En studie for å lære om PF-08634404 alene eller i kombinasjon med Enfortumab Vedotin ved urotelcellekreft
6. oktober 2026 oppdatert av: Pfizer
EN INTERVENSJONSFASE 1B/2, ÅPEN-LABEL-STUDIE FOR Å UNDERSØKE SIKKERHET, ANTITUMOR-AKTIVITET OG FARMAKOKINETIKK FOR PF 08634404 MONOTERAPI ELLER I KOMBINASJON MED ENFORTUMAB VEDOTIN HOS VOKSNE DELTAKERE MED LOKALT AVANSERT ELLER METASTATISK UROTELKREFT
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
132
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-post: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
-
-
New South Wales
-
North Ryde, New South Wales, Australia, 2109
- Rekruttering
- Macquarie University
-
-
Queensland
-
Auchenflower, Queensland, Australia, 4066
- Rekruttering
- Icon Cancer Centre Wesley
-
-
Victoria
-
Clayton, Victoria, Australia, 3168
- Rekruttering
- Monash Health
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, Forente stater, 72703
- Rekruttering
- Highlands Oncology Group, PA
-
Rogers, Arkansas, Forente stater, 72758
- Rekruttering
- Highlands Oncology Group, PA
-
Springdale, Arkansas, Forente stater, 72762
- Rekruttering
- Highlands Oncology Group, PA
-
-
California
-
Alhambra, California, Forente stater, 91801
- Rekruttering
- UCLA Hematology/Oncology - Alhambra
-
Atascadero, California, Forente stater, 93422
- Rekruttering
- UCLA Hematology/Oncology - Atascadero
-
Beverly Hills, California, Forente stater, 90212
- Rekruttering
- UCLA Hematology/Oncology - Beverly Hills
-
Burbank, California, Forente stater, 91505
- Rekruttering
- UCLA Hematology/Oncology - Burbank
-
Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
-
Duarte, California, Forente stater, 91010
- Rekruttering
- City of Hope Investigational Drug Services (IDS)
-
Encinitas, California, Forente stater, 92024
- Rekruttering
- UC San Diego Medical Center - Encinitas
-
Encino, California, Forente stater, 91436
- Rekruttering
- UCLA Hematology/Oncology - Encino
-
Irvine, California, Forente stater, 92618
- Rekruttering
- City of Hope at Irvine Lennar
-
Irvine, California, Forente stater, 92612
- Rekruttering
- Chao Family Comprehensive Cancer Center and Ambulatory Care
-
Irvine, California, Forente stater, 92612
- Rekruttering
- UCI Health - Irvine Infusion Pharmacy ACC
-
Irvine, California, Forente stater, 92618
- Rekruttering
- City of Hope Investigational Drug Service (IDS)
-
Irvine, California, Forente stater, 92604
- Rekruttering
- UCLA Hematology/Oncology - Irvine
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Sulpizio Cardiovascular Center
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Moores Cancer Center
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Koman Family Outpatient Pavilion
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- UC San Diego Shiley Eye Institute
-
La Jolla, California, Forente stater, 92037
- Rekruttering
- Viterbi Family Department of Ophthalmology
-
Laguna Hills, California, Forente stater, 92653
- Rekruttering
- UCLA Hematology Oncology- Laguna Hills
-
Long Beach, California, Forente stater, 90813
- Rekruttering
- City of Hope-Long Beach (ELM)
-
Los Angeles, California, Forente stater, 90095
- Rekruttering
- UCLA Hematology/Oncology
-
Los Angeles, California, Forente stater, 90025
- Rekruttering
- START Los Angeles, LLC
-
Los Angeles, California, Forente stater, 90067
- Rekruttering
- Los Angeles Cancer Network - Century City
-
Los Angeles, California, Forente stater, 90095
- Rekruttering
- (IRB# 26-0433) Ronald Reagan UCLA Medical Center, Drug Information Center
-
Marina del Rey, California, Forente stater, 90292
- Rekruttering
- UCLA Hematology/Oncology - Marina del Rey
-
Orange, California, Forente stater, 92868
- Rekruttering
- UC Irvine Health
-
Pasadena, California, Forente stater, 91105
- Rekruttering
- UCLA Hematology/Oncology - Pasadena
-
Porter Ranch, California, Forente stater, 91326
- Rekruttering
- UCLA Hematology Oncology - Porter Ranch
-
San Diego, California, Forente stater, 92101
- Rekruttering
- UC San Diego Medical Center - Bankers Hill
-
San Diego, California, Forente stater, 92103
- Rekruttering
- UC San Diego McGrath Outpatient Pavilion - Hillcrest
-
San Diego, California, Forente stater, 92127
- Rekruttering
- UC San Diego Medical Center - Rancho Bernardo
-
San Diego, California, Forente stater, 92103
- Rekruttering
- UC San Diego Medical Center- Hillcrest
-
San Luis Obispo, California, Forente stater, 93401
- Rekruttering
- UCLA Hematology/Oncology - San Luis Obispo
-
Santa Barbara, California, Forente stater, 93101
- Rekruttering
- UCLA Hematology/Oncology- Santa Barbara
-
Santa Monica, California, Forente stater, 90404
- Rekruttering
- UCLA Hematology/Oncology- Santa Monica
-
Torrance, California, Forente stater, 90505
- Rekruttering
- UCLA Hematology/Oncology - Torrance
-
Upland, California, Forente stater, 91786
- Rekruttering
- City of Hope UPLAND
-
Valencia, California, Forente stater, 91355
- Rekruttering
- UCLA Hematology/Oncology - Santa Clarita
-
Ventura, California, Forente stater, 93003
- Rekruttering
- UCLA Hematology/Oncology - Ventura
-
Vista, California, Forente stater, 92081
- Rekruttering
- UC San Diego Medical Center - Vista
-
Westlake Village, California, Forente stater, 91361
- Rekruttering
- UCLA Hematology/Oncology - Westlake
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80012
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
-
Denver, Colorado, Forente stater, 80218
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
-
Lone Tree, Colorado, Forente stater, 80124
- Rekruttering
- Rocky Mountain Cancer Centers, LLP
-
-
Connecticut
-
Derby, Connecticut, Forente stater, 06418
- Rekruttering
- Smilow Cancer Hospital - Derby
-
Fairfield, Connecticut, Forente stater, 06824
- Rekruttering
- Smilow Cancer Hospital - Fairfield
-
Greenwich, Connecticut, Forente stater, 06830
- Rekruttering
- Smilow Cancer Hospital - Greenwich
-
Guilford, Connecticut, Forente stater, 06437
- Rekruttering
- Smilow Cancer Hospital - Guilford
-
New Haven, Connecticut, Forente stater, 06511
- Rekruttering
- Smilow Cancer Hospital Phase 1 Unit
-
New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale-New Haven Hospital-Yale Cancer Center
-
New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Smilow Cancer Hospital - Yale New Haven Health
-
New Haven, Connecticut, Forente stater, 06511
- Rekruttering
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
-
New Haven, Connecticut, Forente stater, 06510
- Rekruttering
- Yale Eye Center
-
North Haven, Connecticut, Forente stater, 06473
- Rekruttering
- Smilow Cancer Hospital - North Haven
-
Norwich, Connecticut, Forente stater, 06360
- Rekruttering
- Eastern Connecticut Hematology and Oncology Associates
-
Stamford, Connecticut, Forente stater, 06902
- Rekruttering
- Smilow Cancer Hospital - Long Ridge
-
Trumbull, Connecticut, Forente stater, 06835
- Rekruttering
- Smilow Cancer Hospital - Trumbull
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20016
- Rekruttering
- Sibley Memorial Hospital
-
Washington D.C., District of Columbia, Forente stater, 20016
- Rekruttering
- Sibley Memorial Hospital Pharmacy Department
-
-
Georgia
-
Ringgold, Georgia, Forente stater, 30736
- Rekruttering
- Tennessee Oncology, PLLC- Ringgold
-
-
Illinois
-
Shiloh, Illinois, Forente stater, 62269
- Rekruttering
- Siteman Cancer Center - Shiloh
-
Shiloh, Illinois, Forente stater, 62269
- Rekruttering
- Memorial Hospital
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Johns Hopkins Hospital
-
Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- Johns Hopkins Outpatient Center
-
Baltimore, Maryland, Forente stater, 21231
- Rekruttering
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, Forente stater, 21287
- Rekruttering
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
Baltimore, Maryland, Forente stater, 21231
- Rekruttering
- Oncology Research Pharmacy and lnvestigational Drug Service
-
-
Missouri
-
City of Saint Peters, Missouri, Forente stater, 63376
- Rekruttering
- Siteman Cancer Center - St. Peters
-
Creve Coeur, Missouri, Forente stater, 63141
- Rekruttering
- Siteman Cancer Center - West County
-
Florissant, Missouri, Forente stater, 63031
- Rekruttering
- Siteman Cancer Center - North County
-
St Louis, Missouri, Forente stater, 63108
- Rekruttering
- Siteman Cancer Center
-
St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University School of Medicine - Siteman Cancer Center
-
St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Barnes-Jewish Hospital
-
St Louis, Missouri, Forente stater, 63129
- Rekruttering
- Siteman Cancer Center - South County
-
-
New Jersey
-
Basking Ridge, New Jersey, Forente stater, 07920
- Har ikke rekruttert ennå
- MSK Basking Ridge
-
Middletown, New Jersey, Forente stater, 07748
- Har ikke rekruttert ennå
- MSK Monmouth
-
Montvale, New Jersey, Forente stater, 07645
- Har ikke rekruttert ennå
- MSK Bergen
-
-
New York
-
Albany, New York, Forente stater, 12206
- Rekruttering
- New York Oncology Hematology
-
Clifton Park, New York, Forente stater, 12065
- Rekruttering
- New York Oncology Hematology
-
Commack, New York, Forente stater, 11725
- Har ikke rekruttert ennå
- MSK Commack
-
Harrison, New York, Forente stater, 10604
- Har ikke rekruttert ennå
- MSK Westchester
-
Long Island City, New York, Forente stater, 11101
- Har ikke rekruttert ennå
- Investigational Drug Service
-
New York, New York, Forente stater, 10029
- Rekruttering
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Forente stater, 10021
- Har ikke rekruttert ennå
- Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
-
New York, New York, Forente stater, 10065
- Har ikke rekruttert ennå
- Memorial Sloan Kettering Cancer Center-Main Campus
-
New York, New York, Forente stater, 10065
- Har ikke rekruttert ennå
- Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
-
New York, New York, Forente stater, 10065
- Har ikke rekruttert ennå
- Evelyn H. Lauder Breast and Imaging Center (BAIC)
-
Uniondale, New York, Forente stater, 11553
- Har ikke rekruttert ennå
- MSK Nassau
-
-
North Carolina
-
Cary, North Carolina, Forente stater, 27518
- Rekruttering
- Duke Cancer Center Cary
-
Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke University Medical Center
-
Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke University Medical Center (location of scans)
-
Durham, North Carolina, Forente stater, 27710
- Rekruttering
- Duke University Medical Center - Duke University Hospital (location of scans)
-
Durham, North Carolina, Forente stater, 27713
- Rekruttering
- Duke University
-
Raleigh, North Carolina, Forente stater, 27609
- Rekruttering
- Duke Raleigh Hospital
-
Raleigh, North Carolina, Forente stater, 27609
- Rekruttering
- Duke Cancer Center Raleigh
-
Raleigh, North Carolina, Forente stater, 27609
- Rekruttering
- Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Forente stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, Forente stater, 44195
- Rekruttering
- Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
-
-
Oregon
-
Eugene, Oregon, Forente stater, 97401
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
Portland, Oregon, Forente stater, 97213
- Rekruttering
- Northwest Cancer Specialists, P.C.
-
Portland, Oregon, Forente stater, 97227
- Rekruttering
- Northwest Cancer Specialists, P.C.
-
Springfield, Oregon, Forente stater, 97477
- Rekruttering
- Oncology Associates of Oregon, P.C.
-
Tigard, Oregon, Forente stater, 97223
- Rekruttering
- Northwest Cancer Specialists, P.C.
-
-
Tennessee
-
Chattanooga, Tennessee, Forente stater, 37403
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Downtown
-
Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Med Park II
-
Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga Memorial
-
Chattanooga, Tennessee, Forente stater, 37421
- Rekruttering
- Tennessee Oncology, PLLC - Chattanooga East
-
Chattanooga, Tennessee, Forente stater, 37404
- Rekruttering
- Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
-
Cookeville, Tennessee, Forente stater, 38501
- Rekruttering
- Tennessee Oncology, PLLC- Cookeville
-
Dickson, Tennessee, Forente stater, 37055
- Rekruttering
- Tennessee Oncology, PLLC - Dickson
-
Franklin, Tennessee, Forente stater, 37067
- Rekruttering
- Tennessee Oncology, PLLC - Franklin
-
Franklin, Tennessee, Forente stater, 37067
- Rekruttering
- Tennessee Oncology, PLLC - Proton Center
-
Gallatin, Tennessee, Forente stater, 37066
- Rekruttering
- Tennessee Oncology, PLLC - Gallatin
-
Hendersonville, Tennessee, Forente stater, 37075
- Rekruttering
- Tennessee Oncology, PLLC - Hendersonville
-
Lebanon, Tennessee, Forente stater, 37090
- Rekruttering
- Tennessee Oncology, PLLC - Lebanon
-
Mount Juliet, Tennessee, Forente stater, 37122
- Rekruttering
- Tennessee Oncology, PLLC - Mount Juliet
-
Murfreesboro, Tennessee, Forente stater, 37129
- Rekruttering
- Tennessee Oncology, PLLC - Murfreesboro
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Sarah Cannon Research Institute
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- SCRI Oncology Partners
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Investigational Drug Services
-
Nashville, Tennessee, Forente stater, 37205
- Rekruttering
- Tennessee Oncology, PLLC - Saint Thomas West
-
Nashville, Tennessee, Forente stater, 37207
- Rekruttering
- Tennessee Oncology, PLLC- Skyline
-
Nashville, Tennessee, Forente stater, 37211
- Rekruttering
- Tennessee Oncology, PLLC- Southern Hills
-
Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology
-
Shelbyville, Tennessee, Forente stater, 37160
- Rekruttering
- Tennessee Oncology, PLLC -Shelbyville
-
Smyrna, Tennessee, Forente stater, 37167
- Rekruttering
- Tennessee Oncology, PLLC - Smyrna
-
-
Texas
-
Austin, Texas, Forente stater, 78705
- Rekruttering
- Texas Oncology - Central/South Texas
-
Austin, Texas, Forente stater, 78731
- Rekruttering
- Texas Oncology - Central/South Texas
-
Austin, Texas, Forente stater, 78745
- Rekruttering
- Texas Oncology - Central/South Texas
-
Beaumont, Texas, Forente stater, 77702
- Rekruttering
- Texas Oncology - Gulf Coast
-
Harlingen, Texas, Forente stater, 78550
- Rekruttering
- Texas Oncology - Central/South Texas
-
Houston, Texas, Forente stater, 77024
- Rekruttering
- Texas Oncology - Gulf Coast
-
Houston, Texas, Forente stater, 77054
- Rekruttering
- Texas Oncology - Gulf Coast
-
Irving, Texas, Forente stater, 75063
- Rekruttering
- US Oncology Investigational Products Center (IPC)
-
Irving, Texas, Forente stater, 75063
- Rekruttering
- US Oncology Investigational Product Center (IPC)
-
McAllen, Texas, Forente stater, 78503
- Rekruttering
- Texas Oncology - Central/South Texas
-
Pearland, Texas, Forente stater, 77584
- Rekruttering
- Texas Oncology - Gulf Coast
-
Sugar Land, Texas, Forente stater, 77479
- Rekruttering
- Texas Oncology - Gulf Coast
-
The Woodlands, Texas, Forente stater, 77380
- Rekruttering
- Texas Oncology - Gulf Coast
-
Waco, Texas, Forente stater, 76712
- Rekruttering
- Texas Oncology - Central/South Texas
-
Webster, Texas, Forente stater, 77598
- Rekruttering
- Texas Oncology - Gulf Coast
-
Weslaco, Texas, Forente stater, 78596
- Rekruttering
- Texas Oncology - Central South
-
-
Utah
-
Salt Lake City, Utah, Forente stater, 84112
- Rekruttering
- Huntsman Cancer Institute - University of Utah
-
-
Virginia
-
Blacksburg, Virginia, Forente stater, 24060
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Fairfax, Virginia, Forente stater, 22031
- Rekruttering
- Virginia Cancer Specialists, PC
-
Low Moor, Virginia, Forente stater, 24457
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Norfolk, Virginia, Forente stater, 23502
- Rekruttering
- Virginia Oncology Associates
-
Roanoke, Virginia, Forente stater, 24014
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Salem, Virginia, Forente stater, 24153
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
Wytheville, Virginia, Forente stater, 24382
- Rekruttering
- Oncology & Hematology Associates of Southwest Virginia, Inc.,DBA Blue Ridge Cancer Care
-
-
Washington
-
Edmonds, Washington, Forente stater, 98026
- Rekruttering
- Eye Associates Northwest - Edmonds Clinic
-
Kirkland, Washington, Forente stater, 98034
- Rekruttering
- Eye Associates Northwest - Kirkland Clinic
-
Seattle, Washington, Forente stater, 98109
- Rekruttering
- Fred Hutchinson Cancer Center
-
Seattle, Washington, Forente stater, 98104
- Rekruttering
- Harborview Medical Center
-
Seattle, Washington, Forente stater, 98104
- Rekruttering
- Eye Associates Northwest - Ballard Clinic and Surgery Center
-
Seattle, Washington, Forente stater, 98104
- Rekruttering
- Eye Associates Northwest - First Hill Clinic
-
Seattle, Washington, Forente stater, 98125
- Rekruttering
- Eye Associates Northwest - Northgate Clinic
-
Seattle, Washington, Forente stater, 98195
- Rekruttering
- University Of Washington Medical Center
-
Vancouver, Washington, Forente stater, 98684
- Rekruttering
- Northwest Cancer Specialists, P.C.
-
-
-
-
-
Fukuoka, Japan, 811-1395
- Rekruttering
- National Hospital Organization Kyushu Cancer Center
-
Yamagata, Japan, 990-9585
- Rekruttering
- Yamagata University Hospital
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japan, 1608582
- Rekruttering
- Keio university hospital
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210000
- Rekruttering
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300211
- Rekruttering
- The Second Hospital of Tianjin Medical University
-
-
Zhejiang
-
Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- The first affiliated hospital of Ningbo university
-
-
-
-
-
Manati, Puerto Rico, 00674
- Rekruttering
- Pan American Center for Oncology Trials, LLC - Manati Office
-
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
-
-
-
-
-
Madrid, Spania, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Seville, Spania, 41013
- Rekruttering
- Hospital Universitario Virgen Del Rocio
-
-
Barcelona [barcelona]
-
Barcelona, Barcelona [barcelona], Spania, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron
-
Barcelona, Barcelona [barcelona], Spania, 08003
- Rekruttering
- Parc de Salut Mar - Hospital del Mar
-
-
Cantabria
-
Santander, Cantabria, Spania, 39008
- Rekruttering
- Hospital Universitario Marqués de Valdecilla
-
-
Catalunya [cataluña]
-
Barcelona, Catalunya [cataluña], Spania, 08041
- Rekruttering
- Hospital de la Santa Creu i Sant Pau
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort A
Participants with previously treated LA/mUC will receive PF-08634404 administered intravenously as monotherapy. |
Concentrate for solution for Infusion.
Andre navn:
|
|
Eksperimentell: Cohort B
Participants with untreated LA/mUC will receive PF-08634404 in combination with enfortumab vedotin |
Concentrate for solution for Infusion.
Andre navn:
Powder for concentrate for solution for infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. mars 2026
Primær fullføring (Antatt)
28. desember 2027
Studiet fullført (Antatt)
25. september 2028
Datoer for studieregistrering
Først innsendt
12. februar 2026
Først innsendt som oppfylte QC-kriteriene
12. februar 2026
Først lagt ut (Faktiske)
19. februar 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Urologiske neoplasmer
- Karsinom
- Urinblæresykdommer
- Neoplasmer i urinblæren
- Karsinom, overgangscelle
- Enfortumab Vedotin
Andre studie-ID-numre
- C6461006
- 2025-523523-21-00 (Registeridentifikator: CTIS (EU))
- Symbiotic-GU-06 (Annen identifikator: Pfizer)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .