Une étude sur le PF-08634404 seul ou en combinaison avec l'enfortumab vedotin dans le cancer urothélial
6 octobre 2026 mis à jour par: Pfizer
UNE ÉTUDE INTERVENTIONNELLE DE PHASE 1B/2, OUVERTE, POUR ÉVALUER L'INNOCUITÉ, L'ACTIVITÉ ANTITUMORALE ET LA PHARMACOCINÉTIQUE DU PF 08634404 EN MONOTHÉRAPIE OU EN COMBINAISON AVEC L'ENFORTUMAB VEDOTIN CHEZ DES PARTICIPANTS ADULTES ATTEINTS D'UN CANCER UROTHÉLIAL LOCALEMENT AVANCÉ OU MÉTATSTATIQUE
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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
132
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Pfizer CT.gov Call Center
- Numéro de téléphone: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Lieux d'étude
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New South Wales
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North Ryde, New South Wales, Australie, 2109
- Recrutement
- Macquarie University
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Queensland
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Auchenflower, Queensland, Australie, 4066
- Recrutement
- Icon Cancer Centre Wesley
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Victoria
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Clayton, Victoria, Australie, 3168
- Recrutement
- Monash Health
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100142
- Recrutement
- Beijing Cancer hospital
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Jiangsu
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Nanjing, Jiangsu, Chine, 210000
- Recrutement
- 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, Chine, 300211
- Recrutement
- The Second Hospital of Tianjin Medical University
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Zhejiang
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Ningbo, Zhejiang, Chine, 315010
- Recrutement
- The first affiliated hospital of Ningbo university
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Madrid, Espagne, 28041
- Recrutement
- Hospital Universitario 12 de Octubre
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Seville, Espagne, 41013
- Recrutement
- Hospital Universitario Virgen Del Rocio
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Barcelona [barcelona]
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Barcelona, Barcelona [barcelona], Espagne, 08035
- Recrutement
- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona [barcelona], Espagne, 08003
- Recrutement
- Parc de Salut Mar - Hospital del Mar
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Cantabria
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Santander, Cantabria, Espagne, 39008
- Recrutement
- Hospital Universitario Marqués de Valdecilla
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], Espagne, 08041
- Recrutement
- Hospital de la Santa Creu i Sant Pau
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Fukuoka, Japon, 811-1395
- Recrutement
- National Hospital Organization Kyushu Cancer Center
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Yamagata, Japon, 990-9585
- Recrutement
- Yamagata University Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japon, 1608582
- Recrutement
- Keio university hospital
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Manati, Porto Rico, 00674
- Recrutement
- Pan American Center for Oncology Trials, LLC - Manati Office
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Mayagüez, Porto Rico, 00680
- Recrutement
- Pan American Center for Oncology Trials, LLC - Mayaguez Office
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Rio Piedras, Porto Rico, 00935
- Recrutement
- Pan American Center for Oncology Trials, LLC
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Rio Piedras, Porto Rico, 00935
- Recrutement
- Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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Arkansas
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Fayetteville, Arkansas, États-Unis, 72703
- Recrutement
- Highlands Oncology Group, PA
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Rogers, Arkansas, États-Unis, 72758
- Recrutement
- Highlands Oncology Group, PA
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Springdale, Arkansas, États-Unis, 72762
- Recrutement
- Highlands Oncology Group, PA
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California
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Alhambra, California, États-Unis, 91801
- Recrutement
- UCLA Hematology/Oncology - Alhambra
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Atascadero, California, États-Unis, 93422
- Recrutement
- UCLA Hematology/Oncology - Atascadero
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Beverly Hills, California, États-Unis, 90212
- Recrutement
- UCLA Hematology/Oncology - Beverly Hills
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Burbank, California, États-Unis, 91505
- Recrutement
- UCLA Hematology/Oncology - Burbank
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Duarte, California, États-Unis, 91010
- Recrutement
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, États-Unis, 91010
- Recrutement
- City of Hope Investigational Drug Services (IDS)
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Encinitas, California, États-Unis, 92024
- Recrutement
- UC San Diego Medical Center - Encinitas
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Encino, California, États-Unis, 91436
- Recrutement
- UCLA Hematology/Oncology - Encino
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Irvine, California, États-Unis, 92618
- Recrutement
- City of Hope at Irvine Lennar
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Irvine, California, États-Unis, 92612
- Recrutement
- Chao Family Comprehensive Cancer Center and Ambulatory Care
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Irvine, California, États-Unis, 92612
- Recrutement
- UCI Health - Irvine Infusion Pharmacy ACC
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Irvine, California, États-Unis, 92618
- Recrutement
- City of Hope Investigational Drug Service (IDS)
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Irvine, California, États-Unis, 92604
- Recrutement
- UCLA Hematology/Oncology - Irvine
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Sulpizio Cardiovascular Center
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Moores Cancer Center
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Koman Family Outpatient Pavilion
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La Jolla, California, États-Unis, 92037
- Recrutement
- UC San Diego Shiley Eye Institute
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La Jolla, California, États-Unis, 92037
- Recrutement
- Viterbi Family Department of Ophthalmology
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Laguna Hills, California, États-Unis, 92653
- Recrutement
- UCLA Hematology Oncology- Laguna Hills
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Long Beach, California, États-Unis, 90813
- Recrutement
- City of Hope-Long Beach (ELM)
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Los Angeles, California, États-Unis, 90095
- Recrutement
- UCLA Hematology/Oncology
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Los Angeles, California, États-Unis, 90025
- Recrutement
- START Los Angeles, LLC
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Los Angeles, California, États-Unis, 90067
- Recrutement
- Los Angeles Cancer Network - Century City
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Los Angeles, California, États-Unis, 90095
- Recrutement
- (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
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Marina del Rey, California, États-Unis, 90292
- Recrutement
- UCLA Hematology/Oncology - Marina del Rey
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Orange, California, États-Unis, 92868
- Recrutement
- UC Irvine Health
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Pasadena, California, États-Unis, 91105
- Recrutement
- UCLA Hematology/Oncology - Pasadena
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Porter Ranch, California, États-Unis, 91326
- Recrutement
- UCLA Hematology Oncology - Porter Ranch
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San Diego, California, États-Unis, 92101
- Recrutement
- UC San Diego Medical Center - Bankers Hill
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San Diego, California, États-Unis, 92103
- Recrutement
- UC San Diego McGrath Outpatient Pavilion - Hillcrest
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San Diego, California, États-Unis, 92127
- Recrutement
- UC San Diego Medical Center - Rancho Bernardo
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San Diego, California, États-Unis, 92103
- Recrutement
- UC San Diego Medical Center- Hillcrest
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San Luis Obispo, California, États-Unis, 93401
- Recrutement
- UCLA Hematology/Oncology - San Luis Obispo
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Santa Barbara, California, États-Unis, 93101
- Recrutement
- UCLA Hematology/Oncology- Santa Barbara
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Santa Monica, California, États-Unis, 90404
- Recrutement
- UCLA Hematology/Oncology- Santa Monica
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Torrance, California, États-Unis, 90505
- Recrutement
- UCLA Hematology/Oncology - Torrance
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Upland, California, États-Unis, 91786
- Recrutement
- City of Hope UPLAND
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Valencia, California, États-Unis, 91355
- Recrutement
- UCLA Hematology/Oncology - Santa Clarita
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Ventura, California, États-Unis, 93003
- Recrutement
- UCLA Hematology/Oncology - Ventura
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Vista, California, États-Unis, 92081
- Recrutement
- UC San Diego Medical Center - Vista
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Westlake Village, California, États-Unis, 91361
- Recrutement
- UCLA Hematology/Oncology - Westlake
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Colorado
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Aurora, Colorado, États-Unis, 80012
- Recrutement
- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, États-Unis, 80218
- Recrutement
- Rocky Mountain Cancer Centers, LLP
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Lone Tree, Colorado, États-Unis, 80124
- Recrutement
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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Derby, Connecticut, États-Unis, 06418
- Recrutement
- Smilow Cancer Hospital - Derby
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Fairfield, Connecticut, États-Unis, 06824
- Recrutement
- Smilow Cancer Hospital - Fairfield
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Greenwich, Connecticut, États-Unis, 06830
- Recrutement
- Smilow Cancer Hospital - Greenwich
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Guilford, Connecticut, États-Unis, 06437
- Recrutement
- Smilow Cancer Hospital - Guilford
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New Haven, Connecticut, États-Unis, 06511
- Recrutement
- Smilow Cancer Hospital Phase 1 Unit
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Yale-New Haven Hospital-Yale Cancer Center
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Smilow Cancer Hospital - Yale New Haven Health
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New Haven, Connecticut, États-Unis, 06511
- Recrutement
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
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New Haven, Connecticut, États-Unis, 06510
- Recrutement
- Yale Eye Center
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North Haven, Connecticut, États-Unis, 06473
- Recrutement
- Smilow Cancer Hospital - North Haven
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Norwich, Connecticut, États-Unis, 06360
- Recrutement
- Eastern Connecticut Hematology and Oncology Associates
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Stamford, Connecticut, États-Unis, 06902
- Recrutement
- Smilow Cancer Hospital - Long Ridge
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Trumbull, Connecticut, États-Unis, 06835
- Recrutement
- Smilow Cancer Hospital - Trumbull
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20016
- Recrutement
- Sibley Memorial Hospital
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Washington D.C., District of Columbia, États-Unis, 20016
- Recrutement
- Sibley Memorial Hospital Pharmacy Department
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Georgia
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Ringgold, Georgia, États-Unis, 30736
- Recrutement
- Tennessee Oncology, PLLC- Ringgold
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Illinois
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Shiloh, Illinois, États-Unis, 62269
- Recrutement
- Siteman Cancer Center - Shiloh
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Shiloh, Illinois, États-Unis, 62269
- Recrutement
- Memorial Hospital
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Maryland
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- Johns Hopkins Hospital
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- Johns Hopkins Outpatient Center
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Baltimore, Maryland, États-Unis, 21231
- Recrutement
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, États-Unis, 21287
- Recrutement
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, États-Unis, 21231
- Recrutement
- Oncology Research Pharmacy and lnvestigational Drug Service
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Missouri
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City of Saint Peters, Missouri, États-Unis, 63376
- Recrutement
- Siteman Cancer Center - St. Peters
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Creve Coeur, Missouri, États-Unis, 63141
- Recrutement
- Siteman Cancer Center - West County
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Florissant, Missouri, États-Unis, 63031
- Recrutement
- Siteman Cancer Center - North County
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St Louis, Missouri, États-Unis, 63108
- Recrutement
- Siteman Cancer Center
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University School of Medicine - Siteman Cancer Center
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Barnes-Jewish Hospital
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St Louis, Missouri, États-Unis, 63129
- Recrutement
- Siteman Cancer Center - South County
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New Jersey
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Basking Ridge, New Jersey, États-Unis, 07920
- Pas encore de recrutement
- MSK Basking Ridge
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Middletown, New Jersey, États-Unis, 07748
- Pas encore de recrutement
- MSK Monmouth
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Montvale, New Jersey, États-Unis, 07645
- Pas encore de recrutement
- MSK Bergen
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New York
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Albany, New York, États-Unis, 12206
- Recrutement
- New York Oncology Hematology
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Clifton Park, New York, États-Unis, 12065
- Recrutement
- New York Oncology Hematology
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Commack, New York, États-Unis, 11725
- Pas encore de recrutement
- MSK Commack
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Harrison, New York, États-Unis, 10604
- Pas encore de recrutement
- MSK Westchester
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Long Island City, New York, États-Unis, 11101
- Pas encore de recrutement
- Investigational Drug Service
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New York, New York, États-Unis, 10029
- Recrutement
- Icahn School of Medicine at Mount Sinai
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New York, New York, États-Unis, 10021
- Pas encore de recrutement
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
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New York, New York, États-Unis, 10065
- Pas encore de recrutement
- Memorial Sloan Kettering Cancer Center-Main Campus
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New York, New York, États-Unis, 10065
- Pas encore de recrutement
- Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
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New York, New York, États-Unis, 10065
- Pas encore de recrutement
- Evelyn H. Lauder Breast and Imaging Center (BAIC)
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Uniondale, New York, États-Unis, 11553
- Pas encore de recrutement
- MSK Nassau
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North Carolina
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Cary, North Carolina, États-Unis, 27518
- Recrutement
- Duke Cancer Center Cary
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Medical Center
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Medical Center (location of scans)
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Medical Center - Duke University Hospital (location of scans)
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Durham, North Carolina, États-Unis, 27713
- Recrutement
- Duke University
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Duke Raleigh Hospital
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- Duke Cancer Center Raleigh
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Raleigh, North Carolina, États-Unis, 27609
- Recrutement
- 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, États-Unis, 44195
- Recrutement
- Cleveland Clinic Foundation
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Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, États-Unis, 44195
- Recrutement
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
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Oregon
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Eugene, Oregon, États-Unis, 97401
- Recrutement
- Oncology Associates of Oregon, P.C.
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Portland, Oregon, États-Unis, 97213
- Recrutement
- Northwest Cancer Specialists, P.C.
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Portland, Oregon, États-Unis, 97227
- Recrutement
- Northwest Cancer Specialists, P.C.
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Springfield, Oregon, États-Unis, 97477
- Recrutement
- Oncology Associates of Oregon, P.C.
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Tigard, Oregon, États-Unis, 97223
- Recrutement
- Northwest Cancer Specialists, P.C.
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37403
- Recrutement
- Tennessee Oncology, PLLC - Chattanooga Downtown
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Chattanooga, Tennessee, États-Unis, 37404
- Recrutement
- Tennessee Oncology, PLLC - Chattanooga Med Park II
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Chattanooga, Tennessee, États-Unis, 37404
- Recrutement
- Tennessee Oncology, PLLC - Chattanooga Memorial
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Chattanooga, Tennessee, États-Unis, 37421
- Recrutement
- Tennessee Oncology, PLLC - Chattanooga East
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Chattanooga, Tennessee, États-Unis, 37404
- Recrutement
- Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
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Cookeville, Tennessee, États-Unis, 38501
- Recrutement
- Tennessee Oncology, PLLC- Cookeville
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Dickson, Tennessee, États-Unis, 37055
- Recrutement
- Tennessee Oncology, PLLC - Dickson
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Franklin, Tennessee, États-Unis, 37067
- Recrutement
- Tennessee Oncology, PLLC - Franklin
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Franklin, Tennessee, États-Unis, 37067
- Recrutement
- Tennessee Oncology, PLLC - Proton Center
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Gallatin, Tennessee, États-Unis, 37066
- Recrutement
- Tennessee Oncology, PLLC - Gallatin
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Hendersonville, Tennessee, États-Unis, 37075
- Recrutement
- Tennessee Oncology, PLLC - Hendersonville
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Lebanon, Tennessee, États-Unis, 37090
- Recrutement
- Tennessee Oncology, PLLC - Lebanon
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Mount Juliet, Tennessee, États-Unis, 37122
- Recrutement
- Tennessee Oncology, PLLC - Mount Juliet
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Murfreesboro, Tennessee, États-Unis, 37129
- Recrutement
- Tennessee Oncology, PLLC - Murfreesboro
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Sarah Cannon Research Institute
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- SCRI Oncology Partners
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Tennessee Oncology, PLLC - Investigational Drug Services
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Nashville, Tennessee, États-Unis, 37205
- Recrutement
- Tennessee Oncology, PLLC - Saint Thomas West
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Nashville, Tennessee, États-Unis, 37207
- Recrutement
- Tennessee Oncology, PLLC- Skyline
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Nashville, Tennessee, États-Unis, 37211
- Recrutement
- Tennessee Oncology, PLLC- Southern Hills
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
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Shelbyville, Tennessee, États-Unis, 37160
- Recrutement
- Tennessee Oncology, PLLC -Shelbyville
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Smyrna, Tennessee, États-Unis, 37167
- Recrutement
- Tennessee Oncology, PLLC - Smyrna
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Texas
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Austin, Texas, États-Unis, 78705
- Recrutement
- Texas Oncology - Central/South Texas
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Austin, Texas, États-Unis, 78731
- Recrutement
- Texas Oncology - Central/South Texas
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Austin, Texas, États-Unis, 78745
- Recrutement
- Texas Oncology - Central/South Texas
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Beaumont, Texas, États-Unis, 77702
- Recrutement
- Texas Oncology - Gulf Coast
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Harlingen, Texas, États-Unis, 78550
- Recrutement
- Texas Oncology - Central/South Texas
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Houston, Texas, États-Unis, 77024
- Recrutement
- Texas Oncology - Gulf Coast
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Houston, Texas, États-Unis, 77054
- Recrutement
- Texas Oncology - Gulf Coast
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Irving, Texas, États-Unis, 75063
- Recrutement
- US Oncology Investigational Products Center (IPC)
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Irving, Texas, États-Unis, 75063
- Recrutement
- US Oncology Investigational Product Center (IPC)
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McAllen, Texas, États-Unis, 78503
- Recrutement
- Texas Oncology - Central/South Texas
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Pearland, Texas, États-Unis, 77584
- Recrutement
- Texas Oncology - Gulf Coast
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Sugar Land, Texas, États-Unis, 77479
- Recrutement
- Texas Oncology - Gulf Coast
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The Woodlands, Texas, États-Unis, 77380
- Recrutement
- Texas Oncology - Gulf Coast
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Waco, Texas, États-Unis, 76712
- Recrutement
- Texas Oncology - Central/South Texas
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Webster, Texas, États-Unis, 77598
- Recrutement
- Texas Oncology - Gulf Coast
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Weslaco, Texas, États-Unis, 78596
- Recrutement
- Texas Oncology - Central South
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Recrutement
- Huntsman Cancer Institute - University of Utah
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Virginia
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Blacksburg, Virginia, États-Unis, 24060
- Recrutement
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Fairfax, Virginia, États-Unis, 22031
- Recrutement
- Virginia Cancer Specialists, PC
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Low Moor, Virginia, États-Unis, 24457
- Recrutement
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Norfolk, Virginia, États-Unis, 23502
- Recrutement
- Virginia Oncology Associates
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Roanoke, Virginia, États-Unis, 24014
- Recrutement
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Salem, Virginia, États-Unis, 24153
- Recrutement
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Wytheville, Virginia, États-Unis, 24382
- Recrutement
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Washington
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Edmonds, Washington, États-Unis, 98026
- Recrutement
- Eye Associates Northwest - Edmonds Clinic
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Kirkland, Washington, États-Unis, 98034
- Recrutement
- Eye Associates Northwest - Kirkland Clinic
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Seattle, Washington, États-Unis, 98109
- Recrutement
- Fred Hutchinson Cancer Center
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Harborview Medical Center
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Eye Associates Northwest - Ballard Clinic and Surgery Center
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Seattle, Washington, États-Unis, 98104
- Recrutement
- Eye Associates Northwest - First Hill Clinic
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Seattle, Washington, États-Unis, 98125
- Recrutement
- Eye Associates Northwest - Northgate Clinic
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Seattle, Washington, États-Unis, 98195
- Recrutement
- University Of Washington Medical Center
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Vancouver, Washington, États-Unis, 98684
- Recrutement
- Northwest Cancer Specialists, P.C.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
Concentrate for solution for Infusion.
Autres noms:
|
|
Expérimental: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
Concentrate for solution for Infusion.
Autres noms:
Powder for concentrate for solution for infusion
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Confirmed Objective Response Rate (ORR) by investigator
Délai: 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)
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Duration of Response (DOR) per RECIST v1.1 by investigator
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 mars 2026
Achèvement primaire (Estimé)
28 décembre 2027
Achèvement de l'étude (Estimé)
25 septembre 2028
Dates d'inscription aux études
Première soumission
12 février 2026
Première soumission répondant aux critères de contrôle qualité
12 février 2026
Première publication (Réel)
19 février 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Tumeurs urologiques
- Carcinome
- Maladies de la vessie urinaire
- Tumeurs de la vessie urinaire
- Carcinome à cellules transitionnelles
- enfortumab vedotin
Autres numéros d'identification d'étude
- C6461006
- 2025-523523-21-00 (Identificateur de registre: CTIS (EU))
- Symbiotic-GU-06 (Autre identifiant: Pfizer)
- 2025 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .