Taking people in United StatesPhase 2

Tests disitamab vedotin alone or with pembrolizumab in HER2-expressing bladder cancer

Tests disitamab vedotin, with or without pembrolizumab, in adults with HER2-expressing urothelial cancer.

Plain-language title generated from the registry record
Registry title: A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Key facts

Where: Anaheim, Arcadia, Baldwin Park, Basking Ridge, Bellflower, Beverly Hills, Big Rapids, Bonita Springs, Bradenton, Burbank, Cape Coral, Carrollton, Cartersville, Chapel Hill, Charlotte, Chicago, Cleveland, Columbus, Commack, Concord, Dallas, Daytona Beach, Deerfield, Detroit, Douglasville, Duarte, Encino, Fairfax, Farmington Hills, Fleming Island, Flossmoor, Fontana, Fort Myers, Gastonia, Gilbert, Glendora, Grand Rapids, Harbor City, Harrison, Harvey, Hiram, Holland, Houston, Irvine, Knoxville, Lake Success, Lansing, Long Island City, Los Angeles, Marietta, Middletown, Milwaukee, Monroe, Montecito, Montvale, N. Venice, Naples, New Lenox, New York, Newport Beach, Norton Shores, Oklahoma City, Ontario, Orange, Orland Park, Panorama City, Pasadena, Port Charlotte, Porter Ranch, Riverside, San Diego, San Francisco, San Gabriel, San Luis Obispo, San Marcos, Santa Monica, Sarasota, Seattle, Simi Valley, Stuart, Syracuse, Tallahassee, Tampa, Temple, Templeton, Thousand Oaks, Tinley Park, Torrance, Uniondale, Valencia, Venice, Ventura, Vero Beach, Washington D.C., Wellington, West Palm Beach, Westlake Village, Woodland Hills, and Worcester, United StatesSee the 154 sites
Phase: Phase 2

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with urothelial cancer that has spread or cannot be removed by surgery. The cancer must show HER2 on testing in most groups. Disitamab vedotin is given alone or with pembrolizumab.

Age: 18 years or older
Sex: All sexes can join
Disease stage: Urothelial cancer (renal pelvis, ureter, bladder or urethra) that is locally advanced and cannot be removed by surgery, or has spread. At least one measurable tumor.
Earlier treatment: Depends on the group. Some groups need 1 or 2 earlier lines of treatment, including platinum chemotherapy. One group needs earlier platinum chemotherapy, PD-(L)1 inhibitor and enfortumab vedotin. Two groups need no earlier systemic treatment for the advanced disease.
Biomarker or test result: HER2 expression of IHC 1+, 2+ or 3+ on a tumor sample, checked by the central laboratory (all groups except Cohort D).

Main reasons for not taking part

Known allergy to disitamab vedotin or pembrolizumab (in the groups that get it)
Any cancer treatment within 2 weeks before the start
Earlier HER2-directed treatment
Nerve damage (neuropathy) of Grade 2 or higher (Grade 1 or higher in some groups)
Major surgery not yet recovered from within 4 weeks

Read by machine on 9 November 2026.

Where in United States

Kaiser Permanente Anaheim Kraemer Medical OfficesAnaheim, United StatesTaking people
Foothill CardioologyArcadia, United StatesTaking people
Kaiser Permanente Baldwin Park Medical CenterBaldwin Park, United StatesTaking people
MSK Basking Ridge.Basking Ridge, United StatesTaking people
Kaiser Permanente Bellflower Medical OfficesBellflower, United StatesTaking people
Beverly Hills Multi-Specialties PracticeBeverly Hills, United StatesTaking people
The Cancer & Hematology CentersBig Rapids, United StatesTaking people
Florida Cancer SpecialistsBonita Springs, United StatesTaking people
Florida Cancer SpecialistsBradenton, United StatesTaking people
Providence Saint Joseph Medical CenterBurbank, United StatesTaking people
UCLA Burbank CardiologyBurbank, United StatesTaking people
UCLA Hematology/Oncology - BurbankBurbank, United StatesTaking people
Florida Cancer SpecialistsCape Coral, United StatesTaking people
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa RicaCarrollton, United StatesNo longer taking part
West Georgia Infusion Center, a Service of Tanner Medical Center Villa RicaCarrollton, United StatesNo longer taking part
Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalCartersville, United StatesNo longer taking part
UNC Hospitals, The University of North Carolina at Chapel HillChapel Hill, United StatesNot yet recruiting
UNC Lineberger Comprehensive Cancer Center / University of North CarolinaChapel Hill, United StatesNot yet recruiting
Atrium Health Mercy (biopsy only)Charlotte, United StatesTaking people
Atrium Health University City (biopsy only)Charlotte, United StatesTaking people
Carolinas Medical Center (biopsy only)Charlotte, United StatesTaking people
Carolinas Medical Center Investigational Drug ServicesCharlotte, United StatesTaking people
Levine Cancer InstituteCharlotte, United StatesTaking people
Levine Cancer Institute UniversityCharlotte, United StatesTaking people
Levine Cancer Institute-BallantyneCharlotte, United StatesTaking people
UChicago Medicine - River EastChicago, United StatesTaking people
University of Chicago Medical CenterChicago, United StatesTaking people
University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
Ohio State UniversityColumbus, United StatesTaking people
Ohio State University HospitalColumbus, United StatesTaking people
OSU Wexner Medical Center & James Cancer HospitalColumbus, United StatesTaking people
The James Cancer Hospital & Solove Research Institute at The OSU Comprehensive Cancer CenterColumbus, United StatesTaking people
The James Outpatient Care West CampusColumbus, United StatesTaking people
MSK Commack.Commack, United StatesTaking people
Atrium Health Cabarrus (biopsy only)Concord, United StatesTaking people
Levine Cancer Institute ConcordConcord, United StatesTaking people
Baylor, Scott and White Research InstituteDallas, United StatesNot yet recruiting
Florida Cancer SpecialistsDaytona Beach, United StatesNo longer taking part
Accellacare - DeerfieldDeerfield, United StatesTaking people
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)Detroit, United StatesTaking people
Karmanos Cancer InstituteDetroit, United StatesTaking people
Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalDouglasville, United StatesNo longer taking part
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesNo longer taking part
UCLA Encino Specialty Care (Radiology)Encino, United StatesTaking people
UCLA Hematology/Oncoclogy-EncinoEncino, United StatesTaking people
Inova Schar Cancer InstituteFairfax, United StatesTaking people
Karmanos Cancer Institute Weisberg Cancer Treatment CenterFarmington Hills, United StatesTaking people
Florida Cancer SpecialistsFleming Island, United StatesTaking people
UChicago Medicine at Ingalls - FlossmoorFlossmoor, United StatesTaking people
Kaiser Permanente Fontana Medical CenterFontana, United StatesTaking people
Florida Cancer SpecialistsFort Myers, United StatesTaking people
Levine Cancer Institute-GastonGastonia, United StatesTaking people
Banner Gateway Medical CenterGilbert, United StatesTaking people
Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
Foothill Cardiology GlendoraGlendora, United StatesTaking people
Cancer & Hematology Centers of Western Michigan, PC- Kit StorageGrand Rapids, United StatesTaking people
The Cancer & Hematology CentersGrand Rapids, United StatesTaking people
Kaiser Permanente South Bay Medical CenterHarbor City, United StatesTaking people
MSK WesrchesterHarrison, United StatesTaking people
UChicago Medicine Ingalls MemorialHarvey, United StatesTaking people
Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalHiram, United StatesNo longer taking part
WellStar Paulding HospitalHiram, United StatesNo longer taking part
The Cancer & Hematology CentersHolland, United StatesTaking people
The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesTaking people
Kaiser Permanente Alton/Sand Canyon Medical OfficesIrvine, United StatesTaking people
University of Tennessee Medical CenterKnoxville, United StatesTaking people
Northwell HealthLake Success, United StatesNo longer taking part
Karmanos Cancer Institute at McLaren Greater LansingLansing, United StatesTaking people
Memorial Sloan Kattering Cancer Centre- Investigational Drug Service PharmacyLong Island City, United StatesTaking people
Kaiser Permanente Los Angeles Medical OfficesLos Angeles, United StatesTaking people
Kaiser Permanente West Los Angeles Medical CenterLos Angeles, United StatesTaking people
Ronald Reagan UCLA Medical Center - Drug Information CenterLos Angeles, United StatesTaking people
UCLA Cardiovascular CenterLos Angeles, United StatesTaking people
UCLA Downtown Los Angeles Primary & Specialty CareLos Angeles, United StatesTaking people
UCLA Hematology-OncologyLos Angeles, United StatesTaking people
UCLA Santa Monica CardiologyLos Angeles, United StatesTaking people
UCLA Westwood Specialty CareLos Angeles, United StatesTaking people
Valkyrie Clinical TrialsLos Angeles, United StatesNot yet recruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb HospitalMarietta, United StatesNo longer taking part
MSK Monmouth.Middletown, United StatesTaking people
Froedtert Hospital/Medical College of WisconsinMilwaukee, United StatesTaking people
Atrium Health Union (biopsy only)Monroe, United StatesTaking people
UCLA Montecito Primary & Specialty CareMontecito, United StatesTaking people
MSK Bergen.Montvale, United StatesTaking people
Florida Cancer SpecialistsN. Venice, United StatesTaking people
Florida Cancer SpecialistsNaples, United StatesTaking people
University of Chicago Comprehensive Cancer Center at Silver Cross HospitalNew Lenox, United StatesTaking people
Evelyn H. Lauder Breast and Imaging Centre (BAIC)New York, United StatesTaking people
Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesTaking people
Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesTaking people
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer CenterNew York, United StatesTaking people
Newport Diagnostics Center (Radiology)Newport Beach, United StatesTaking people
The Cancer & Hematology CentersNorton Shores, United StatesTaking people
OU Health Stephenson Cancer CenterOklahoma City, United StatesTaking people
OU Medical CenterOklahoma City, United StatesTaking people
Kaiser Permanente Ontario Medical CenterOntario, United StatesTaking people
UC Irvine HealthOrange, United StatesTaking people
The University of Chicago Medicine Center for Advanced Care Orland ParkOrland Park, United StatesTaking people
Kaiser Permanente Panorama City Medical Center, Medical Offices 3Panorama City, United StatesTaking people
Foothill Cardiology PasadenaPasadena, United StatesTaking people
Southern California Heart SpecialistsPasadena, United StatesTaking people
UCLA Hematology/Oncology - PasadenaPasadena, United StatesTaking people
Florida Cancer SpecialistsPort Charlotte, United StatesTaking people
UCLA Hematology/Oncology - Porter RanchPorter Ranch, United StatesTaking people
UCLA Porter Ranch Primary & Specialty CarePorter Ranch, United StatesTaking people
Kaiser Permanente Riverside Medical CenterRiverside, United StatesTaking people
Southern California Permanente Medical Group (SCPMG)Riverside, United StatesTaking people
Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)San Diego, United StatesTaking people
Kaiser Permanente Zion Medical CenterSan Diego, United StatesTaking people
UCSF Cancer Center MZ PhlebotomySan Francisco, United StatesTaking people
UCSF Investigational Drugs PharmacySan Francisco, United StatesTaking people
UCSF Mount Zion PhlebotomySan Francisco, United StatesTaking people
UCSF Parnassus PhlebotomySan Francisco, United StatesTaking people
University of California San FranciscoSan Francisco, United StatesTaking people
University of California, San Francisco | HDFCCC - Hematopoietic MalignanciesSan Francisco, United StatesTaking people
Diagnostic Medical Group of Southern California (Radiology)San Gabriel, United StatesTaking people
Southern California Heart CentersSan Gabriel, United StatesTaking people
Sierra Vista Regional Medical CenterSan Luis Obispo, United StatesTaking people
UCLA Hematology/Oncology - San Luis ObispoSan Luis Obispo, United StatesTaking people
Kaiser Permanente San Marcos Medical OfficesSan Marcos, United StatesTaking people
UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesTaking people
Florida Cancer SpecialistsSarasota, United StatesTaking people
Florida Cancer Specialists Sarasota Memorial Hospital (SAD)Sarasota, United StatesTaking people
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Harborview Medical CenterSeattle, United StatesTaking people
University of Washington Medical CenterSeattle, United StatesTaking people
UCLA Simi Valley Alamo Specialty CareSimi Valley, United StatesTaking people
Florida Cancer SpecialistsStuart, United StatesNo longer taking part
SUNY Upstate Medical UniversitySyracuse, United StatesNo longer taking part
Florida Cancer SpecialistsTallahassee, United StatesTaking people
Moffitt Cancer CenterTampa, United StatesTaking people
Moffitt Cancer Center McKinley HospitalTampa, United StatesTaking people
Baylor Scott & White Medical Center - TempleTemple, United StatesNot yet recruiting
Twin Cities Community HospitalTempleton, United StatesTaking people
UCLA Thousand Oaks Primary & Specialty CareThousand Oaks, United StatesTaking people
UChicago Medicine at Ingalls - Tinley ParkTinley Park, United StatesTaking people
UCLA Hematology/Oncology - TorranceTorrance, United StatesTaking people
UCLA Torrance Lomita Specialty CareTorrance, United StatesTaking people
MSK Nassau.Uniondale, United StatesTaking people
UCLA Hematology-Oncology Clinic - Santa ClaritaValencia, United StatesTaking people
UCLA Santa Clarita Primary & Specialty CareValencia, United StatesTaking people
Florida Cancer SpecialistsVenice, United StatesTaking people
UCLA Hematology/Oncology - VenturaVentura, United StatesTaking people
UCLA Ventura CardiologyVentura, United StatesTaking people
Florida Cancer SpecialistsVero Beach, United StatesNo longer taking part
MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
Florida Cancer SpecialistsWellington, United StatesNo longer taking part
Florida Cancer SpecialistsWest Palm Beach, United StatesNo longer taking part
UCLA Hematology/Oncology- WestlakeWestlake Village, United StatesTaking people
Kaiser Permanente Woodland Hills Medical CenterWoodland Hills, United StatesTaking people
Umass Memorial Medical CenterWorcester, United StatesTaking people
University of Massachusetts Chan Medical SchoolWorcester, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Print a page for my doctor

Trial details

Who runs it: Seagen, a wholly owned subsidiary of Pfizer
Trial code: NCT04879329 EU 2022-500030-28-01
Record updated: 22 July 2026
Original description: This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.Read full original descriptionShow less
A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.
Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.
Inclusion: Cohorts A and B; Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra; Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy; At least one measurable lesion by investigator assessment based on RECIST version 1.1; HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Cohort C; Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra; No prior systemic therapy for LA/mUC; Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy; At least one measurable lesion by investigator assessment based on RECIST v1.1; Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation; HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample; ECOG performance status of 0, 1, or 2; Cohort D; Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra; Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:; a. One prior line of platinum-containing chemotherapy; b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment; c. Prior enfortumab vedotin therapy; At least one measurable lesion by investigator assessment based on RECIST v1.1; ECOG performance status of 0 or 1; Cohort E; Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra; No prior systemic therapy for LA/mUC; Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy; At least one measurable lesion by investigator assessment based on RECIST v1.1; Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation; HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample; ECOG performance status of 0 or 1; Cohort G; Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra; Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab; The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin; At least one measurable lesion by investigator assessment based on RECIST version 1.1; HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion: Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B); Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia); Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy; Major surgery that has not fully recovered within 4 weeks prior to dose administration; Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C); Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia); Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy; Major surgery that has not fully recovered within 4 weeks prior to dose administration; Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug; Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded; Cohort D; Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D); Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia); Prior HER2-directed therapy; Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy; Major surgery that has not fully recovered within 4 weeks prior to dose administration; Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E); Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia); Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy; Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy; Major surgery that has not fully recovered within 4 weeks prior to dose administration; Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug; Cohort G; Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G); Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia); Prior HER2-directed therapy; Major surgery that has not fully recovered within 4 weeks prior to dose administration; Known hypersensitivity to disitamab vedotin or any of their components; Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components; Known hypersensitivity to disitamab vedotin or any of their components; Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components; Known hypersensitivity to disitamab vedotin or any of their components; Cohorts A and B; Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline; Cohort C; Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline; Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline; Cohort E; Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline; Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline; There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
ClinicalTrials.gov NCT04879329 · EU CTIS 2022-500030-28-01