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Recommended rescue medication is Granulocyte Colony-Stimulating Factor (G-CSF).",[9],[44],{"name":45,"affiliation":5,"role":46},"Medical Director","STUDY_DIRECTOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":23,"email":52},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[54,72,85,98,111,126,141,155,167,182,195,208,217,226,240,252],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"UCSF Medical Center at Mission Bay ( Site 5044)","RECRUITING","San Francisco","California","94158","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-122.41942,37.77493,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":71,"phoneExt":23,"email":23},"Study Coordinator","415-699-7286",{"facility":73,"status":56,"city":74,"state":75,"zip":76,"country":60,"countryCode":61,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University of Chicago Medical Center ( Site 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GD",{"type":63,"coordinates":188},[189,190],4.47917,51.9225,{"lat":190,"lon":189},[193],{"name":70,"role":50,"phone":194,"phoneExt":23,"email":23},"+31107040704",{"facility":196,"status":56,"city":197,"state":23,"zip":198,"country":199,"countryCode":23,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Severance Hospital, Yonsei University Health System ( Site 5903)","Seoul","03722","South Korea",{"type":63,"coordinates":201},[202,203],126.9784,37.566,{"lat":203,"lon":202},[206],{"name":70,"role":50,"phone":207,"phoneExt":23,"email":23},"+8215887757",{"facility":209,"status":56,"city":197,"state":23,"zip":210,"country":199,"countryCode":23,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"Asan Medical Center ( Site 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Kingdom","UK",{"type":63,"coordinates":260},[261,262],-0.12574,51.50853,{"lat":262,"lon":261},[265],{"name":70,"role":50,"phone":266,"phoneExt":23,"email":23},"+442078228498",{"type":268,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100610824","phase-1-keymaker-u04-substudy-04d-a-clinical-study-of-new-treatments-given-with-enfortumab-vedotin-and-pembrolizumab-in-people-with-urothelial-cancer-mk-3475-04dkeymaker-u04-100610824",false,"NCT07232602","KEYMAKER-U04 Substudy 04D: A Clinical Study of New Treatments Given With Enfortumab Vedotin and Pembrolizumab in People With Urothelial Cancer (MK-3475-04D\u002FKEYMAKER-U04)","A Phase 1\u002F2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04-Substudy 04D","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically documented urothelial carcinoma (UC) that is locally advanced and unresectable or metastatic\n* Must provide a newly obtained or archival tumor tissue sample (core or excisional biopsy)\n* Must not have received prior systemic therapy for locally advanced or metastatic UC\n* If infected with Human Immunodeficiency Virus (HIV), has well controlled HIV on antiretroviral therapy\n* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load before randomization\n* If participant has a history of hepatitis C virus (HCV), has undetectable HCV viral load before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or corneal disease that prevents\u002Fdelays corneal healing\n* Has active keratitis or corneal ulcerations\n* Has active inflammatory bowel disease requiring immunosuppressive medication, or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention\n* Has a history of uncontrolled diabetes\n* Has pleural effusion, ascites, and\u002For pericardial effusion that are symptomatic or require repeated drainage\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy\n* If infected with HIV, has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has concurrent active HBV and HCV infection\n* Has a history of stem cell\u002Fsolid organ transplant","ALL","18 Years",{"count":279,"type":280},55,"ESTIMATED","INTERVENTIONAL",[283,284],"PHASE1","PHASE2","Researchers are looking for new ways to treat people with urothelial cancer (UC) that is locally advanced or metastatic. The standard treatment for locally advanced or metastatic UC is enfortumab vedotin (EV) given with pembrolizumab.\n\nThe goals of this study are to learn about:\n\n* The safety of the study treatment when given with standard treatment and if people tolerate it\n* The number of people who have the cancer respond (cancer gets smaller or goes away) with the new study treatment when given with standard treatment.",[287],"Bladder Cancer","2026-06-25",{"date":290,"type":291},"2026-06-26","ACTUAL",{"date":293,"type":291},"2026-02-09",{"date":295,"type":280},"2031-07-08",{"name":5,"class":6},16]