[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"muscle-invasive-bladder-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:muscle-invasive-bladder-carcinoma":118},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,102,131,162,188,214,248,269,292,336,362,385,407,431,455,479,505,528,556,583,606,634,660,684,705],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928",false,"NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"ALL","40 Years","75 Years",{"count":22,"type":23},2000,"ESTIMATED","OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","RECRUITING","2026-07-01",{"date":92,"type":93},"2026-07-02","ACTUAL",{"date":95,"type":93},"2022-08-18",{"date":97,"type":23},"2027-02-28",{"name":99,"class":100},"Alliance for Clinical Trials in Oncology","OTHER",745,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100641890","phase-1-consolidative-therapy-after-ev--pembrolizumab-in-muscle-invasive-bladder-cancer-reinforce-trial-100641890","NCT07579195","Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial","Consolidative Radiation Therapy or Cystectomy After Initial Favorable Response Succeeding Enfortumab Vedotin Plus Pembrolizumab (REINFORCE)--- A Phase I\u002FII Pilot Feasibility Trial","Inclusion Criteria:\n\n* Age \\>= 18 at the time of screening\n* Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of potential study participants\n* Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis\n* Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria and at the determination of treating physicians) after 3-9 cycles of induction EV + pembro\n* If M1 after completion of EV + pembro, patients need to have =\\\u003C 5 sites of metastasis and all sites of metastasis should be extracranial\n\n  * Note: when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastatic lesions, etc). Five or fewer sites of metastasis applies after the completion of EV + pembro, not at initial diagnosis\n* Be a candidate for consolidative radiation therapy (RT) to the pelvis (if indicated) or cystectomy (if indicated), and all sites of metastasis are amenable to RT\n* Life expectancy \\> 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Absolute neutrophil count (ANC) \\>= 1500 \u002FmcL (within 180 days of trial registration)\n* Platelets \\>= 100,000\u002FmcL (within 180 days of trial registration)\n* Hemoglobin \\> 9 g\u002FdL (within 180 days of trial registration)\n* Creatinine =\\\u003C 1.5 x upper limit of normal (ULN) OR \\>= 60 mL\u002Fmin (within 180 days of trial registration)\n* Total bilirubin =\\\u003C 1.5 ULN OR direct bilirubin =\\\u003C ULN if total bilirubin \\> 1.5 x ULN (within 180 days of trial registration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN OR \\\u003C 5 x ULN if patient has live metastasis (within 180 days of trial registration)\n* Albumin \\>= 2.5 g\u002FdL (within 180 days of trial registration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range (within 180 days of trial registration)\n* PTT =\\\u003C 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range (within 180 days of trial registration)\n* Participants of child-bearing potential must be willing to employ two highly effective and acceptable forms of contraception during, and for at least 90 days after the end of radiation therapy. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of treatment initiation\n* HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial\n\nExclusion Criteria:\n\n* Prior radiation therapy with field overlapping with current proposed radiation field, precluding delivery of meaningful dose of radiation\n* Intracranial metastasis\n* Any small cell component, or predominant (\\> 50%) sarcomatoid or plasmacytoid histology\n* Other active malignancy or clinically relevant malignancy within past 2 years, per discussion with the principal investigator\n* Genetic conditions that increase sensitivity to radiation, such as Fanconi syndrome, ataxia telangiectasia, and Nijmegen breakage syndrome\n* Active human immunodeficiency virus (HIV) not adequately controlled, active hepatitis B (e.g., hepatitis B virus surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected)\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any other medical condition that may interfere with trial therapy delivery","18 Years",{"count":111,"type":23},12,"INTERVENTIONAL",[114,115],"PHASE1","PHASE2","This phase I\u002FII clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and pembrolizumab. Although this combination has significantly improved outcomes compared to traditional chemotherapy, many patients are left with residual cancer in the bladder or other sites, and there is currently no established standard approach for managing this remaining disease or determining the optimal duration of systemic therapy. Prolonged treatment can lead to cumulative side effects and negatively impact quality of life.\n\nThis study investigates whether adding consolidative treatment-such as radiation therapy to the bladder and metastatic sites or surgical removal of the bladder (radical cystectomy)-can safely eliminate residual disease and delay cancer progression. Radiation therapy uses high-energy x-rays to precisely target and destroy cancer cells while minimizing exposure to surrounding normal tissues. In selected patients, surgery may be used to remove remaining tumor in the bladder. Targeted radiation techniques, such as stereotactic body radiation therapy (SBRT), may also be used to treat small metastatic sites. This approach may allow for safe discontinuation of systemic therapy, potentially reducing long-term treatment-related side effects.\n\nA key component of this trial is the integration of biomarker testing using circulating tumor DNA (ctDNA) from blood and urine tumor DNA (utDNA). These tests detect small amounts of tumor-derived genetic material and may help identify patients most likely to benefit from consolidative treatment, as well as guide decisions about ongoing therapy. By combining response to systemic therapy with personalized local treatment and biomarker-driven monitoring, this study aims to improve cancer control, reduce complications from untreated local disease, and inform future treatment strategies for patients with advanced bladder cancer.",[118,119,120],"Muscle Invasive Bladder Carcinoma","Stage III Bladder Cancer AJCC v8","Stage IV Bladder Cancer AJCC v8","NOT_YET_RECRUITING","2026-06-17",{"date":124,"type":93},"2026-06-22",{"date":90,"type":23},{"date":127,"type":23},"2029-12-31",{"name":129,"class":100},"University of Washington",1,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":112,"phases":140,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":130},"100556800","phase-1-personalized-cancer-vaccine-pcv-strategy-in-patients-with-solid-tumors-and-molecular-residual-disease-100556800","NCT06529822","Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease","Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease","Inclusion Criteria Cohort #1:\n\n* Age ≥ 18 years.\n* ECOG performance status ≤ 2 (Karnofsky ≥ 60%).\n* Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and\u002For ureter).\n* Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.\n* Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and\u002For ureter). Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: pT2-4aN0M0 or pT0-4aN+M0.\n* Patient must have fully recovered from surgical resection in the opinion of the treating MD.\n* ctDNA positive result as identified by Signatera.\n* Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.\n* Adequate bone marrow and organ function as defined below:\n\n  * WBC ≥ 1.5 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 50 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* No concurrent investigational therapies outside of this protocol are allowed.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria Cohort #1:\n\n* Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy are allowed.\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.\n* A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and\u002For medical record.\n* Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \\> 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.\n* Known HIV-positive status.\n* History of positive test for Hepatitis B virus surface antigen (HBsAg) and\u002For positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia. For treatment enrollment the patient must have completed all prior cancer treatments \\> 28 days prior to vaccine administration with the exception of adjuvant SOC immunotherapy.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial per discussion with the PI.\n* Currently receiving any other investigational agents.\n* Live vaccine administered within 30 days prior to enrollment.\n* Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 30 days of enrollment.\n* Active autoimmune disease (excluding diabetes mellitus and\u002For vitiligo), solid organ or allogeneic bone marrow transplant, or other known contraindications to receiving immunotherapy.\n* Severe hypersensitivity (grade ≥ 3) to checkpoint inhibitors and\u002For any of its excipients.\n* Current pneumonitis, a history of (non-infectious) pneumonitis requiring steroids, or history of clinically significant interstitial lung disease.\n* Active tuberculosis test within 3 months prior to treatment initiation.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days of study entry.\n\nInclusion Criteria Cohort #2:\n\n* Age ≥ 18 years.\n* ECOG performance status ≤ 2 (Karnofsky ≥ 60%)\n* Histologically confirmed gastroesophageal adenocarcinoma\n* Stage II or III gastroesophageal adenocarcinoma (GEC).\n* Complete surgical resection of GEC (R0). Full recovery from surgery and enrollment within 52 weeks following surgery with curative intent. Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows:\n\n  * Esophageal and Esophagogastric junction adenocarcinoma T1 N1-3 M0 or T2-4 N0-2M0.\n  * Gastric adenocarcinoma T1-2 N1-3 M0 or T3-4 N0-3 M0.\n* Patient must have fully recovered from surgical resection in the opinion of the treating MD.\n* ctDNA positive result as identified by Signatera.\n* Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.\n* Adequate bone marrow and organ function as defined below:\n\n  * WBC ≥ 1.5 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 50 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of synthetic long peptide personalized cancer vaccines and Hiltonol and on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* No concurrent investigational therapies outside of this protocol are allowed.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria Cohort #2:\n\n* Receiving any other investigational agents or planning to receive other investigational agents as part of neoadjuvant therapy. Patients who have received perioperative neoadjuvant chemotherapy and immunotherapy are allowed.\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.\n* A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and\u002For medical record.\n* Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \\> 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.\n* Known HIV-positive status.\n* History of positive test for Hepatitis B virus surface antigen (HBsAg) and\u002For positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia. For treatment enrollment the patient must have completed all prior cancer treatments \\> 28 days prior to vaccine administration with the exception of adjuvant SOC immunotherapy.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial per discussion with the PI.\n* Currently receiving any other investigational agents.\n* Live vaccine administered within 30 days prior to enrollment.\n* Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 30 days of enrollment.\n* Active autoimmune disease (excluding diabetes mellitus and\u002For vitiligo), solid organ or allogeneic bone marrow transplant, or other known contraindications to receiving immunotherapy.\n* Severe hypersensitivity (grade ≥ 3) to checkpoint inhibitors and\u002For any of its excipients.\n* Current pneumonitis, a history of (non-infectious) pneumonitis requiring steroids, or history of clinically significant interstitial lung disease.\n* Active tuberculosis test within 3 months prior to treatment initiation.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days of study entry.\n\nInclusion Criteria Cohort #3:\n\n* Age ≥ 18 years.\n* ECOG performance status ≤ 1.\n* Histologically or cytologically confirmed diagnosis of Melanoma. Stage IIB\u002FC or IIIB-C (per AJCC 8th edition). Completed R0 resection within 36 months prior to enrollment and have fully recovered from surgery.\n* Planning to receive or have received adjuvant immunotherapy for 1 year.\n* Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n* Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.\n* Adequate bone marrow and organ function as defined below:\n\n  * WBC ≥ 1.5 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 50 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria Cohort #3:\n\n* Receiving any other investigational agents or planning to receive other investigational agents in the neoadjuvant or adjuvant setting.\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.\n* A psychiatric illness or social situation that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and\u002For medical record.\n* Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease, taking inhaled corticosteroids that do not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allowed if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \\> 7 consecutive days. Systemic steroids must be discontinued at least 7 days prior to the first dose of SLP-01. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if they are eligible for this investigational treatment.\n* History of allogeneic stem cell transplant of solid organ transplant.\n* History of grade ≥3 immune-related adverse events with prior checkpoint inhibitors that, in the investigator's opinion, preclude further IO or vaccine therapy.\n* Untreated or unstable CNS metastases.\n* Known HIV-positive status.\n* History of positive test for Hepatitis B virus surface antigen (HBsAg) and\u002For positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days of study entry.\n\nInclusion Criteria Cohort #4:\n\n* Age ≥ 18 years.\n* ECOG performance status ≤ 1.\n* Histological diagnosis of non-small cell lung carcinoma, stages II, IIIA or IIIB with complete R0 resection. Completed R0 resection within 9 months of surgery.\n* Planned to receive or have received adjuvant immunotherapy for 1 year.\n* Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n* Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.\n* Adequate bone marrow and organ function as defined below:\n\n  * WBC ≥ 1.5 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 50 K\u002Fcumm\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria Cohort #4:\n\n* Receiving any other investigational agents or planning to receive other investigational agents in the neoadjuvant or adjuvant setting.\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.\n* A psychiatric illness or social situation that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and\u002For medical record.\n* Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease, taking inhaled corticosteroids that do not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allowed if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \\> 7 consecutive days. Systemic steroids must be discontinued at least 7 days prior to the first dose of SLP-01. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if they are eligible for this investigational treatment.\n* Known EGFR activating mutations (exon 19 deletion or L858R) or ALK, RET, or ROS1 gene rearrangements in subjects for whom adjuvant targeted therapy is planned.\n* History of allogeneic stem cell transplant or solid organ transplant.\n* History of grade ≥3 immune-related adverse events with prior checkpoint inhibitors that, in the investigator's opinion, preclude further IO or vaccine therapy.\n* Known HIV-positive status.\n* History of positive test for Hepatitis B virus surface antigen (HBsAg) and\u002For positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days of study entry.",{"count":139,"type":23},64,[114],"This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.",[43,143,42,144],"Gastroesophageal Adenocarcinoma","Non-small Cell Lung Cancer",[146,147,148,149,143,150,42,151,152],"Personalized cancer vaccine","Solid tumor","Immunotherapy","Bladder cancer","GEC","NSCLC","Non-small cell lung cancer","2026-06-16",{"date":155,"type":93},"2026-06-18",{"date":157,"type":93},"2025-03-20",{"date":159,"type":23},"2034-06-30",{"name":161,"class":100},"Washington University School of Medicine",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":112,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":130},"100538427","phase-2-partial-cystectomy--extended-pelvic-lymph-node-dissection-with-soc-perioperative-systemic-therapy-100538427","NCT06290687","Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy","Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)","Inclusion Criteria:\n\n* Subjects must have histologically confirmed urothelial carcinoma of the bladder, clinical stage T2-3N0M0. Micropapillary, glandular, squamous, and sarcomatoid histologic variants of urothelial carcinoma are allowed.\n* Subjects must have unifocal or limited multifocal disease amenable to complete surgical resection with partial cystectomy, as judged by the treating urologic oncologist.\n* Age \\>18 years. Because of the rarity of this disease and limited data on treatment efficacy in subjects 18 years of age, children are excluded from this study.\n* Performance status - Karnofsky Performance Status ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1.\n* Subjects must have normal organ and marrow function as defined below:\n\n  * Total bilirubin within normal limits\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal\n  * Bone marrow:\n\n    * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3\n    * Platelet count ≥ 80,000\u002Fmm3, Hemoglobin ≥ 9.0 g\u002FdL\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Subjects must have tumor less than or equal to 5 cm in largest dimension as assessed radiographically.\n* Treatment naive for MIBC.\n\nExclusion Criteria:\n\n* Presence of hydronephrosis.\n* Presence of multifocal disease that is not amenable to complete resection with partial cystectomy.\n* Presence of distant carcinoma in situ.\n* Presence of clinical N+ or M+ disease.\n* Presence of cT4+ disease.\n* Non-urothelial histology.\n* Concurrent upper tract (ureter or renal pelvis) or urethral urothelial carcinoma.\n* Subjects who are not surgical candidates due to competing medical comorbidities or who refuse surgical treatment.\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.","19 Years",{"count":171,"type":23},40,[115],"The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.",[175,118],"Malignant Neoplasm of Bladder",[177,178],"Partial cystectomy","Pelvic Lymph Node Dissection","2026-06-04",{"date":181,"type":93},"2026-06-05",{"date":183,"type":23},"2026-07",{"date":185,"type":23},"2027-12-29",{"name":187,"class":100},"Case Comprehensive Cancer Center",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":112,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":130},"100548145","phase-2-bladder-preservation-for-patients-with-muscle-invasive-bladder-cancer-mibc-with-variant-histology-100548145","NCT06417190","Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology","IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology","Inclusion Criteria:\n\n* Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C\u002FA\u002FP and\u002For PET.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Evidence of diffuse cis on pathology\n* Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)\n* Prior radiotherapy to the pelvis\n* History of systemic therapy for MIBS\n* Presence of concurrent cancer (remote history of cancer (\\>5 years) allowed if the patient is without evidence of disease)",{"count":196,"type":23},20,[115],"This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +\u002F- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +\u002F- IO and is therefore a viable option in patients who are risk of systemic disease spread.",[43,200],"Tumor",[202,203,204],"Trimodal Therapy (TMT)","Neoadjuvant Chemotherapy","muscle-invasive urothelial cell bladder cancer (MIBC)","2026-05-01",{"date":207,"type":93},"2026-05-04",{"date":209,"type":93},"2026-01-16",{"date":211,"type":23},"2030-12",{"name":213,"class":100},"Leslie Ballas",{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":223,"conditions":224,"keywords":229,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100633335","immune-stromal-landscape-in-muscle-invasive-bladder-cancer-100633335","NCT07525349","Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer","The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study","Inclusion Criteria:\n\n* Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.\n* Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.\n\nExclusion Criteria:\n\n* Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma).\n* Patients who received neoadjuvant chemotherapy or radiotherapy.\n* Cases with missing or inaccessible clinical follow-up data.\n* History of prior or concurrent malignancy.",{"count":222,"type":23},100,"Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy). However, even after surgery, it can be difficult for doctors to accurately predict how an individual patient's disease will progress using standard staging methods.\n\nThis retrospective observational study aims to find better ways to predict patient outcomes by examining the tumor microenvironment, which is the environment immediately surrounding the cancer cells. Specifically, researchers are looking at the relationship between the tumor cells, the surrounding supportive tissue (the stroma), and the patient's natural immune cells.\n\nThe study will review existing medical records and archived tumor tissue samples from at least 100 patients who underwent radical cystectomy at the South Egypt Cancer Institute between 2018 and 2024. Under a microscope, researchers will assess three main features:\n\n* Tumor-Stroma Ratio (TSR): The amount of tumor tissue compared to the surrounding supportive tissue.\n* Tumor-Infiltrating Lymphocytes (TILs): The number of immune cells that have moved into the tumor to try and fight it.\n* Tertiary Lymphoid Structures (TLS): Organized clusters of immune cells that form near the tumor.\n\nBy analyzing these features, the researchers hope to determine if specific patterns of immune and supportive cells are linked to better or worse survival rates, such as Overall Survival and Disease-Free Survival. Understanding this immune-stromal landscape could lead to more personalized risk assessments and better treatment plans for future bladder cancer patients.",[43,225,226,227,228],"Urothelial Carcinoma (UC)","Bladder Cancer","Muscle-Invasive Urothelial Bladder Carcinoma","Urinary Bladder Neoplasms",[230,231,232,233,234,235,236,237,238],"Muscle-Invasive Bladder Cancer (MIBC)","Urothelial Carcinoma","Radical Cystectomy","Tumor Microenvironment","Tumor-Stroma Ratio (TSR)","Tumor-Infiltrating Lymphocytes (TILs)","Tertiary Lymphoid Structures (TLS)","Glasgow Microenvironment Score (GMS)","Klintrup-Mäkinen (KM) Score","2026-04-07",{"date":241,"type":93},"2026-04-13",{"date":243,"type":23},"2026-05",{"date":245,"type":23},"2027-06",{"name":247,"class":100},"Assiut University",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":112,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":130},"100503331","phase-1-adaptive-radiation-therapy-with-concurrent-sacituzumab-govitecan-sg-for-muscle-invasive-bladder-cancer-100503331","NCT05833867","Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Muscle Invasive Bladder Cancer","Adaptive RADiation Therapy With Concurrent Sacituzumab Govitecan (SG) for Bladder Preservation in Patients With MIBC (RAD-SG).","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothelial carcinoma will be eligible for the trial, except for small cell or neuroendocrine component\n* Participants must have received no prior systemic chemotherapy for this disease. Participants must refuse conventional radio-sensitizing chemotherapy, (and\u002For) must not be eligible for or refuse cystectomy while on study Participants may receive cystectomy following the end of treatment (EOT)\u002F Safety Visit if deemed necessary by their clinical team while still in follow-up.\n* Performance status: ECOG Performance status ≤ 2\n* Participants must have normal organ and marrow function as defined below:\n\n  * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \\[SGOT\\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x laboratory upper limit of normal (ULN)\n  * Total serum bilirubin ≤ 2.0 x ULN\n  * Absolute neutrophil count (ANC) ≥ 1500\u002FμL\n  * Platelets ≥ 100,000\u002FμL\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Serum calcium ≤ 12.0 mg\u002FdL\n  * Calculated Creatinine Clearance ≥ 30 mL\u002Fmin. Calculated using Cockcroft-Gault formula: Creatinine Clearance = \\[\\[140 - age(yr)\\] multiplied by body weight(kg)\\]\u002F \\[72 multiplied by serum Cr(mg\u002FdL)\\] (multiply total by 0.85 for women).\n* Participants must have adequate baseline bladder function to warrant bladder preservation as assessed by the treating provider, including absence of bilateral hydronephrosis or acute obstruction related to bladder tumor after TURBT. Unilateral hydronephrosis is permitted.\n* Participants must undergo a TURBT within ≤ 60 days prior to treatment start. In a situation where a participant is referred from an outside site to the Cleveland Clinic Foundation, participant must have a repeat cystoscopy by the urologist who will be following the participant on the clinical trial to assess the adequacy of the prior TURBT. Participant may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist.\n* Participants may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection.\n* Participant must undergo radiological staging within 60 days prior to treatment start. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Participants must not have evidence of T4b and\u002For N1-3 dT4bN1-3 disease. Eligibility is based on review by Cleveland Clinic Foundation (CCF) radiology department and\u002For PI.\n* Participants must not have had urothelial carcinoma or any histological variant at any site outside of the urinary bladder within the previous 24 months except Ta\u002FT1\u002FCarcinoma in situ (CIS) of the upper urinary tract including renal, pelvis, and ureter if the participant had undergone complete nephroureterectomy.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants receiving or utilizing any other investigational agents or devices.\n* Has received prior pelvic \u002F local radiation therapy for MIBC or any other cancer type.\n* Has received any prior systemic treatment, chemoradiation, and \u002F or radiation therapy for MIBC or non-muscle-invasive bladder cancer (NMIBC). Note: Prior treatment for NMIBC with intravesical instillation therapy such as BCG or intravesical chemotherapy is permitted.\n* Has diagnosed Bilateral hydronephrosis.\n* Has limited bladder function as noted by a provider, with frequency of small amounts of urine, urinary incontinence including stress\u002Furge, requires self-catheterization or a permanent indwelling catheter.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SG or any of its' components.\n* Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because SG and radiation effects during pregnancy have potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with SG, breastfeeding should be discontinued if the mother is treated with Sacituzumab Govitecan.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n\nNote: Participants who have entered the Follow-up Phase of an investigational study may participate if it has been 4 weeks after the last dose of the previous investigational agent.\n\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":196,"type":23},[114],"The purpose of this study is to examine the safety and tolerability of treatment with concurrent Sacituzumab Govitecan (SG) and adaptive radiation therapy. The main objective is to establish the safety, tolerability, and feasibility of bladder preservation therapy treatment with concurrent SG and adaptive image-guided radiation therapy for participants with localized MIBC. Participants will receive the study drug, SG, through an IV once weekly on days 1 and 8 of each 21-day treatment cycle. The first cycle of SG will begin 21 days prior to the scheduled start of radiation therapy. The second and third cycles of SG will be given while the participant is receiving radiation therapy. Participants will be asked to undergo computed tomography (CT) and magnetic resonance imaging (MRI) pre-and post-treatment. Participation in the research will last up to 5 years, depending on treatment outcomes, with a treatment period of 8 weeks and a study follow-up period of up to 2-5 years thereafter, and a survival follow-up, with only phone call communication from years 3-5.",[259,43],"Localized Muscle Invasive Bladder Urothelial Carcinoma","2026-03-12",{"date":262,"type":93},"2026-03-13",{"date":264,"type":93},"2024-04-01",{"date":266,"type":23},"2027-10",{"name":268,"class":100},"Shilpa Gupta, MD",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":112,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":130},"100552222","phase-1-enfortumab-vedotin-and-pembrolizumab-combined-with-radiotherapy-in-muscle-invasive-bladder-cancer-100552222","NCT06470282","Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer","EV-PRIME: Phase Ib\u002FII Study of Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy as a Bladder-Sparing Trimodality Therapy in Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Biopsy-confirmed muscle-invasive bladder cancer (cT2,T3,T4a). (Note: Tissue samples are required.) (Participants with cT3\u002FT4a staged disease will be capped at 25% of patients treated at RP2D).\n* Urothelial histology present. Mixed histologies other than small cell\u002Fneuroendocrine are allowed as long as some urothelial histology is present. Neuroendocrine histology of any component and pure variant (non-urothelial) histology tumors will be excluded. (Patients with \\\u003C 50% urothelial histology will be capped at 25% of patients treated at RP2D).\n* Must be judged by the investigator to be ineligible for radical cystectomy or electing not to undergo radical cystectomy.\n* Must be eligible for and agree to receive bladder irradiation as determined by the treating investigator.\n* Must have a TURBT within 8 weeks of combination treatment start with viable tumor content. If no viable tumor content is present on TURBT, the patient will be replaced in the study.\n* Patients who have autoimmune disease will be evaluated on a case-by-case basis and can only enroll so long as participants are not on active immunosuppression with a corticoid steroid allowance exceeding 10mg of prednisone or equivalent per day.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 1.\n* Absolute neutrophil count ≥ 1,500\u002Fmicroliter (mcL).\n* Platelets \\>= 100,000\u002FmcL.\n* Hemoglobin \\>= 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL.\n\n  \\* Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks\n* Total bilirubin \\\u003C= 1.5 × upper limit of normal, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits.\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) \\\u003C= 2.5 X institutional upper limit of normal.\n* Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) \\\u003C= 2.5 X institutional upper limit of normal.\n* Creatinine clearance glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2, calculated by Cockcroft-Gault or measured using 24-hour creatinine clearance.\n* International normalized ratio (INR) OR prothrombin time (PT) \\\u003C= 1.5 × upper limit of normal (ULN).\n\n  \\* If participant is receiving anticoagulant therapy, as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants, participant is eligible.\n* Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 × ULN.\n\n  \\* If participant is receiving anticoagulant therapy, as long as PT or aPTT is within therapeutic range of intended use of anticoagulants, participant is eligible.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants who are hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) anti-viral 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 local guidelines for HBV anti-viral therapy post completion of study intervention.\n\n  \\* Note: Hepatitis B screening tests are not required unless patients have a known history of HBV infection.\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\n  \\* Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to cycle 1 day 1.\n* Women of child-bearing potential and men with sexual partners of childbearing potential must agree to use adequate contraception for the duration of study participation. Enfortumab vedotin (EV) may cause fetal harm. Women of child-bearing potential must use contraception during treatment with EV and for 120 days after the last dose. Men with female partners who are women of child-bearing potential must use contraception during treatment with EV and for 120 days after the last dose. 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. Acceptable methods include barrier method, hormonal method, as well as intrauterine devices\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 8 weeks after last administration of study treatment.\n\nExclusion Criteria:\n\n* Presence of distant metastases on imaging (M1 disease).\n* Presence of ≥ N2 disease on imaging (N1 disease allowed, but participants with N1 disease will be capped at 25% of patients treated at RP2D).\n* Presence of small cell \u002F neuroendocrine histology in tumor sample (any content).\n* Absence of urothelial histology in TURBT tumor sample (pure variant histology).\n* Presence of untreated upper tract urothelial cancer.\n* Presence of severe hydronephrosis precluding therapy in the judgement of the treating physician.\n* Presence of extensive carcinoma in situ (CIS) is exclusionary; moderate CIS that could still benefit from radiation treatment in the judgement of treating physician is allowed.\n* Baseline neuropathy grade 2 (G2) or greater.\n* Baseline uncontrolled diabetes mellitus.Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c 7 to \\\u003C 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n\n  \\* Note: Patients with prior diagnosis but with disease under control are eligible\n* Prior treatment with systemic immunotherapy or chemotherapy for urothelial cancer. (with the exception of prior systematic therapy treatment \\>12 months prior). Note: Prior bacillus calmette-guerin (BCG) and intravesical treatments are allowed\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to cycle 1 day 1.\n* Has received prior radiotherapy within 2 weeks of cycle 1 day 1 or had radiation-related toxicities requiring corticosteroids.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention.\n\n  \\* Note: Administration of killed vaccines is allowed. Any licensed coronavirus 2019 (COVID-19) vaccine (including for emergency use) is allowed in the study as long as they are messenger ribonucleic acid (mRNA) vaccines, replication-incompetent adenoviral vaccines, or inactivated vaccines.\n* Major surgery within 2 weeks prior to first dose of EV.\n\n  \\* Note: Cataract surgery, standard tissue biopsies, and standard of care cardiac devices, such as a pacemaker or stent placed on an elective basis, are allowable procedures.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n\n  \\* Note: Inhaled or topical steroids are permitted.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* History of another significant life-limiting malignancy requiring systematic treatment within 2 years prior to the first dose of study drugs, or any evidence of residual disease from a previously diagnosed malignancy.\n\n  \\* Note: Patients with nonmelanoma skin cancer, curatively treated localized prostate cancer, curatively treated upper tract urothelial cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Hypersensitivity to pembrolizumab or enfortumab vedotin, or any of their excipients.\n* Prior allogeneic stem cell or solid organ transplant.\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a 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* History of Hepatitis B with detectable HBV viral load (participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and\u002For have undetectable HBV viral load prior to randomization) or known active hepatitis C virus (defined as detectable HCV RNA .\\[qualitative\\]) infection.\n\n  \\* Note: Testing for Hepatitis B or C is not required unless clinically indicated or if there is a known history of hepatitis infection. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Pregnant and breast feeding participants are excluded from this study because targeted chemotherapy and radiation have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EV+pembrolizumab, breastfeeding should be discontinued if the mother is treated with these investigational products.",{"count":277,"type":23},47,[114,115],"This phase Ib\u002FII trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.",[226,43,281,282],"Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8","2026-02-13",{"date":285,"type":93},"2026-02-18",{"date":287,"type":93},"2025-03-31",{"date":289,"type":23},"2028-01-31",{"name":291,"class":100},"University of California, San Francisco",{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":112,"phases":302,"briefSummary":304,"conditions":305,"keywords":309,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":335},"100611006","clinical-trial-to-evaluate-post-operative-outcomes-of-ureteral-stent-vs-ureteral-stent-free-radical-cystectomy-100611006","NCT07234968","Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","Inclusion Criteria:\n\n* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:\n\n  * Provide signed and dated informed consent form\n  * Willing to comply with all study procedures and be available for the duration of the study\n  * Male or female, age 18 to 85\n  * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Current or history of pelvic radiation\n  * Retroperitoneal fibrosis\n  * Untreated urinary tract infection (UTI) within 30 days prior to RCIC\n  * Pregnancy","85 Years",{"count":301,"type":23},70,[303],"NA","Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.",[226,43,231,306,307,308],"Pelvic Malignancy","Bladder Transitional Cell Carcinoma","Bladder Neoplasm",[310,311,312,313,314,306,226,315,316,317,318,319,320,321,322,323,324,325],"Bladder","Stent-free Cystectomy","Urinary Tract Infection","Urinary Leak","UTI","Urologic Oncology","Muscle-invasive Bladder Cancer","indocyanine green","fluorescence imaging","ureteral stents","RCIC","cystectomy","colorectal","prostate","gynecologic","ileal conduit urinary diversion","2026-02-12",{"date":328,"type":93},"2026-02-17",{"date":330,"type":93},"2025-12-23",{"date":332,"type":23},"2028-04-30",{"name":334,"class":100},"Thomas Jefferson University",2,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":112,"phases":346,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":130},"100619064","supporting-sexual-health-in-bladder-cancer-patients-a-sequential-mixed-methods-intervention-study-100619064","NCT07339761","Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study","SPICE: Supporting Sexual Health in Bladder Cancer Patients: A Sequential Mixed-Methods Intervention Study","SPICE","Inclusion Criteria study 1a:\n\n* The participant has one of the following diagnoses and received initial treatment approximately 12 months ago:\n\n  1. Non-muscle-invasive bladder cancer treated with transurethral resection of the bladder (TUR-B)\n  2. Non-muscle-invasive bladder cancer treated with TUR-B and subsequent intravesical instillation therapy with chemotherapy or immunotherapy\n  3. Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant has experienced changes and\u002For difficulties in sexual function related to the cancer diagnosis and\u002For its treatment\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1a:\n\n* The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer\n* The participant has a history of breast cancer\n\nInclusion Criteria study 1b:\n\n* The participant is diagnosed with Muscle-invasive bladder cancer treated with cystectomy (removal of the bladder)\n* The participant speaks and understands Danish\n* The participant is aged 18 years or older\n* The participant has read and understood the oral and written study information\n* The participant has provided written informed consent\n\nExclusion Criteria study 1b:\n\n* The participant has a history of other cancers located in the pelvic region, including rectal cancer, sarcomas, uterine cancer, cervical cancer, ovarian cancer, prostate cancer, or penile cancer\n* The participant has a history of breast cancer",{"count":345,"type":23},30,[303],"Despite increasing recognition of sexual dysfunction and sexual distress as important survivorship issues in oncology, research and clinical attention remain uneven across cancer types. This imbalance is particularly evident in bladder cancer, where sexual health has received limited research and clinical attention. However, existing studies demonstrate substantial sexual dysfunction and reduced intimacy among patients following disease and treatment.\n\nThe treatment of bladder cancer is a multimodal and multidisciplinary discipline. Low-risk non-muscle-invasive bladder cancer (NMIBC) is treated by transurethral resection of the bladder (TURB) alone, while recurrent intermediate- and high-risk NMIBC undergo a combination of TURB and adjuvant intravesical instillation therapy. For patients with muscle-invasive bladder cancer (MIBC) and specific high-risk NMIBC cases, the first-line treatment option is radical cystectomy with urinary diversion, with or without neoadjuvant chemotherapy.\n\nThese treatment modalities are known to have a negative impact on sexual function, and studies in both men and women demonstrate profound impairments in sexual function, intimacy, and body image after treatment. Among men, erectile and ejaculatory dysfunction are prevalent for this patient group and frequently associated with diminished sexual satisfaction and body-image concerns. Likewise, women experience loss of sexual desire, orgasmic disorders, dyspareunia, and vaginal dryness following cystectomy.\n\nA targeted literature search further identified no contemporary sexology-focused interventional or feasibility trials specifically in bladder cancer (neither MIBC or NMIBC). Existing evidence on the topic is largely descriptive or addresses non-sexological rehabilitation, demonstrating a evidence gap\\[1\\].\n\nQualitative research has also explored informational and psychosocial needs among bladder cancer patients, revealing limited communication about sexual health and unmet needs for professional support. Such studies provide valuable insight into patient experiences but have not yet translated this knowledge into the development of structured, sexological interventions.\n\nEvidence from other cancer populations demonstrates that counselling and psychoeducational programmes addressing intimacy and sexuality are both feasible and beneficial, suggesting that similar interventions could be adapted for bladder cancer care.\n\nTo develop a relevant and acceptable intervention, it is essential to understand how patients themselves perceive their sexual health challenges, informational needs, and preferences for professional support regarding sexual health.\n\nThis project therefore consists of two sequential sub-studies:\n\n* Study 1a (Development phase): A qualitative, exploratory study to develop a sexological intervention with patient and clinician involvement.\n* Study 1b (Feasibility phase): A one-armed feasibility trial assessing the implementation and acceptability of the intervention among patients with muscle-invasive bladder cancer (MIBC).",[226,349,43],"Non-Muscle-Invasive Bladder Cancer (NMIBC)",[351,226,352],"Sexual Health","Sexual Rehabilitation","2026-01-05",{"date":355,"type":93},"2026-01-14",{"date":357,"type":93},"2026-01-01",{"date":359,"type":23},"2028-08-31",{"name":361,"class":100},"University of Aarhus",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":112,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":384},"100536309","phase-2-futibatinib-in-combination-with-durvalumab-prior-to-cystectomy-for-the-treatment-of-muscle-invasive-bladder-cancer-patients-who-are-ineligible-for-cisplatin-based-therapy-100536309","NCT06263153","Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy","A Phase II Trial of Futibatinib in Combination With Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients With Muscle-Invasive Bladder Cancer Before Cystectomy","Inclusion Criteria:\n\n* Able to provide signed informed consent\n* Female or male subjects \\>= 18 years old\n* Bodyweight \\>30kg\n* FGFR1, 2, or 3 overexpression as defined by a score of 3+ or 4+ on ribonucleic acid (RNA) in-situ hybridization (RNAScope assay)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Histologically confirmed urothelial carcinoma of the bladder\n\n  * Mixed histologies are permitted if urothelial carcinoma is the predominant histology ( \\>= 50%)\n* Clinical stage T2-T4a, N0, M0 disease by trans urethral removal of bladder tumour (TURBT) and imaging studies (stage II-IIIA per American Joint Committee on Cancer \\[AJCC\\] 2018)\n* Refuse or ineligible for cisplatin-based neoadjuvant chemotherapy as defined by any of the following:\n\n  * ECOG performance status (PS) \\> 1\n  * Creatinine clearance (calculated or measured) \\\u003C 60 mL\u002Fmin as measured by the Cockcroft-Gault formula\n  * Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0) grade \\>= 2 hearing loss\n  * CTCAE v 5.0 grade \\>= 2 neuropathy\n  * New York Heart Association (NYHA) class \\> II cardiac dysfunction\n* Treatment with anti-PD-1\u002FPD-L1 therapy for non-muscle invasive bladder cancer (NMIBC) is permitted if it is completed \\> 3 months before registration\n* Eligible for radical cystectomy by the following:\n\n  * Fit and planned for radical cystectomy according to local guidelines\n* Archival transurethral resection of bladder tumor (TURBT) tissue submission must be 30 unstained slides. If archival tissue is unavailable, the patient must undergo cystoscopy and biopsy. The tumor sample must contain at least 20% viable tumor\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.\n* Female subjects of childbearing potential and male subjects must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the duration of study participation through 90 days following the last dose of study drug.\n* Hemoglobin \\>= 9.0 g\u002FdL\n* Absolute neutrophil count (ANC) \\> 1500 per mm\\^3\n* Platelet count \\>= 100 x 10\\^9\u002FL\n* International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C 1.5 × upper limit of normal (ULN), unless the patient is receiving anticoagulation therapy provided INR or PTT is within the therapeutic range of the intended anticoagulant therapy\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal\n* Phosphorus ≤ institutional upper limit of normal (ULN)\n* Measured creatinine clearance (CL) \\> 30 mL\u002Fmin or calculated creatinine CL \\> 30 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Must have a life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy\n* Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks before the first dose of trial treatment\n* Has upper tract urothelial carcinoma\n* Has small-cell carcinoma component on histology\n* Evidence of measurable nodal or metastatic disease\n* Concurrent anticancer therapy (e.g., chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, intravesical therapy, or tumor embolization)\n* Received prior systemic chemotherapy for muscle-invasive bladder cancer at any time in the patient's medical history\n* Has received anti-PD-1\u002FPD-L1 therapy or FGFR inhibitor previously for MIBC, except if used in earlier stage urothelial carcinoma such as non-muscle invasive bladder cancer (NMIBC) and completed \\> 3 months prior to registration\n\n  * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n  * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n  * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n  * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.\n* Underwent major surgery and has not recovered adequately from the intervention's toxicity and\u002For complications before starting therapy\n* Has an active second malignancy except for low-risk localized prostate cancer on \"watch and wait\"\n* Subjects with a history of malignancy that has been completely treated, with no evidence of active cancer for 2 years before enrollment, or subjects with surgically cured tumors with a low risk of recurrence are allowed to enroll at PI's discretion (e.g. adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease and effectively treated carcinoma in situ without evidence of disease).\n* Has active cardiac disease, defined as:\n\n  * Myocardial infarction or unstable angina pectoris within 3 months of the first date of study therapy\n  * Unstable arrhythmias\n  * Decompensated heart failure\n  * Uncontrolled hypertension and unstable angina pectoris\n  * Average QT corrected by the Fridericia formula (QTcF) \\> 470 msec (males and females) (Note: If the QTcF is \\> 470 msec in the first electrocardiography \\[ECG\\], a total of 3 ECGs separated by \\>= 5 minutes should be performed. If the average of these 3 consecutive results for QTcF is =\\\u003C 470 msec, the subject meets eligibility in this regard.)\n* Has any medical condition that may prevent the patient from undergoing radical cystectomy\n* Must be at least 2 weeks beyond high-dose systemic corticosteroids; chronic steroid use up to 10 mg daily prednisone (or equivalent), intranasal, inhaled, topical steroids, local steroid injections (e.g., intra articular injection), steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are permitted\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician\n  * Patients with celiac disease controlled by diet alone\n* Has a known history of HIV-1\u002F2 with detectable viral load and\u002For CD4 count \\\u003C 300\u002FmL within the previous 3 months or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Has detectable hepatitis B virus (HBV) or hepatitis C virus (HCV) viral load polymerase chain reaction (PCR) if there is a known history of active hepatitis B or hepatitis C\n* History and\u002For current evidence of significant ectopic mineralization\u002Fcalcification including but not limited to the soft tissues, kidneys, intestines, myocardium, and lungs, except calcified lymph nodes and asymptomatic coronary calcification\n* Current evidence of corneal or retinal disorder\u002F keratopathy including but not limited to bullous\u002F band keratopathy, corneal abrasion, inflammation\u002Fulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination\n* Have current evidence of endocrine alterations of calcium\u002Fphosphate homeostasis (e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis) unless well controlled\n* Have used drugs that are dual p-glycoprotein and strong CYP3A inducers or inhibitors within 7 days prior to the first dose of the study drug\n* Has other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of the study procedure and follow-up examinations\n* Known allergy or hypersensitivity to study drugs or any excipient.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90days after the last dose of IP.\n* Has other uncontrolled illnesses, ongoing or active infection, or serious chronic gastrointestinal conditions associated with diarrhea\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n  * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician\n* History of allogenic organ transplantation",{"count":370,"type":23},24,[115],"This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.",[374,118,281,282],"Bladder Urothelial Carcinoma","2025-12-15",{"date":377,"type":93},"2025-12-17",{"date":379,"type":93},"2024-12-30",{"date":381,"type":23},"2026-12-31",{"name":383,"class":100},"Yuanquan Yang",3,{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":112,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":130},"100557426","interest-of-late-images-for-the-assessment-of-extensions-in-18fgd-pet-ct-of-muscle-invasive-bladder-cancers-100557426","NCT06537960","Interest of Late Images for the Assessment of Extensions in 18FGD PET-CT of Muscle-Invasive Bladder Cancers","Intérêt Des Images Tardives Pour le Bilan d'Extensions en TEP-TDM au 18FGD Des Cancers de Vessie Infiltrant le Muscle (TARDITEP)","TARDITEP","Inclusion Criteria:\n\n* Patient 18 years of age or older,\n* With histologically proven muscle-invasive bladder cancer (≥pT2) at endoscopic bladder resection,\n* Scheduled to undergo 18FDG PET-CT in the nuclear medicine department at Hôpital Foch,\n* Having signed a consent form,\n* Affiliated to a health insurance scheme.\n\nExclusion Criteria:\n\n* Patient with a history of pelvic or genitourinary cancer,\n* Patient with known metastatic disease,\n* Patient with a contraindication to 18FDG PET-CT,\n* Pregnant or breast-feeding woman,\n* Patient deprived of liberty or under guardianship.",{"count":394,"type":23},66,[303],"The goal of this study is to demonstrate a significant gain in sensitivity versus surgical curage (extended pelvic) for initial lymph node staging of late FDG-PET images (2.5 hours) versus standard images (1 hour), analyzed by side (right iliac\u002Fleft iliac areas in Patients with muscle-invasive bladder tumor (MIBT) (≥pT2) referred for FDG-PET in the nuclear medicine department of Hôpital Foch as part of their initial extension workup.\n\nBefore performing 18FDG PET-CT, the operator checks that the patient has fasted for at least 6 hours and that blood glucose levels are below 11 mmol\u002Fl. In the absence of contraindication, intravenous (IV) injection of the radiopharmaceutical (18FDG at a dose of 3 MBq\u002Fkg) and a diuretic (Furosemide 20mg) will be performed as part of routine care. The 18FDG PET-CT scan will be performed in 2 phases:\n\n1st phase: Standard acquisition (vertex to mid-thigh) at 1 hour post-injection of radiotracer. PET acquisition is coupled to a \"base-dose\" CT scan in spontaneous contrast, for anatomical location, measurement of lymph node size, and creation of an attenuation map, necessary for correction of attenuation and diffusion on PET images (DLP estimated at around 500 mGy.cm on average). Micturition is performed as part of routine care just before the first acquisition.\n\nPhase 2: Complementary abdomino-pelvic acquisition at 2.5 hours post-injection (2 or 3 steps depending on patient size. This second PET acquisition is coupled to an \"ultra-base-dose\" CT scan in spontaneous contrast, to be used only for attenuation and diffusion correction (DLP estimated at around 100 mGy.cm on average). Micturition is performed 30 minutes before the second acquisition.\n\nThe patient's proposed therapeutic management will be decided at the PCR once the extension work-up has been carried out, as part of routine care. For this purpose, only \"standard\" 18FDG PET-CT images may be used.\n\nAs a general rule, patients with distant metastases (stage pT2N+M+) will receive palliative treatment, while surgical treatment from the outset, or after chemotherapy for patients with stage pT2N0M0 or pT2N+M0, will be discussed on a case-by-case basis at the multidisciplinary consultation meeting.\n\nLate\" images will be used after lymph node curage, in patients who have not had chemotherapy prior to surgery (cystectomy + extended pelvic lymph node curage), to determine the sensitivity of these complementary images.",[43,226],"2025-11-18",{"date":400,"type":93},"2025-11-21",{"date":402,"type":93},"2023-12-14",{"date":404,"type":23},"2027-03-15",{"name":406,"class":100},"Hopital Foch",{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":112,"phases":416,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":130},"100530700","early-phase-1-prophylactic-antibiotics-in-cystectomy-with-diversion-100530700","NCT06190197","Prophylactic Antibiotics in Cystectomy With Diversion","Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion","Inclusion Criteria:\n\n* Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Currently receiving antimicrobials for active infection\n* Poor renal function with GFR \\\u003C 30 ml\u002Fmin\n* Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)\n* Pregnancy\n* Unable to provide Informed consent\n* Prior pelvic radiation",{"count":415,"type":23},120,[417],"EARLY_PHASE1","Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.",[43,232,420,421],"Ileal Conduit","Neobladder Diversion","2025-11-13",{"date":424,"type":93},"2025-11-17",{"date":426,"type":93},"2024-05-13",{"date":428,"type":23},"2027-10-15",{"name":430,"class":100},"University of Minnesota",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":112,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":130},"100560020","phase-2-gemcitabinecisplatin-plus-cemiplimab-with-or-without-fianlimab-in-localized-muscle-invasive-bladder-cancer-neostop-it-100560020","NCT06571708","Gemcitabine\u002FCisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)","A Phase 2, Randomized, Open-label Study of Gemcitabine\u002FCisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)","NeoSTOP-IT","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Life expectancy \\> 12 months.\n* Performance status of 0-1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T3, N0, M0 stage. Mixed histology is permitted if there is a urothelial component. Upper tract disease in not permitted.\n* Prior Bacillus Calmette-Guerin (BCG) or other intravesical treatment of non-muscle invasive bladder cancer is permitted if completed at least 6 weeks prior to initiating study treatment. Only one course (includes induction + maintenance) of BCG or intravesical therapy is permitted.\n* No metastatic disease based on cross-sectional imaging.\n* Considered cisplatin eligible based on protocol specified criteria.\n* Not received any adjuvant or neoadjuvant chemotherapy or immunotherapy.\n* Agree to pre- and post-treatment TURBT as well as surveillance with cystoscopies, cross-sectional imaging, and urine cytology unless medically contraindicated in the opinion of the treating physician, and discussed with the principal investigator\n\nExclusion Criteria:\n\n* Concurrent upper urinary tract (i.e., ureter, renal pelvis) invasive urothelial carcinoma. (NOTE: Patients with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post- treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible).\n* Received prior immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-LAG-3 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways ), as well as cellular vaccines, cellular therapies, or systemic oncolytic virus therapy.\n* Received bladder-directed radiation therapy previously for bladder cancer.\n* Received prior systemic chemotherapy for muscle-invasive bladder cancer.\n* Receiving any other investigational agents concurrently or within 4 weeks of start of treatment.\n* Had a solid organ or hematologic transplant.\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* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (at a dose greater than 10mg\u002Fday of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* Has a history of myocarditis.\n* Patients with another active second malignancy other than non-melanoma skin cancers.\n* Has a known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.\n* Has an active infection requiring systemic therapy.\n* History or current evidence of significant (Common Terminology Criteria for Adverse Events (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* Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n* Is pregnant or is a breastfeeding woman.",{"count":440,"type":23},36,[115],"The goal of this clinical trial is to learn if gemcitabine\u002Fcisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer?\n\nParticipants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab.\n\nParticipants will:\n\n* Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles)\n* After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging\n* Participants with a complete response will continue maintenance cemiplimab or cemiplimab\u002Ffianlimab for 13 more cycles with imaging every 3 months\n* Participants without a complete clinical response will undergo cystectomy (bladder surgery).",[226,43],[445],"Urothelial Predominant Histology","2025-08-25",{"date":448,"type":93},"2025-09-02",{"date":450,"type":93},"2025-08-14",{"date":452,"type":23},"2028-12",{"name":454,"class":100},"Columbia University",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":169,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":112,"phases":465,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":130},"100557364","phase-2-neo-blast-neoadjuvant-therapy-for-bladder-cancer-followed-by-active-surveillance-vs-treatment-100557364","NCT06537154","NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment","Active Surveillance Versus Definitive Local Therapy for Patients Showing Clinical Complete Response Following Neoadjuvant Therapy for Muscle Invasive Bladder Cancer","NEO-BLAST","Inclusion Criteria:\n\n* Male or female \\>18 years\n* Primary urothelial or predominantly (\\>50%) urothelial carcinoma of the bladder with histologic evidence of muscularis propria invasion.\n* Clinical stage T2-T4aN0M0 (Radiographic lymphadenopathy greater than 1.5 cm in short axis by imaging must be proven by biopsy to be free of cancer)\n* No concomitant multifocal carcinoma in situ; a single focus is allowed.\n* ECOG performance status 0, 1, or 2.\n* Participants must be able to undergo pelvis MRI.\n* Medically appropriate candidate for radical cystectomy (assessed by uro-oncologist) or chemo-radiation (assess by radiation-oncologist and medical-oncologist)\n* Participants must be candidate to received standard of care (SOC) neoadjuvant systemic treatment at time of enrolment (assessed by medical-oncologist): 4 or more cycles of cisplatin-based chemotherapy (gemcitabine\u002Fcisplatin (GC) or methotrexate\u002Fvinblastine\u002FAdriamycin\u002Fcisplatin (MVAC) or dose-dense MVAC (ddMVAC). If SOC evolves from the time of trial design and enrolment, eligibility to any SOC NAT (for example immunotherapy and\u002For antibody drug conjugate, as per NCCN guideline) will be allowed.\n* Adequate bladder function and\u002For absence of significant urethral stricture to allow cystoscopic surveillance, as evaluate by urologist.\n\nExclusion Criteria:\n\n* Any component of small cell or plasmacytoid histology.\n* Prior systemic chemotherapy or immunotherapy (an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) or antibody-drug conjugate (NECTIN-4, HER2 or other) : Participants who have received any previous systemic therapy for urothelial carcinoma or cytotoxic chemotherapy, immunotherapy or other targeted therapy for another malignancy within 2 year of study entry are ineligible.\n* No available bladder tumor tissue from prior TURBT for tumor sequencing.\n* Prior or concurrent malignancy of any other site EXCEPT for non-melanoma skin cancer OR low risk malignancy not requiring treatment (such as prostate cancer Grade Group 1 under adequate surveillance, carcinoma in situ of the breast, cervix, etc.) AND unless free of disease for ≥ 5 years. Other cancers at low risk of recurrence may be allowed after review by principal investigator.\n* Prior radiation therapy for bladder cancer.\n* Participants who have received experimental agents within 4 weeks of study entry.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure (NYHA \\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnancy. People of childbearing potential must have a negative serum pregnancy test before general anesthesia procedure and MRI\n* No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed.",{"count":464,"type":23},688,[115,466],"PHASE3","Invasive bladder cancer is managed with neoadjuvant therapy followed by bladder removal (cystectomy). Research shows that approximately 40% of patient will have no remaining cancer left in their bladder after completion of the initial systemic treatment, and perhaps could have avoided the surgery. However, currently physicians lack the ability to identify these patients.\n\nThe investigators believe that by using advanced imaging (MRI), bladder biopsies and novel biomarkers that detect tumor DNA in blood, they can better identify participants without any remaining cancer after chemotherapy. This will make active surveillance of these participants safer. In this study, participants without evidence of residual cancer will be randomized to active surveillance vs conventional bladder treatment (bladder removal, or chemo-radiation of the bladder). This study will be a pilot randomized control trial (RCT), and if successful, it will transition to a larger phase 3 RCT.",[43],[470,226],"Muscle invasive bladder urothelial carcinoma","2025-07-28",{"date":473,"type":93},"2025-07-30",{"date":471,"type":93},{"date":476,"type":23},"2030-12-31",{"name":478,"class":100},"Peter Black",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":112,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":130},"100535837","phase-2-surveillance-of-the-genetic-signature-in-circulating-tumor-dna-for-guiding-adjuvant-chemotherapy-in-urothelial-carcinoma-100535837","NCT06257017","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma","Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n1. aged 18-70 years old;\n2. a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;\n3. receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;\n4. histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;\n5. Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;\n6. absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment;\n7. adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:\n\n   * ANC≥1500 cells\u002FμL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)\n   * WBC counts \\> 2500 cells\u002FμL\n   * Lymphocyte count ≥ 300 cells\u002FμL\n   * Platelet count ≥ 100,000 cells\u002FμL (without transfusion within 2 weeks prior to Cycle 1, Day 1)\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),\n   * PTT ≤ 1.5 × ULN\n   * PT ≤ 1.5 × ULN or INR \\\u003C 1.7\n   * Calculated creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n8. able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent\n\nExclusion Criteria:\n\n1. receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;\n2. participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;\n3. suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;\n4. conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) \\\u003C50 mL\u002Fmin, hearing impairment, and inadequate marrow function;\n5. anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;\n6. active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;\n7. pregnancy or breastfeeding.","70 Years",{"count":196,"type":23},[115],"Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.",[491,43],"Muscle Invasive Bladder Urothelial Carcinoma",[493,494,495],"circulating tumor DNA","ctDNA","molecular residual disease","2025-04-01",{"date":498,"type":93},"2025-04-04",{"date":500,"type":93},"2024-02-02",{"date":502,"type":23},"2025-12-30",{"name":504,"class":100},"Yung NA",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":112,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":130},"100554012","phase-2-modular-trial-of-sephb4-hsa-in-ephrinb2-high-solid-tumors-100554012","NCT06493552","Modular Trial of sEphB4-HSA in EphrinB2-High Solid Tumors","A Modular, Open Label, Randomized Phase II\u002FIII Trial to Assess Efficacy of Combining sEphB4-HSA (EphrinB2 Inhibitor) With Immunotherapy Regimens in Patients With EphrinB2-High Solid Tumors","Inclusion Criteria:\n\nGeneral Inclusion Criteria for Both Arms\n\n* Willing and able to provide informed consent.\n* Men and women 18 years of age, or older.\n* Must provide the cell block or a minimum of 15 slides from the diagnostic biopsy or archival tissue.\n* Tumor tissue must be submitted for molecular profile through a commercial service such as Tempus, CARIS, Foundation One, etc. This must include a PD-L1 assay.\n* Tumor must express EphrinB2 as assessed by USC Norris Core Lab.\n* Zubrod performance status of less than or equal to 1.\n* Women of childbearing potential must use method(s) of contraception. The individual methods of contraception should be determined in consultation with the treating physician or investigator.\n* Women of childbearing potential are eligible if serum pregnancy test obtained during screening is negative. Women are also eligible if one of the following criteria is met:\n\n  * Have undergone a documented hysterectomy and\u002For bilateral oophorectomy; OR\n  * Have medically confirmed ovarian failure; OR\n  * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; OR\n  * A serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal women.\n* Women must not be breastfeeding.\n* Men who are sexually active with women of childbearing potential must agree to use 2 contraceptive methods with a failure rate of less than 1% per year.\n\n  o NOTE: Contraception should be continued using two highly effective methods for a period of 120 days after the last dose of treatment.\n* Adequate organ function as defined below using baseline laboratory requirements obtained within 14 days prior to randomization:\n\n  * Measured or calculated creatinine clearance (CrCl) greater than or equal to 30 mL\u002Fmin using the Cockcroft-Gault formula using actual weight (NOT ideal or adjusted weights).\n  * WBC ≥2000\u002FuL\n  * Neutrophils ≥1500\u002FuL\n  * Platelets ≥100x103\u002FuL\n  * Hemoglobin ≥9g\u002FdL\n  * AST ≤3 x ULN\n  * ALT ≤3 x ULN\n  * Bilirubin ≤1.5 x ULN\n\nModule A Inclusion Criteria\n\n* Urothelial carcinoma, variant components and differentiations allowed. Pure small cell not allowed.\n* cT2 to cT4a N0M0, by TURBT or imaging.\n* No systemic therapy for cancer in the previous 12 months.\n* Choice of treatment if randomized to the control arm must be declared prior to randomization. If cisplatin ineligible or refusing, pembrolizumab must be approved by patient's insurance prior to randomization.\n\nModule B inclusion Criteria\n\n* Urothelial carcinoma, variant components and differentiations allowed. Pure small cell not allowed.\n* Tumor must be Nectin4 non-amplified- testing performed during pre-screening assessment.\n* No systemic therapy for cancer in the previous 12 months.\n* Measurable disease as defined by RECIST1.1 criteria\n\nExclusion Criteria:\n\n* Patients with known symptomatic brain metastases requiring systemic corticosteroids. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable. Mild neurological deficit is allowed, if it does not interfere with the ability to judge the safety on the trial.\n* History of or active autoimmune disorders (including but not limited to: Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) and other conditions that compromise or impair the immune system.\n* Known active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) -related illness. Routine testing is not required; however, treating physicians may use their discretion to determine whether testing is necessary.\n* Uncontrolled adrenal insufficiency.\n* Any known active chronic liver disease.\n* Concurrent or active second malignancy requiring systemic therapy is excluded.\n* Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.\n* Major surgery less than 6 weeks prior to the first dose of study drug. Minor surgery less than 4 weeks prior to the first dose of study drug. Insertion of vascular access device ≥ 7 days prior to 1st dose of study drug is allowed.\n* History of severe hypersensitivity reaction to any monoclonal antibody.",{"count":513,"type":23},700,[115,466],"Patients with solid tumors that have high expression levels of EphrinB2 are treated with regimens that include EphrinB2 inhibitor, sEphB4-HSA. The primary objective of this study is to demonstrate additive therapeutic benefit for sEphB4-HSA. The secondary objectives are to determine whether the sEphB4-HSA containing regimen is safe and whether the oncological endpoints of importance in each cohort improve as a result of treatment with sEphB4-HSA containing regimen relative to a predefined threshold or to a control arm in the cohort where available. Treatment continues until progression of disease or unacceptable toxicities arise.",[43,517],"Metastatic Urothelial Carcinoma","2025-03-30",{"date":520,"type":93},"2025-04-03",{"date":522,"type":93},"2025-03-15",{"date":524,"type":23},"2034-08",{"name":526,"class":527},"Vasgene Therapeutics, Inc","INDUSTRY",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":112,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":130},"100418147","phase-2-evaluating-the-impact-of-18f-fdg-pet-ct-on-risk-stratification-and-treatment-adaptation-for-patients-with-muscle-invasive-bladder-cancer-100418147","NCT04724928","Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer","Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial","EFFORT-MIBC","Inclusion Criteria:\n\n* Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment\n* T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT\u002F MRI)\n* Age \\> 18 years\n* WHO 0-2\n* Willingness to undergo 18F-FDG-PET-CT\n* Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively\n* Willingness and ability to provide a signed informed consent according to ICH\u002FGCP and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT\u002F MRI)\n* Refusal of or having contraindications to 18F-FDG-PET-CT\n* Refusal of MDT or immunotherapy\n* Prior radiotherapy unabling MDT\n* Contraindications to radiotherapy (including active inflammatory bowel disease)\n* Contraindications to immunotherapy\n* Other primary tumor diagnosed \\\u003C 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.",{"count":537,"type":23},156,[115],"Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.",[43],[542,543,544,545,546,148],"18F-FDG-PET-CT","Staging","Distand metastasis","Oligometastatic disease","Metastasis directed therapy","2025-01-13",{"date":549,"type":93},"2025-01-15",{"date":551,"type":93},"2021-04-29",{"date":553,"type":23},"2030-05",{"name":555,"class":100},"University Hospital, Ghent",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":112,"phases":565,"briefSummary":566,"conditions":567,"keywords":569,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":130},"100500022","pre-habilitation-with-mindfulness-and-exercise-for-patients-undergoing-radical-cystectomy-primer-trial-100500022","NCT05790850","Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)","PRIMER","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged ≥18 years of age\n* Good surgical candidate determined by treating surgeon\n* Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology\n* Adequate Organ Function per protocol definition\n* ECOG performance status ≤2\n* Received medical clearance to complete cardiopulmonary exercise testing\n* Willing to use the personal or study provided devices for monitoring and performing the exercise routines.\n* Fluent in English or Spanish for the EORTC QLQ questionnaire\n* No known contraindications to high intensity exercise\n\nExclusion Criteria:\n\n* Contraindications to participating in aerobic exercise\n* Currently participating in an aerobic exercise program\n* New onset chest pain nor dyspnea with exertion\n* Histologically documented micropapillary or sarcomatoid bladder cancer\n* Distant metastatic carcinoma","90 Years",{"count":345,"type":23},[303],"The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.",[226,568,43],"Non-muscle-invasive Bladder Cancer",[570,571,572,573],"Mindfulness","Meditation","Physical Exercise","Pre-habilitation","2024-12-10",{"date":576,"type":93},"2024-12-16",{"date":578,"type":93},"2023-03-30",{"date":580,"type":23},"2026-06",{"name":582,"class":100},"University of Virginia",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":112,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":130},"100542325","phase-1-rc48-combined-with-toripalimab-as-neoadjuvant-therapy-for-cisplatin-ineligible-mibc-patients-100542325","NCT06341400","RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients","Perioperative Efficacy of RC48 Combined with Toripalimab in Treatment of Cisplatin Ineligible MIBC","Inclusion Criteria:\n\n1. Voluntarily agree to provide written informed consent.\n2. Male or female, aged ≥18 years old.\n3. Patients must be ineligible for cisplatin-based chemotherapy or refuse cisplatin-based chemotherapy because of any of the following:\n\n   Creatinine clearance (CrCl) \\\u003C60 mL\u002Fmin, ECOG performance status (PS) 0-1 Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin, ECOG PS 2 (if the patient is eligible for RC) Hearing impairment ≥ CTCAE level 2 According to CTCAE criteria, neuropathy was ≥ grade 2 The patient declined cisplatin-based chemotherapy\n4. Patients must be medically suitable for TURBT and RC.\n5. Pathological examination and immunohistochemical Her-2 (≥1+)\n6. measurable lesions according to RECIST 1.1.\n7. Adequate organ function, as demonstrated by the following laboratory results within 7 days before study treatment:\n\n   The heart ejection fraction was ≥50%. Hemoglobin ≥9 g\u002FdL; Absolute neutrophil count ≥ 1.5×109 \u002FL and platelet ≥ 100×109 \u002FL; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5×ULN.\n8. All female subjects will be considered to be of reproductive potential unless they are postmenopausal or have been surgically sterilized. Female subjects of childbearing potential had to consent to the use of highly effective contraception. Male subjects of childbearing potential and their female partners had to consent to the use of highly effective contraception.\n9. Be willing to comply with the study access schedule and the prohibitions and restrictions set forth in this Agreement.\n\nExclusion Criteria:\n\n1. known hypersensitivity to components of recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab.\n2. toxicity from previous antineoplastic therapy did not revert to CTCAE grade 0-1 (except grade 2 alopecia).\n3. pleural or abdominal effusion with clinical symptoms requiring ongoing treatment.\n4. history of major surgery within 4 weeks of planned initiation of trial treatment.\n5. received live virus vaccine within 4 weeks after planned initiation of trial treatment.\n6. currently known active HIV or tuberculosis infection.\n7. diagnosed as HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.\n8. there is history or current evidence of any condition, treatment, or laboratory abnormality that the treatment investigator believes may confound the trial results, interfere with the participant's participation throughout the trial, or be inconsistent with the participant's participation.\n9. history of other malignancies within the past 5 years.\n10. known central nervous system metastases\n11. uncontrolled hypertension, diabetes, interstitial lung disease, or chronic obstructive pulmonary disease.\n12. receiving systemic therapy (e.g., immunomodulatory agents, corticosteroids, or immunosuppressive agents) for autoimmune disease within 2 years before study treatment.\n13. NYHA class III heart failure.\n14. pregnancy or lactation.\n15. were assessed by the investigator as unable or unwilling to comply with the requirements of the protocol.",{"count":591,"type":23},55,[114,115],"A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.",[226,43],[596],"Neoadjuvant Therapy","2024-11-30",{"date":599,"type":93},"2024-12-04",{"date":601,"type":93},"2024-06-19",{"date":603,"type":23},"2027-05-01",{"name":605,"class":100},"Zhujiang Hospital",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":112,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":130},"100454928","phase-2-cisplatin-nab-paclitaxel-nivolumab-with-radiotherapy-after-resection-of-non-metastatic-muscle-invasive-bladder-cancer-100454928","NCT05203913","Cisplatin, Nab-paclitaxel, Nivolumab With Radiotherapy After Resection of Non-Metastatic Muscle Invasive Bladder Cancer","Efficacy and Safety of the Combination of Cisplatin Plus Nab-paclitaxel and Nivolumab With Radiotherapy After Maximal Tumor Resection in Non-metastatic Muscle Invasive Bladder Cancer.","CNN-BC","Inclusion Criteria:\n\n1. 18 years old or older\n2. Histologic diagnosis of predominantly urothelial carcinoma of the bladder. Focal differentiation allowed other than small cell histology.\n3. Stage T2-T3 N0M0 (AJCC-TNM version 6) based on trans-urethral resection of bladder tumor (TURBT), CT or MRI imaging, +\u002F- bimanual examination under anaesthesia.\n4. FDG-PET within 6 weeks from the start of treatments, showing no evidence of lymph nodes or metastatic disease.\n5. Attempt of complete trans urethral resection of bladder tumour (TURBT) within 56 days (8 weeks) prior to the start of chemoradiotherapy. If TURBT was performed \\> 8 weeks prior but a recent cystoscopy shows no residual disease, then a repeat TURBT is not necessary.\n6. Life expectancy greater than 6 months\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better\n8. Another primary cancer is allowed only if treated with curative intent at least 3 years prior to enrolment without evidence of recurrence or if the untreated cancer is clinically indolent (e.g., lower risk prostate cancer).\n9. Patients must be considered able to tolerate systemic chemotherapy combined with pelvic intensity-modulated radiation therapy (IMRT) by the joint agreement of the participating radiation oncologist and medical oncologist.\n10. Able and willing to give written informed consent.\n11. For women of childbearing potential (WOCBP), study participants must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) for at least 5 months after the last dose of study intervention. Men receiving any study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of chemotherapy with cisplatin or nab-paclitaxel.\n\n    The investigator or a designated associate is requested to advise the subject how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care. Acceptable methods are oral contraceptives, hormonal implants, hormonal patches, IDU, Diaphragm with spermicides, cervical cape with spermicide, and condom with spermicide.\n12. Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:\n13. Total bilirubin ≤1∙5 × the upper limit of normal (ULN).\n14. Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of their cancer).\n15. International normalized ratio (INR) and partial thromboplastin time (PTT) ≤1∙5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring with at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care.\n16. Platelet count ≥100 000\u002Fmm3, haemoglobin \\>9 g\u002Fdl, absolute neutrophil count \\>1,500\u002Fmm3.\n17. Alkaline phosphatase limit ≤2∙5 × ULN (≤5 × ULN for patients with liver involvement of their cancer).\n18. Creatinine clearance greater than 40 ml\u002Fmin as evaluated by Cockcroft-Gault formula.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for other urothelial tumours.\n2. Prior RT to the pelvis\n3. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or five half-lives of the drug, whichever is longer, prior to enrolment.\n4. Malignancies other than urothelial cancer within 3 years prior to Cycle 1, Day 1:\n\n   1. Patients with localized lower risk prostate cancer (defined as Stage ≤T2b, Gleason score ≤ 7, and PSA at prostate cancer diagnosis ≤ 20 ng\u002FmL \\[if measured\\]) treated with radical prostatectomy and without prostate-specific antigen (PSA) recurrence are eligible.\n   2. Patients with lower risk prostate cancer (defined as Stage T1\u002FT2a, Gleason score ≤ 7 and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n   3. Patients with malignancies of a negligible risk of metastasis or death (e.g., risk of metastasis or death \\\u003C5% at 5 years) are eligible provided they meet all the following criteria:\n   4. Malignancy treated with expected curative intent (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated surgically with curative intent) No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.\n5. Pre-existing medical conditions precluding treatment (e.g., previous history of immune-related adverse reactions, pneumonitis, colitis, etc.)\n6. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n7. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.\n8. Active tuberculosis\n9. For women of childbearing potential (WOCBP), study participants must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year) for at least 5 months after the last dose of study intervention. Men receiving any study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of chemotherapy with cisplatin or nab-paclitaxel.\n\n   Acceptable methods are oral contraceptives, hormonal implants, hormonal patches, IDU, Diaphragm with spermicides, cervical cape with spermicide, and condom with spermicide.\n10. Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor \\[TNFR\\] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n11. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.\n12. Active autoimmune disease that has required systemic treatment in past 2 years.\n13. Received or will receive a live vaccine within 4 weeks prior to first dose of study drug except for vaccine against SARS-CoViD2. Influenza vaccination should be given during influenza season only (approximately October through May in the Northern Hemisphere and approximately April through September in the Southern Hemisphere). Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist®) within 28 days prior to randomization, during treatment or within 5 months following the last dose of nivolumab.\n14. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n15. Active infection requiring IV systemic therapy.\n16. Receipt of therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.\n17. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \\\u003C 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.\n18. Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the course of the study\n19. Prior allogeneic stem cell or solid organ transplant\n20. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.\n21. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies)\n22. Patients with active Hepatitis B virus (HBV) or Hepatitis C virus (HCV)\n23. Not willing or unable to sign a consent form.",{"count":615,"type":23},32,[115],"In this phase II study, eligible patients will be treated with maximal tumor resection and then started treatment within 8 weeks. Chemotherapy, Nivolumab and radiotherapy (RT) will be started on day one. Chemotherapy will be administered weekly during radiotherapy. Radiotherapy will be performed from Monday to Friday for five weeks. Nivolumab will be administered for one year (13 infusions).\n\nPatients will have the complete tumour assessment by computed tomography scan (CT-scan) and cystoscopy up to 5 years after radiotherapy.",[43],[620,621,622,623,624],"nivolumab","nab-paclitaxel","cisplatin","trimodal therapy","radiotherapy","2024-10-03",{"date":627,"type":93},"2024-10-04",{"date":629,"type":93},"2023-05-01",{"date":631,"type":23},"2026-06-15",{"name":633,"class":100},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":638,"acronym":4,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":112,"phases":643,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":658,"locationsCount":130},"100532682","phase-4-the-nephroprotective-effect-of-metformin-with-cisplatin-in-bladder-cancer-100532682","NCT06215976","The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer","Inclusion Criteria:\n\n1. Non-diabetic adults of age between 18 to 65.\n2. Chemotherapy naïve patients diagnosed with bladder cancer.\n3. Patients with stable renal function: eGFR is above 60 ml\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n1. Patients with history of lactic acidosis.\n2. Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).\n3. Unstable renal function (defined as an increase in serum creatinine of 0.3 mg\u002FdL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification\n4. Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).\n5. Severe infection and sepsis.\n\n   * Any infection requiring hospitalization.\n   * Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.\n6. Alcohol intake.\n7. Respiratory failure.\n8. Severe hepatic impairment (Child-Pugh class C).\n9. Patients with metastasis.","65 Years",{"count":642,"type":23},78,[644],"PHASE4","The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:\n\n* To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.\n* To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer",[43],[648,622,649,650,651],"Metformin","nephroprotective effect","nephrotoxicity","bladder cancer","2024-08-19",{"date":654,"type":93},"2024-08-20",{"date":656,"type":93},"2023-06-01",{"date":379,"type":23},{"name":659,"class":100},"Cairo University",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":112,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":682,"locationsCount":130},"100556698","phase-2-bladder-preservation-with-sacituzumab-govitecan--zimberelimab-for-muscle-invasive-bladder-cancer-100556698","NCT06528483","Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer","Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer in Cisplatin-unfit and Unwilling for Cystectomy Patients: Phase II Trial","preSAVE","Inclusion Criteria:\n\n* Participant is at least 18 years old of age, at the time of providing informed consent.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Patients deemed ineligible for Radical Cystectomy (RC) + Retroperitoneal lymphnode dissection (RPNLD) by a urologist and\u002For oncologist and\u002For anesthesiology.\n* Cisplatin unfit patients as per Galsky criteria (ECOG Performance Status of 2 and\u002For creatinine-clearance \\\u003C 60 ml\u002Fmin and\u002For CTCAE Gr ≥ 2 hearing loss and\u002For CTCAE Gr ≥ 2 neuropathy).\n* Cisplatin-fit patients are admitted if they are unwilling to undergo Radical Cystectomy (RC) and unwilling for cisplatin-based chemotherapy.\n* Patients deemed eligible for surgery will be included if they will be unwilling to undergo RC and will be ineligible and\u002For unwilling to cisplatin-based chemotherapy.\n* cT2-cT4 bladder cancer patients with predominant urothelial histology or Squamous cell histologic variant with histological confirmed diagnosis of muscle-invasive bladder cancer (MIBC) obtained via a diagnostic or maximal TURBT performed within 90 days before enrollment.\n* cN0-1 bladder cancer patients with predominant urothelial histology or Squamous cell histologic variant\n* Have adequate organ function as defined as follow (Specimens must be collected within 10 days prior to the start of study intervention):\n\n  * Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study treatment initiations (hemoglobin ≥ 9 g\u002FdL, ANC ≥ 1500\u002Fmm3, and platelets ≥ 100,000\u002FμL).\n  * Adequate hepatic function (bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN or ≤ 5 × ULN if known liver metastases, and serum albumin \\> 3 g\u002FdL).\n  * Creatinine clearance ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation.\n  * International normalized ratio (INR)\u002FPT and PTT or aPTT ≤ 1.5 ULN unless patient is currently receiving therapeutic anticoagulant therapy.\n* Patients with HIV must be on antiretroviral therapy (ART) and have a well-controlled\n\nHIV infection\u002Fdisease defined as:\n\n* Patients on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm3 at time of screening.\n* Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies\u002FmL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening.\n* Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).\n* The combination ART regimen must not contain any medications that may interfere with SN-38 metabolism.\n\nExclusion Criteria:\n\n1. Positive serum pregnancy test (Appendices 9.4) or women who are breastfeeding.\n2. Known hypersensitivity to the study drug, its metabolites, or formulation excipient.\n3. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section.\n4. Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy or targeted small molecule therapy. Patients participating in observational studies are eligible.\n5. Have previously received topoisomerase 1 inhibitors.\n6. Have an active second malignancy. Note: patients with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll. Other exception are localized prostate cancer with a Gleason score of 6 (treated within the last 24 months or untreated and under surveillance) and localized prostate cancer with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence.\n7. Patients with neuroendocrine histology will be excluded.\n8. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n9. Have active serious infection requiring antibiotics.\n10. Have known history of HIV-1 or 2 (or positive HIV-1\u002F2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n11. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n    * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n    * Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n12. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n13. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.\n14. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.",{"count":669,"type":23},63,[115],"Patients with MIBC N0\u002FN1 unwilling or unfit for cystectomy will receive SG + Zimberelimab for 3 cycles of treatment prior of first radiological and TURB re-evaluation.\n\nPatients with stable disease or downstaging will continue Zimberelimab up to 1 year. The goal of this trial is to demonstate that Sacituzumab Govitecan + Zimberelimab can avoid cistectomy and can prolong or avoid recurrence to metastatic disease in selected patients with muscle-invasive bladder cancer.\n\nThe primary endpoint of this trial is Event Free Survival that is defined as clinical evidence of new or progressing nodal or any distant metastatic disease, radical cystectomy, or death due to any cause from date of inclusion to the first documentation of a EFS event.",[226,374,308,43],[651,674,675],"muscle-invasive bladder cancer","bladder sparing","2024-07-25",{"date":678,"type":93},"2024-07-30",{"date":680,"type":23},"2024-12-02",{"date":127,"type":23},{"name":683,"class":100},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":169,"maxAge":4,"enrollmentInfo":691,"targetDuration":693,"studyType":24,"phases":4,"briefSummary":694,"conditions":695,"keywords":696,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":704,"locationsCount":4},"100541097","predicting-response-to-neoadjuvant-chemotherapy-in-muscle-invasive-bladder-cancer-100541097","NCT06325423","Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer","The Impact of Tumor Microenvironment and Clinicopathological Features in Predicting Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Pathologically proven pure urothelial carcinoma, or morphologic variant of urothelial carcinoma.\n* Patients with ≥T2, N0-1, M0, according to American Joint Committee on Cancer (AJCC) TNM Staging System for Bladder Cancer 8th ed., 2017.\n* Patients who received platinum-based neoadjuvant chemotherapy before RC or BP.\n* Available paraffin-embedded TUR specimens for Immunohistochemistry (IHC).\n\nExclusion Criteria:\n\n* Non urothelial carcinoma.\n* Not muscle invasive \\\u003C T2.\n* Metastatic bladder cancer.\n* No available paraffin-embedded TUR specimens for IHC.",{"count":692,"type":23},50,"2 Years","Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.\n\nThe mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.\n\nThe 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.\n\nTumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.\n\nNETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.\n\nOn the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC.",[43],[697],"MIBC","2024-03-22",{"date":700,"type":93},"2024-03-26",{"date":702,"type":23},"2024-04",{"date":245,"type":23},{"name":247,"class":100},{"id":706,"slug":707,"hasResults":12,"nctId":708,"briefTitle":709,"officialTitle":710,"acronym":4,"eligibilityCriteria":711,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":712,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":714,"conditions":715,"keywords":728,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":729,"lastUpdatePostDateStruct":730,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":130},"100529161","study-on-the-quality-of-life-and-pathological-state-in-patients-who-underwent-radical-cystectomy-100529161","NCT06170177","Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy","Inclusion Criteria:\n\n* subjects underwent radical cystectomy\n* \\> 18 years old\n* Ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Inability to read and sign the informed consent",{"count":713,"type":23},4000,"Observational study on the quality of life and pathological state of patients underwent radical cystectomy.",[43,491,716,717,718,719,720,226,721,722,723,724,374,725,726,727,232],"Bladder Cancer TNM Staging","Bladder Cancer Stage IIa","Bladder Cancer Stage IIb","Bladder Cancer Stage IV","Bladder Leiomyosarcoma","Bladder Cancer Stage II","Bladder Cancer Stage IIIa","Bladder Cancer Stage IIIb","Bladder Cancer Stage IIIc","Progression, Disease","Urinary Diversion","Neobladder",[232],"2023-12-06",{"date":402,"type":93},{"date":732,"type":93},"2013-02-04",{"date":734,"type":23},"2063-02",{"name":736,"class":100},"IRCCS San Raffaele"]