En undersøgelse af PF-08634404 alene eller i kombination med enfortumab vedotin ved urotelcancer
6. oktober 2026 opdateret af: Pfizer
EN INTERVENTIONEL FASE 1B/2, ÅBEN-LABEL STUDIE TIL AT UNDERSØGE SIKKERHEDEN, ANTITUMORAKTIVITETEN OG FARMAKOKINETIKKEN AF PF 08634404-MONOTERAPI ELLER I KOMBINATION MED ENFORTUMAB VEDOTIN HOS VOKSNE DELTAGERE MED LOKALT FREMSKREDEN ELLER METASTATISK UROTELIALCANCER
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/mUC), meaning the cancer has spread to nearby tissues or other parts of the body.
The 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.
To join the study, participants must:
- Be adults (18 years or older) and
- Have locally advanced or metastatic urothelial cancer,
The study has two groups:
- Cohort A: People who have already received treatment for their cancer will get the study medicine ( PF-08634404) alone.
- Cohort B: People who have not had treatment before will get the study medicine along with another cancer medicine called enfortumab vedotin.
Everyone 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.
Before 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.
If 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.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
132
Fase
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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New South Wales
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North Ryde, New South Wales, Australien, 2109
- Rekruttering
- Macquarie University
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Queensland
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Auchenflower, Queensland, Australien, 4066
- Rekruttering
- Icon Cancer Centre Wesley
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Victoria
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Clayton, Victoria, Australien, 3168
- Rekruttering
- Monash Health
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-
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Rekruttering
- Highlands Oncology Group, PA
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Rogers, Arkansas, Forenede Stater, 72758
- Rekruttering
- Highlands Oncology Group, PA
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Springdale, Arkansas, Forenede Stater, 72762
- Rekruttering
- Highlands Oncology Group, PA
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California
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Alhambra, California, Forenede Stater, 91801
- Rekruttering
- UCLA Hematology/Oncology - Alhambra
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Atascadero, California, Forenede Stater, 93422
- Rekruttering
- UCLA Hematology/Oncology - Atascadero
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Beverly Hills, California, Forenede Stater, 90212
- Rekruttering
- UCLA Hematology/Oncology - Beverly Hills
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Burbank, California, Forenede Stater, 91505
- Rekruttering
- UCLA Hematology/Oncology - Burbank
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope Investigational Drug Services (IDS)
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Encinitas, California, Forenede Stater, 92024
- Rekruttering
- UC San Diego Medical Center - Encinitas
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Encino, California, Forenede Stater, 91436
- Rekruttering
- UCLA Hematology/Oncology - Encino
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- City of Hope at Irvine Lennar
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Irvine, California, Forenede Stater, 92612
- Rekruttering
- Chao Family Comprehensive Cancer Center and Ambulatory Care
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Irvine, California, Forenede Stater, 92612
- Rekruttering
- UCI Health - Irvine Infusion Pharmacy ACC
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- City of Hope Investigational Drug Service (IDS)
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Irvine, California, Forenede Stater, 92604
- Rekruttering
- UCLA Hematology/Oncology - Irvine
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Sulpizio Cardiovascular Center
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Moores Cancer Center
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Koman Family Outpatient Pavilion
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Shiley Eye Institute
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La Jolla, California, Forenede Stater, 92037
- Rekruttering
- Viterbi Family Department of Ophthalmology
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Laguna Hills, California, Forenede Stater, 92653
- Rekruttering
- UCLA Hematology Oncology- Laguna Hills
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Long Beach, California, Forenede Stater, 90813
- Rekruttering
- City of Hope-Long Beach (ELM)
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Hematology/Oncology
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Los Angeles, California, Forenede Stater, 90025
- Rekruttering
- START Los Angeles, LLC
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Los Angeles, California, Forenede Stater, 90067
- Rekruttering
- Los Angeles Cancer Network - Century City
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
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Marina del Rey, California, Forenede Stater, 90292
- Rekruttering
- UCLA Hematology/Oncology - Marina del Rey
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Orange, California, Forenede Stater, 92868
- Rekruttering
- UC Irvine Health
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Pasadena, California, Forenede Stater, 91105
- Rekruttering
- UCLA Hematology/Oncology - Pasadena
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Porter Ranch, California, Forenede Stater, 91326
- Rekruttering
- UCLA Hematology Oncology - Porter Ranch
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San Diego, California, Forenede Stater, 92101
- Rekruttering
- UC San Diego Medical Center - Bankers Hill
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San Diego, California, Forenede Stater, 92103
- Rekruttering
- UC San Diego McGrath Outpatient Pavilion - Hillcrest
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San Diego, California, Forenede Stater, 92127
- Rekruttering
- UC San Diego Medical Center - Rancho Bernardo
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San Diego, California, Forenede Stater, 92103
- Rekruttering
- UC San Diego Medical Center- Hillcrest
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San Luis Obispo, California, Forenede Stater, 93401
- Rekruttering
- UCLA Hematology/Oncology - San Luis Obispo
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Santa Barbara, California, Forenede Stater, 93101
- Rekruttering
- UCLA Hematology/Oncology- Santa Barbara
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Santa Monica, California, Forenede Stater, 90404
- Rekruttering
- UCLA Hematology/Oncology- Santa Monica
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Torrance, California, Forenede Stater, 90505
- Rekruttering
- UCLA Hematology/Oncology - Torrance
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Upland, California, Forenede Stater, 91786
- Rekruttering
- City of Hope UPLAND
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Valencia, California, Forenede Stater, 91355
- Rekruttering
- UCLA Hematology/Oncology - Santa Clarita
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Ventura, California, Forenede Stater, 93003
- Rekruttering
- UCLA Hematology/Oncology - Ventura
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Vista, California, Forenede Stater, 92081
- Rekruttering
- UC San Diego Medical Center - Vista
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Westlake Village, California, Forenede Stater, 91361
- Rekruttering
- UCLA Hematology/Oncology - Westlake
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, Forenede Stater, 80218
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Lone Tree, Colorado, Forenede Stater, 80124
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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Derby, Connecticut, Forenede Stater, 06418
- Rekruttering
- Smilow Cancer Hospital - Derby
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Fairfield, Connecticut, Forenede Stater, 06824
- Rekruttering
- Smilow Cancer Hospital - Fairfield
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Greenwich, Connecticut, Forenede Stater, 06830
- Rekruttering
- Smilow Cancer Hospital - Greenwich
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Guilford, Connecticut, Forenede Stater, 06437
- Rekruttering
- Smilow Cancer Hospital - Guilford
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New Haven, Connecticut, Forenede Stater, 06511
- Rekruttering
- Smilow Cancer Hospital Phase 1 Unit
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale-New Haven Hospital-Yale Cancer Center
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Smilow Cancer Hospital - Yale New Haven Health
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New Haven, Connecticut, Forenede Stater, 06511
- Rekruttering
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
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New Haven, Connecticut, Forenede Stater, 06510
- Rekruttering
- Yale Eye Center
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North Haven, Connecticut, Forenede Stater, 06473
- Rekruttering
- Smilow Cancer Hospital - North Haven
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Norwich, Connecticut, Forenede Stater, 06360
- Rekruttering
- Eastern Connecticut Hematology and Oncology Associates
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Stamford, Connecticut, Forenede Stater, 06902
- Rekruttering
- Smilow Cancer Hospital - Long Ridge
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Trumbull, Connecticut, Forenede Stater, 06835
- Rekruttering
- Smilow Cancer Hospital - Trumbull
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Rekruttering
- Sibley Memorial Hospital
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Rekruttering
- Sibley Memorial Hospital Pharmacy Department
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Georgia
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Ringgold, Georgia, Forenede Stater, 30736
- Rekruttering
- Tennessee Oncology, PLLC- Ringgold
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Illinois
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Shiloh, Illinois, Forenede Stater, 62269
- Rekruttering
- Siteman Cancer Center - Shiloh
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Shiloh, Illinois, Forenede Stater, 62269
- Rekruttering
- Memorial Hospital
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins Hospital
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Johns Hopkins Outpatient Center
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Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Forenede Stater, 21231
- Rekruttering
- Oncology Research Pharmacy and lnvestigational Drug Service
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Missouri
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City of Saint Peters, Missouri, Forenede Stater, 63376
- Rekruttering
- Siteman Cancer Center - St. Peters
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Creve Coeur, Missouri, Forenede Stater, 63141
- Rekruttering
- Siteman Cancer Center - West County
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Florissant, Missouri, Forenede Stater, 63031
- Rekruttering
- Siteman Cancer Center - North County
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St Louis, Missouri, Forenede Stater, 63108
- Rekruttering
- Siteman Cancer Center
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine - Siteman Cancer Center
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Barnes-Jewish Hospital
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St Louis, Missouri, Forenede Stater, 63129
- Rekruttering
- Siteman Cancer Center - South County
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New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Ikke rekrutterer endnu
- MSK Basking Ridge
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Middletown, New Jersey, Forenede Stater, 07748
- Ikke rekrutterer endnu
- MSK Monmouth
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Montvale, New Jersey, Forenede Stater, 07645
- Ikke rekrutterer endnu
- MSK Bergen
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New York
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Albany, New York, Forenede Stater, 12206
- Rekruttering
- New York Oncology Hematology
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Clifton Park, New York, Forenede Stater, 12065
- Rekruttering
- New York Oncology Hematology
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Commack, New York, Forenede Stater, 11725
- Ikke rekrutterer endnu
- MSK Commack
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Harrison, New York, Forenede Stater, 10604
- Ikke rekrutterer endnu
- MSK Westchester
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Long Island City, New York, Forenede Stater, 11101
- Ikke rekrutterer endnu
- Investigational Drug Service
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New York, New York, Forenede Stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
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New York, New York, Forenede Stater, 10021
- Ikke rekrutterer endnu
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
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New York, New York, Forenede Stater, 10065
- Ikke rekrutterer endnu
- Memorial Sloan Kettering Cancer Center-Main Campus
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New York, New York, Forenede Stater, 10065
- Ikke rekrutterer endnu
- Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10065
- Ikke rekrutterer endnu
- Evelyn H. Lauder Breast and Imaging Center (BAIC)
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Uniondale, New York, Forenede Stater, 11553
- Ikke rekrutterer endnu
- MSK Nassau
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North Carolina
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Cary, North Carolina, Forenede Stater, 27518
- Rekruttering
- Duke Cancer Center Cary
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Medical Center
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Medical Center (location of scans)
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Medical Center - Duke University Hospital (location of scans)
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Durham, North Carolina, Forenede Stater, 27713
- Rekruttering
- Duke University
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Raleigh, North Carolina, Forenede Stater, 27609
- Rekruttering
- Duke Raleigh Hospital
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Raleigh, North Carolina, Forenede Stater, 27609
- Rekruttering
- Duke Cancer Center Raleigh
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Raleigh, North Carolina, Forenede Stater, 27609
- Rekruttering
- Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates of Oregon, P.C.
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Portland, Oregon, Forenede Stater, 97213
- Rekruttering
- Northwest Cancer Specialists, P.C.
-
Portland, Oregon, Forenede Stater, 97227
- Rekruttering
- Northwest Cancer Specialists, P.C.
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Springfield, Oregon, Forenede Stater, 97477
- Rekruttering
- Oncology Associates of Oregon, P.C.
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Tigard, Oregon, Forenede Stater, 97223
- Rekruttering
- Northwest Cancer Specialists, P.C.
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Downtown
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Med Park II
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Memorial
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Chattanooga, Tennessee, Forenede Stater, 37421
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga East
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Chattanooga, Tennessee, Forenede Stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
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Cookeville, Tennessee, Forenede Stater, 38501
- Rekruttering
- Tennessee Oncology, PLLC- Cookeville
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Dickson, Tennessee, Forenede Stater, 37055
- Rekruttering
- Tennessee Oncology, PLLC - Dickson
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Franklin, Tennessee, Forenede Stater, 37067
- Rekruttering
- Tennessee Oncology, PLLC - Franklin
-
Franklin, Tennessee, Forenede Stater, 37067
- Rekruttering
- Tennessee Oncology, PLLC - Proton Center
-
Gallatin, Tennessee, Forenede Stater, 37066
- Rekruttering
- Tennessee Oncology, PLLC - Gallatin
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Hendersonville, Tennessee, Forenede Stater, 37075
- Rekruttering
- Tennessee Oncology, PLLC - Hendersonville
-
Lebanon, Tennessee, Forenede Stater, 37090
- Rekruttering
- Tennessee Oncology, PLLC - Lebanon
-
Mount Juliet, Tennessee, Forenede Stater, 37122
- Rekruttering
- Tennessee Oncology, PLLC - Mount Juliet
-
Murfreesboro, Tennessee, Forenede Stater, 37129
- Rekruttering
- Tennessee Oncology, PLLC - Murfreesboro
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Sarah Cannon Research Institute
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Investigational Drug Services
-
Nashville, Tennessee, Forenede Stater, 37205
- Rekruttering
- Tennessee Oncology, PLLC - Saint Thomas West
-
Nashville, Tennessee, Forenede Stater, 37207
- Rekruttering
- Tennessee Oncology, PLLC- Skyline
-
Nashville, Tennessee, Forenede Stater, 37211
- Rekruttering
- Tennessee Oncology, PLLC- Southern Hills
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
-
Shelbyville, Tennessee, Forenede Stater, 37160
- Rekruttering
- Tennessee Oncology, PLLC -Shelbyville
-
Smyrna, Tennessee, Forenede Stater, 37167
- Rekruttering
- Tennessee Oncology, PLLC - Smyrna
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Texas
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Austin, Texas, Forenede Stater, 78705
- Rekruttering
- Texas Oncology - Central/South Texas
-
Austin, Texas, Forenede Stater, 78731
- Rekruttering
- Texas Oncology - Central/South Texas
-
Austin, Texas, Forenede Stater, 78745
- Rekruttering
- Texas Oncology - Central/South Texas
-
Beaumont, Texas, Forenede Stater, 77702
- Rekruttering
- Texas Oncology - Gulf Coast
-
Harlingen, Texas, Forenede Stater, 78550
- Rekruttering
- Texas Oncology - Central/South Texas
-
Houston, Texas, Forenede Stater, 77024
- Rekruttering
- Texas Oncology - Gulf Coast
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- Texas Oncology - Gulf Coast
-
Irving, Texas, Forenede Stater, 75063
- Rekruttering
- US Oncology Investigational Products Center (IPC)
-
Irving, Texas, Forenede Stater, 75063
- Rekruttering
- US Oncology Investigational Product Center (IPC)
-
McAllen, Texas, Forenede Stater, 78503
- Rekruttering
- Texas Oncology - Central/South Texas
-
Pearland, Texas, Forenede Stater, 77584
- Rekruttering
- Texas Oncology - Gulf Coast
-
Sugar Land, Texas, Forenede Stater, 77479
- Rekruttering
- Texas Oncology - Gulf Coast
-
The Woodlands, Texas, Forenede Stater, 77380
- Rekruttering
- Texas Oncology - Gulf Coast
-
Waco, Texas, Forenede Stater, 76712
- Rekruttering
- Texas Oncology - Central/South Texas
-
Webster, Texas, Forenede Stater, 77598
- Rekruttering
- Texas Oncology - Gulf Coast
-
Weslaco, Texas, Forenede Stater, 78596
- Rekruttering
- Texas Oncology - Central South
-
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Rekruttering
- Huntsman Cancer Institute - University of Utah
-
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Virginia
-
Blacksburg, Virginia, Forenede Stater, 24060
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists, PC
-
Low Moor, Virginia, Forenede Stater, 24457
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Oncology Associates
-
Roanoke, Virginia, Forenede Stater, 24014
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Salem, Virginia, Forenede Stater, 24153
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Wytheville, Virginia, Forenede Stater, 24382
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
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Washington
-
Edmonds, Washington, Forenede Stater, 98026
- Rekruttering
- Eye Associates Northwest - Edmonds Clinic
-
Kirkland, Washington, Forenede Stater, 98034
- Rekruttering
- Eye Associates Northwest - Kirkland Clinic
-
Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Center
-
Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Harborview Medical Center
-
Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Eye Associates Northwest - Ballard Clinic and Surgery Center
-
Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Eye Associates Northwest - First Hill Clinic
-
Seattle, Washington, Forenede Stater, 98125
- Rekruttering
- Eye Associates Northwest - Northgate Clinic
-
Seattle, Washington, Forenede Stater, 98195
- Rekruttering
- University Of Washington Medical Center
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Vancouver, Washington, Forenede Stater, 98684
- Rekruttering
- Northwest Cancer Specialists, P.C.
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-
-
-
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Fukuoka, Japan, 811-1395
- Rekruttering
- National Hospital Organization Kyushu Cancer Center
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Yamagata, Japan, 990-9585
- Rekruttering
- Yamagata University Hospital
-
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 1608582
- Rekruttering
- Keio university hospital
-
-
-
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Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital
-
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Jiangsu
-
Nanjing, Jiangsu, Kina, 210000
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300211
- Rekruttering
- The Second Hospital of Tianjin Medical University
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Zhejiang
-
Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- The first affiliated hospital of Ningbo university
-
-
-
-
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Manati, Puerto Rico, 00674
- Rekruttering
- Pan American Center for Oncology Trials, LLC - Manati Office
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Mayagüez, Puerto Rico, 00680
- Rekruttering
- Pan American Center for Oncology Trials, LLC - Mayaguez Office
-
Rio Piedras, Puerto Rico, 00935
- Rekruttering
- Pan American Center for Oncology Trials, LLC
-
Rio Piedras, Puerto Rico, 00935
- Rekruttering
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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-
-
-
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Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen Del Rocio
-
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Barcelona [barcelona]
-
Barcelona, Barcelona [barcelona], Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
Barcelona, Barcelona [barcelona], Spanien, 08003
- Rekruttering
- Parc de Salut Mar - Hospital del Mar
-
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Cantabria
-
Santander, Cantabria, Spanien, 39008
- Rekruttering
- Hospital Universitario Marqués de Valdecilla
-
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], Spanien, 08041
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥18 years at the time of screening.
- Histologically confirmed locally advanced or metastatic urothelial carcinoma (LA/mUC).
- Measurable disease per RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Adequate organ function, including hematologic, hepatic, and renal parameters.
- Willingness to comply with study procedures and provide informed consent.
- For participants of childbearing potential: agreement to use effective contraception during the study and for a defined period after the last dose.
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
- 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
- Known active CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- Active autoimmune diseases requiring systemic treatment within the past 2 years
- Participation in another investigational study within 30 days or 5 half-lives of the investigational product.
- Pregnant or breastfeeding individuals.
- Inability or unwillingness to comply with study requirements.
- Study staff or their immediate family members directly involved in the conduct of the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
Concentrate for solution for Infusion.
Andre navne:
|
|
Eksperimentel: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
Concentrate for solution for Infusion.
Andre navne:
Powder for concentrate for solution for infusion
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Confirmed Objective Response Rate (ORR) by investigator
Tidsramme: Up to approximately 3 years
|
ORR is defined as the proportion of participants in the analysis population having a BOR of confirmed CR or confirmed PR according to RECIST v1.1 as assessed by investigator. |
Up to approximately 3 years
|
|
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Through 90 days after the last study intervention; Up to approximately 3 years
|
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness and relationship to study intervention. |
Through 90 days after the last study intervention; Up to approximately 3 years
|
|
Number of participants with dose limiting toxicity (DLT) in Part 1 of Cohort B
Tidsramme: Through 90 days after the last study intervention; Up to approximately 3 years
|
The number of participants who experienced DLTs in participants receiving PF-08634404 in combination with EV. |
Through 90 days after the last study intervention; Up to approximately 3 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Response (DOR) per RECIST v1.1 by investigator
Tidsramme: Up to approximately 3 years
|
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. |
Up to approximately 3 years
|
|
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Tidsramme: Up to approximately 3 years
|
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first. |
Up to approximately 3 years
|
|
Overall Survival (OS)
Tidsramme: Up to approximately 3 years
|
Overall survival defined as the time from the date of C1D1 to the date of death due to any cause. |
Up to approximately 3 years
|
|
Number of Participants With Clinical Laboratory Abnormalities
Tidsramme: Through 90 days after the last study intervention; Up to approximately 3 years
|
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) |
Through 90 days after the last study intervention; Up to approximately 3 years
|
|
Pharmacokinetics (PK): Serum concentration of PF-08634404
Tidsramme: Up to 37 days after the last dose of treatment
|
To characterize the pharmacokinetics (PK) of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC. |
Up to 37 days after the last dose of treatment
|
|
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Tidsramme: Up to 37 days after the last dose of treatment
|
To evaluate the immunogenicity of PF-08634404 as monotherapy in participants with previously treated LA/mUC and in combination with EV in participants with previously untreated LA/mUC. |
Up to 37 days after the last dose of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
11. marts 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
28. december 2027
Studieafslutning (Anslået)
Studieafslutning
25. september 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
12. februar 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
12. februar 2026
Først opslået (Faktiske)
Først opslået
19. februar 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
8. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Urologiske neoplasmer
- Karcinom
- Urinblæresygdomme
- Urinblære neoplasmer
- Carcinom, overgangscelle
- Enfortumab Vedotin
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- C6461006
- 2025-523523-21-00 (Registry Identifier: CTIS (EU))
- Symbiotic-GU-06 (Anden identifikator: Pfizer)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .