[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,63,90,126,158,191,215,244,266,296,323,351,375,405,434,458,485,516,542,566,588],{"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":28,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100636474","phase-3-enfortumab-vedotin-in-combination-with-pembrolizumab-vs-concurrent-chemoradiotherapy-ccrt-in-people-with-muscle-invasive-bladder-cancer-ev-309-100636474",false,"NCT07566156","Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)","A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE ENFORTUMAB VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB IN ADULT PARTICIPANTS WITH MUSCLE-INVASIVE BLADDER CANCER WHO ARE INELIGIBLE FOR OR HAVE ELECTED NOT TO UNDERGO CYSTECTOMY","Inclusion Criteria:\n\n* Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0\n* Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline\n* Eligible for and agree to receive chemoradiotherapy and one of the protocol-specified radiosensitizing chemotherapy regimens\n* Fit for systemic therapy and elect bladder preservation, including participants who are ineligible for or have elected not to undergo cystectomy\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Advanced or metastatic disease (N+, M1), non-urothelial carcinoma, diffuse or multifocal CIS, urothelial carcinoma or histological variant at any site outside the urinary bladder within previous 24 months prior to randomization except Ta\u002FT1\u002FCIS of the upper urinary tract including renal pelvis and ureter if the participant had undergone complete nephrectomy\n* Has received any prior systemic treatment, chemoradiation, and\u002For radiation for MIBC or NMIBC\n* Prior pelvic radiation for any reason\n* Inadequate bladder function\n* Other active malignancies within 3 years prior to randomization\n* Previously treated with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs)\n* Previously treated with a PD(L)-1 inhibitor, defined as a PD-1 inhibitor or PD-L1 inhibitor\n* Uncontrolled diabetes\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted\n* Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection\n* Received major surgery (defined as requiring general anesthesia and \\>24 hour inpatient hospitalization) within 4 weeks prior to randomization\n* Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin\n* Known genetic disorders associated with radiosensitivity (eg, ataxia telangiectasia, Nijmegen breakage syndrome, Fanconi syndrome)\n* Active keratitis or corneal ulcerations\n* History of autoimmune disease that has required systemic treatment in the past 2 years\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Prior allogeneic stem cell or solid organ transplant\n* Received a live attenuated vaccine within 30 days prior to randomization","ALL","18 Years",{"count":19,"type":20},390,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together as a bladder preservation approach to treat patients with muscle invasive bladder cancer. The study will compare these drugs to concurrent chemoradiotherapy that is usually used to treat this cancer (standard of care). The study will enroll patients with muscle-invasive bladder cancer (MIBC) who have cancer that has not spread outside the bladder.",[26,27],"Urothelial Cancer","Urinary Bladder Neoplasms",[29,30,31,32,33,34,35,36,37,38,39,27,40,41,42,43,44,45,46,26,47,48,49],"Urologic Neoplasms","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Female Urogenital Diseases","Female Urogenital Diseases and Pregnancy","Complications","Urogenital Diseases","Urinary Bladder Diseases","Urologic Diseases","Male Urogenital Diseases","Cisplatin","Fluorouracil","Mitomycin","Gemcitabine","Muscle Invasive Bladder Cancer","Enfortumab vedotin","Pembrolizumab","Urothelial Carcinoma","Bladder-sparing","Bladder Preservation","RECRUITING","2026-07-01",{"date":53,"type":54},"2026-07-02","ACTUAL",{"date":56,"type":54},"2026-05-11",{"date":58,"type":20},"2032-02-29",{"name":60,"class":61},"Astellas Pharma Global Development, Inc.","INDUSTRY",11,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100602936","phase-2-study-of-datopotamab-deruxtecan-plus-carboplatin-or-cisplatin-versus-gemcitabine-plus-carboplatin-or-cisplatin-in-participants-with-locally-advanced-or-metastatic-urothelial-carcinoma-100602936","NCT07129993","Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized, Open-Label, Phase 2\u002F3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)","Key Inclusion Criteria:\n\n* Adult ≥18 years at the time the ICF is signed (if the legal age of consent is \\> 18 years old, then follow the local regulatory requirements).\n* Histologically or cytologically confirmed unresectable locally advanced (T4b, any N; or any T, N 2-3) or metastatic (any T, any N, M1) urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra.\n\nParticipants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible if the histology is predominantly urothelial.\n\n\\> Note 1: Urachal, small cell, and adenocarcinoma histology is not permitted.\n\n* Note 2: Participants with la\u002FmUC and a history of nonclinically active prostate cancer are allowed into the trial if:\n\n  1. Participant does not have radiological metastasis of a proven prostate cancer.\n  2. Participant with nonmetastatic prostate cancer do not have rising PSA (as determined using local testing by a validated or approved test method) defined as follows:\n\n     * Increase in PSA within 2 consecutive measurements separated by at least 1 week (completed within 4 weeks prior to consent or within Screening) and neither of the measurements with an absolute value above 2 ng\u002FmL.\n  3. Participant does not currently receive androgen deprivation therapy for the treatment of prostate cancer.\n* Note 3: Participant with MIBC (T2-T4aN0M0 or T1-T4aN1M0) who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1\u002FPD-L1 inhibitors) as neoadjuvant\u002Fadjuvant therapy and progressed during treatment or within 12 months of treatment completion may be considered for enrollment, with approval from the Sponsor's Medical Monitor or designee.\n\n  * Must provide tumor tissue sample from archival tissue or newly obtained pretreatment biopsy for exploratory biomarker testing. Tumor tissue sample should not be collected from a lesion that was irradiated unless documentation can be provided confirming that the tumor tissue was collected at least 3 months after radiation and the lesion increased\u002Fappeared since radiation occurred. Tumor tissue must be of sufficient quantity (as defined in the Laboratory Manual).\n\n    a. Archival tissue collected after the most recent anticancer treatment and within 12 months before the informed consent date is preferred.\n  * Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment. Participants eligible for cisplatin will receive cisplatin. If a participant received gemcitabine, carboplatin, or cisplatin for early UC in the adjuvant\u002Fneoadjuvant setting, the decision to rechallenge the participant with platinum therapy will be at the discretion of the investigator. Participants only receive carboplatin if they are ineligible for cisplatin. Participants are cisplatin-ineligible if they meet any of the following criteria:\n\n    1. GFR \\\u003C60 mL\u002Fmin (GFR may be estimated by calculated CrCl using the Cockcroft-Gault formula, Modification of Diet in Renal Disease, or 24-hour urine)\n\nFor Phase 2 part:\n\n* Participants with a GFR \\\u003C60 mL\u002Fmin but ≥50 mL\u002Fmin but have no other cisplatin ineligibility criteria (items b, c, and d) may be considered cisplatin-eligible based on the investigator's clinical judgment.\n\nFor Phase 3 Part:\n\n* Participants with borderline renal function CrCl ≥40 mL\u002Fmin to \\\u003C60 mL\u002Fmin who have no other cisplatin ineligibility criteria (items b, c, and d) may receive cisplatin using a split-dose regimen, administered as cisplatin 35 mg\u002Fm2 on Days 1 and 8 of each 21-day cycle, for a maximum of 4 to 6 cycles.\n* In participants with CrCl ≥50 mL\u002Fmin to \\\u003C60 mL\u002Fmin, full-dose cisplatin may also be administered at the investigator's discretion, based on the overall clinical assessment.\n\nThe dosing schedule and dose level for Dato-DXd or gemcitabine are not altered when combined with either split-dose or full-dose cisplatin.\n\nFor both Phase 2 and Phase 3:\n\nb. NCI-CTCAE Grade ≥2 audiometric hearing loss c. NCI-CTCAE Grade ≥2 peripheral neuropathy d. NYHA Class III heart failure\n\n• Must have experienced radiographic progression or relapse during or after 1L of EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors).\n\nParticipants who discontinued EV (or other agents with a vedotin payload) and pembrolizumab (or other PD-1\u002FPD-L1 inhibitors) in 1L due to toxicity are eligible if they have experienced disease progression following discontinuation. Participant who received EV (or other agents with a vedotin payload) plus pembrolizumab (or other PD-1\u002FPD-L1) inhibitors in a neoadjuvant\u002Fadjuvant setting and progressed during treatment or within 12 months of treatment completion will also be considered for enrollment, after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n\nKey Exclusion Criteria:\n\n* Has had prior systemic therapy other than the combination of EV and pembrolizumab for la\u002FmUC. The following participants may be considered eligible after approval by the Sponsor's Medical Monitor or Sponsor's designee.\n\n  a. Participant who progressed during or after treatments with assets that include either anti-Nectin 4 or vedotin payload (MMAE or other microtubule inhibitors) combined with PD1\u002FPD-L1 inhibitors in 1L la\u002FmUC.\n* Treatment with any of the following:\n\n  1. History of an allogeneic bone marrow or solid organ transplant.\n  2. Concomitant treatment with any prohibited medications in this protocol.\n  3. Prior TROP2 directed ADC therapy.\n* Uncontrolled or significant cardiovascular disease, including:\n\n  1. QTcF interval \\>470 ms based on the average of triplicate 12-lead (ECG per local read) at screening.\n  2. Myocardial infarction within 6 months prior to randomization.\n  3. Uncontrolled angina pectoris within 6 months prior to randomization.\n  4. NYHA Class 3 or 4 congestive heart failure at screening.\n  5. Uncontrolled hypertension (resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).\n* Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening.\n* Has clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior complete pneumonectomy.\n* Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \\>2 for at least 3 months prior to randomization and managed with standard of care treatment) which the investigator deems related to previous anticancer therapy, comprised of (including but not limited to):\n\n  1. Anticancer therapy-induced neuropathy\n  2. Residual toxicities from prior immunotherapy treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n* Hypothyroidism\u002F hyperthyroidism\n* Type I diabetes\n* Hyperglycemia\n* Adrenal insufficiency\n* Adrenalitis c. Skin hypopigmentation (vitiligo)",{"count":71,"type":20},630,[73,23],"PHASE2","This is a global, multicenter, randomized, open-label, Phase 2\u002F3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la\u002FmUC who progressed during or after EV plus pembrolizumab combination treatment.\n\nThis trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified when the data allow sufficient assessment of activity, safety, and tolerability. The Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into consideration the totality of information.",[26,76],"Bladder Cancer",[47,78,79,80,81],"Dato-DXd","TROPION","DS-1062a","Datopotamab Deruxtecan",{"date":53,"type":54},{"date":84,"type":54},"2025-09-26",{"date":86,"type":20},"2030-01-22",{"name":88,"class":61},"Daiichi Sankyo",100,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":112,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100575356","phase-1-slv-154-treatment-of-metastatic-solid-tumors-100575356","NCT06771219","SLV-154 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:\n\n   1. SCCHN\n   2. NSCLC\n   3. SCLC\n   4. Breast cancer\n   5. Cervical cancer\n   6. Endometrial cancer\n   7. Ovarian cancer\n   8. Urothelial cancer\n   9. Sarcoma\n   10. Thyroid cancer\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.",{"count":98,"type":20},70,[100],"PHASE1","This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.",[103,104,105,106,107,108,109,26,110,111],"Squamous Cell Cancer of Head and Neck (SCCHN)","NSCLC","SCLC","Cervical Cancer Metastatic","Breast Cancer Metastatic","Endometrial Cancer","Ovarian Cancer","Sarcoma","Thyroid Cancer",[113,114,115],"metastatic solid tumors","metastatic cancer","solid tumor","2026-06-29",{"date":118,"type":54},"2026-06-30",{"date":120,"type":54},"2025-05-14",{"date":122,"type":20},"2027-04",{"name":124,"class":61},"Solve Therapeutics",10,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":144,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":157},"100371266","phase-2-anti-pd-1-mab-plus-metabolic-modulator-in-solid-tumor-malignancies-100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or 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.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":134,"type":20},72,[73],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[138,104,139,26,140,141,142,143],"Melanoma","Hepatocellular Carcinoma","Gastric Adenocarcinoma","HNSCC","Esophageal Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor",[145,146],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)","2026-06-18",{"date":149,"type":54},"2026-06-23",{"date":151,"type":54},"2020-09-14",{"date":153,"type":20},"2032-04-30",{"name":155,"class":156},"Dan Zandberg","OTHER",1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100476843","phase-2-study-of-dato-dxd-as-monotherapy-and-in-combination-with-anti-cancer-agents-in-patients-with-advanced-solid-tumours-tropion-pantumor03-100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd","130 Years",{"count":167,"type":20},454,[73],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[108,171,172,109,173,26,174],"Gastric Cancer","Metastatic Castration-resistant Prostate Cancer","Colorectal Cancer","Biliary Tract Cancer",[176,177,178,179,180],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)","2026-06-16",{"date":183,"type":54},"2026-06-17",{"date":185,"type":54},"2022-09-06",{"date":187,"type":20},"2027-10-01",{"name":189,"class":61},"AstraZeneca",96,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100601151","phase-2-phase-23-trial-of-izalontamab-brengitecan-vs-platinum-based-chemotherapy-for-metastatic-urothelial-cancer-with-disease-progression-on-or-after-immunotherapy-100601151","NCT07106762","Phase 2\u002F3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy","IZABRIGHT-Bladder01: A Randomized, Open-label, Phase 2\u002F3 Trial of Izalontamab Brengitecan Versus Platinum-based Chemotherapy for Metastatic Urothelial Cancer in Participants With Disease Progression on or After an Immunotherapy-based Treatment","Inclusion Criteria:\n\n* Participants must have histologically confirmed advanced urothelial carcinoma.\n* Participants must be eligible to receive platinum-based chemotherapy.\n* Participants must be Anti-PD-(L)1-experienced (in locally advanced or metastatic setting), either in combination with or sequential to another systemic therapy.\n* Participants treated only in the peri-operative setting must have relapsed within 12 months of the last dose of the treatment.\n* Participants must have ≥ 1 measurable lesion per RECIST v1.1.\n* Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n\nExclusion Criteria:\n\n* Participants must not have platinum-based chemotherapy exposure within 12 months.\n* Participants must not have received \\>2 prior regimens irrespective of the setting.\n* Participants must not have prior ADC therapy targeting EGFR or HER3.\n* Participants must not have prior therapy with topoisomerase 1 inhibitor.\n* Participants must not have active, untreated brain metastases.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":199,"type":20},470,[73,23],"A Phase 2\u002F3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer with Disease Progression on or After Immunotherapy",[26],[204],"Bladder cancer","2026-06-05",{"date":207,"type":54},"2026-06-08",{"date":209,"type":54},"2025-09-30",{"date":211,"type":20},"2033-11-18",{"name":213,"class":61},"Bristol-Myers Squibb",163,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":224,"conditions":225,"keywords":228,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":157},"100433365","a-multi-center-natural-history-of-urothelial-cancer-and-rare-genitourinary-tract-malignancies-100433365","NCT04923178","A Multi-Center Natural History of Urothelial Cancer and Rare Genitourinary Tract Malignancies","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed urothelial or rare genitourinary cancer including but not limited to the following: small cell carcinoma of the bladder; adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma; any penile cancer; any testicular cancer, sarcomatoid renal cell carcinoma; sarcomatoid urothelial carcinoma; renal medullary carcinoma or other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to micropapillary, giant cell, lipid-rich, clear cell and nested variants, large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer, testicular Sertoli or Leydig cell tumors. Any genitourinary cancer can be included at the principal investigator's discretion.\n* Age \\>=18 years.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-None",{"count":222,"type":20},1100,"OBSERVATIONAL","Background:\n\nTumors in the genitourinary tracts can occur in the kidney, bladder, prostate, and testicles and can have common and rare histologies. Some cancers that occur along the genitourinary (GU) tract are rare. Some GU tumors are so rare that they are not included in treatment studies or tissue banks. This makes it hard for researchers to determine standards of care. Researchers want to learn more about common and rare GU tumors.\n\nObjective:\n\nTo learn more about urinary tract cancers.\n\nEligibility:\n\nPeople ages 18 and older with urinary tract or GU cancer such as bladder, kidney, testicular, prostate, penis, or neuroendocrine cancer.\n\nDesign:\n\nParticipants will be screened with questions about their medical history. Their medical records will be reviewed.\n\nParticipants will have a physical exam. They will give blood and urine samples. They will complete a survey about their family cancer history. Clinical photographs will be taken to document skin lesions.\n\nParticipants may have imaging scans of their chest, abdomen, and pelvis. They may have a contrast agent injected into their arm.\n\nParticipants will get recommendations about how to best manage and treat their cancer. They can ask as many questions as they would like.\n\nParticipants will provide existing tumor samples if available. They may have optional tumor biopsies up to twice a year. For needle biopsies, the biopsy area will be numbed and they will get a sedative. A needle will be inserted through their skin to collect a tumor sample. For skin biopsies, their skin will be numbed. A small circle of skin will be removed.\n\nSome blood and tumor samples may be used for genetic tests.\n\nParticipants will have frequent follow-up visits. If they cannot visit NIH, their home doctor will be contacted. They will be followed on this study for life....",[26,76,226,30,227],"Genitourinary Cancer","Urogenital Cancer",[229,230,231,232,233,234],"bladder\u002Furachal adenocarcinoma","renal tumors","penile cancers","small cell neuroendocrine carcinoma of the prostate","Renal Cell Carcinoma","Natural History","2026-06-04",{"date":205,"type":54},{"date":238,"type":54},"2022-10-24",{"date":240,"type":20},"2042-12-01",{"name":242,"class":243},"National Cancer Institute (NCI)","NIH",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":157},"100380606","phase-1-bintrafusp-alfa-m7824-and-pds01adc-alone-and-in-combination-with-stereotactic-body-radiation-therapy-sbrt-in-adults-with-metastatic-non-prostate-genitourinary-malignancies-100380606","NCT04235777","Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies","A Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies","* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed diagnosis of a metastatic non-prostate genitourinary tumor.\n* Participants must have metastatic disease defined as new or progressive lesions on cross-sectional imaging. Radiological evaluation should occur within 21 days prior to enrollment.\n* Participants must have evaluable or measurable disease, per RECIST 1.1.\n* Participants in Arms 2 and 3 must have at least one site of disease that is amenable to irradiation (irradiation of up to 4 different sites is permitted)\n* Participants must have at least one measurable site of disease (according to RECIST criteria) that will not be irradiated.\n* Participants may have been previously treated with cytotoxic chemotherapy regimen or targeted agent. Participants may have received any number of prior cytotoxic agents.\n* Participants may have been previously treated with radiation therapy. However, re-irradiation of a previously irradiated site is not permitted unless explicitly discussed with protocol PI and treating radiation oncologist.\n* Participants may have had prior immunomodulating therapy including therapy with a checkpoint inhibitor but excluding prior treatment with M7824 and\u002For PDS01ADC.\n* Participants with locally advanced\u002Fmetastatic clear cell renal cell cancer must have previously received, refused or been ineligible for either axitinib plus pembrolizumab, cabozantinib plus nivolumab, levantinib plus pembrolizumab, axitinib plus avelumab, nivolumab plus ipilumumab, cabozantinib, pazopanib, sunitinib or axitinib.\n* Participants with locally advanced or mestastatic germ cell tumors must have received, refused or been ineligible for prior bleomycin plus etoposide plus cisplatin, etoposide plus cisplatin, etoposide plus ifosfamide plus cisplatin, vinblastine plus ifosfamide plus cisplatin, paclitaxel plus ifosfamide plus cisplatin or autologous hematopoietic cell transplantation.\n* Participants with locally advanced\u002Fmetastatic urothelial cancer must have previously received, refused or been ineligible for platinum chemotherapy and\u002For single agent PD-1\u002FPD-L1 inhibitor.\n* Pre-treatment tissue availability for PD-L1 expression testing is mandatory for enrollment. If tissue is determined to be of insufficient\u002Funsuitable quality\u002Fquantity, a pre-treatment biopsy prior to initiation of study therapy will be required.\n* Male and female participants who are at least 18 years of age on the day of signing the informed consent will be enrolled in the study.\n* ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes greater than or equal to 2500mcL\n  * absolute neutrophil count greater than or equal to 1500\u002FmcL\n  * platelets greater than or equal to 100,000\u002FmcL\n  * Aspartate Aminotransferase (AST)\u002F Alanine Aminotransferase (ALT) less than or equal to 1.5 X institutional upper limit of normal (ULN)\n  * Hemoglobin (Hgb) greater than or equal to 9g\u002FdL (Packed red blood cells (pRBC) transfusions are allowed to achieve acceptable Hgb)\n* Participants may have mild to moderate hepatic impairment with total bilirubin less than or equal to 3.0 x ULN.\n* For participants with liver involvement in their tumor, we allow the following: AST less than or equal to 5.0 x ULN, ALT less than or equal to 5.0 x ULN, and bilirubin less than or equal to 3.0 x ULN.\n* Calculated Creatinine clearance greater than or equal to 20 mL\u002Fmin (using either CKD-EPY equation)\n* The effects of M7824 and\u002For PDS01ADC on the developing human fetus are unknown. For this reason, individuals of child-bearing potential (IOCBP) and individuals able to father a child must agree to use strict and effective contraception during treatment and after the last dose of M7824 administration - at least 65 days after for IOCBP and 125 days after for individuals able to father a child. Should IOCBPs become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately.\n* Human Immunoodeficiency Virus (HIV)-positive participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), CD4 counts are greater than 350 cells\u002Fmm3 and viral load is undetectable.\n* Participants with previously treated brain or central nervous system (CNS) metastases are eligible provided that the participant has recovered from any acute effects of radiotherapy and is not requiring steroids, and any whole brain radiation therapy was completed at least 2 weeks prior to M7824 administration, or any stereotactic radiosurgery was completed at least 2 weeks prior to M7824 administration.\n* Hepatitis B Virus (HBV) positive participants are eligible-they must have been treated and on a stable dose of antivirals \\[eg, entecavir, tenofovir, or lamivudine; (adefovir or interferon are not allowed)\\] at study entry and with planned monitoring and management according to appropriate labeling guidance.\n* Hepatitis B Virus (HCV) positive participants are eligible if participants are on active HCV therapy at study entry and must be on a stable dose without documented clinically significant impaired liver function test or hematologic abnormalities and with planned monitoring and management according to appropriate labeling guidance.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to M7824 and\u002For PDS01ADC investigational agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Participants with a history of bleeding diathesis or recent clinically significant bleeding events considered by the Investigator as high risk for investigational drug treatment are also excluded with the exception of hematuria.\n* Participants unwilling to accept blood products as medically indicated\n* Pregnant individuals are excluded from this study because M7824 and\u002For PDS01ADC are agents with 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 M7824 and\u002For PDS01ADC, nursing should be discontinued if the nursing individual is treated with these agents.\n* Participants with any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required treatment with either systemic corticosteroids (\\> 10 mg daily prednisone equivalent) or immunosuppressive medications. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants with inflammatory bowel disease that have been in remission for at least 5 years whether or not they are currently on immunosuppressive therapy provided that they are not on systemic corticosteroids (\\> 10mg daily prednisone equivalent) are eligible.\n* Participants with any active or recent history of inflammatory bowel disease, active lupus or scleroderma or other medical conditions (i.e., pneumonits with planned SBRT to lung lesion) or genetic radiosensitivity syndromes will be excluded from the study unless deemed eligible by Principal Investigator because these diseases make the participant unsafe or ineligible for radiation therapy with SBRT.\n* Participants with a \"currently active\" second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ or incidental organ-confined prostate cancer found on cystoprostatectomy (provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score \\\u003C= 3+4, Prostate-Specific Antigen (PSA) undetectable). Participants are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for \\>= 2 years and currently do not require systemic therapy.\n* Participants having tumor lesion(s) in the liver or chest which are 10 cm or larger.","120 Years",{"count":89,"type":20},[100],"Background:\n\nGenitourinary cancers are some of the most common types of cancer. They are lethal when they spread. The drug M7824 blocks the paths that cancer cells use to stop the immune system from fighting cancer. The drug PDS01ADC triggers the immune system to fight cancer. Researchers want to learn if these drugs can help fight these cancers when given with and without Stereotactic Body Radiation Therapy (SBRT) radiation.\n\nObjective:\n\nTo learn if M7824 and PDS01ADC, with or without SBRT, can help the immune system to fight cancer better.\n\nEligibility:\n\nPeople 18 and older with cancer that started in the bladder, kidneys, or other genitourinary organs (but not the prostate) and has spread to other parts of the body.\n\nDesign:\n\nParticipants will be screened with:\n\nmedical history\n\nphysical exam\n\nability to do their normal activities\n\nblood tests\n\nurine tests\n\nelectrocardiogram\n\nbody scans.\n\nParticipants will give a tumor sample or have a tumor biopsy.\n\nScreening tests will be repeated during the study.\n\nParticipants will get PDS01ADC . It is injected under the skin every 4 weeks. They will also get M7824 through an intravenous (IV) infusion every 2 weeks. For this, a small plastic tube is put into a vein in the arm. They will get these drugs in 28-day cycles until they leave the study. They may have SBRT.\n\nParticipants will give tissue and saliva samples.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will get phone calls or emails every 12 weeks indefinitely.",[26,76,226,30,227],[257,233,258,259],"Immunocytokine","Urothelial carcinoma","Immune Therapy",{"date":205,"type":54},{"date":262,"type":54},"2020-07-13",{"date":264,"type":20},"2027-12-01",{"name":242,"class":243},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100625366","phase-1-symbiotic-gu-06-a-study-to-learn-about-pf-08634404-alone-or-in-combination-with-enfortumab-vedotin-in-urothelial-cancer-100625366","NCT07421700","Symbiotic-GU-06: A Study to Learn About PF-08634404 Alone or In Combination With Enfortumab Vedotin in Urothelial Cancer","AN INTERVENTIONAL PHASE 1B\u002F2, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY, ANTITUMOR ACTIVITY, AND PHARMACOKINETICS OF PF 08634404 MONOTHERAPY OR IN COMBINATION WITH ENFORTUMAB VEDOTIN IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER","Inclusion Criteria:\n\n* Age ≥18 years at the time of screening.\n* Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA\u002FmUC).\n* Measurable disease per RECIST v1.1 criteria.\n* ECOG performance status of 0 or 1.\n* Adequate organ function, including hematologic, hepatic, and renal parameters.\n* Willingness to comply with study procedures and provide informed consent.\n* For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.\n\nExclusion Criteria:\n\nParticipants will be excluded if they meet any of the following:\n\n* History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy\n* Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Active autoimmune diseases requiring systemic treatment within the past 2 years\n* Participation in another investigational study within 30 days or 5 half-lives of the investigational product.\n* Pregnant or breastfeeding individuals.\n* Inability or unwillingness to comply with study requirements.\n* Study staff or their immediate family members directly involved in the conduct of the study.",{"count":274,"type":20},132,[100,73],"This study is being done to learn more about a new medicine called PF-08634404. It is for adults with a type of bladder cancer called locally advanced or metastatic urothelial cancer (LA\u002FmUC), meaning the cancer has spread to nearby tissues or other parts of the body.\n\nThe purpose of the study is to see if PF-08634404 is safe, how well it works, how it moves through the body, and how it affects the cancer. The study will also look at how the medicine may change certain markers in the body that are linked to cancer.\n\nTo join the study, participants must:\n\n* Be adults (18 years or older) and\n* Have locally advanced or metastatic urothelial cancer,\n\nThe study has two groups:\n\n* Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.\n* Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.\n\nEveryone in the study will get the study medicine through a vein (IV infusion) with or without enfortumab vedotin. Treatment will continue as long as it helps and side effects are manageable.\n\nBefore starting, participants will go through a screening period to check if they are eligible. During the study, they will have regular visits for treatment, health checks, and tests to see how the cancer is responding. Scans will be done regularly to monitor the cancer.\n\nIf the cancer gets worse but the treatment is still helping and side effects are manageable, participants may be allowed to continue treatment with their doctor's and the sponsor's agreement.",[26,278,47],"Advanced\u002FMetastatic Urothelial Cancer",[280,281,282,283,284,285,286],"urothelial cancer","metastatic urothelial cancer","locally advanced urothelial cancer","bladder cancer","urothelial carcinoma","PD-1","VEGF","2026-06-03",{"date":235,"type":54},{"date":290,"type":54},"2026-03-11",{"date":292,"type":20},"2028-09-05",{"name":294,"class":61},"Pfizer",50,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":311,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":125},"100607819","phase-1-beacon-1-study-of-avzo-103-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-avzo-103-1001-100607819","NCT07193511","BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4\u002FTrop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","Key Inclusion Criteria:\n\n* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria:\n\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* Prior Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of allogenic stem cell or solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.",{"count":304,"type":20},355,[100,73],"This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors.",[308,309,310,26],"Solid Tumor Cancer","Locally Advanced","Metastatic Solid Tumors",[312,313,309,26],"Solid Tumors","Metastatic","2026-05-21",{"date":316,"type":54},"2026-05-26",{"date":318,"type":54},"2025-10-02",{"date":320,"type":20},"2030-09",{"name":322,"class":61},"Avenzo Therapeutics, Inc.",{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":157},"100603730","phase-1-dk222-study-at-hopkins-100603730","NCT07140315","DK222 Study at Hopkins","An Open-label, Single-center Clinical Trial of [18F]DK222 PET\u002FCT for Imaging of Patients With Non-Small-Cell Lung Cancer (NSCLC) and Urothelial Cancer Who Are Eligible for Treatment With Anti-PD(L)-1","Inclusion Criteria:\n\n* Subjects must sign informed consent prior to inclusion in this trial.\n* Subjects must be ≥18 years of age and competent to give informed consent.\n* Subjects must be diagnosed with histologically confirmed NSCLC or UC and eligible for anti-PD(L)-1 therapy.\n* PD-L1 immunohistochemistry result using a Clinical Laboratory Improvement Amendments (CLIA) assay must be available or if not available then sufficient tissue must be available to perform PD-L1 testing.\n* Subjects must score at least 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Subjects must have adequate organ function as defined by the following laboratory values (determined within 28 days prior to randomization\u002Fregistration) or as deemed not clinically significant by physician on record:\n\n  * White blood cells (WBC) ≥ 2000 \u002FμL\n  * Absolute neutrophil count (ANC) ≥ 1500 \u002FμL\n  * Platelets ≥ 100 x103 \u002FμL\n  * Hemoglobin ≥ 9 g\u002FdL or ≥ 5.6 mmol\u002FL\n  * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) or creatinine clearance greater than or equal to 60 ml\u002Fmin (using the Cockcroft-Gault formula)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times ULN\n  * Bilirubin ≤ 1.5 times ULN (Except patients with the Gilbert Syndrome, for whom a maximum of ≤ 3.0 mg\u002FdL is acceptable)\n* Women of childbearing potential (WOCBP) should have a negative serum pregnancy test within 24 hours prior to receiving the first administration \\[18F\\]DK222. Women with non-childbearing potential may be included if either surgically sterile or have been postmenopausal for ≥ 1 year.\n* WOCBP and men who are sexually active with WOCBP must agree to use appropriate method(s) of contraception.\n\nExclusion Criteria:\n\n* Prior treatment, in either de novo disease or during this recurrence, with an anti-PD-L1 or anti-PD-L2 antibody. A minimum of 4 month washout period is required for patients treated with anti-PD-L1 or anti-PD-L2 therapy. Patients with disease that was previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, but now have a new recurrence, would be eligible.\n* Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1 or better from the adverse events due to previous cancer therapy.\n* Treatment with corticosteroids in an increasing dosage in the 7 days prior to the first administration of anti-PD1. (A stable or decreasing dosage of ≤ 10 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)\n* A severe hypersensitivity reaction to prior treatment with a monoclonal antibody, or known hypersensitivity to study drugs components.\n* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patients to receive protocol therapy.\n* Women of childbearing potential with a positive serum or urine pregnancy test (minimum sensitivity 10 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of imaging.\n* Breastfeeding women.\n* Inability to comply with other requirements of the protocol.",{"count":331,"type":20},6,[100],"This Phase 1 clinical trial will test a new drug called \\[18F\\]DK222 in people with cancer. The goal is to see if the drug is safe, how it spreads through the body, how long it stays in the body, and how much radiation it gives off. \\[18F\\]DK222 is designed to attach strongly and specifically to a protein called PD-L1, which helps cancer hide from the immune system.\n\nThis is a first in human study to collect preliminary safety and toxicity data of \\[18F\\]DK222.",[335,26],"Non-Small Cell Lung Cancer",[337,285,338,339,340,341,283,342,343],"PD-L1","PET","Imaging","MSCLC","UC","lung cancer","radiotracer",{"date":345,"type":54},"2026-05-22",{"date":51,"type":20},{"date":348,"type":20},"2027-07-01",{"name":350,"class":156},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":374},"100517008","a-study-to-survey-adults-in-south-korea-with-cancer-who-receive-padcev-injection-100517008","NCT06011954","A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection","Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea","Inclusion Criteria:\n\n* Patients who receive treatment with PADCEV Injection, according to the approved local label.\n\nExclusion Criteria:\n\n* Patients with any contraindication for PADCEV Injection, according to the approved local label.\n* Patients who receive or are going to receive any investigational medicine during the observation period.",{"count":359,"type":20},202,"Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer.\n\nPeople in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only.\n\nThis study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study.\n\nOnce a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.",[26],[26,76,363,364],"enfortumab vedotin","PADCEV","2026-05-13",{"date":367,"type":54},"2026-05-14",{"date":369,"type":54},"2023-11-01",{"date":371,"type":20},"2027-07-31",{"name":373,"class":61},"Astellas Pharma Korea, Inc.",18,{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":392,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":374},"100595891","phase-1-aventine-1-study-of-avzo-1418-as-a-single-agent-and-in-combination-therapy-in-patients-with-locally-advanced-or-metastatic-solid-tumors-avzo-1418-1001-100595891","NCT07038343","AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria\n\n* Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \\> 3 months.\n* Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic malignancies for tumor types of preferred indications:\n\n  o Locally advanced or metastatic epithelial solid tumors (as specified in the protocol).\n* Measurable disease as assessed by Investigator using RECIST v1.1.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable.\n* Other protocol-defined Inclusion criteria apply.\n\nKey Exclusion Criteria\n\n* Uncontrolled hypertension.\n* Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.\n* History of drug-induced interstitial lung disease (ILD).\n* History of any serious cardiovascular condition.\n* Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.\n* History of a solid organ transplant.\n* Other protocol-defined Exclusion criteria apply.","75 Years",{"count":384,"type":20},480,[100,73],"This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.",[308,309,310,388,389,390,26,391],"Lung Cancers","Epithelial Tumor","Biliary Tract Cancer (BTC)","Nasopharyngeal Cancers",[312,313,309,393,394,174,26,105,395,396,397,398,104],"Lung Cancer","Epithelial Solid Tumors","HER3","EGFR","BTC","Small Cell Lung Cancer",{"date":365,"type":54},{"date":401,"type":54},"2025-06-04",{"date":403,"type":20},"2030-12",{"name":322,"class":61},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":21,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":157},"100579262","phase-2-sequential-gemcitabine-and-mitomycin-treatment-for-favorable-high-risk-upper-urinary-tract-urothelial-carcinoma-100579262","NCT06822010","SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma","A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)","Inclusion Criteria:\n\n* Subjects must meet all of the following applicable inclusion criteria to participate in the study:\n\n  1. Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.\n  2. Patient is at least 18 years of age.\n  3. Naive or recurrent patients with High Grade Ta +\u002F- CIS, non-invasive UTUC in the upper tract (pyelocalyceal system or ureter).\n* Histologic confirmation with biopsy is necessary.\n* All patients must undergo ureteroscopy with biopsy.\n* Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated with ≤ 15 mm residual papillary disease in total.\n\n  4\\. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).\n  1. If the bladder is involved with NMIBC it should be treated prior to or during Gem\u002FJel treatments.\n\n     5\\. Patients with ECOG (Eastern Cooperative Oncology Group) performance status \\\u003C3 (with Karnofsky \\>40).\n\n     6\\. Patients with life expectancy greater than 24 months at time of screening. 7. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis\\*.\n\n     8\\. Female Patients of childbearing potential\\*\\*, must have a negative serum pregnancy test at screening and must agree to use two acceptable \\& effective methods of contraception\\*\\*\\*, until 6 months post treatment 9. All sexually active male patients must agree to use a condom during intercourse, for at least 48 hours post each instillation.\n\n     10\\. Male patients who have a partner that is a female of childbearing potential must agree to use two acceptable \\& effective methods of contraception until 6 months post treatment.\n\n     11\\. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator.\n\n     Exclusion Criteria:\n\n     Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.\n\n     4\\. Any other malignancy diagnosed within 2 years of trial entry with the exception of:\n\n  a. Basal or squamous cell skin cancers, or b. Noninvasive cancer of the cervix, or c. Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period (basal or squamous cell skin cancers, noninvasive cancer of the cervix, prostate cancer under active surveillance, renal cancer under active surveillance).\n\n  4\\. Administration not feasible via nephrostomy tube. 5. Inability to deliver the investigational drug to the pyelocalyceal system. 6. Patient has any other medical or mental condition(s) that make(s) his\u002Fher participation in the trial unadvisable in the opinion of the treating urologist.\n\n  7\\. Patient has contraindication to mitomycin C (MMC )treatment, or known sensitivity to MMC.\n\n  8\\. Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease).\n\n  9\\. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1.\n\n  10\\. Pregnant (positive serum pregnancy test), planning to become pregnant during the trial period, breast-feeding, or of childbearing potential and not practicing reliable contraception\\*\\*\\*.\n\n  \\* In case of a symptomatic UTI the patient will be treated with a full course of antibiotics, and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of the treatment is left to the discretion of the PI.\n\n  \\*\\* Women of non-childbearing potential:\n  1. At least 12 months since the last menses, or\n  2. Without uterus and\u002For both ovaries, or\n  3. Has been surgically sterile for at least 6 months prior to trial drug administration.\n\n     * Acceptable methods of birth control which are considered to have a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen\u002Fprogesterone) oral contraceptives, intrauterine devices (IUDs-only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.","99 Years",{"count":414,"type":20},28,[73],"This Phase II clinical trial, titled \"A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT),\" aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.",[418,419,26],"Urinary Bladder Cancer","Upper Tract Urothelial Cancer",[421,280,422,423,424],"upper tract urothelial cancer","gemcitabine","jelmyto","mitomycin","2026-05-02",{"date":427,"type":54},"2026-05-06",{"date":429,"type":54},"2026-03-06",{"date":431,"type":20},"2029-04-01",{"name":433,"class":156},"Rutgers, The State University of New Jersey",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":448,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100634856","phase-1-a-phase-1a1b-first-time-in-human-study-of-ct-202-a-nectin-4-directed-bispecific-antibody-in-participants-with-recurring-triple-negative-breast-colorectal-urothelial-cancers-100634856","NCT07545122","A Phase 1a\u002F1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers","A Phase 1a\u002F1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers","CT-202","Inclusion Criteria:\n\n* Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies\n* Participants with measurable disease per RECIST 1.1\n* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks\n* Participants have adequate organ function.\n\nExclusion Criteria:\n\n* History of severe skin toxicity\n* Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.\n* Concurrent participation in another investigational clinical trial.",{"count":443,"type":20},162,[100],"This is a Phase 1a\u002F1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory\u002Fresistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.",[447,173,26],"Triple Negative Breast Cancer (TNBC)","NOT_YET_RECRUITING","2026-04-16",{"date":451,"type":54},"2026-04-22",{"date":453,"type":20},"2026-09",{"date":455,"type":20},"2030-01",{"name":457,"class":61},"Context Therapeutics Inc.",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":465,"sex":16,"minAge":17,"maxAge":251,"enrollmentInfo":466,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":157},"100238234","care-of-the-urothelial-cancer-patient-and-prospective-procurement-of-urothelial-cancer-tissue-100238234","NCT02379429","Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue","Care of the Urothelial Cancer Patient and Prospective Collection of Biospecimens From Healthy Volunteers and Urothelial Cancer Patients","* INCLUSION CRITERIA FOR UROTHELIAL CANCER PARTICIPANTS:\n* Adults (\\>= 18 years of age) with biopsy-proven or suspected urothelial cancer who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up\u002Fsurveillance for their neoplasm.\n* ECOG performance status of 0-3.\n* Must be willing and able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are pregnant.\n* Subjects co-morbidities preclude diagnostic or therapeutic intervention. Co-morbidities include:\n\n  --Ongoing treatment for another non-skin malignancy.\n* History of hepatitis B\u002FC or HIV. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.\n\nELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS\n\nINCLUSION CRITERIA:\n\n-Adults (greater than or equal to 18 years of age) and able to give informed consent.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are pregnant.\n* Diagnosis of cancer requiring treatment other than minor resection of basal cell or squamous cell skin cancers.\n* Heart, lung, kidney disease, or other medical conditions as per Principal Investigator discretion.\n* History of acute or chronic hepatitis B\u002FC or HIV infection. Patients who are HIV positive are excluded from this study because treatment with immunomodulatory agents for immunosuppressed patients would affect sample analysis and skew the data.\n* Healthy volunteers who are family members with germline mutations.",true,{"count":467,"type":20},500,"Background:\n\nUrothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it.\n\nObjective:\n\n\\- To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy.\n\nEligibility:\n\n\\- Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer.\n\nDesign:\n\n* Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed.\n* Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank.\n* Participants medical records may be reviewed.\n* Participants may have a medical history and physical exam.\n* Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research.\n* If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research.\n* Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits.\n* Participants will be called every 6 months to give health updates.",[76,470,26,471],"Urinary Tract Cancer","Healthy Volunteers",[473,474,475,476,234],"Specimen Collection","Urine","Blood","Saliva","2026-04-01",{"date":479,"type":54},"2026-04-02",{"date":481,"type":54},"2015-11-10",{"date":483,"type":20},"2028-01-01",{"name":242,"class":243},{"id":486,"slug":487,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":494,"briefSummary":495,"conditions":496,"keywords":502,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":331},"100610406","phase-1-a-study-of-stro-004-in-adults-with-refractoryrecurrent-metastatic-cancer-100610406","NCT07227168","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",{"count":493,"type":20},200,[100],"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",[497,498,499,171,173,500,501,108,26],"Head and Neck Squamous Cell Carcinoma HNSCC","Non-Small Cell Lung Cancer NSCLC","Esophageal Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Cervical Cancer",[503,504,505,506],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","ADC","2026-03-03",{"date":509,"type":54},"2026-03-05",{"date":511,"type":54},"2025-11-07",{"date":513,"type":20},"2028-04",{"name":515,"class":61},"Sutro Biopharma, Inc.",{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100566590","peripheral-neuropathy-in-patients-receiving-enfortumab-vedotin-and-pembrolizumab-as-first-line-treatment-for-metastatic-or-locally-advanced-urothelial-carcinoma-100566590","NCT06657157","Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma","Peripheral Neuropathy in Patients Receiving Pembrolizumab and Enfortumab Vedotin as First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma. An Investigator-Initiated, Prospective, Multicenter, Non-Interventional Trial.","P-EVOLUTION","Inclusion Criteria:\n\n* Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF)\n* Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma\n* Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)\n* Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information\n\nExclusion Criteria:\n\n* Patients with contraindications for enfortumab vedotin and\u002For pembrolizumab\n* Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)\n* Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors\n* Patients who received neoadjuvant or adjuvant platinum-based chemotherapy \\\u003C12 months ago",{"count":525,"type":20},80,"The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Conducted at two German university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. Approximately 80 patients are expected to be enrolled over one year.",[26],[363,46,529,530,531],"peripheral neuropathy","metastatic urothelial carcinoma","advanced urothelial carcinoma","2026-02-21",{"date":534,"type":54},"2026-02-24",{"date":536,"type":54},"2025-01-22",{"date":538,"type":20},"2027-02",{"name":540,"class":156},"Comprehensive Cancer Center Munich (CCCM)",4,{"id":543,"slug":544,"hasResults":11,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":448,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":157},"100625301","international-multicentric-retrospective-study-on-the-use-of-evp-as-first-line-therapy-in-patients-with-lamuc-100625301","NCT07420855","International Multicentric Retrospective Study on the Use of EV+P as First-line Therapy in Patients With la\u002FmUC","International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced\u002FMetastatic Urothelial Cancer (ARON-2PLUS)","ARON-2PLUS","Inclusion Criteria:\n\n* Patients aged \\>18years\n* Histologically confirmed diagnosis of la\u002FmUC of upper and\u002For lower urinary tract or histologically confirmed diagnosis of rare GU tumors.\n* Histologically or radiologically confirmed metastatic disease\n* Patients treated with first-line EV+P combination\n\nExclusion Criteria:\n\n* Patients without histologically confirmed diagnosis of UC\n* Patients without histologically or radiologically confirmed la or mUC",{"count":551,"type":20},361,"The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced\u002Fmetastatic Urothelial Cancer.\n\nTwo supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.",[554,26],"Locally Advanced or Metastatic Urothelial Cancer",[280,556,363,557],"pembrolizumab","rare genitourinary tumors","2026-02-12",{"date":560,"type":54},"2026-02-19",{"date":562,"type":20},"2026-02",{"date":403,"type":20},{"name":565,"class":156},"Aron Research Foundation Ets",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":465,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":574,"conditions":575,"keywords":578,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":157},"100123330","evaluation-of-non-invasive-assays-for-the-detection-of-urothelial-cancer-100123330","NCT00872495","Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer","Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer of the Bladder and Kidney","Inclusion Criteria:\n\n* Patients scheduled to have a nephroureterectomy, cystectomy, cytoscopy (newly diagnosed bladder cancer and those with recurrent disease in follow up)\n* Control Group: No known evidence of bladder cancer-one urine sample\n* \\> than 18 years of age\n\nExclusion Criteria:\n\n* \\\u003C than 18 years of age",{"count":467,"type":20},"The purpose of this study is to determine if analysis of DNA and protein material found in urine will be useful in the detection of urothelial cancer of the bladder and kidney. This analysis may be helpful to determine if how a particular cancer will act regarding remission and recurrence",[26,576,577,418],"Cancer","Bladder Neoplasms",[26,576,577,418],"2025-12-01",{"date":581,"type":54},"2025-12-08",{"date":583,"type":4},"2002-09",{"date":585,"type":20},"2028-11",{"name":587,"class":156},"Lahey Clinic",{"id":589,"slug":590,"hasResults":11,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":21,"phases":597,"briefSummary":598,"conditions":599,"keywords":602,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":157},"100418077","phase-1-sacituzumab-govitecan-plus-ev-in-metastatic-uc-100418077","NCT04724018","Sacituzumab Govitecan Plus EV in Metastatic UC","Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I\u002FII Trial","Phase II Study Cohort A (dose expansion study to assess efficacy of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination)\n\nInclusion Criteria:\n\n* Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra). Patients with squamous differentiation or mixed cell types are eligible if the urothelial component is more than 50%; small-cell carcinoma is not allowed. Patients with locally advanced unresectable disease are eligible.\n* Patient who are cisplatin eligible must have received prior treatment with platinum containing therapy defined as within the adjuvant\u002Fneoadjuvant setting with ≥ ypT2 disease at surgery or recurrent or progressive disease within 12 months or receiving treatment with platinum in locally advanced or metastatic setting. In addition, they must have received a checkpoint inhibitor (CPI) in locally advanced or metastatic urothelial cancer setting. Patients who received CPI therapy in the neoadjuvant\u002Fadjuvant setting and had recurrent or progressive disease either during or within 12 months of therapy completion are eligible. A CPI is defined as a PD-1 or PD-L1 inhibitor.\n* Patients who are cisplatin-ineligible need only have progressed on or since one line of therapy defined as therapy given in the adjuvant\u002Fneoadjuvant setting within 12 months of progression or receiving therapy for locally advanced or metastatic disease\n* Patient must be progressing on or since most recent therapy\n* Age ≥18 years. Children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status 0-1.\n* Participants must have adequate organ and marrow function as defined below:\n* Leukocytes ≥3,000\u002FmcL\n* Absolute neutrophil count ≥1,500\u002FmcL\n* Platelets ≥100,000\u002FmcL\n* Total bilirubin ≤ institutional upper limit of normal (ULN)\n* AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN OR\n* ≤5x ULN with liver metastases and serum albumin \\> 3 g\u002FdL\n* Glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2 (by Cockcroft Gault formula)\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\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. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\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, participants should be class 2B or better.\n* Have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1 criteria). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>2 years\n* The effects of SG and EV on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 6 months after last study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study and up to 6 months after last study drug dose, she should inform her treating physician immediately. 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 4 months after completion of SG administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria at Screening\u002FDay 1 of treatment will not be enrolled in the study.\n\n* Women who are pregnant or lactating. Pregnant women are excluded from this study because SG and EV 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 EV or SG, breastfeeding should be discontinued if the mother is treated on protocol.\n* Have had a prior anti-cancer biologic agent (including immune checkpoint inhibitors) within 4 weeks prior to Cycle 1 Day 1 (C1D1) or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Subjects participating in observational studies are eligible.\n* Presence of any toxicities attributed to prior anti-cancer therapy that are not resolved to Grade 1 or baseline that could impose serious risk for complications before administration of study drug agent\n* Note: If subjects received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n* Have previously received topoisomerase 1 inhibitors, SG or EV\n* Have an active second malignancy. Subjects with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to start of therapy on trial (Cycle 1 Day 1 \\[C1D1\\]), or subjects with surgically-cured tumors with low risk of recurrence are allowed to enroll.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤20 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active cardiac disease, defined as:\n* Myocardial infarction or unstable angina pectoris within 6 months prior to C1D1\n* History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation\n* New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of C1D1\n* Have active serious infection requiring antibiotics (Contact sponsor-investigator for clarification)\n* 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.\n* Patients with conditions requiring high doses of steroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n* History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to EV or SG or any excipient contained in the drug formulations (including 2 (N morpholino) ethane sulfonic acid (MES), histidine, treahalose dihydrate polysorbate 80 and polysorbate 20).\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1C \\>8% or 7-8% with associated diabetes symptoms that are otherwise not explained\n* Uncontrolled tumor related bone pain or impending spinal cord compression.\n\nPhase II Study Cohort B (assessing Sacituzumab Govitecan (SG) + Enfortumab vedotin-ejfv (EV) + Pembrolizumab combination)\n\nInclusion Criteria:\n\n* Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra). Patients with squamous differentiation or mixed cell types are eligible if the transitional component is more than 50%; small-cell carcinoma is not allowed. Patients with locally advanced unresectable disease are eligible.\n* No prior therapy for metastatic urothelial carcinoma. Therapy in the perioperative setting is allowed with no time restrictions on platinum dosing. Prior immunotherapy is allowed provided it has been \\> 6 months from last dose of immune checkpoint blockade.\n* Age ≥18 years; children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status 0-1.\n* Participants must have adequate organ and marrow function as defined below:\n* Leukocytes ≥3,000\u002FmcL\n* Absolute neutrophil count ≥1,500\u002FmcL\n* Platelets ≥100,000\u002FmcL\n* Total bilirubin ≤ institutional upper limit of normal (ULN)\n* AST(SGOT)\u002FALT(SGPT) ≤2.5x institutional ULN OR\n* ≤5x ULN with liver metastases and serum albumin \\> 3 g\u002FdL\n* Glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m2 (by Cockcroft Gault formula)\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\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. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\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, participants should be class 2B or better.\n* Have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1 criteria). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions\n* Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>2 years\n* The effects of Pembrolizumab, SG and EV on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 6 months after last study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study and up to 6 months after last study drug dose, she should inform her treating physician immediately. 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 4 months after completion of SG administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria at Screening\u002FDay 1 of treatment will not be enrolled in the study.\n\n* Women who are pregnant or lactating. Pregnant women are excluded from this study because SG and EV 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 EV or SG, breastfeeding should be discontinued if the mother is treated on protocol.\n* Have had a prior anti-cancer biologic agent (including immune checkpoint inhibitors) or chemotherapy within 26 weeks prior to Cycle 1 Day 1 (C1D1) Subjects participating in observational studies are eligible.\n* Have previously received topoisomerase 1 inhibitors, SG or EV\n* Have an active second malignancy. Subjects with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to start of therapy on trial (Cycle 1 Day 1 \\[C1D1\\]), or subjects with surgically-cured tumors with low risk of recurrence are allowed to enroll.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤10 mg\u002Fday of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have active cardiac disease, defined as:\n\n  * Myocardial infarction or unstable angina pectoris within 6 months prior to C1D1\n  * History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation\n* New York Heart Association (NYHA) Class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of C1D1\n* Have active serious infection requiring antibiotics (Contact sponsor PI or Co-PI for clarification)\n* 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.\n* Patients with conditions requiring high doses of steroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressive medications are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n* History idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, EV or SG or any excipient contained in the drug formulations (including 2 (N morpholino) ethane sulfonic acid (MES), histidine, treahalose dihydrate polysorbate 80 and polysorbate 20).\n* Participants with uncontrolled intercurrent illness.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1C \\>8% or 7-8% with associated diabetes symptoms that are otherwise not explained\n* Uncontrolled tumor related bone pain or impending spinal cord compression.\n* History of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n  1. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n  2. Brief (\\\u003C7 days) use of systemic corticosteroids is allowed when use is considered standard of care.\n  3. Subjects with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma\u002Fatopy will not be excluded.\n  4. Subjects requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded.\n  5. Subjects with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded.",{"count":596,"type":20},106,[100,73],"Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination.\n\nThe names of the study drugs in these investigational combinations are:\n\n* Enfortumab Vedotin\n* Sacituzumab Govitecan\n* Pembrolizumab",[26,600,601,76],"Metastatic Urothelial Carcinoma","Metastatic Urothelial Carcinoma of the Renal Pelvis and Ureter",[603,600,601,76],"Urothelial cancer","2025-11-03",{"date":606,"type":54},"2025-11-04",{"date":608,"type":54},"2021-05-20",{"date":610,"type":20},"2028-05-01",{"name":612,"class":156},"Dana-Farber Cancer Institute"]