[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,91,0,25,[9,52,96,130,154,180,210,233,265,296,332,379,401,432,458,489,512,532,556,598,621,654,679,708,734],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100605991","phase-1-a-study-to-investigate-alep03-as-monotherapy-in-adult-patients-with-selected-advanced-or-metastatic-cldn1-solid-tumors-100605991",false,"NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[28,29,30,31,32],"Cervical Squamous Cell Carcinoma","Squamous Non-small-cell Lung Cancer","Colorectal Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[34,35,36,37,38],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2025-08-26",{"date":47,"type":21},"2029-10-04",{"name":49,"class":50},"Alentis Therapeutics AG","INDUSTRY",41,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":74,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100431255","phase-1-a-study-of-bms-986340-as-monotherapy-and-as-combination-therapy-in-participants-with-advanced-solid-tumors-100431255","NCT04895709","A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria\n\n* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Radiographically documented progressive disease on or after the most recent therapy.\n* Received standard-of-care therapies, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced\u002Fmetastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated.\n* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant.\n\nExclusion Criteria\n\n* Women who are pregnant or breastfeeding.\n* Primary central nervous system (CNS) malignancy.\n* Untreated CNS metastases.\n* Leptomeningeal metastases.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment.\n* Active, known, or suspected autoimmune disease.\n* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment.\n* Prior organ or tissue allograft.\n* Uncontrolled or significant cardiovascular disease.\n* Major surgery within 4 weeks of study drug administration.\n* History of or with active interstitial lung disease or pulmonary fibrosis.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":60,"type":21},1109,[24,25],"The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.",[64,65,66,67,68,69,32,70,71,72,73],"Cervical Cancer","Gastric\u002FGastroesophageal Junction Adenocarcinoma","Microsatellite Stable Colorectal Cancer","Non-Small-Cell Lung Cancer","Squamous Cell Carcinoma of Head and Neck","Carcinoma, Renal Cell","Pancreatic Adenocarcinoma","Melanoma","Ovarian Neoplasms","Triple Negative Breast Neoplasms",[75,64,76,77,78,65,79,66,80,81,67,82,83,68,69,32,70,71,72,73,84,85],"BMS-986340","CRC","First-in-human","GEJ","HNSCC","MSS CRC","Nivolumab","NSCLC","SCCHN","Docetaxel","Pumitamig","2026-06-29",{"date":88,"type":43},"2026-06-30",{"date":90,"type":43},"2021-05-27",{"date":92,"type":21},"2031-08-31",{"name":94,"class":50},"Bristol-Myers Squibb",47,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100633916","phase-1-a-study-of-bms-986504-with-standard-of-care-therapy-for-people-with-solid-tumor-cancer-100633916","NCT07532902","A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer","A Phase 1a\u002F1b Basket Trial of BMS-986504 With Standard-of-Care Therapy For Patients With Select Metastatic MTAP-deleted Solid Tumors","Inclusion Criteria:\n\n* Documentation of Disease:\n* Patients must have pathologic confirmation of one of three diseases:\n* Diffuse pleural mesothelioma (DPM)\n* Gastroesophageal carcinoma (GEC) including adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach.\n* PD-L1 CPS ≥1 (using clone 73-10, DAKO)\n* HER2 overexpression negative (using clone 4B5, Ventana): HER2 IHC 0-1+, or HER2 2+ with ISH showing HER2:CEP17 ratio \\\u003C2 and average HER2 copy number \\\u003C6.0 signals\u002Fcell\n* Urothelial carcinoma (UC)\n* Archival tissue is acceptable\n* Metastatic or advanced\u002Funresectable disease:\n* For Diffuse Pleural Mesothelioma (DPM) and Gastroesophageal Carcinoma (GEC )cohorts: no prior systemic treatment for metastatic disease\n* Patients with metastatic disease after treatment for localized GEC may have received prior systemic therapy (chemotherapy and\u002For chemoradiation) if \\>6 months have elapsed between the end of therapy and registration.\n* One prior cycle of standard-of-care therapy alone without BMS-986504 or other MTAP inhibitors (ipi\u002Fnivo for DPM, FOLFOX + nivo for GEC) is acceptable with PI approval.\n* For UC cohort: must have received at least 1 prior line of treatment without prior gemcitabine (prior tx with Gem+Platinum in the perioperative setting is permitted if at least 12 months have elapsed from trial enrollment)\n* Patients with recurrent disease within 1 year of completion of prior perioperative systemic therapy are eligible with PI approval.\n* One prior cycle of standard-of-care therapy alone with gemcitabine + platinum, without BMS-986504 or other MTAP inhibitors, is acceptable with PI approval.\n* Confirmation of MTAP deletion by either IHC or NGS:\n* MTAP deletion must be detected by either IHC and\u002For NGS (including FACETS), done on tumor tissue (not blood):\n* IHC (using antibody 1813, NBP2-75730, Novus Biologicals)30\n* IHC staining showing loss of MTAP expression\n* Tissue-based NGS options\n* MSK-IMPACT version 7 or beyond showing homozygous MTAP copy number loss\n* FACETS showing homozygous deletion\n* Other CLIA-approved commercial Template Version: 1-21-25\n* Full report must be available for review and confirmation\n* Cases with discordant results between NGS and IHC, in which one test shows MTAP loss\u002FMTAP del and the other shows MTAP intact, are acceptable with PI approval\n* Measurable disease per RECIST v 1.1 (or, for DPM cohort, by either RECIST v 1.1 or modified RECIST \\[mRECIST\\] for mesothelioma31)\n* No contraindications to receiving other standard-of-care agents per package inserts (and see Appendix IV), and per the discretion of the PI:\n* DPM: Ipilimumab + nivolumab\n* GEC: FOLFOX (5-FU, leucovorin, and oxaliplatin) + nivolumab\n* UC: Gemcitabine + platinum (carboplatin or cisplatin)\n* Age ≥ 18\n* KPS ≥ 70\u002FECOG \\\u003C1\n* Reproductive Status:\n* Female participants of child-bearing potential (as assigned at birth) must have a negative highly sensitive urine or serum (as required by local regulations) pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study intervention.\n* If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Female participants of child-bearing potential (as assigned at birth) must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \\\u003C 1% per year)during the intervention period and for 14 months (for females) after the last dose of study intervention (or longer if required by institutional guidelines) Hormonal contraceptive methods alone are not allowed.\n* Female participants of child-bearing potential (as assigned at birth) must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.\n* If needed, these participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.\n* Female participants (as assigned at birth) are deemed to be without child-bearing potential if they meet one of the following criteria:\n* Postmenopausal for at least 1 year before the screening visit\n* Permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL (\\\u003C140 pmol\u002FL)\n* Male participants (as assigned at birth) will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with a female of childbearing potential, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male participants (as assigned at birth) should continue to use a condom during the intervention period and for at least 11 months after the last dose of study intervention (or longer if required by institutional guidelines).\n* Male participants must refrain from donating sperm during the intervention period and for at least 11 months after the last dose of study intervention (or longer if required by institutional guidelines).\n* If needed, male participants should be advised to seek advice about sperm donation and cryopreservation of germ cells before treatment.\n* Individuals of child-bearing potential who are partners of male participants should be advised to use a highly effective method of contraception during the intervention period and for at least 11 months after the last dose of study intervention for the male participant\n* Male participants (as assigned at birth) with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 11 months after the last dose of study intervention\n* Breastfeeding partners of male participants (as assigned at birth) should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms\n* Recovery from the adverse effects of prior therapy at the time of enrollment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria \\[eg, hematology parameters\\]). Note: Participants with prior endocrine adverse effects are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n* Required organ function\n* Adequate hematologic function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm\\^3\n* Platelets ≥ 100,000 cells\u002Fmm3\n* Hemoglobin ≥ 8 g\u002Fdl\n* Adequate renal function defined as follows:\n* Creatinine clearance (CrCL) of ≥50 mL\u002Fmin by the CKD-Epi creatinine equation\n* Adequate hepatic function defined as follows:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n* AST and ALT ≤5 x ULN\n* Signed informed consent form (ICF)\n\nExclusion Criteria:\n\n* Prior treatment with PRMT5i or MAT2Ai\n* Symptomatic CNS metastases\n* Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and the patient is on a stable dose of corticosteroids\n* Received palliative radiation therapy within 3 days prior to initiation of study treatment or definitive SRS including CNS SRS within 14 days prior to initiation of study treatment\n* Patients who have had major surgery within 3 weeks of start of study drug\n\n  o Note: procedures such as biopsy, pleural catheter insertion, central venous catheter or other minor procedures are permitted\n* Any of the following cardiac abnormalities:\n* Unstable angina pectoris or myocardial infarction within 6 months prior to enrollment\n* Congestive heart failure ≥ NYHA Class 3 within 6 months prior to enrollment\n* Prolonged QTc \\> 500 milliseconds or history of Long QT Syndrome\n* Child-Pugh class C liver cirrhosis\n* Ongoing medical illness not otherwise listed which would preclude study at the discretion of the PI\n* Inability to take medications PO (BMS-986504 cannot be taken via gastrostomy tube), refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, or any other condition that significantly affects gut motility or absorption and would preclude adequate absorption of BMS-986504 in the opinion of the treating physician and\u002For PI\n* Ongoing need for a medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4 and\u002For P-glycoprotein (P-gp) or proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry\n* HIV, HBV, or HCV with detectable viral load\n* For patients with known HIV, HBV, and\u002For HCV infection:\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable with or without suppressive therapy\n* Patients with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Active infection requiring parenteral antibiotic(s)\n* Pregnant or breastfeeding\n* Presence of another malignancy that could be mistaken for the malignancy under study during disease assessments.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.",{"count":104,"type":21},60,[24],"The researchers are doing this study to test the safety of BMS-986504 in combination with standard disease-specific anticancer medication in people with metastatic\u002Fadvanced unresectable MTAP-deleted solid tumor cancer.",[108,109,32],"Diffuse Pleural Mesothelioma","Gastroesophageal Carcinoma",[111,112,113,81,114,115,116,117,118,119],"BMS-986504","Metastatic MTAP-deleted Solid Tumors","Ipilimumab","5-fluorouracil","Leucovorin","Oxaliplatin","Gemcitabine","Carboplatin","Cisplatin","2026-06-25",{"date":86,"type":43},{"date":123,"type":43},"2026-04-07",{"date":125,"type":21},"2029-04",{"name":127,"class":128},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100523867","locally-ablative-therapy-in-oligo-progressive-genitourinary-tumors-layover-100523867","NCT06101290","Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)","LAYOVER","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed genitourinary malignancies:\n\n   1. Cohort A: prostate cancer\n   2. Cohort B: urothelial carcinoma\n   3. Cohort C: renal cell carcinoma\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",{"count":138,"type":21},150,[140],"NA","This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[143,144,32,145],"Prostate Cancer","Oligoprogressive","Renal Cell Carcinoma",{"date":88,"type":43},{"date":148,"type":43},"2023-12-05",{"date":150,"type":21},"2035-01-15",{"name":152,"class":128},"University of California, Davis",1,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100543460","phase-2-study-of-neoadjuvant-enfortumab-vedotin-and-pembrolizumab-in-cisplatin-eligible-upper-tract-urothelial-cancer-100543460","NCT06356155","Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer","A Phase II, Open-label, Single-arm, Multi-center Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (NEPTUNE)","NEPTUNE","Inclusion Criteria:\n\n* Patients must have a diagnosis of high-grade upper tract (renal pelvis and\u002For ureter) urothelial carcinoma proven by biopsy or cytology within 60 days prior to registration with the following (cT1-4 N0-1 M0): a. Upper urinary tract mass on cross-sectional imaging or Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology. b. No regional lymph node metastasis or a single regional lymph node metastasis.\n* Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥50%) subtype is urothelial carcinoma.\n* Patients must be considered to be a candidate for definitive surgery (nephroureterectomy or distal ureterectomy) with curative intent by the treating urologist. Lymph node dissection is strongly encouraged but its scope and determination will be at the discretion of the treating urologist. Details of the surgery such as bladder cuff removal are left to the discretion of the treating urologist. Robotic or open approaches are allowed.\n* Patients must be eligible for cisplatin. Cisplatin eligibility is defined as meeting all of the following criteria: a. Creatinine clearance ≥ 45 mL\u002Fmin calculated by Cockcroft-Gault equation (using actual body weight) or measured by 24-hour urine collection. b. Absence of Grade ≥ 2 peripheral neuropathy. c. Absence of New York Heart Association Class III or higher heart failure.\n* Prior local endoscopic therapy for upper tract urothelial cancer is permitted if completed at least 6 months prior to the initiation of study treatment and if all toxicities from such therapy have improved to grade 1 or resolved.\n* Prior uro-oncologic history: a. History of or active non-invasive carcinoma or carcinoma in situ of the bladder\u002Furethra or upper tract is allowed. b. Patients may have received prior intravesical chemotherapy or immunotherapy such as BCG. c. Prior neoadjuvant or adjuvant chemotherapy or antibody-drug conjugate for bladder cancer or invasive contralateral upper tract cancer is allowed but must have been completed ≥ 1 year prior to study registration.\n* Patients must be age ≥ 18 on the date of registration.\n* ECOG Performance Status 0-1.\n* Criteria for patients with hepatitis B or C are listed below. Hepatitis B and C screening tests are not required unless there is a known history of HBV or HCV infection or as mandated by local healthy authority. Hepatitis B positive subjects • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment. • Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. • Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment.\n* Patients must have adequate organ and bone marrow function as defined in Table 1. Specimens must be collected within 14 business days prior to start of study enrollment.\n* Women and men of reproductive potential must agree to use an effective contraceptive method during treatment and for 4 months after the last dose of study drug. See Section 16.3, Appendix 3. Men must also refrain from donating sperm during this period.\n* Women of reproductive potential must have a negative pregnancy test within 14 days prior to registration and are not breastfeeding.\n* Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the treating oncologist.\n* All patients must be informed of the investigational nature of this study. The patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a legally authorized representative or caregiver and\u002For family member available will also be considered eligible.\n\nExclusion Criteria:\n\n* Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4), anti-PD1, anti-PD-L1, anti-PD-L2 antibodies, and therapeutic anticancer vaccines.\n* Prior exposure to monomethyl auristatin E antibody-drug conjugates (MMAE ADC).\n* Patient is currently on or used immunosuppressive medication within 14 days prior to the first dose of pembrolizumab. The following are exceptions to this criterion: o Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection). o Use of chronic immunosuppressive agents at baseline at doses not to exceed more than prednisone 10 mg\u002Fday or equivalent. o Steroids as premedications for hypersensitivity reactions (e.g., CT scan premedication).\n* Active or prior documented autoimmune or inflammatory disorders requiring immunosuppressive therapy within 2 years prior to registration. Exceptions are well-controlled hyper\u002Fhypothyroidism, celiac disease controlled by diet alone, diabetes mellitus type 1, alopecia, psoriasis, eczema, lichen planus, vitiligo, or similar skin\u002Fmucosa conditions.\n* Evidence of metastasis (N2-3 or M1) on axial imaging at baseline.\n* History of invasive, node positive, or metastatic bladder cancer OR invasive contralateral upper tract cancer within 2 years prior to registration.\n* Enrolled in another interventional clinical trial at the time of registration.\n* Patient has another active malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 1 year. The time requirement does not apply to participants who underwent successful definitive resection of non-melanoma skin cancers, superficial bladder cancer (described above in inclusion criteria 6), in situ cervical cancer, other in situ cancers, or either clinically insignificant per the investigator (e.g., ≤Gleason 3+4) on surveillance or previously treated prostate cancer without rising PSA and no plan to treat. NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patient has one kidney.\n* Patient is pregnant or lactating.\n* Has severe hypersensitivity (≥ Grade 3) to enfortumab vedotin, pembrolizumab, and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.\n* Has an active infection requiring systemic therapy.\n* Has a history or current evidence of any condition or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has had an allogenic tissue (e.g., hematopoietic stem cell transplant HSCT)\u002Fsolid organ transplant.\n* Has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment.\n* Has known active keratitis or corneal ulcerations\n* Has any of the following: a. Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria outlined in Table 1). b. Uncontrolled diabetes mellitus as deemed by Hemoglobin A1c of 8 or greater.",{"count":163,"type":21},32,[25],"This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized\u002Flocally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.",[32],[168,169],"Neoadjuvant","cisplatin-eligible","2026-06-22",{"date":172,"type":43},"2026-06-23",{"date":174,"type":43},"2025-07-22",{"date":176,"type":21},"2028-03",{"name":178,"class":128},"University of Michigan Rogel Cancer Center",2,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":196,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":153},"100644360","phase-2-sacituzumab-tirumotecan-vs-mmae-adcs-in-advanced-urothelial-carcinoma-fuscc-spare-uc-01-100644360","NCT07662863","Sacituzumab Tirumotecan vs MMAE-ADCs in Advanced Urothelial Carcinoma (FUSCC-SPARE-UC-01)","A Randomized, Open-label, Phase II Study Evaluating the Neurotoxicity and Efficacy of Sacituzumab Tirumotecan (Sac-TMT) Versus MMAE-based ADCs in Patients With Advanced Urothelial Carcinoma: The SPARE-UC-01 Trial","SPARE-UC-01","Inclusion Criteria\n\n1. Must voluntarily sign the written Institutional Review Board (IRB)\u002FEthics Committee (EC) approved informed consent form (ICF) prior to any screening procedures.\n2. Age \\> 18 years at the time of signing the ICF.\n3. Histologically or cytologically confirmed locally advanced (unresectable) or metastatic urothelial carcinoma (UC), including bladder, ureter, renal pelvis, or urethra. Participants with mixed histology are eligible provided that UC is the predominant component (\\> 50%).\n4. Must have received at least one prior line of systemic therapy for locally advanced or metastatic UC (e.g., Enfortumab Vedotin plus Pembrolizumab, Disitamab Vedotin plus Toripalimab, platinum-based chemotherapy, immune checkpoint inhibitors, Nectin-4 ADCs, HER2 ADCs, FGFR inhibitors, or other palliative chemotherapy regimens).\n5. Neuropathy Status:\n\n   Cohort A\u002FB: Baseline peripheral neuropathy (PN) Grade 0-1 (per NCI-CTCAE v5.0) with stable nerve function confirmed by Nerve Conduction Study (NCS) during screening.\n\n   Cohort C (Observational): Baseline PN Grade 2, or a history of PN \\> Grade 2 where the investigator deems the patient unsuitable for MMAE-based ADC treatment.\n6. At least one measurable lesion per RECIST v1.1. (Lesions in previously irradiated areas are considered target lesions only if clear progression is documented after radiotherapy).\n7. ECOG Performance Status of 0 or 1 at screening.\n8. Expected survival \\> 3 months.\n9. Must have adequate organ and bone marrow function (no blood transfusion, growth factors, or albumin support within 14 days prior to screening):\n\n   * Hematological: ANC \\>= 1.5 x 10\\^9\u002FL; Platelets \\>= 75 x 10\\^9\u002FL; Hemoglobin \\>= 90 g\u002FL.\n   * Hepatic: ALT and AST \\\u003C= 2.5 x ULN (or \\\u003C= 5 x ULN for patients with liver metastases); Total Bilirubin \\\u003C= 1.5 x ULN (if Total Bilirubin \\> 1.5 x ULN, Direct Bilirubin must be \\\u003C= ULN).\n   * Coagulation: INR \\\u003C= 1.5; APTT \\\u003C= 1.5 x ULN; PT \\\u003C ULN + 4 seconds.\n   * Renal: Creatinine Clearance (CrCl) \\>= 30 mL\u002Fmin, or Serum Creatinine \\\u003C= 1.5 x ULN.\n\nExclusion Criteria\n\n1. Prior treatment with TROP2-targeted ADCs, topoisomerase I inhibitors (e.g., irinotecan, topotecan), or ADCs containing topoisomerase I inhibitor payloads.\n2. Patients previously treated with both Enfortumab Vedotin (EV) and Disitamab Vedotin (DV) are excluded from Cohorts A and B (eligible for Cohort C only).\n3. Treatment with any investigational anti-tumor agents, chemotherapy, immunotherapy, monoclonal antibodies, targeted therapy, or radical radiotherapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose. Major surgery within 4 weeks prior to the first dose.\n4. Active CNS or meningeal metastases. Patients with previously treated CNS metastases are eligible if clinically stable for ≥ 4 weeks, off systemic corticosteroids for ≥ 2 weeks (physiological replacement ≤ 10 mg\u002Fday prednisone equivalent is allowed), and no evidence of radiographic progression.\n5. History of non-infectious pneumonitis\u002Finterstitial lung disease (ILD) requiring steroids. Current ILD or suspected ILD on screening chest CT (even if asymptomatic). Severe COPD, severely impaired lung function, or requirement for long-term oxygen therapy.\n6. QTcF interval \\> 470 ms (females) or \\> 450 ms (males). Within 6 months prior to the first dose: myocardial infarction, unstable angina, severe arrhythmia requiring intervention, uncontrolled hypertension, stroke, or TIA. NYHA Class III or IV congestive heart failure.\n7. Active keratitis, corneal ulcer, or severe dry eye syndrome.\n8. Active Hepatitis B (HBsAg positive and HBV-DNA \\> 2000 IU\u002FmL; patients with lower HBV-DNA must receive antiviral therapy); Active Hepatitis C (HCV antibody and RNA positive); Known HIV infection; Severe infection requiring IV antibiotics within 2 weeks prior to first dose.\n9. Hypersensitivity: Known severe hypersensitivity to sac-TMT, EV, DV, or their excipients.\n10. Any severe or uncontrolled systemic disease that, in the investigator's opinion, increases the risk to the participant.\n11. HbA1c ≥ 8% (Patients with well-controlled blood glucose, fasting glucose ≤ 10 mmol\u002FL, and investigator approval are eligible).\n12. History of allogeneic stem cell transplant or solid organ transplant.\n13. Pregnant or breastfeeding females.",{"count":189,"type":21},75,[25],"The main goal of this clinical trial is to learn if a new targeted cancer drug called sacituzumab tirumotecan (sac-TMT) works to treat cancer while causing less nerve damage in patients with advanced urothelial carcinoma who have progressed on or could not tolerate previous treatment such as enfortumab vedotin plus pembrolizumab (EVP) or disitamab vedotin plus toripalimab (DVT).\n\nThe main question it aims to answer is: Does sac-TMT lower the risk of getting severe nerve damage, as measured together by doctors, machines, and the participants?\n\nResearchers will compare sac-TMT to alternative MMAE-based ADC drugs (switching to a different MMAE-based ADC after the first one stopped working) to see if sac-TMT causes less nerve damage while still effectively treating the cancer. A small group of participants who had to stop their previous MMAE-based ADC treatment because of nerve damage will also receive sac-TMT to learn if the drug is safe for their nerves.\n\nParticipants will:\n\n1. Receive either sac-TMT or another MMAE-based ADC drug\n2. Have regular physical exams by a doctor to check their nerves\n3. Have machine tests to measure how well their nerves work\n4. Answer survey questions about their pain, numbness, and daily activities",[193,194,32,195],"Bladder Cancer","Metastatic Urothelial Carcinoma","Peripheral Neuropathy",[195,197,198,199,200],"Sacituzumab Tirumotecan","Enfortumab Vedotin","MMAE","Disitamab Vedotin","NOT_YET_RECRUITING","2026-06-17",{"date":172,"type":43},{"date":205,"type":21},"2026-07-15",{"date":207,"type":21},"2029-12-01",{"name":209,"class":128},"Fudan University",{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100624937","phase-1-a-study-of-gen1106-in-participants-with-solid-tumors-100624937","NCT07416123","A Study of GEN1106 in Participants With Solid Tumors","First-In-Human, Open-Label, Dose Escalation and Expansion Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of GEN1106 in Participants With Solid Tumors","Key Inclusion Criteria:\n\n* Have progressed on or after standard of care (SoC) therapy, which should include chemotherapy, anti-programmed cell death protein 1 (PD-1)\u002Fprogrammed cell death ligand 1 (PD-L1) therapies, and enfortumab vedotin (EV), if applicable for the tumor type, or for whom there is no available standard therapy likely to provide clinical benefit, and for whom experimental therapy with GEN1106 may be beneficial, in the opinion of the investigator.\n* Have measurable disease according to RECIST v1.1.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1 at screening.\n* Part 1: Have histologically or cytologically confirmed diagnosis of cancer as specified per protocol.\n* Parts 2 and 3: Have histologically or cytologically confirmed diagnosis of metastatic urothelial carcinoma (mUC).\n\nKey Exclusion Criteria:\n\n* Prior treatment with topoisomerase 1 inhibitor-based antibody-drug conjugate (ADC) therapy.\n* Treatment with an anticancer agent within 4 weeks or for systemic therapies within 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration.\n* Has clinically significant toxicities from previous anticancer therapies that have not resolved to baseline levels or to grade 1 or lower, except for alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy must have recovered to grade 2.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":218,"type":21},103,[24],"The purpose of this trial is to learn about the safety and effectiveness of GEN1106 when it is used for the treatment of participants with certain types of cancer.\n\nThe trial has multiple parts. The first part of the trial tests different doses of GEN1106 to find out if it is safe and determine what are the best doses to use. The second and third parts continues to test the safety of and how well GEN1106 works in additional participants with a specific cancer type and at doses chosen based on results from the first part of the trial.\n\nFor each participant, the trial will last approximately 17 months but will vary for each person. This includes up to 21 days for screening prior to receiving trial treatment, approximately 5 months of treatment (the duration of treatment may vary for each participant), and approximately 11 months of follow up after trial treatment ends (the duration of follow up may vary for each participant).\n\nParticipation in the trial will require visits to the site, with more frequent visits during the first 6 weeks of treatment and then less frequent visits afterwards. At site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, computed tomography \\[CT\\] scans) to monitor whether the treatment is safe and effective.\n\nAll participants will receive active drug; no one will be given placebo.",[222,32],"Solid Tumors","2026-06-12",{"date":225,"type":43},"2026-06-15",{"date":227,"type":43},"2026-04-14",{"date":229,"type":21},"2029-06-25",{"name":231,"class":50},"Genmab",8,{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":254,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":153},"100590480","research-of-double-positive-circulating-cells-tumor-marker--cd45-in-several-types-of-metastatic-cancers-100590480","NCT06967961","Research of Double-positive Circulating Cells (Tumor Marker \u002F CD45+) in Several Types of Metastatic Cancers","DP-PAN-CANCER","Inclusion Criteria:\n\n* 1\\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors\n* 2\\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet\n* 3\\. Age ≥ 18 years\n* 4\\. Patient affiliated to a French Social Security scheme\n* 5\\. Patient having signed his\u002Fher informed consent prior to inclusion in the study and prior to any specific procedure for the study.\n\nExclusion Criteria:\n\n* 1\\. Patient with localized disease.\n* 2\\. Pregnant or breast-feeding women.\n* 3\\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and\u002For procedures set out in the study protocol.\n* 4\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":241,"type":21},450,[140],"A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.\n\nEach patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.\n\n450 patients will be enrolled in total.",[32,245,246,247,248,249,250,251,252,253],"Renal Cancer","Prostate Adenocarcinoma","Adenocarcinoma of Endometrium","Cutaneous Melanoma","Soft Tissue Sarcoma (STS)","Nonseminomatous Germ Cell Tumor","Seminomatous Germ Cell Tumor","Upper Aerodigestive Tract Carcinoma","Cervical Carcinoma",[255,256,257],"metastatic cancers","Double Positive Circulating cells","liquid biopsy",{"date":225,"type":43},{"date":260,"type":43},"2025-07-23",{"date":262,"type":21},"2029-07-23",{"name":264,"class":128},"Institut Claudius Regaud",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":295},"100575580","phase-3-a-phase-3-single-arm-study-of-ugn-104-for-the-treatment-of-low-grade-upper-tract-urothelial-cancer-100575580","NCT06774131","A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer","A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)","Inclusion Criteria:\n\n1. Provide written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.\n2. Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system, with the following disease characteristics:\n\n   1. At least 1 measurable papillary LG tumor, evaluated visually, ≤ 15 mm. The largest lesion should not exceed 15 mm. Debulking to ≤ 15 mm is permitted.\n   2. Biopsy taken from at least 1 tumor located above the ureteropelvic junction revealing LG urothelial carcinoma (UC). Patients who have been biopsied within 8 weeks before Screening for this study and shown to have LG UC may have these historical biopsies used for enrollment into the study and do not require repeat biopsy during Screening.\n   3. Patient should have at least 1 remaining papillary LG tumor evaluated visually with a diameter of at least 5 mm post-biopsy.\n   4. Wash urine cytology sampled from the pyelocalyceal system documenting the absence of high-grade (HG) UC, diagnosed not more than 8 weeks before Screening.\n   5. Patients with bilateral LG-UTUC may be enrolled if at least 1 side meets the inclusion criteria for the study and if the other kidney does not require further treatments. (The disease in the other kidney must be completely ablated before receiving treatment in the study.) Note: If both upper tracts meet inclusion criteria, the treating urologist in consultation with the sponsor's medical monitor can decide which side to treat in the study. The pyelocalyceal system not under study must be free of cancer before the first instillation on the side to be treated in the study.\n3. Patients with Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C 3 (with Karnofsky \\> 40).\n4. Patients with life expectancy \\> 24 months at time of Screening.\n5. Patients must have adequate organ and bone marrow function as determined by the following routine laboratory tests:\n\n   1. Leukocytes ≥ 3,000\u002FμL (≥ 3 × 10\\^9\u002FL).\n   2. Absolute neutrophil count ≥ 1,500\u002FμL (≥ 1.5 × 10\\^9\u002FL).\n   3. Platelets ≥ 100,000\u002FμL (≥ 100 × 10\\^9\u002FL).\n   4. Hemoglobin ≥ 9.0 g\u002FdL.\n   5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n   7. Alkaline phosphatase ≤ 2.5 × ULN.\n   8. Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin.\n6. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis. Note: In case of a symptomatic UTI the patient will be treated with antibiotics and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of treatment is at the discretion of the investigator.\n7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants.\n\nFemale patients of childbearing potential (defined as premenopausal women who have not been sterilized) and male patients with female partners of childbearing potential must agree to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment. Sexually active male patients must agree to use a condom during intercourse for at least 48 hours after each instillation.\n\nAcceptable methods of birth control considered to have a low failure rate (ie, less than 1% per year) when used consistently and correctly include implants, injectable, combined (estrogen\u002Fprogesterone) oral contraceptives, intrauterine devices (only hormonal), condoms with spermicide, sexual abstinence\\* or vasectomized partner.\n\n\\* Sexual abstinence is defined as refraining from intercourse from enrollment through 6 months post treatment. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is NOT an acceptable method of contraception.\n\nExclusion Criteria:\n\n1. UC specific exclusions:\n\n   1. Patient received Bacillus Calmette-Guérin (BCG) treatment for UC during the 6 months before enrollment.\n   2. The patient has untreated concurrent UC in locations other than the target area (unless treated and resolved during Screening); ie, ureteral and lower urinary tract tumors must be completely ablated before entry.\n   3. Patient has a history of carcinoma in situ (CIS) in the urinary tract.\n   4. Patient has a history of invasive UC in the past 5 years.\n   5. Patient has a history of HG papillary UC in the urinary tract in the past 2 years.\n2. Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the study.\n3. Any other malignancy diagnosed within 2 years before enrollment with the exception of:\n\n   1. Basal or squamous cell skin cancers.\n   2. Noninvasive cancer of the cervix.\n   3. Any other cancer deemed to be of low risk for progression or patient morbidity during the study period in the opinion of the investigator.\n4. Patient with urinary obstruction such that there is an inability to deliver the study treatment to the pyelocalyceal system either via ureteral catheter (retrograde administration) or nephrostomy tube (antegrade administration).\n5. Known allergy or sensitivity to any component of the study treatment (including excipients) that in the investigator's opinion cannot be readily managed.\n6. Patient has an intractable bleeding disorder (eg, coagulation factors deficiencies, Von Willebrand disease).\n7. Patient is currently receiving any other investigational product, has participated in a research protocol involving administration of an investigational product in the past 30 days, or plans to participate in a research protocol involving administration of an investigational product during study conduct.\n8. Patient was previously treated with JELMYTO (product code UGN-101) for UTUC.\n9. Women who are pregnant (positive urine or serum pregnancy test), planning to become pregnant during the study period, or who are breastfeeding are not eligible to enroll.\n10. Patient has any other medical or mental condition(s) that make(s) his\u002Fher participation in the study unadvisable in the opinion of the investigator.\n11. Where applicable per country regulation, the patient must not be currently committed to an institution by virtue of an order issued by either judicial or administrative authorities.",{"count":273,"type":21},70,[275],"PHASE3","This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \\[mitomycin\\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).",[278,32],"Upper Urinary Tract Urothelial Carcinoma",[280,281,282,283,284,285,286,287],"UTUC","Low Grade UTUC","Low-grade Upper Tract Urothelial Cancer","UGN-104","Mitomycin","Nephrostomy Tube","LG-UTUC","UGN-101",{"date":289,"type":43},"2026-06-16",{"date":291,"type":43},"2025-08-06",{"date":176,"type":21},{"name":294,"class":50},"UroGen Pharma Ltd.",62,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":318,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100569561","phase-2-a-phase-2-study-of-zanidatamab-in-patients-with-her2-expressing-tumors-100569561","NCT06695845","A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors","A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)","Inclusion Criteria:\n\n1. Is at least 18 years of age inclusive at the time of signing the informed consent\n2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.\n3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.\n4. All participants must have adequate tumor sample for submission to allow central HER2 testing.\n5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Has a life expectancy of at least 3 months, in the opinion of the investigator.\n8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:\n\n   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.\n   2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \\\u003C Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \\> 7 days prior to Cycle 1 Day 1.\n   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.\n9. Adequate organ functions.\n10. Females of childbearing potential must have a negative pregnancy test result.\n11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.\n\nExclusion Criteria:\n\n1. Has known or suspected leptomeningeal disease and\u002For untreated brain metastasis.\n2. Has uncontrolled or significant cardiovascular disease\n3. Has ongoing toxicity related to prior cancer therapy\n4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.\n5. Has known Human Immunodeficiency Virus (HIV) infection.\n6. Has active hepatitis B or C infection.\n7. Has an active SARS-CoV-2 infection.\n8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.\n9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.\n10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.\n11. Prior treatment with HER2-targeted therapy (Cohort 1 only).\n12. Has a history of trauma or major surgery\n13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n14. Received zanidatamab at any time prior to the current study.\n15. Colorectal Cancer (CRC) participants with known KRAS\u002FNRAS and BRAF mutations.\n16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.\n17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.\n18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.",{"count":304,"type":21},200,[25],"The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.",[308,309,310,311,30,312,313,314,32,315,316,317],"Breast Cancer","Gastric Cancer","Esophageal Cancer","Gastroesophageal Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Ovarian Cancer","Salivary Gland Cancer","Pancreatic Cancer","HER-2 Protein Overexpression",[319,320,321],"JZP598","ZW25","HER2 IHC 3+ Overexpression Solid Tumors","2026-06-05",{"date":324,"type":43},"2026-06-09",{"date":326,"type":43},"2025-01-14",{"date":328,"type":21},"2027-12-31",{"name":330,"class":50},"Jazz Pharmaceuticals",28,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":153},"100536473","phase-2-comparison-of-in-home-versus-in-clinic-administration-of-subcutaneous-nivolumab-through-cancer-care-connected-access-and-remote-expertise-beyond-walls-ccbw-program-100536473","NCT06265285","Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program","MC230716 Pilot Single-Arm, Pragmatic Trial Of In-Home Versus In-Clinic Subcutaneous Nivolumab Administration Through Cancer CARE (Connected Access And Remote Expertise) Beyond Walls (CCBW) Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed malignancies for which treatment with intravenous nivolumab is currently Food and Drug Administration (FDA) approved and who are recommended to initiate a new treatment regimen with single agent intravenous (IV) nivolumab by their treating oncologist for any of the indications outlined below and who are willing to switch to subcutaneous nivolumab. Additionally, patients who are currently receiving single-agent IV nivolumab are eligible, provided they transition to subcutaneous nivolumab on-study, with their first subcutaneous (subQ) dose administered on cycle 1, day 1 of the study.\n\n  * Single agent nivolumab administered in the adjuvant setting for one of the following indications:\n\n    * Completely resected stage IIB\u002FC, III or IV melanoma\n    * Urothelial carcinoma status post radical resection and have a high risk of recurrence\n    * Completely resected esophageal or gastroesophageal junction carcinoma with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT)\n  * Single agent nivolumab for advanced\u002Fmetastatic cancer for one or more of the following indications:\n\n    * Renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy\n    * Non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (Note: patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab)\n    * Unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy\n    * Unresectable or metastatic cutaneous melanoma\n    * Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy\n    * Unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.\n\n      * Subcutaneous nivolumab to be initiated as monotherapy following six cycles of cisplatin + gemcitabine\n    * Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Patients transitioning to maintenance nivolumab and who are willing to switch to subcutaneous nivolumab after completion of Ipilimumab and nivolumab combination therapy for one or more of the indications listed below (Note: patients who discontinue ipilimumab for immune-related toxicities, but are deemed to be eligible to continue on single agent nivolumab maintenance by their treating oncologist are eligible):\n\n    * First-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC)\n    * Unresectable or metastatic cutaneous melanoma\n    * Hepatocellular carcinoma (HCC) previously treated with sorafenib\n    * Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan\n  * Single agent nivolumab administered in the adjuvant setting following neoadjuvant nivolumab with platinum doublet chemotherapy for patients with resectable (tumors ≥ 4 cm and\u002For node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements\n* Patients have recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and\u002For surgery (i.e., residual toxicity no worse than grade 1 \\[grade 2 treatment-associated peripheral neuropathy, grade 2 fatigue and\u002For any grade of alopecia are acceptable assuming all other inclusion criteria are met\\]) before registration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Aspartate transaminase (AST) values ≤ 3 × the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase\n* Alanine transaminase (ALT) values ≤ 3 x the upper limit of normal (ULN). For patients with documented baseline liver metastasis, the following limits will apply: 5 x ULN for transaminase\n* Serum total bilirubin values of ≤ 1.5 x ULN ( ≤ 2 x ULN for patients with known Gilbert's syndrome). For patients with documented baseline liver metastasis, the following limits will apply: 2 x ULN for bilirubin\n* Absolute neutrophil count (ANC) of ≥ 1500\u002FμL\n* Platelet count of ≥ 100,000\u002FμL\n* Hemoglobin of ≥ 9 g\u002FdL (patients may be transfused to this level, if necessary, but transfusion must occur \\> 1 week prior to registration)\n* Serum creatinine ≤ 2.0 x the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 30 mL\u002Fmin by the Cockcroft-Gault Equation measured ≤ 7 days prior to registration\n* Patients are residing ≤ 35 miles of clinic (hub) or within the area serviced by supplier and paramedic network\n* Residence has Wi-Fi to enable a reliable connection with the remote command center\n* Patients have signed Informed Consent Form (ICF)\n* Patients are willing and able to comply with the study protocol in the investigator's judgment\n* Patients are able and willing to complete study questionnaire(s) by themselves or with assistance\n* Women of childbearing potential (WOCBP) must:\n\n  * Have a negative pregnancy test (serum or urine) ≤ 3 days before the first dose of study drug\n  * Be agreeable to use a contraceptive method that is highly effective during the intervention period and for at least 5 months after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period\n\nExclusion Criteria:\n\n* Patients receiving any other investigational or standard of care agent which would be considered as a treatment for the primary neoplasm and is not part of the eligible treatment regimen\n* Patients requiring 24\u002F7 assistance with activities of daily living (ADLs)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with any severe infection ≤ 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections\n* Patients with an active, known or suspected autoimmune disease. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with celiac disease controlled with diet modification are not excluded\n* Patients with a condition requiring systemic treatment with either corticosteroids ( \\> 10 mg daily prednisone equivalent) ≤ 14 days or other immunosuppressive medications ≤ 30 days prior to registration. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease\n* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active ≤ 2 years prior to registration (i.e., participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization\u002Ftreatment assignment and the patient has no evidence of disease). Participants with history of prior early stage basal\u002Fsquamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible\n* Patients have undergone prior solid organ and\u002For non-autologous hematopoietic stem cell or bone marrow transplant\n* Patients with active brain metastases or leptomeningeal metastases, aside from the exceptions below. Participants with brain metastases are eligible if they are:\n\n  * Asymptomatic\n  * Have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the central nervous system \\[CNS\\] treatment), and\n  * There is no MRI evidence of progression for at least 4 weeks after CNS directed therapy is complete and ≤ 28 days prior to registration\n  * In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to registration\n* Participants with brain disease treated with whole brain radiation\n* Anticipation of the need for major surgery during the course of study treatment\n* Participants who are pregnant or breastfeeding\n* Treatment with any live attenuated vaccines ≤ 30 days of registration (vaccines that are not live attenuated are allowed, including COVID-19 vaccine)\n* Known human deficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count \\\u003C 350 cells\u002FuL, aside from the exceptions below. Participants with HIV are eligible if:\n\n  * They have received antiviral therapy (ART) for at least 4 weeks prior to treatment assignment as clinically indicated while enrolled in the study\n  * They continue on ART as clinically indicated while enrolled on study\n  * CD4 counts and viral load are monitored per standard of care by a local healthcare provider\n* History of allergy or hypersensitivity to study drug components\n* Any positive test result for hepatitis B virus (HBV) indicating presence of virus (e.g., hepatitis B surface antigen \\[HBsAg, Australia antigen\\]) positive\n* Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-ribonucleic acid \\[RNA\\]). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll",{"count":340,"type":21},50,[25],"This phase II trial compares the impact of subcutaneous (SC) nivolumab given in an in-home setting to an in-clinic setting on cancer care and quality of life. Currently, most drug-related cancer care is conducted in clinic type centers or hospitals which may isolate patients from family, friends and familiar surroundings for many hours per day. This separation adds to the physical, emotional, social, and financial burden for patients and their families. Traveling to and from medical facilities costs time, money, and effort and can be a disadvantage to patients living in rural areas, those with low incomes or poor access to transport. Studies have shown that cancer patients often feel more comfortable and secure being cared for in their own home environments. SC nivolumab in-home treatment may be safe, tolerable and\u002For effective when compared to in-clinic treatment and may reduce the burden of cancer and improve the quality of life in cancer patients.",[344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,194,363,364,145,365,366,367,368,369,370,32,371],"Advanced Esophageal Squamous Cell Carcinoma","Advanced Renal Cell Carcinoma","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8","Esophageal Carcinoma","Gastroesophageal Junction Adenocarcinoma","Hepatocellular Carcinoma","Locally Advanced Urothelial Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Metastatic Colorectal Carcinoma","Metastatic Cutaneous Melanoma","Metastatic Esophageal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Recurrent Esophageal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Stage III Renal Cell Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Unresectable Cutaneous Melanoma","Unresectable Esophageal Squamous Cell Carcinoma","Unresectable Urothelial Carcinoma",{"date":324,"type":43},{"date":374,"type":43},"2024-04-30",{"date":376,"type":21},"2026-12-31",{"name":378,"class":128},"Mayo Clinic",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":51},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":241,"type":21},[24],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[390,82,79,71,391,310,309,64,30,32,392,393],"Locally Advanced or Metastatic Solid Tumors","TNBC","Clear Cell RCC","HCC",{"date":324,"type":43},{"date":396,"type":43},"2022-10-20",{"date":398,"type":21},"2028-07-31",{"name":400,"class":50},"Genentech, Inc.",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":415,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":340},"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":409,"type":21},132,[24,25],"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.",[413,414,32],"Urothelial Cancer","Advanced\u002FMetastatic Urothelial Cancer",[416,417,418,419,420,421,422],"urothelial cancer","metastatic urothelial cancer","locally advanced urothelial cancer","bladder cancer","urothelial carcinoma","PD-1","VEGF","2026-06-03",{"date":425,"type":43},"2026-06-04",{"date":427,"type":43},"2026-03-11",{"date":429,"type":21},"2028-09-05",{"name":431,"class":50},"Pfizer",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100457670","phase-2-enfortumab-vedotin-and-pembrolizumab-in-people-with-bladder-cancer-100457670","NCT05239624","Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer","Enfortumab Vedotin in Combination With Pembrolizumab for Locally Advanced and\u002For Node Positive Urothelial Carcinoma Prior to Surgery (EV-ECLIPSE)","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of muscle invasive bladder cancer (previously known as transitional cell) carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra)\n* Clinical Stage T2-T4, N1-N3, M0 OR cT1, N2-N3, M0\n* Pathology:\n\n  * Representative urothelial carcinoma FFPE tumor specimens (tumor blocks or 20 unstained slides). Patients with \\\u003C 20 slides may be enrolled after discussion with the principal investigator.\n  * Muscle invasive urothelial carcinoma of the bladder histologically confirmed at the enrolling institution from TURBT. (Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed provided the extent of disease is confirmed via imaging and\u002For EUA.)\n  * Evidence of urothelial carcinoma from FNA of lymph node OR lymphadenopathy suspicious for nodal disease on cross-sectional imaging, MRI, or u\u002Fs.\n  * Node positivity for eligibility will be defined as imaging read with suspicious lymph node ≤ 1.0 cm in the short axis, with biopsy, as documented by the radiologist at the treating center. While biopsy to confirm lymph node involvement is preferred, patients without biopsy proven urothelial carcinoma in lymph nodes may be enrolled if imaging shows a lymph node ≥ 1.0 cm in the short axis, and with confirmation from the study principal investigator. If biopsy positive, LN can be any size. If biopsy not performed, LN ≥ 1.0 cm in short axis.\n* Deemed medically appropriate for radical cystectomy with treatment response achieved, as per MSK or participating site Attending Urologic Oncologist\n* Platinum eligible and ineligible patients are permitted on study\n* No prior treatments for muscle invasive or metastatic urothelial carcinoma\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n* Estimated glomerular filtration rate (eGFR) ≥ 30 ml\u002Fmin\u002F1.73 m2 using the CKD-EPI equation: eGFR = 141 x min(Scr\u002Fk, 1)a x max (Scr\u002Fk, 1)-1.209 x 0.993Age x 1.018 \\[if female\\] x 1.159 \\[if black\\]\n\n  °Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr\u002Fk or 1, and max indicates the maximum of Scr\u002Fk or 1\n* Be willing and able to provide written informed consent for the trial\n* Contraception requirements:\n\n  1. Male participants:\n\n     A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 days following the last dose of treatment, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and enfortumab vedotin) plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period.\n  2. Female participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\ni. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR ii. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least \\[90 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and enfortumab vedotin) plus 30 days (a menstruation cycle)\\] after the last dose of study treatment.\n\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study treatment either prior to consent or at the study screening visit.\n* Hematological\n\n  * Absolute neutrophil count (ANC) ≥1500\u002FμL\n  * Platelets ≥100 000\u002FμL\n  * Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FLa\n* Renal\n\n  °Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) GFR or CrCl of ≥ 30 mL\u002Fmin\n* Hepatic\n\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN\n* Coagulation °International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\na Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b eGFR as calculated by the CKD-EPI equation can be used in place of the creatinine clearance\n\nNote: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies\n\nExclusion Criteria:\n\n* Evidence of NYHA functional class III or IV heart disease\n* Any of the following within 6 months prior to study drug administration: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack\n* On-going cardiac dysrhythmias of NCI CTCAE Version 5.0 grade ≥ 2. However, stable atrial fibrillation controlled medically or with a device (i.e. pacemaker) or prior ablation is allowed\n* Pre-existing sensory grade ≥ 2 neuropathy\n* Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure aside from cystectomy during the course of the study. Transurethral resection or other urinary tract diagnostic procedures, excisional biopsy, IR-guided biopsy, or MEDIPORT placement are NOT defined as major surgical procedures.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.\n\n* Is currently enrolled in another therapeutic trial. Patients cannot receive concurrent treatment on another clinical trial; Patients are allowed to enroll on supportive care trials or non-treatment trials (e.g. QOL, dietary survey studies) concurrently\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.\n\n  * Prior treatment with an antibody drug conjugate for bladder cancer directed therapy\n  * Prior systemic chemotherapy (prior intravesical therapy is allowed)\n  * Prior radiation therapy to the bladder\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed. COVID-19 vaccination is permitted.\n\n  °Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.\n* Has receieved intravesical bacillus Calmette-Guerin (BCG) within 4 weeks before Cycle 1, Day 1 14.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a history of poorly controlled human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness. Patients with a history of an aids-defining opportunistic infection within the last 12 months or who are on prophylactic antimicrobials related to underlying HIV are not eligible. Patients with a history of HIV and a CD4 T cell count of ≥350 are eligible to enroll in this study with the approval of the study PI.\n* Subjects with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \\\u003C8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n* Has a history of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, systemic vasculitis, or glomerulonephritis.\n\n  * Patients with history of autoimmune related hypothyroidism on stable dose of thyroid replacement hormone may be eligible for this study\n  * Patients with controlled Type I diabetes mellitus on a stable dose of insulin may be eligible for this study\n* Has a history of idiopathic pulmonary fibrosis, pneumonitis\u002Finterstitial lung disease that requires steroids or has current pneumonitis\u002Finterstitial lung disease (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Patients with active hepatitis B virus (HBV, chronic or acute, defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C antibody\n\n  * Patients with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBc Ab\\] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to Cycle 1, Day 1 and confirmed to be negative.\n  * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Active tuberculosis or BCG infection\n* Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1. Abnormal urinalysis does not constitute signs\u002Fsymptoms of infection unless urine culture obtained at screening grows ≥ 100,000 colonies of bacteria.\n* Therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1\n\n  * Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligible.\n  * Patients receiving antibiotics for active infection are not eligible\n* Prior allogeneic stem cell or solid organ transplant\n* AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia\n* Patients with a history of or active bone marrow disorders expected to interfere with study therapy (e.g. acute leukemias, accelerated\u002Fblast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma)\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; and inherited liver disease\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* Patients with active keratitis or history of corneal ulcers are excluded\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\n\n  * Rash must cover less than 10% of body surface area (BSA)\n  * Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\n  * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)\n* Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-ofcare management (e.g. prostate cancer with Gleason score ≤ 7, and prostate-specific antigen \\[PSA\\] ≤ 10 mg\u002FmL, etc).",{"count":440,"type":21},23,[25],"This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery.\n\nThe researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.",[32],[445,446,447,448,449],"Locally Advanced and\u002For Node Positive","Enfortumab vedotin","Pembrolizumab","Clinical Stage T2-T4, N1-N3, M0 OR cT1, N2-N3, M0","21-316","2026-06-02",{"date":425,"type":43},{"date":453,"type":43},"2022-06-02",{"date":455,"type":21},"2027-06",{"name":127,"class":128},10,{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":468,"briefSummary":469,"conditions":470,"keywords":476,"overallStatus":201,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":4},"100639777","phase-1-a-first-in-human-study-of-hh160-in-patients-with-advanced-solid-tumors-100639777","NCT07623369","A First-in-Human Study of HH160 in Patients With Advanced Solid Tumors","An Open-Label, Multicenter, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of HH160 in Patients With Advanced Solid Tumors","Key Inclusion Criteria\n\n1. Adults aged 18 to 75 years with signed informed consent.\n2. Histologically or cytologically confirmed advanced solid tumors meeting phase-specific disease requirements.\n3. At least 1 measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status of 0 or 1 with life expectancy ≥ 12 weeks.\n5. Adequate organ function based on protocol-specified laboratory criteria.\n\nKey Exclusion Criteria\n\n1. Active leptomeningeal disease or uncontrolled\u002Funtreated brain metastases.\n2. History of severe hypersensitivity reactions to monoclonal antibodies, bispecific antibodies, trispecific antibodies, or study drug components.\n3. Other malignancy within 3 years prior to first dose, except specified curatively treated cancers.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n5. Significant bleeding risk, severe coagulopathy, gastrointestinal hemorrhage, or recent pulmonary hemorrhage\u002Fhemoptysis.\n\nNOTE: Other eligibility criteria may apply.","75 Years",{"count":467,"type":21},56,[24],"This study is evaluating the safety, side effects, how the body processes HH160, and its early anticancer activity when given alone or with other cancer treatments in participants with advanced solid tumors. The study will also identify the recommended dose for future studies. The trial includes two phases and is expected to last about 4 years, with treatment and follow-up lasting approximately 6-12 months each.",[471,313,355,30,472,145,312,64,473,474,32,475],"Solid Tumor","Head and Neck Squamous Cell Carcinoma","Small-cell Lung Cancer","Triple Negative Breast Cancer","Gastroesophageal Adenocarcinoma",[477,478,313,82,355,393,30,76,479,472,145,480,312,64,473,474,391,32,475,314],"HH160","PD-1×CTLA-4×VEGF-A Antibody","GEA","RCC","2026-05-29",{"date":423,"type":43},{"date":484,"type":21},"2026-06",{"date":486,"type":21},"2028-08",{"name":488,"class":50},"Huahui Health",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":497,"phases":4,"briefSummary":498,"conditions":499,"keywords":501,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":129},"100622976","a-study-of-neuropathy-caused-by-enfortumab-vedotin-in-people-with-urothelial-carcinoma-100622976","NCT07390617","A Study of Neuropathy Caused by Enfortumab Vedotin in People With Urothelial Carcinoma","Interrogating Enfortumab Vedotin-associated Neuropathy in Patients With Metastatic or Muscle-Invasive Urothelial Carcinoma Receiving Enfortumab Vedotin","Inclusion Criteria:\n\n* Written informed consent by and HIPAA authorization for release of personal health information obtained from the research participant.\n* Able to speak and read English to a sufficient level of fluency to provide informed consent and complete the study questionnaires.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of ≤ 3 within 28 days prior to consent.\n* Histological or cytologically confirmed urothelial carcinoma.\n* Patients must be planned to start systemic therapy with enfortumab vedotin\n* At time of enrollment, patients must be planned to start enfortumab with or without pembrolizumab\n\nExclusion Criteria:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Inability of the subject to understand and comply with study procedures.\n* Having previously received enfortumab vedotin\n* Students\u002Femployees of the study institution, pregnant women, prisoners, and institutionalized individuals (to prevent enrollment of vulnerable subjects).",{"count":340,"type":21},"OBSERVATIONAL","The purpose of this study is to see how results of nerve tests change in people with urothelial cancer who receive treatment with enfortumab vedotin (EV)",[500,32,194],"Neuropathy",[420,502,503,127,504],"metastatic urothelial carcinoma","neuropathy","25-371","2026-05-26",{"date":481,"type":43},{"date":508,"type":43},"2026-01-20",{"date":510,"type":21},"2028-01-20",{"name":127,"class":128},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":331},"100482499","phase-1-a-substudy-of-investigational-agents-in-programmed-cell-death-1ligand-1-pd-1l1-refractory-locally-advanced-or-metastatic-urothelial-carcinoma-muc-mk-3475-04a-100482499","NCT05562830","A Substudy of Investigational Agents in Programmed Cell Death-1\u002FLigand 1 (PD-1\u002FL1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)","A Phase 1\u002F2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1\u002FL1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A","Inclusion Criteria:\n\nThe main inclusion and exclusion criteria include but are not limited to the following:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced\u002Funresectable or mUC of the renal pelvis, ureter (upper urinary tract), bladder, or urethra.\n* Arm A: PD-1\u002FL1 refractory locally advanced or mUC as evidenced by: EITHER disease progression while on treatment or after treatment with an anti-PD-1\u002FL1 monoclonal antibody (mAb) for locally advanced\u002Funresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies OR disease recurrence while on treatment or after treatment with an anti-PD-1\u002FL1 mAb for muscle-invasive urothelial carcinoma (MIUC) administered as monotherapy.\n* Arm A: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating UC, not previously irradiated, and adequate for biomarker evaluation.\n* Arm B: PD-1\u002FL1 refractory locally advanced or mUC as evidenced by: EITHER disease progression after treatment with an anti-PD-1\u002FL1 mAb for locally advanced\u002Funresectable or mUC administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies; OR disease recurrence after treatment with an anti-PD-1\u002FL1 mAb for MIUC administered as monotherapy or in combination with other checkpoint therapies \\>12 months after last dose of treatment with an anti-PD-1\u002FL1 mAb.\n* Arm B: Participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion from a metastatic site or from a primary tumor that has become locally advanced and not previously irradiated.\n\nExclusion Criteria:\n\n* Known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization\u002Fallocation.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\u002Fallocation.\n* Active infection requiring systemic therapy.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Known history of human immunodeficiency virus (HIV).\n* Known history of hepatitis B or known hepatitis C virus infection.",{"count":520,"type":21},48,[24,25],"This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1\u002Fligand 1 (PD-1\u002FL1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.",[32],{"date":525,"type":43},"2026-05-27",{"date":527,"type":43},"2022-11-16",{"date":529,"type":21},"2029-02-26",{"name":531,"class":50},"Merck Sharp & Dohme LLC",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":555},"100590331","phase-1-study-of-dcc-2812-in-participants-with-advanced-genitourinary-cancers-100590331","NCT06966024","Study of DCC-2812 in Participants With Advanced Genitourinary Cancers","An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n* Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer\n* Able to take oral medication\n* If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements\n* Adequate organ function and electrolytes\n\nKey Exclusion Criteria:\n\n* Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812\n* Impaired cardiac function\n* Major surgery within 28 days of the first dose of study drug",{"count":104,"type":21},[24],"This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced\u002Fmetastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.",[145,32,543],"Castration-resistant Prostate Cancer",[545],"Advanced malignancies","2026-05-18",{"date":548,"type":43},"2026-05-20",{"date":550,"type":43},"2025-08-27",{"date":552,"type":21},"2029-02",{"name":554,"class":50},"Deciphera Pharmaceuticals, LLC",5,{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":153},"100614857","phase-2-the-cancer-connected-access-and-remote-expertise-beyond-walls-program-to-provide-in-home-cancer-treatment-and-improve-treatment-satisfaction-in-cancer-patients-living-in-the-florida-panhandle-and-surrounding-areas-100614857","NCT07285044","The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas","Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas","Inclusion Criteria:\n\n* Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \\[NCCN\\], American Society of Clinical Oncology \\[ASCO\\], American Society of Hematology \\[ASH\\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician\n* Female or male patients age \\>= 18 years at the time of consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required.\n\n  * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens\n  * Eligible disease cancer types:\n\n    * Amyloidosis\n    * Basal cell carcinoma\n    * Biliary\n    * Bladder\n    * Breast\n    * Cervical\n    * Colorectal\n    * Endometrial\n    * Fallopian tube\n    * Gastroesophageal\n    * Glioblastoma\n    * Head and neck\n    * Hepatocellular\n    * Hodgkin lymphoma\n    * Lung\n    * Mantle cell lymphoma\n    * Merkle cell carcinoma\n    * Multiple myeloma\n    * Melanoma\n    * Myelodysplastic syndrome\n    * Ovarian\n    * Pancreatic\n    * Peritoneal\n    * Prostate\n    * Renal cell carcinoma\n    * Squamous cell carcinoma\n    * Urothelial carcinoma\n  * Eligible regimens\n\n    * Atezolizumab +\u002F- bevacizumab\n    * Avelumab\n    * Bevacizumab\n    * Bortezomib\n    * Cemiplimab\n    * Daratumumab +\u002F- bortezomib\n    * Darbepoetin alpha\n    * Degarelix\n    * Denosumab (Xgeva)\n    * Durvalumab\n    * Fluorouracil +\u002F- bevacizumab\n    * Fulvestrant\n    * Goserelin\n    * Ipilimumab +\u002F- Nivolumab\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + relatlimab\n    * Octreotide\n    * Pembrolizumab\n    * Pertuzumab +\u002F- trastuzumab\n    * Trastuzumab +\u002F- pertuzumab\n    * Zoledronic acid (Zometa)\n* Willingness to follow birth control requirements for females and males of reproductive potential\n* Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network\n* Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic\n* Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \\>= 12 weeks from the time of registration\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any investigational agent which would be considered as a treatment for the primary neoplasm.\n\n  * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial\n* Individuals who require continuous (24\u002F7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)",{"count":564,"type":21},27,[25],"This phase II trial studies whether providing cancer treatment in the home is preferred over the traditional clinic setting and if it improves treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas. Typically, drug-related cancer care is provided at a medical center which causes patients to have to spend considerable time away from their family, friends, and familiar surroundings. This may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team trained to provide cancer treatment in the patient's home setting. It is designed to support remote connection between the home health team and providers and Mayo clinic. This may be preferred over the traditional clinic setting which may improve treatment satisfaction in cancer patients living in the Florida Panhandle and surrounding areas.",[568,569,570,571,572,253,573,574,575,576,577,578,579,355,580,581,358,582,71,583,584,585,586,587,588,589,145,590,32],"Amyloidosis","Basal Cell Carcinoma","Biliary Tract Carcinoma","Bladder Carcinoma","Breast Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Fallopian Tube Carcinoma","Gastroesophageal Junction Carcinoma","Glioblastoma","Head and Neck Carcinoma","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lung Carcinoma","Mantle Cell Lymphoma","Merkel Cell Carcinoma","Multiple Myeloma","Myelodysplastic Syndrome","Ovarian Carcinoma","Pancreatic Carcinoma","Primary Peritoneal Carcinoma","Prostate Carcinoma","Squamous Cell Carcinoma","2026-05-15",{"date":546,"type":43},{"date":594,"type":43},"2025-12-18",{"date":596,"type":21},"2026-12-18",{"name":378,"class":128},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":607,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":620},"100436943","phase-1-a-study-evaluating-the-safety-pharmacokinetics-and-early-efficacy-of-ava6000-in-solid-tumours-100436943","NCT04969835","A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours","Inclusion Criteria:\n\n1. The patient has been fully informed about the study and has signed the Informed Consent Form.\n2. Male or female patients, ≥ 18 years of age.\n3. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic:\n\n   a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or metastatic setting and anthracycline naïve (any setting) and would otherwise be a candidate for doxorubicin hydrochloride treatment; OR ii. has received a total doxorubicin dose of \\\u003C 150mg\u002Fm2 (any setting (\\\u003C 2 cycles of 75 mg\u002Fm2 Q21 days) and has discontinued due to intolerance or toxicity related to doxorubicin\n\n   b) Phase 1b: patients with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic tumour of one of the following types:\n   1. High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting\n   2. SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)\n   3. TNBC: Locally advanced or metastatic triple negative breast cancer confirmed by histopathology who have received any prior therapy in the locally advanced or metastatic setting. Patients must be BRCA wild-type.\n4. In Phase 1b, patients must meet the following additional criteria:\n\n   Patients must demonstrate (as documented, per the investigator's assessment), radiological disease progression over the 6 months (±2 months) prior to screening. However, this requirement does not apply if the patient is newly diagnosed, recurrent or newly metastatic.\n   * Patients must have measurable disease per RECIST.\n   * Patients with high grade soft tissue sarcoma or salivary gland cancer must not have previously received an anthracycline-based therapy.\n   * Patients with TNBC may receive up to 250mg\u002Fm2 of prior doxorubicin (or an equivalent anthracycline). Prior anthracycline based therapy must have been completed at least 6 months before the planned Cycle 1 Day 1 AVA6000 infusion. Prior anthracycline use must have been in the adjuvant or neoadjuvant setting only.\n   * Patients must provide at least 1 tissue sample collection, either archival or fresh tissue (approximately 10 slides) unless the biopsy is medically not able to be performed or the principal investigator deems it is not medically feasible.\n5. Has a life expectancy of ≥12 weeks, in the opinion of the investigator.\n6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n7. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE grade ≤1 or returned to baseline, except alopecia and peripheral neuropathy, which can be up to CTCAE grade 2).\n8. Has adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose):\n\n   * Absolute Neutrophil count (ANC) of ≥1.5 × 109 cells\u002FL.\n   * Haemoglobin ≥9.0 g\u002FdL.\n   * Platelet count of ≥75,000\u002FµL.\n   * International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN).\n9. Has adequate liver function:\n\n   * Total bilirubin below ULN (except for patients with Gilbert's Syndrome who must have a total bilirubin \\\u003C3 × ULN).\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, \\\u003C5 × ULN is allowed).\n   * Alkaline phosphatase (ALP) \\\u003C5 × ULN in patients with documented liver or bone metastases, or ALP \\\u003C 2 × ULN in patients without documented metastases.\n10. Has adequate renal function (creatinine clearance ≥50 mL\u002Fmin by Cockcroft-Gault formula) or patients with normal plasmatic creatinine despite creatinine clearance \\\u003C 50 mL\u002Fmin as per Cockcroft-Gault formula are eligible for the study.\n11. Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.\n12. Contraception requirements:\n\n    * Female patients of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    * Male patients must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n13. All patients should have peripheral veins or central line that are, in the opinion of the Investigator or delegate, suitable for peripheral or central intravenous infusion of AVA6000.\n14. The patient is willing and able to comply with the protocol, including any PK blood sampling requirements and agrees to return to hospital for follow-up visits and examinations.\n\nExclusion Criteria:\n\n1. Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.\n2. Has received a prior total cumulative anthracycline dose of ≥ 350 mg\u002Fm2 doxorubicin (or equivalent anthracycline dose).\n3. Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.\n4. Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.\n5. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n6. In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \\>150 mm Hg and\u002For diastolic blood pressure \\>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \\>II), left ventricular ejection fraction (LVEF) \\\u003C55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).\n7. Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \\>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia \\\u003C45 beats\u002Fmin or a baseline resting tachycardia of \\>100 beats\u002Fmin.\n8. HIV infection:\n\n   * Patients with an AIDS-defining infection within 12 months of planned study Day 1.\n   * Patients on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\> 400 copies\u002FmL prior to study Day 1.\n9. Active hepatitis B (HBV) or hepatitis C (HCV) infection defined as:\n\n   1. Has a positive hepatitis B surface antigen (HBsAG) test at screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen \\[antiHBc\\] antibody test) are eligible.\n   2. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.\n   3. Chronic HBV (HbSAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Patients with active disease who have not on\u002Finitiated anti-retroviral treatment prior to study Day 1.\n   5. Patients with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Patients with treated HCV infection but with a HCV viral load above the level of quantification.\n10. Has a severe infection (requiring iv treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia.\n11. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.",{"count":606,"type":21},158,[24],"This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[610,32,586,308,611],"Salivary Gland Tumor","Soft Tissue Sarcoma","2026-05-13",{"date":591,"type":43},{"date":615,"type":43},"2021-07-16",{"date":617,"type":21},"2026-08-15",{"name":619,"class":50},"Avacta Life Sciences Ltd",9,{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":637,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":653},"100437528","phase-1-gi-101gi-101a-as-a-single-agent-or-in-combination-with-pembrolizumab-or-lenvatinib-in-advanced-solid-tumors-100437528","NCT04977453","GI-101\u002FGI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101\u002FGI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n* Has adequate organ and marrow function as defined in protocol.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status 0-1.\n* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.\n* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease as defined in protocol.\n\nKey Exclusion Criteria:\n\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* An active second malignancy\n* Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has active tuberculosis or has a known history of active tuberculosis\n* Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.\n* History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Previous immunotherapies related to mode of action of GI-101.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.\n* Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.\n* Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy\n* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.\n* Known hypersensitivity to any of the components of the drug products and\u002For excipients of GI-101\u002FGI-101A, pembrolizumab or lenvatinib.\n\nOther protocol defined inclusion exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol.",{"count":629,"type":21},317,[24,25],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101\u002FGI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and\u002For metastatic solid tumors.",[633,634,64,32,635,636],"Advanced Solid Tumor","Metastatic Solid Tumor","Clear Cell Renal Cell Cancer (ccRCC)","Squamous Cell Non Small Cell Lung Cancer",[638,639,640,641,642,447,643,644,645],"GI-101\u002FGI-101A","CD80-IgG4 Fc-IL2 variant","Immunotherapy","IL-2","Interleukin-2","Lenvatinib","CPI-refractory","Immunocytokine",{"date":591,"type":43},{"date":648,"type":43},"2021-08-02",{"date":650,"type":21},"2028-06-30",{"name":652,"class":50},"GI Innovation, Inc.",12,{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":22,"phases":663,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":232},"100505967","phase-2-a-study-of-enfortumab-vedotin-in-people-with-urothelial-carcinoma-of-the-upper-urinary-tract-100505967","NCT05868265","A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract","Neoadjuvant Enfortumab Vedotin in High-Grade Urothelial Carcinoma of the Upper Urinary Tract (Including Ureter and Renal Pelvis)","Inclusion Criteria:\n\n* Histologically confirmed high grade urothelial carcinoma of the upper tract and\u002For radiographically visible tumor stage T2-T4a N0\u002Fx M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component. Discussion with PI strongly encouraged.) Retroperitoneal lymph nodes \\\u003C15 mm in the short axis will be eligible.\n* Patients who are\n\n  o Ineligible for cisplatin based on any of the following criteria:\n  * Estimated or calculated creatinine clearance ≥ 30ml\u002Fmin but \\\u003C 60 ml\u002Fmin\n  * Grade 2 or above audiometric hearing loss (per CTCAE v5.0) or\n  * Declined cisplatin-based neoadjuvant chemotherapy, as documented in medical chart\n* Availability of tumor specimen block, cell block or 30 unstained slides from diagnosis. Patients with fewer than 30 slides available may be enrolled after discussion with the Principal Investigator.Additional research biopsy is not required.\n* Karnofsky performance status ≥ 70%.\n* Medically appropriate candidate for radical surgery (nephroureterectomy, nephrectomy, or ureterectomy), as per treating Attending Urologic Oncologist\n* Age ≥ 18 years.\n* Required initial laboratory values:\n\n  * Absolute neutrophil count ≥ 1.5 x 10\\^9 \u002FL\n  * Platelets ≥ 100 x 109 \u002FL\n  * Bilirubin ≤1.5 times the upper limit of normal (x ULN)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN PTT\u002FPT ≤1.5 x ULN or INR \\\u003C 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose\n* If patients are HIV (+) they are eligible as long as they have: cd4 \\>200, undetectable viral load and on HAART therapy.\n\nExclusion Criteria:\n\n* Presence of metastatic disease.\n* Prior treatment with systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years. (Prior intravesical treatment such as BCG is allowed).\n* Grade 2 or higher peripheral neuropathy.\n* Patients with active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator.\n* Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8% or HbA1c 7% to \\\u003C8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n* Unstable angina.\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* History of myocardial infarction within 6 months.\n* History of stroke within 6 months.\n* Evidence of bleeding diathesis or coagulopathy. Therapeutic anticoagulation is permitted, but patients must be on a stable dose.\n* Major surgical procedure within 28 days prior to the study. (Transurethral resection of bladder tumor is permitted)\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Patients with active tuberculosis.\n* Other prior malignancy active within the previous 2 years except for local or organ confined early stage cancer that has been definitively treated with curative intent or does not require treatment, does not require ongoing treatment, has no evidence of active disease, and has a negligible risk of recurrence and is therefore unlikely to interfere with the endpoints of the study.\n* Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs).\n* No known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Women who are breastfeeding or pregnant as evidenced by a positive pregnancy test within 14 days of first dose.\n* Known severe (≥ Grade 3) hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20).\n* Male subjects who are unwilling to use contraception during the treatment and for at least 31 weeks after the last dose of study treatment (5 half-lives of study drug plus 90 days duration of sperm turnover).\n* Women of childbearing potential (WOCBP) not using a medically acceptable means of contraception throughout the study treatment and for at least 23 weeks following the last dose of study treatment (5 half-lives of study drug plus 30 days duration of ovulatory cycle).\n\n  °WOCBP are defined as those who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopausal is defined as:\n* Amenorrhea ≥ 12 consecutive months without another cause, or\n* For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.\n* Inability to comply with study and\u002For follow-up procedures.",{"count":662,"type":21},24,[25],"The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.",[32],[198,667,668,669,670],"Upper Urinary Tract","High Grade","Radical surgery + pelvic lymph node dissection","21-393","2026-05-11",{"date":673,"type":43},"2026-05-12",{"date":675,"type":43},"2023-06-02",{"date":677,"type":21},"2027-06-02",{"name":127,"class":128},{"id":680,"slug":681,"hasResults":12,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":685,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":22,"phases":689,"briefSummary":690,"conditions":691,"keywords":694,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":703,"leadSponsor":705,"locationsCount":707},"100611531","phase-2-phase-ii-study-of-trastuzumab-rezetecan-or-in-combination-with-adebrelimab-in-her2-expressing-locally-advanced-or-metastatic-urothelial-carcinoma-lamuc-100611531","NCT07241793","Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","TRAIN-UC-01","Inclusion Criteria:\n\n* Patients included in this study must meet all of the following criteria:\n\n  1. Age ≥ 18 years;\n  2. Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la\u002FmUC), including bladder, ureter, renal pelvis, and urethra. HER2 expression is defined as immunohistochemical (IHC) staining results of 1+ to 3+, and must be confirmed by the pathology department of Sun Yat-sen University Cancer Center according to ASCO\u002FCAP guidelines.\n  3. Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed\u002Fprogressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2: Patients who have not received prior systemic therapy or relapsed\u002Fprogressed more than 12 months after neoadjuvant\u002Fadjuvant therapy, or those who could not tolerate treatment due to AEs. Cohort 3: Patients who have previously received platinum-based chemotherapy (including cisplatin, carboplatin, etc.), immunotherapy (including PD-1, PD-L1 inhibitors), and Disitamab Vedotin ;\n  4. At least one measurable target lesion according to RECIST 1.1 criteria;\n  5. ECOG performance status ≤ 2;\n  6. Adequate bone marrow, renal (calculated creatinine clearance \\> 30 mL\u002Fmin using the CG formula), hepatic, and coagulation function;\n  7. Expected survival ≥ 3 months;\n  8. The patient understands the study procedures and has provided written informed consent to participate in the study;\n  9. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required.\n  10. Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study treatment.\n\nExclusion Criteria:\n\n1. Locally advanced patients who are candidates for curative local treatment;\n2. Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological\u002Fpsychiatric diseases;\n3. Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at least 1 month and have discontinued corticosteroids for \\> 2 weeks;\n4. Known severe allergic reactions to the study drug's active ingredients and\u002For excipients, or allergy to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab);\n5. Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from adverse events;\n6. Participated in any investigational drug treatment within 4 weeks before the study started;\n7. Known or suspected interstitial lung disease, or moderate to severe pulmonary diseases that might interfere with the evaluation of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia, bronchitis obliterans, pulmonary embolism, severe asthma, COPD, restrictive pulmonary diseases, or any autoimmune, connective tissue or inflammatory lung diseases, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or a history of total lung resection;\n8. Known hereditary or acquired bleeding disorders (e.g., hemophilia, coagulopathy);\n9. Received spinal cord radiation or has not recovered from radiation-related adverse events within 4 weeks before study start;\n10. Diagnosed with immunodeficiency or received systemic corticosteroid treatment or any other immunosuppressive therapy within 7 days before the first study drug administration. Physiological doses of corticosteroids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n11. Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., requiring disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapies (e.g., thyroid hormones, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. A history of non-infectious pneumonia requiring corticosteroid treatment or current interstitial lung disease within 1 year before the first dose is excluded;\n12. History of organ or hematopoietic stem cell transplantation;\n13. Known HIV infection (HIV 1\u002F2 positive);\n14. Untreated active hepatitis B (HBV). Note: Hepatitis B carriers with an HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) before the first dose are eligible, but should receive antiviral therapy during chemotherapy to prevent reactivation.\n\n    For anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load subjects, preventive antiviral therapy is not required, but close monitoring is necessary.\n15. Active hepatitis C (HCV) infection (HCV antibody positive and HCV RNA level above detection threshold;\n16. Received live vaccines within 30 days before the first dose of the study drug. Note: Inactivated flu vaccines are allowed within 30 days before the first dose, but live attenuated flu vaccines are not permitted.\n17. History of other malignancies within the past 3 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or low-risk prostate cancer (T2N0M0, Gleason score \\\u003C7, or undetectable PSA);\n18. Any condition or disease history that may interfere with the study results or hinder the participant's full participation, including abnormal laboratory values, or situations deemed inappropriate by the investigator;\n19. Breastfeeding women.",{"count":688,"type":21},96,[25],"This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\u002FmUC).",[32,692,693],"Advanced Urothelial Carcinoma","Urothelial Carcinoma Recurrent",[695,696,697],"Urothelial carcinoma","Antibody-Drug Conjugate","immune checkpoint inhibitor","2026-04-29",{"date":700,"type":43},"2026-04-30",{"date":702,"type":43},"2025-11-20",{"date":704,"type":21},"2031-07-01",{"name":706,"class":128},"Sun Yat-sen University",6,{"id":709,"slug":710,"hasResults":12,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":4,"eligibilityCriteria":714,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":715,"targetDuration":4,"studyType":22,"phases":716,"briefSummary":717,"conditions":718,"keywords":720,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":728,"completionDateStruct":730,"leadSponsor":732,"locationsCount":153},"100568553","phase-2-adjuvant-sacituzumab-govitecan-and-nivolumab-in-muscle-invasive-urothelial-carcinoma-at-high-risk-recurrence-100568553","NCT06682728","Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence","Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of study consent.\n* ECOG Performance Status of 0, 1 or 2 (see Appendix A).\n* Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed.\n* Underwent curative-intent surgery (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation.\n* Radiographic disease-free status as determined by imaging within 28 days of C1D1 of study treatment.\n* Prior platinum-based NAC is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \\[10\\]) or refuse platinum AC.\n* Prior treatment with neoadjuvant investigational agents is allowed (except PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan). No washout from neoadjuvant therapy is required.\n* If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on RC or nephroureterectomy surgical spec-imen.\n* If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on RC or nephroureterectomy surgical speci-men.\n* Adequate organ and marrow function as defined below:\n* ANC ≥ 1000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease)\n* AST\u002FALT ≤ 3 × institutional ULN\n* Alkaline phosphatase ≤ 3 × institutional ULN\n* Serum albumin ≥ 2.8 g\u002FdL\n* Creatinine Creatinine clearance of ≥30 mL\u002Fmin (calculated with Cockroft-Gault formula)\n* Hemoglobin ≥ 9.0 g\u002FdL\n* aPTT ≤ 1.5 × institutional ULN\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including male condom, female condom, or diaphragm with spermicidal gel, etc.) that are approved by the Investigator. Contra-ception must be used during the course of the treatment and for 6 months after the last dose of study treatment.\n* Female subjects of childbearing potential must not be pregnant following signing the study consent form. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal sta-tus (defined as at least 12 months of amenorrhea in a woman ≥ 45 years-of-age in the ab-sence of other biological or physiological causes).\n* Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless the AE(s) is clinically non-significant and\u002For stable on supportive therapy as per discretion of the Investigator.\n* Subjects with any type of genitourinary catheters (i.e. nephrostomy, Foley, etc) are al-lowed.\n* Ability to understand and the willingness to sign a written informed consent. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, hard of hearing, and illiterate individuals are eligible for this trial.\n\nExclusion Criteria\n\n* Underwent a partial cystectomy or partial nephrectomy.\n* History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, following surgical removal of UC.\n* History of treatment with PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan prior to study treatment initiation.\n* History of previous radiation therapy for treatment of UC.\n* Radiographic evidence of metastasis.\n* Receipt of or planning to receive any other concurrent investigational agents.\n* History of active, known, or suspected autoimmune disease.\n* Conditions requiring treatment with either systemic high-dose corticosteroids (e.g. prednisone dose of ≥ 10 mg or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.\n* Inhaled or topical steroids are permitted in the absence of active autoimmune dis-ease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Major surgery within 28 days or minor surgery within 14 days before the first dose of study treatment. Subjects must have complete wound healing and resolution from complications of major or minor surgery before first dose of study treatment.\n* Active malignancy within 3 years of study entry, except treated localized non-melanoma skin cancer, Gleason 6 prostate cancer on active surveillance, or curatively treated in situ cancer of the breast or cervix.\n* Patients who do not have adequate organ and marrow function, as defined in Section 4.1 above.\n* Uncontrolled intercurrent illness including, but not limited to, the following conditions:\n* Active and\u002For uncontrolled bacterial, viral, or fungal infection within 7 days of study treatment initiation.\n* History of HIV infection with detectable viral load.\n* History of Hepatitis B or C infection with detectable viral load.\n* History of severe liver impairment (Child-Pugh C liver cirrhosis).\n* History of active tuberculosis (Bacillus tuberculosis).\n* Congestive heart failure New York Heart Association (NYHA) Class 3 or 4, unstable angina pectoris, or serious uncontrolled cardiac arrhythmias.\n* Stroke (including transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic arterial event within 90 days before first dose of study treatment.\n* Severe, uncontrolled bleeding within 14 days before first dose of study treatment.\n* Uncontrolled diarrheal illness ≥ Grade 3 in severity within 14 days before first dose of study treatment.\n* History of inflammatory bowel disease (i.e. ulcerative colitis, Crohn's disease, etc.) or any other condition that puts patients at high risk of developing severe diarrhea.\n* Psychiatric illness\u002Fsocial situations causing inability to comply with study proce-dures or follow up.\n* Pregnancy at the time of or following study consent.\n* Breastfeeding at the time of or following study consent.\n* Received a live vaccine within 28 days prior to the first dose of study treatment.\n* Known or suspected severe hypersensitivity (Grade ≥ 3) to nivolumab, sacituzumab govitecan, irinotecan, and\u002For any of their components.\n* History or current evidence of any condition, therapy, or laboratory\u002Fradiographic abnormal-ity that might confound the results of the study, interfere with the patient's ability to participate for the full duration of the study, or is not in the best interest of the patient to partici-pate in the study, in the opinion of the Investigator.",{"count":440,"type":21},[25],"This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.",[32,719],"Muscle-invasive Bladder Cancer",[721,32,722,723,724,725],"UC","muscle-invasive urothelial carcinoma","MIBC","sacituzumab govitecan","nivolumab","2026-04-28",{"date":700,"type":43},{"date":729,"type":43},"2024-11-15",{"date":731,"type":21},"2026-12-01",{"name":733,"class":128},"University of California, Irvine",{"id":735,"slug":736,"hasResults":12,"nctId":737,"briefTitle":738,"officialTitle":739,"acronym":4,"eligibilityCriteria":740,"healthyVolunteers":12,"sex":17,"minAge":741,"maxAge":4,"enrollmentInfo":742,"targetDuration":4,"studyType":22,"phases":744,"briefSummary":745,"conditions":746,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":749,"lastUpdatePostDateStruct":750,"startDateStruct":752,"completionDateStruct":754,"leadSponsor":756,"locationsCount":153},"100488928","bladder-cancer-screening-trial-100488928","NCT05646485","Bladder Cancer Screening Trial","Optimal Screening Strategy for Bladder Cancer in at Risk Patients","Inclusion Criteria:\n\n* Age ≥ 50\n* Smoking: ≥15 pack-year smoking history\n* Occupation:≥ 15 years of occupational exposures including: textile worker, painter, dry cleaners\n\nExclusion Criteria:\n\n* Prior history of bladder, kidney, or prostate cancer\n* Prior evaluation of micro or gross hematuria within the last 2 years\n* Do not provide informed consent","50 Years",{"count":743,"type":21},1000,[140],"There is currently no accepted screening strategy for patients at high risk of developing bladder cancer. This study will ask patients to complete a urine test every 6 months for 2 years to help assess if routine screening helps finding bladder cancer at an earlier stage.",[193,32,747,748],"Hematuria","Smoking Cessation","2026-04-27",{"date":751,"type":43},"2026-05-01",{"date":753,"type":43},"2023-05-05",{"date":755,"type":21},"2028-04",{"name":757,"class":128},"University of Texas Southwestern Medical Center"]