[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-bladder-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-bladder-neoplasm":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,66,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":41,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821",false,"NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention","ALL","18 Years",{"count":20,"type":21},420,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Metastatic Solid Tumor","Recurrent Solid Tumor","Advanced Solid Tumor","Urinary Bladder Neoplasm","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Esophageal Cancer","Pancreatic Cancer","Ovarian Cancer","Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Cancer","Renal Pelvis Cancer","Bladder Cancer",[40,42,43,44,45,46,39,47,48,49,50,51,52],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","RECRUITING","2026-08-04",{"date":56,"type":57},"2026-08-05","ACTUAL",{"date":59,"type":57},"2024-07-01",{"date":61,"type":21},"2027-05",{"name":63,"class":64},"Eli Lilly and Company","INDUSTRY",39,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":80,"conditions":81,"keywords":92,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100499704","phase-2-determine-trial-treatment-arm-04-trastuzumab-in-combination-with-pertuzumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-her2-amplification-or-activating-mutations-100499704","NCT05786716","DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 04 (TRASTUZUMAB AND PERTUZUMAB) OUTLINED BELOW\\*\n\n\\*When trastuzumab- and pertuzumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the trastuzumab- and pertuzumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring HER2 amplification, or an appropriate activating mutation as defined by the MTB, using an analytically validated next-generation sequencing method.\n\n• A HER2 amplification copy number between 5-9 will require an MTB discussion. A HER2 amplification copy number ≥10 will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Age 12 years or above.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\nHave a negative serum or urine pregnancy test before enrolment and;\n\nAgree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal):\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nVIII. male or female condom with or without spermicide\n\nIX. cap, diaphragm or sponge with spermicide\n\nEffective from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception as in C, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion Criteria:\n\nA. Diagnosis of HER2-positive early or metastatic breast cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within seven months following their last dose of trastuzumab or pertuzumab (whichever is later).\n\nC. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n\nD. Known hypersensitivity to trastuzumab or pertuzumab, murine proteins, or to any of the excipients.\n\nE. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during trastuzumab and pertuzumab treatment or within six months after the final dose of trastuzumab and pertuzumab.\n\nF. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), NYHA class III or IV congestive heart failure.\n\nLeft Ventricular Ejection Fraction \\\u003C55%.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of trastuzumab and pertuzumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of trastuzumab and pertuzumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to trastuzumab or pertuzumab.\n\nH. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of trastuzumab and pertuzumab, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.","12 Years",{"count":76,"type":21},30,[78,79],"PHASE2","PHASE3","This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nTrastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[82,83,30,84,85,86,87,88,89,90,91],"Haematological Malignancy","Colorectal Neoplasms","Gallbladder Neoplasms","Salivary Gland Neoplasm","Lung Neoplasm","Pancreatic Neoplasm","Ovarian Neoplasms","Prostatic Neoplasm","Skin Neoplasm","Solid Tumour",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107],"Adult","Antibodies, monoclonal","Cancer","Child","Molecular Targeted Therapy","Mutation","Paediatric","Pertuzumab","Precision Medicine","Rare","Receptor, ErbB-2","Targeted","Trastuzumab","Tumour-agnostic","Young adult","2025-11-25",{"date":110,"type":57},"2025-12-02",{"date":112,"type":57},"2023-03-07",{"date":114,"type":21},"2029-10",{"name":116,"class":117},"Cancer Research UK","OTHER",27,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":5},"100396486","bladder-fiducial-markers-and-multiparametric-mri-mp-mri-to-optimize-bladder-chemo-radiotherapy-100396486","NCT04442724","Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy","FMBRT","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.\n* Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder\n* Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation\n* Adequate renal function: Serum creatinine \\\u003C 2 mg\u002FdL OR calculated creatinine clearance (CrCl) \\> 30ml\u002Fmin\n* Ability to understand and willingness to sign a written informed consent\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation\n\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed\n* Known distant metastatic disease (e.g. pulmonary or hepatic metastases)\n\n  * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed\n* Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)\n* Planned (or prior history of) definitive bladder irradiation\n* Intravesical chemo- or biologic therapy within 6 weeks of first treatment\n* Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion\n* Clinically significant active infection or uncontrolled medical condition that would preclude participation in study\n* Pregnant or nursing women are excluded\n* Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment\n* Individuals with severe renal failure and cannot receive MRI contrast",{"count":127,"type":21},60,[129],"NA","The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.",[40,30,132,133,134],"Urologic Neoplasms","Neoplasms","Urinary Bladder Diseases",[136,137],"Fiducial marker","Fiducial marker guided technique","2025-08-11",{"date":140,"type":57},"2025-08-14",{"date":142,"type":57},"2020-07-01",{"date":144,"type":21},"2026-06-30",{"name":146,"class":117},"Cedars-Sinai Medical Center"]