[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iiia-bladder-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iiia-bladder-cancer-ajcc-v8":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,54,81,104,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053221","phase-2-combining-immunotherapy-and-radiation-therapy-to-help-patients-avoid-bladder-removal-after-treatment-shrinks-muscle-invasive-bladder-cancer-bright-trial-100053221",false,"NCT07061964","Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial","Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)","Inclusion Criteria:\n\n* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)\n* Participants must have had CT chest\u002Fabdomen\u002Fpelvis (C\u002FA\u002FP), MRI C\u002FA\u002FP or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0\n* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed\n\n  * NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT\n* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT\n* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement\n\n  * NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)\n* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT\n* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology\n* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta\u002FT1\u002Fcarcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy\n\n  * NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\\> 50%) of the tumor is urothelial cell carcinoma\n* Participants will be allowed to continue PD-1\u002FL-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)\n* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \\[GC\\] with or without PD-1\u002FL1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1\u002FL1 inhibitor\n* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC\n\n  * NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed\n* Participants must not have had prior pelvic radiotherapy\n* Participants must not have received a live attenuated vaccination within 28 days prior to registration\n* Participants with conditions requiring immunosuppressive doses of steroids (\\> 10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 3 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)\n\n  * Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)\n* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations","ALL","18 Years",{"count":19,"type":20},111,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.",[26,27,28],"Muscle Invasive Bladder Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-11-25",{"date":37,"type":20},"2027-07-31",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",148,{"id":43,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":21,"phases":45,"briefSummary":24,"conditions":46,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":51,"leadSponsor":52,"locationsCount":53},"100597705",{"count":19,"type":20},[23],[26,27,28],"2026-06-25",{"date":49,"type":33},"2026-06-26",{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},144,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100618494","phase-2-neoadjuvant-intravesical-nadofaragene-firadenovec-with-gemcitabine-cisplatin-and-durvalumab-for-the-treatment-of-muscle-invasive-bladder-cancer-trifecta-trial-100618494","NCT07332351","Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle Invasive Bladder Cancer, TRIFECTA Trial","Intravesical Nadofaragene Firadenovec With Neoadjuvant Chemotherapy and Durvalumab in Patients With Muscle Invasive Bladder Cancer (TRIFECTA)","TRIFECTA","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of screening\n* Ability to understand and willingness to sign the written informed consent document\n* Patients with confirmed muscle-invasive urothelial carcinoma of the bladder (cT2-4a, N0-1, M0 or cT1, N1, M0), who are planning to undergo RC\n* Pure urothelial or mixed histologic subtypes are allowed if urothelial is the primary histology (regardless of the % of conventional urothelial histology)\n* Eligible to receive neoadjuvant cisplatin\u002Fgemcitabine and durvalumab per the patient's medical oncologist's discretion\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Hemoglobin count ≥ 9 gm\u002FdL\n* Absolute neutrophil count of ≥ 1500 cells\u002FuL\n* Platelet count of ≥ 100,000\u002FuL\n* Alanine and aspartate aminotransferase levels ≤ 2.5 x upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN for Gilbert syndrome)\n* Creatinine clearance or estimated glomerular filtration rate (GFR) ≥ 40ml\u002Fmin (using Chronic Kidney Disease Epidemiology Collaboration Formula \\[CKD-EPI\\] 2021 equation)\n* For patients with evidence of, or history of HIV, chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, the viral load must be undetectable, or the infection must have been treated and cured. Patients are not allowed to be on immunosuppressive agents for HIV, HBV or HCV. Routine testing for HIV, HBV and HCV is not required for patients without such history unless clinically indicated\n* Individuals with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are allowed to enroll\n\nExclusion Criteria:\n\n* cT4b, N2-3, or M1 stage at time of screening\n* Any known concurrent clinically relevant malignancies\n* Prior systemic therapy for muscle-invasive bladder carcinoma (MIBC) (prior intravenous pembrolizumab for non-muscle invasive bladder carcinoma \\[NMIBC\\] is allowed)\n* Current or prior use of systemic immunosuppressive medication within 14 days before first dose of investigational product. The following are allowed (not systemic route): intranasal, inhaled, intra-articular, topical steroids, local steroid injections\n* Pure non-urothelial histology subtype\u002Fvariant or any neuroendocrine (small or large cell) component\n* Prior treatment with adenovirus-based drugs\n* Known hypersensitivity or allergy to any components of rAd-interferon (IFN)a\u002FSyn3\n* Currently receiving other investigational agent\n* Pregnant or lactating women",{"count":63,"type":20},33,[23],"This phase II trial tests the effect of intravesical nadofaragene firadenovec in combination with gemcitabine, cisplatin and durvalumab before (neoadjuvant) radical cystectomy (RC) in treating patients with muscle invasive bladder cancer. The combination of gemcitabine, cisplatin and durvalumab are already considered standard of care in the treatment of muscle invasive bladder cancer. This trial attempts to determine whether the addition of nadofaragene firadenovec to the current standard regiment is safe and can improve oncological outcomes for those with muscle invasive bladder cancer.\n\nNadofaragene firadenovec, a type of intravesical gene therapy, is a weakened adenovirus that carries a copy of the gene for interferon alfa-2b. This medication gets absorbed by the bladder and stimulates the bladder to naturally create interferon alfa-2b, which is thought to kill bladder cancer. Nadofaragene firadenovec is given in a solution that is placed directly into the bladder (intravesical) using a thin tube called a catheter. It is a medication that is already FDA approved for the treatment of non-muscle invasive bladder cancer. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread.",[26,27,28],[68],"Urinary Bladder","NOT_YET_RECRUITING","2026-06-04",{"date":72,"type":33},"2026-06-08",{"date":74,"type":20},"2026-09-01",{"date":76,"type":20},"2027-02-01",{"name":78,"class":79},"University of Washington","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100600411","phase-3-testing-shorter-duration-radiation-therapy-versus-the-usual-radiation-therapy-in-patients-receiving-the-usual-chemotherapy-treatment-for-bladder-cancer-archer-study-100600411","NCT07097142","Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study","The Phase III Adaptive Radiation and Chemotherapy for Muscle Invasive Bladder Cancer Trial (ARCHER)","Inclusion Criteria:\n\n* Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.\n\n  * Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible\n* Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection\n* Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable). Patients must not have evidence of T4 or node positive disease. Fluorodeoxyglucose (FDG) PET imaging is acceptable for radiological staging\n* If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT \u002F MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement prior to randomization\n* No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy\n* No definitive clinical or radiologic evidence of metastatic disease\n* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta\u002FT1\u002FCarcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy\n* Age ≥ 18\n* Zubrod performance status of ≤ 2\n* Not pregnant and not nursing\n\n  * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm\\^3\n* Hemoglobin ≥ 8.0 g\u002Fdl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\]) ≥ 8.0 g\u002Fdl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL\u002Fmin by the Cockcroft-Gault formula\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization\n* For patients who have completed neoadjuvant therapy, they are eligible if the pre-neoadjuvant therapy diagnosis (TURBT path) is within 180 days before randomization\n* Must not have had prior pelvic radiation\n* New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified",{"count":89,"type":20},486,[91],"PHASE3","This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.",[26,27,28],"2026-04-28",{"date":96,"type":33},"2026-05-04",{"date":98,"type":33},"2025-10-07",{"date":100,"type":20},"2030-05-31",{"name":102,"class":79},"NRG Oncology",211,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":80},"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":112,"type":20},47,[114,23],"PHASE1","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.",[117,118,27,28],"Bladder Cancer","Muscle-Invasive Bladder Carcinoma","2026-02-13",{"date":121,"type":33},"2026-02-18",{"date":123,"type":33},"2025-03-31",{"date":125,"type":20},"2028-01-31",{"name":127,"class":79},"University of California, San Francisco",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"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":136,"type":20},24,[23],"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.",[140,141,27,28],"Bladder Urothelial Carcinoma","Muscle Invasive Bladder Carcinoma","2025-12-15",{"date":144,"type":33},"2025-12-17",{"date":146,"type":33},"2024-12-30",{"date":148,"type":20},"2026-12-31",{"name":150,"class":79},"Yuanquan Yang",3]