PET\u002FCT performed for the purposes of radiation planning may serve as planning tools.\n* Adequate hematologic function within 30 days prior to registration, defined as follows:\n\n  * White Blood Count (WBC) ≥ 2,000 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n  * Platelets ≥ 100,000 cells\u002Fmm3\n  * Hemoglobin ≥ 8.0 g\u002FdL; Note: The use of transfusion or other interventions to achieve Hgb ≥ 8.0 g\u002FdL is acceptable\n* Adequate renal function within 30 days prior to registration, defined as follows:\n\n  * Serum creatinine \\\u003C 1.5 mg\u002FdL or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = \\[(140 - age) x (weight in kg)\\] \u002F \\[(Serum Cr mg\u002FdL) x (72)\\] CrCl female = 0.85 x (CrCl male)\n  * Patients with serum creatinine \\> 1.5 mg\u002FdL can be eligible for carboplatin-based chemotherapy with approval of co-PI (Dr. Eric Sherman\n* Adequate hepatic function within 30 days prior to registration, defined as follows:\n\n  * Bilirubin \\\u003C 2 mg\u002FdL\n  * AST or ALT \\\u003C 3 x the upper limit of normal\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential.\n* The subject\u002Flegally authorized representative (LAR) must provide study-specific informed consent prior to study entry.\n\nExclusion Criteria:\n\n* All nasopharyngeal, nasal cavity\u002Fparanasal sinus, oral cavity, salivary gland, thyroid, and cutaneous primary malignancies.\n* Any N3 patients\n* Any prior radiotherapy to the head and neck region.\n* Any prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different non-H\\&N cancer is permissible.\n* Prior chemotherapy or radiotherapy within the last three years.\n* Patients who underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged, radiographically detectable lymph nodes).\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years estimated to be ≥ 90%.\n* Subjects with simultaneous primary cancers outside of the oropharynx\n\n  o Note: Exceptions can be made for patients with simultaneous primaries outside the H\\&N if determined by the PI\u002FCo-PI that the patient can proceed with protocol activities.\n* Pregnant (confirmed by serum b-HCG in women of reproductive age) or breastfeeding.\n* Severe, active co-morbidities defined as follows:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months.\n  * Transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration.\n  * Hepatic Insufficiency resulting in clinical jaundice and\u002For coagulation defects.",{"count":533,"type":20},12,[23],"The purpose of this study is to test the treatment approach of de-escalated radiation and chemotherapy followed by a planned neck dissection surgery in people with head and neck cancer. The study will look at how effective the treatment approach is against participants' cancer.",[537,538,539,540],"Head and Neck Cancer","Head and Neck Carcinoma","Head and Neck Neoplasms","Head and Neck Squamous Cell Carcinoma",[542,537,540,543,544,31,545],"Unknown Primary Squamous Cell Carcinoma","fluoromisonidazole","18F-FMISO","22-227",{"date":354,"type":37},{"date":548,"type":37},"2022-09-12",{"date":550,"type":20},"2027-03-12",{"name":31,"class":43},6,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":21,"phases":562,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":577},"100377838","phase-1-petct-imaging-of-small-cell-lung-cancer-using-89zr-dfo-sc1656-100377838","NCT04199741","PET\u002FCT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56","Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody","Inclusion Criteria:\n\nSubject Inclusion Criteria for Adult population\n\n* Signed, informed consent\n* Age 18 or more years\n* Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR\n* Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR\n* MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n* Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC\n* For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET\u002FCT guided biopsy3 as described in section 9.3.\n\n  1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.\n  2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET\u002FCT scan) may be used at PI's discretion.\n  3. While willingness to undergo the biopsy is required if archival tissue is not available, PET\u002FCT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET\u002FCT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET\u002FCT-guided biopsy\n\nSubject Inclusion Criteria for Pediatric population\n\n* Signed, informed consent\n* Age 4 or more years\n* High risk neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Performance Status: Subjects must have a Lansky (\\\u003C16 years) of at least 40\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n\nExclusion Criteria:\n\nSubject Exclusion Criteria for the Adult population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure\n\nSubject Exclusion Criteria for the Pediatric population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure",{"count":561,"type":20},105,[295,23],"The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.",[565,566],"Small Cell Lung Cancer","Small Cell Lung Carcinoma",[568,566,569,570,31],"Small cell lung cancer","89Zr-DFO-SC16.56","19-292",{"date":354,"type":37},{"date":573,"type":37},"2019-12-11",{"date":575,"type":20},"2027-06-11",{"name":31,"class":43},1,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":21,"phases":587,"briefSummary":588,"conditions":589,"keywords":593,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":44},"100650745","phase-2-radiation-therapy-approaches-for-people-with-prostate-cancer-100650745","NCT07751159","Radiation Therapy Approaches for People With Prostate Cancer","Balancing Radiation Intensification and Quality of Life in Higher-Risk Prostate Cancer (The BALANCE-RT Trial)","Inclusion Criteria:\n\n* Non-metastatic prostate cancer.\n* Classified as unfavorable intermediate-, high-, or very high-risk prostate cancer according to NCCN risk stratification guidelines. (Note: cT3a or T3b by MRI or PSMA PET allowed)\n* Considered by the treating radiation oncologist as a suitable candidate for both HDR brachytherapy boost and SBRT\n\nExclusion Criteria:\n\n* None",{"count":586,"type":20},126,[23],"The purpose of the study is to explore the best ways of giving radiation therapy to balance cancer control and treatment side effects.",[590,591,592],"Prostate Cancer Patients","Non-metastatic Prostate Cancer","High Risk Prostate Cancer",[594,595,596,597,598,31,599],"prostate cancer","Non-metastatic prostate cancer","intermediate prostate cancer","high risk prostate cancer","very high risk prostate cancer","26-288",{"date":354,"type":37},{"date":602,"type":37},"2026-07-31",{"date":604,"type":20},"2030-07-31",{"name":31,"class":43},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":21,"phases":614,"briefSummary":615,"conditions":616,"keywords":621,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":624,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":44},"100642704","phase-1-a-study-of-cemiplimab-and-fianlimab-in-people-with-nasopharyngeal-carcinoma-100642704","NCT07650266","A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma","A Pilot Randomized Trial of Induction Cemiplimab With or Without Fianlimab in De-escalated Chemoradiation for Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18\n* Pathologically (histologically or cytologically) proven (from primary lesion and\u002For lymph node) diagnosis of non-keratinizing nasopharynx carcinoma\n* Pathologic confirmation of EBV status in biopsy sample. EBER (Epstein-Barr virus-encoded RNA) detection via immunohistochemistry or in situ hybridization or polymerase chain reaction, collected as routine clinical standard to determine EBV status.\n* Patient must be seen by head and neck surgery, radiation oncology, medical oncology, as standard of care which includes standard nasopharyngoscopy. All three disciplines need to agree that the patient is eligible. Note: Nasopharyngoscopy does not need to be repeated by all three disciplines. This test is often only performed by head and neck surgery and\u002For radiation oncology.\n* AJCC 8th edition: T1N1, T2N0-1, T1-T2N2 nasopharynx carcinoma\n* ECOG performance status 0-1\n* Adequate organ and bone marrow function documented by:\n\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Absolute neutrophil count (ANC) \\>1.5 x 109 \u002FL\n  * Platelet count \\>100 x 109 \u002FL\n  * Adequate renal function: Serum creatinine \\\u003C1.5 mg\u002FdL or creatinine clearance ≥ 50 ml\u002Fmin determined by 24-hour urine collection or estimated by Cockcroft-Gault formula\n  * Adequate hepatic function: - T bili \\\u003C1.5x ULN, AST or ALT \\\u003C 1.5 ULN, Alkaline phosphatase \\\u003C1.5 x ULN). Note: for patients with Gilbert Syndrome, total Bilirubin \\\u003C3x ULN.\n* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential\n* Signed informed consent form by the participant.\n\nExclusion Criteria:\n\n\\- Evidence of distant metastatic disease by radiographic imaging. Equivocal findings are subject to P.I. and Co-PI approval\n\n* Prior head and neck radiation (Exceptions can be made if the overlap regions are minimal and must be approved by PI\u002FCo-PI)\n* Grade ≥2 hearing loss\n* Grade ≥2 peripheral sensory neuropathy\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 3 years or if cure rate from treatment at 5 years is 90% or greater\n\n  o Note: Exceptions can be made for patients with prior or concurrent invasive malignancy if determined by the PI\u002FCo-PI, then the patient can proceed with protocol activities\n* Prior systemic chemotherapy for the study cancer o Note: prior chemotherapy for a different cancer is allowable, must check with PI\u002FCo-PI\n* Severe, active co-morbidity defined as follows:\n\n  o Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics treatment within 2 weeks prior to the first dose of trial medication\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 30 days of registration\n  * Hepatic insufficiency resulting in clinical jaundice and\u002For coagulation defects\n* Lack of ability to understand and willingness to sign a written informed consent and complete questionnaires.\n* Participants with a history of myocarditis.\n* TnT or troponin I TnI \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the patient may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\n  o Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n  * Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n  * Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n* Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g., infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Patients using immunosuppressive doses (≥10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement will not be eligible for the study.\n* Received a live vaccine within 30 days of planned start of study medication, during treatment and for 90 days after treatment.\n\n  o Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing.\n* Woman of child bearing potential (WOCBP)\\* must have a negative serum (beta-hCG) within 14 days prior to registration.\n\n  * \\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n  * Pregnancy testing and contraception are not required for women who are post-menopausal or permanently sterile.\n  * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation\n  * Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence†\n  * Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.\n  * Periodic abstinence‡, withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n* WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment\n* All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose\n* Pregnant or breastfeeding women. o WOCBP who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include: i. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; ii. intrauterine device; intrauterine hormone-releasing system; iii. bilateral tubal occlusion\u002Fligation; iv. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and\u002For v. sexual abstinence† ‡\n\n  * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.\n\n    * Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.",{"count":19,"type":20},[295],"The purpose of this study is to find out whether cemiplimab, with or without fianlimab, is an effective treatment for advanced nasopharyngeal carcinoma (NPC), when given with standard chemotherapy drugs gemcitabine and cisplatin before standard chemoradiation.",[617,618,619,620],"Nasopharyngeal Carcinoma","Nasopharyngeal Cancer","Nasopharynx Carcinoma","Nasopharynx Cancer",[617,618,619,620,622,31,623],"Locoregionally Advanced Non-Metastatic Nasopharyngeal Carcinoma","26-172",{"date":382,"type":37},{"date":183,"type":20},{"date":627,"type":20},"2030-07",{"name":31,"class":43},""]