Een onderzoek naar PF-08634404 alleen of in combinatie met Enfortumab Vedotin bij urotheelcarcinoom
6 oktober 2026 bijgewerkt door: Pfizer
EEN INTERVENTIONELE FASE 1B/2, OPEN-LABEL STUDIE OM DE VEILIGHEID, ANTITUMORACTIVITEIT EN FARMACOKINETIEK VAN PF 08634404 ALS MONOTHERAPIE OF IN COMBINATIE MET ENFORTUMAB VEDOTIN TE ONDERZOEKEN BIJ VOLWASSEN DEELNEMERS MET LOCCAAL GEVORDERDE OF METASTATISCHE UROTHEELCARCINOOM
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
132
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pfizer CT.gov Call Center
- Telefoonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studie Locaties
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New South Wales
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North Ryde, New South Wales, Australië, 2109
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- Macquarie University
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Queensland
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Auchenflower, Queensland, Australië, 4066
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- Icon Cancer Centre Wesley
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Victoria
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Clayton, Victoria, Australië, 3168
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- Monash Health
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
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- Beijing Cancer hospital
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Jiangsu
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Nanjing, Jiangsu, China, 210000
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- 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, China, 300211
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- The Second Hospital of Tianjin Medical University
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Zhejiang
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Ningbo, Zhejiang, China, 315010
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- The first affiliated hospital of Ningbo university
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Fukuoka, Japan, 811-1395
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- National Hospital Organization Kyushu Cancer Center
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Yamagata, Japan, 990-9585
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- Yamagata University Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 1608582
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- Keio university hospital
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Manati, Puerto Rico, 00674
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- Pan American Center for Oncology Trials, LLC - Manati Office
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Mayagüez, Puerto Rico, 00680
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- Pan American Center for Oncology Trials, LLC - Mayaguez Office
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Rio Piedras, Puerto Rico, 00935
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- Pan American Center for Oncology Trials, LLC
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Rio Piedras, Puerto Rico, 00935
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- Hospital Oncologico Dr. Isaac Gonzalez-Martinez
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Madrid, Spanje, 28041
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- Hospital Universitario 12 de Octubre
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Seville, Spanje, 41013
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- Hospital Universitario Virgen Del Rocio
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Barcelona [barcelona]
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Barcelona, Barcelona [barcelona], Spanje, 08035
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- Hospital Universitari Vall d'Hebron
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Barcelona, Barcelona [barcelona], Spanje, 08003
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- Parc de Salut Mar - Hospital del Mar
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Cantabria
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Santander, Cantabria, Spanje, 39008
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- Hospital Universitario Marqués de Valdecilla
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Catalunya [cataluña]
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Barcelona, Catalunya [cataluña], Spanje, 08041
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- Hospital de la Santa Creu i Sant Pau
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Arkansas
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Fayetteville, Arkansas, Verenigde Staten, 72703
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- Highlands Oncology Group, PA
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Rogers, Arkansas, Verenigde Staten, 72758
- Werving
- Highlands Oncology Group, PA
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Springdale, Arkansas, Verenigde Staten, 72762
- Werving
- Highlands Oncology Group, PA
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California
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Alhambra, California, Verenigde Staten, 91801
- Werving
- UCLA Hematology/Oncology - Alhambra
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Atascadero, California, Verenigde Staten, 93422
- Werving
- UCLA Hematology/Oncology - Atascadero
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Beverly Hills, California, Verenigde Staten, 90212
- Werving
- UCLA Hematology/Oncology - Beverly Hills
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Burbank, California, Verenigde Staten, 91505
- Werving
- UCLA Hematology/Oncology - Burbank
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Duarte, California, Verenigde Staten, 91010
- Werving
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, Verenigde Staten, 91010
- Werving
- City of Hope Investigational Drug Services (IDS)
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Encinitas, California, Verenigde Staten, 92024
- Werving
- UC San Diego Medical Center - Encinitas
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Encino, California, Verenigde Staten, 91436
- Werving
- UCLA Hematology/Oncology - Encino
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Irvine, California, Verenigde Staten, 92618
- Werving
- City of Hope at Irvine Lennar
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Irvine, California, Verenigde Staten, 92612
- Werving
- Chao Family Comprehensive Cancer Center and Ambulatory Care
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Irvine, California, Verenigde Staten, 92612
- Werving
- UCI Health - Irvine Infusion Pharmacy ACC
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Irvine, California, Verenigde Staten, 92618
- Werving
- City of Hope Investigational Drug Service (IDS)
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Irvine, California, Verenigde Staten, 92604
- Werving
- UCLA Hematology/Oncology - Irvine
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Sulpizio Cardiovascular Center
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Moores Cancer Center
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Koman Family Outpatient Pavilion
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La Jolla, California, Verenigde Staten, 92037
- Werving
- UC San Diego Shiley Eye Institute
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La Jolla, California, Verenigde Staten, 92037
- Werving
- Viterbi Family Department of Ophthalmology
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Laguna Hills, California, Verenigde Staten, 92653
- Werving
- UCLA Hematology Oncology- Laguna Hills
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Long Beach, California, Verenigde Staten, 90813
- Werving
- City of Hope-Long Beach (ELM)
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Los Angeles, California, Verenigde Staten, 90095
- Werving
- UCLA Hematology/Oncology
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Los Angeles, California, Verenigde Staten, 90025
- Werving
- START Los Angeles, LLC
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Los Angeles, California, Verenigde Staten, 90067
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- Los Angeles Cancer Network - Century City
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Los Angeles, California, Verenigde Staten, 90095
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- (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
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Marina del Rey, California, Verenigde Staten, 90292
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- UCLA Hematology/Oncology - Marina del Rey
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Orange, California, Verenigde Staten, 92868
- Werving
- UC Irvine Health
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Pasadena, California, Verenigde Staten, 91105
- Werving
- UCLA Hematology/Oncology - Pasadena
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Porter Ranch, California, Verenigde Staten, 91326
- Werving
- UCLA Hematology Oncology - Porter Ranch
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San Diego, California, Verenigde Staten, 92101
- Werving
- UC San Diego Medical Center - Bankers Hill
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San Diego, California, Verenigde Staten, 92103
- Werving
- UC San Diego McGrath Outpatient Pavilion - Hillcrest
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San Diego, California, Verenigde Staten, 92127
- Werving
- UC San Diego Medical Center - Rancho Bernardo
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San Diego, California, Verenigde Staten, 92103
- Werving
- UC San Diego Medical Center- Hillcrest
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San Luis Obispo, California, Verenigde Staten, 93401
- Werving
- UCLA Hematology/Oncology - San Luis Obispo
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Santa Barbara, California, Verenigde Staten, 93101
- Werving
- UCLA Hematology/Oncology- Santa Barbara
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Santa Monica, California, Verenigde Staten, 90404
- Werving
- UCLA Hematology/Oncology- Santa Monica
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Torrance, California, Verenigde Staten, 90505
- Werving
- UCLA Hematology/Oncology - Torrance
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Upland, California, Verenigde Staten, 91786
- Werving
- City of Hope UPLAND
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Valencia, California, Verenigde Staten, 91355
- Werving
- UCLA Hematology/Oncology - Santa Clarita
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Ventura, California, Verenigde Staten, 93003
- Werving
- UCLA Hematology/Oncology - Ventura
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Vista, California, Verenigde Staten, 92081
- Werving
- UC San Diego Medical Center - Vista
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Westlake Village, California, Verenigde Staten, 91361
- Werving
- UCLA Hematology/Oncology - Westlake
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Colorado
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Aurora, Colorado, Verenigde Staten, 80012
- Werving
- Rocky Mountain Cancer Centers, LLP
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Denver, Colorado, Verenigde Staten, 80218
- Werving
- Rocky Mountain Cancer Centers, LLP
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Lone Tree, Colorado, Verenigde Staten, 80124
- Werving
- Rocky Mountain Cancer Centers, LLP
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Connecticut
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Derby, Connecticut, Verenigde Staten, 06418
- Werving
- Smilow Cancer Hospital - Derby
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Fairfield, Connecticut, Verenigde Staten, 06824
- Werving
- Smilow Cancer Hospital - Fairfield
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Greenwich, Connecticut, Verenigde Staten, 06830
- Werving
- Smilow Cancer Hospital - Greenwich
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Guilford, Connecticut, Verenigde Staten, 06437
- Werving
- Smilow Cancer Hospital - Guilford
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New Haven, Connecticut, Verenigde Staten, 06511
- Werving
- Smilow Cancer Hospital Phase 1 Unit
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New Haven, Connecticut, Verenigde Staten, 06510
- Werving
- Yale-New Haven Hospital-Yale Cancer Center
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New Haven, Connecticut, Verenigde Staten, 06510
- Werving
- Smilow Cancer Hospital - Yale New Haven Health
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New Haven, Connecticut, Verenigde Staten, 06511
- Werving
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
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New Haven, Connecticut, Verenigde Staten, 06510
- Werving
- Yale Eye Center
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North Haven, Connecticut, Verenigde Staten, 06473
- Werving
- Smilow Cancer Hospital - North Haven
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Norwich, Connecticut, Verenigde Staten, 06360
- Werving
- Eastern Connecticut Hematology and Oncology Associates
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Stamford, Connecticut, Verenigde Staten, 06902
- Werving
- Smilow Cancer Hospital - Long Ridge
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Trumbull, Connecticut, Verenigde Staten, 06835
- Werving
- Smilow Cancer Hospital - Trumbull
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20016
- Werving
- Sibley Memorial Hospital
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Washington D.C., District of Columbia, Verenigde Staten, 20016
- Werving
- Sibley Memorial Hospital Pharmacy Department
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Georgia
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Ringgold, Georgia, Verenigde Staten, 30736
- Werving
- Tennessee Oncology, PLLC- Ringgold
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Illinois
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Shiloh, Illinois, Verenigde Staten, 62269
- Werving
- Siteman Cancer Center - Shiloh
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Shiloh, Illinois, Verenigde Staten, 62269
- Werving
- Memorial Hospital
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- Johns Hopkins Hospital
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- Johns Hopkins Outpatient Center
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Baltimore, Maryland, Verenigde Staten, 21231
- Werving
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, Verenigde Staten, 21231
- Werving
- Oncology Research Pharmacy and lnvestigational Drug Service
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Missouri
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City of Saint Peters, Missouri, Verenigde Staten, 63376
- Werving
- Siteman Cancer Center - St. Peters
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Creve Coeur, Missouri, Verenigde Staten, 63141
- Werving
- Siteman Cancer Center - West County
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Florissant, Missouri, Verenigde Staten, 63031
- Werving
- Siteman Cancer Center - North County
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St Louis, Missouri, Verenigde Staten, 63108
- Werving
- Siteman Cancer Center
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University School of Medicine - Siteman Cancer Center
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Barnes-Jewish Hospital
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St Louis, Missouri, Verenigde Staten, 63129
- Werving
- Siteman Cancer Center - South County
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New Jersey
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Basking Ridge, New Jersey, Verenigde Staten, 07920
- Nog niet aan het werven
- MSK Basking Ridge
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Middletown, New Jersey, Verenigde Staten, 07748
- Nog niet aan het werven
- MSK Monmouth
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Montvale, New Jersey, Verenigde Staten, 07645
- Nog niet aan het werven
- MSK Bergen
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New York
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Albany, New York, Verenigde Staten, 12206
- Werving
- New York Oncology Hematology
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Clifton Park, New York, Verenigde Staten, 12065
- Werving
- New York Oncology Hematology
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Commack, New York, Verenigde Staten, 11725
- Nog niet aan het werven
- MSK Commack
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Harrison, New York, Verenigde Staten, 10604
- Nog niet aan het werven
- MSK Westchester
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Long Island City, New York, Verenigde Staten, 11101
- Nog niet aan het werven
- Investigational Drug Service
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New York, New York, Verenigde Staten, 10029
- Werving
- Icahn School of Medicine at Mount Sinai
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New York, New York, Verenigde Staten, 10021
- Nog niet aan het werven
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
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New York, New York, Verenigde Staten, 10065
- Nog niet aan het werven
- Memorial Sloan Kettering Cancer Center-Main Campus
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New York, New York, Verenigde Staten, 10065
- Nog niet aan het werven
- Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
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New York, New York, Verenigde Staten, 10065
- Nog niet aan het werven
- Evelyn H. Lauder Breast and Imaging Center (BAIC)
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Uniondale, New York, Verenigde Staten, 11553
- Nog niet aan het werven
- MSK Nassau
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North Carolina
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Cary, North Carolina, Verenigde Staten, 27518
- Werving
- Duke Cancer Center Cary
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center (location of scans)
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Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center - Duke University Hospital (location of scans)
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Durham, North Carolina, Verenigde Staten, 27713
- Werving
- Duke University
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Duke Raleigh Hospital
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- Duke Cancer Center Raleigh
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Raleigh, North Carolina, Verenigde Staten, 27609
- Werving
- 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, Verenigde Staten, 44195
- Werving
- Cleveland Clinic Foundation
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Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, Verenigde Staten, 44195
- Werving
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
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Oregon
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Eugene, Oregon, Verenigde Staten, 97401
- Werving
- Oncology Associates of Oregon, P.C.
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Portland, Oregon, Verenigde Staten, 97213
- Werving
- Northwest Cancer Specialists, P.C.
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Portland, Oregon, Verenigde Staten, 97227
- Werving
- Northwest Cancer Specialists, P.C.
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Springfield, Oregon, Verenigde Staten, 97477
- Werving
- Oncology Associates of Oregon, P.C.
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Tigard, Oregon, Verenigde Staten, 97223
- Werving
- Northwest Cancer Specialists, P.C.
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37403
- Werving
- Tennessee Oncology, PLLC - Chattanooga Downtown
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Werving
- Tennessee Oncology, PLLC - Chattanooga Med Park II
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Werving
- Tennessee Oncology, PLLC - Chattanooga Memorial
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Chattanooga, Tennessee, Verenigde Staten, 37421
- Werving
- Tennessee Oncology, PLLC - Chattanooga East
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Chattanooga, Tennessee, Verenigde Staten, 37404
- Werving
- Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
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Cookeville, Tennessee, Verenigde Staten, 38501
- Werving
- Tennessee Oncology, PLLC- Cookeville
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Dickson, Tennessee, Verenigde Staten, 37055
- Werving
- Tennessee Oncology, PLLC - Dickson
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Franklin, Tennessee, Verenigde Staten, 37067
- Werving
- Tennessee Oncology, PLLC - Franklin
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Franklin, Tennessee, Verenigde Staten, 37067
- Werving
- Tennessee Oncology, PLLC - Proton Center
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Gallatin, Tennessee, Verenigde Staten, 37066
- Werving
- Tennessee Oncology, PLLC - Gallatin
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Hendersonville, Tennessee, Verenigde Staten, 37075
- Werving
- Tennessee Oncology, PLLC - Hendersonville
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Lebanon, Tennessee, Verenigde Staten, 37090
- Werving
- Tennessee Oncology, PLLC - Lebanon
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Mount Juliet, Tennessee, Verenigde Staten, 37122
- Werving
- Tennessee Oncology, PLLC - Mount Juliet
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Murfreesboro, Tennessee, Verenigde Staten, 37129
- Werving
- Tennessee Oncology, PLLC - Murfreesboro
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Sarah Cannon Research Institute
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- SCRI Oncology Partners
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Tennessee Oncology, PLLC - Investigational Drug Services
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Nashville, Tennessee, Verenigde Staten, 37205
- Werving
- Tennessee Oncology, PLLC - Saint Thomas West
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Nashville, Tennessee, Verenigde Staten, 37207
- Werving
- Tennessee Oncology, PLLC- Skyline
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Nashville, Tennessee, Verenigde Staten, 37211
- Werving
- Tennessee Oncology, PLLC- Southern Hills
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Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
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Shelbyville, Tennessee, Verenigde Staten, 37160
- Werving
- Tennessee Oncology, PLLC -Shelbyville
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Smyrna, Tennessee, Verenigde Staten, 37167
- Werving
- Tennessee Oncology, PLLC - Smyrna
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Texas
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Austin, Texas, Verenigde Staten, 78705
- Werving
- Texas Oncology - Central/South Texas
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Austin, Texas, Verenigde Staten, 78731
- Werving
- Texas Oncology - Central/South Texas
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Austin, Texas, Verenigde Staten, 78745
- Werving
- Texas Oncology - Central/South Texas
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Beaumont, Texas, Verenigde Staten, 77702
- Werving
- Texas Oncology - Gulf Coast
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Harlingen, Texas, Verenigde Staten, 78550
- Werving
- Texas Oncology - Central/South Texas
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Houston, Texas, Verenigde Staten, 77024
- Werving
- Texas Oncology - Gulf Coast
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Houston, Texas, Verenigde Staten, 77054
- Werving
- Texas Oncology - Gulf Coast
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Irving, Texas, Verenigde Staten, 75063
- Werving
- US Oncology Investigational Products Center (IPC)
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Irving, Texas, Verenigde Staten, 75063
- Werving
- US Oncology Investigational Product Center (IPC)
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McAllen, Texas, Verenigde Staten, 78503
- Werving
- Texas Oncology - Central/South Texas
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Pearland, Texas, Verenigde Staten, 77584
- Werving
- Texas Oncology - Gulf Coast
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Sugar Land, Texas, Verenigde Staten, 77479
- Werving
- Texas Oncology - Gulf Coast
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The Woodlands, Texas, Verenigde Staten, 77380
- Werving
- Texas Oncology - Gulf Coast
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Waco, Texas, Verenigde Staten, 76712
- Werving
- Texas Oncology - Central/South Texas
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Webster, Texas, Verenigde Staten, 77598
- Werving
- Texas Oncology - Gulf Coast
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Weslaco, Texas, Verenigde Staten, 78596
- Werving
- Texas Oncology - Central South
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84112
- Werving
- Huntsman Cancer Institute - University of Utah
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Virginia
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Blacksburg, Virginia, Verenigde Staten, 24060
- Werving
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Fairfax, Virginia, Verenigde Staten, 22031
- Werving
- Virginia Cancer Specialists, PC
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Low Moor, Virginia, Verenigde Staten, 24457
- Werving
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Norfolk, Virginia, Verenigde Staten, 23502
- Werving
- Virginia Oncology Associates
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Roanoke, Virginia, Verenigde Staten, 24014
- Werving
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Salem, Virginia, Verenigde Staten, 24153
- Werving
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Wytheville, Virginia, Verenigde Staten, 24382
- Werving
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
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Washington
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Edmonds, Washington, Verenigde Staten, 98026
- Werving
- Eye Associates Northwest - Edmonds Clinic
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Kirkland, Washington, Verenigde Staten, 98034
- Werving
- Eye Associates Northwest - Kirkland Clinic
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Seattle, Washington, Verenigde Staten, 98109
- Werving
- Fred Hutchinson Cancer Center
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Seattle, Washington, Verenigde Staten, 98104
- Werving
- Harborview Medical Center
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Seattle, Washington, Verenigde Staten, 98104
- Werving
- Eye Associates Northwest - Ballard Clinic and Surgery Center
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Seattle, Washington, Verenigde Staten, 98104
- Werving
- Eye Associates Northwest - First Hill Clinic
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Seattle, Washington, Verenigde Staten, 98125
- Werving
- Eye Associates Northwest - Northgate Clinic
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Seattle, Washington, Verenigde Staten, 98195
- Werving
- University Of Washington Medical Center
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Vancouver, Washington, Verenigde Staten, 98684
- Werving
- Northwest Cancer Specialists, P.C.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
Concentrate for solution for Infusion.
Andere namen:
|
|
Experimenteel: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
Concentrate for solution for Infusion.
Andere namen:
Powder for concentrate for solution for infusion
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Confirmed Objective Response Rate (ORR) by investigator
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Duration of Response (DOR) per RECIST v1.1 by investigator
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Pfizer CT.gov Call Center, Pfizer
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
11 maart 2026
Primaire voltooiing (Geschat)
28 december 2027
Studie voltooiing (Geschat)
25 september 2028
Studieregistratiedata
Eerst ingediend
12 februari 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 februari 2026
Eerst geplaatst (Werkelijk)
19 februari 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 oktober 2026
Laatste update ingediend die voldeed aan QC-criteria
6 oktober 2026
Laatst geverifieerd
1 oktober 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Mannelijke urogenitale ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Neoplasmata per histologisch type
- Neoplasmata, glandulair en epitheel
- Urologische neoplasmata
- Carcinoom
- Ziekten van de urineblaas
- Neoplasmata van de urineblaas
- Carcinoom, overgangscel
- ENFORTUMAB VEDOTIN
Andere studie-ID-nummers
- C6461006
- 2025-523523-21-00 (Register-ID: CTIS (EU))
- Symbiotic-GU-06 (Andere identificatie: Pfizer)
- 2025 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .