Urothelial CarcinomaPhase 2NCT04879329
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
A Phase 2 study testing disitamab vedotin and pembrolizumab in people with Urothelial Carcinoma, run by Seagen, a wholly owned subsidiary of Pfizer at 221 sites in 12 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- disitamab vedotin and pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 221 sitesin 12 countries
- Study dates
- 3 May 2022to 14 Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Cohorts A and B
- Known hypersensitivity to disitamab vedotin or any of their components
- 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
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- Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
- Cohort C
- Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
- 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
- Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
- 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
- Known hypersensitivity to disitamab vedotin or any of their components
- 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
- Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
- Cohort E
- Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
- 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
- Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
- 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
- Known hypersensitivity to disitamab vedotin or any of their components
- 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
- 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.
Trial locations and contacts
221 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
221 sites in 12 countries
United States158 sites, 143 recruiting
- Recruiting
Kaiser Permanente Anaheim Kraemer Medical Offices
Anaheim, California, 92806
- Recruiting
Foothill Cardioology
Arcadia, California, 91007
- Recruiting
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706
- Recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
- Recruiting
Kaiser Permanente Bellflower Medical Offices
Bellflower, California, 90706
- Recruiting
Beverly Hills Multi-Specialties Practice
Beverly Hills, California, 90211
- Recruiting
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307
- Recruiting
Florida Cancer Specialists
Bonita Springs, Florida, 34135
- Recruiting
Florida Cancer Specialists
Bradenton, Florida, 34205
- Recruiting
Florida Cancer Specialists
Bradenton, Florida, 34211
- Recruiting
Providence Saint Joseph Medical Center
Burbank, California, 91505
- Recruiting
UCLA Burbank Cardiology
Burbank, California, 91505
- Recruiting
UCLA Hematology/Oncology - Burbank
Burbank, California, 91505
- Recruiting
Florida Cancer Specialists
Cape Coral, Florida, 33909
- Active, not recruiting
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117
- Active, not recruiting
West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117
- Active, not recruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Cartersville, Georgia, 30121
- Not yet recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Not yet recruiting
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599
- Recruiting
Carolinas Medical Center (biopsy only)
Charlotte, North Carolina, 28203
- Recruiting
Carolinas Medical Center Investigational Drug Services
Charlotte, North Carolina, 28204
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Atrium Health Mercy (biopsy only)
Charlotte, North Carolina, 28207
- Recruiting
Atrium Health University City (biopsy only)
Charlotte, North Carolina, 28262
- Recruiting
Levine Cancer Institute University
Charlotte, North Carolina, 28262
- Recruiting
Levine Cancer Institute - Ballantyne
Charlotte, North Carolina, 28277
- Recruiting
UChicago Medicine - River East
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
Ohio State University Hospital
Columbus, Ohio, 43210
- Recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
OSU Wexner Medical Center & James Cancer Hospital
Columbus, Ohio, 43210
- Recruiting
The James Cancer Hospital & Solove Research Institute at The OSU Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
The James Outpatient Care West Campus
Columbus, Ohio, 43221
- Recruiting
MSK Commack
Commack, New York, 11725
- Recruiting
Atrium Health Cabarrus (biopsy only)
Concord, North Carolina, 28025
- Recruiting
Levine Cancer Institute Concord
Concord, North Carolina, 28025
- Not yet recruiting
Baylor Scott and White Research Institute
Dallas, Texas, 75204
- Active, not recruiting
Florida Cancer Specialists
Daytona Beach, Florida, 32117
- Recruiting
Accellacare - Deerfield
Deerfield, Illinois, 60015
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
- Active, not recruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Douglasville, Georgia, 30134
- Active, not recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
- Recruiting
UCLA Encino Specialty Care (Radiology)
Encino, California, 91436
- Recruiting
UCLA Hematology/Oncoclogy-Encino
Encino, California, 91436
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
- Recruiting
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
- Recruiting
Florida Cancer Specialists
Fleming Island, Florida, 32003
- Recruiting
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422
- Recruiting
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33905
- Recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33908
- Recruiting
Levine Cancer Institute- Gaston
Gastonia, North Carolina, 28054
- Recruiting
Banner Gateway Medical Center
Gilbert, Arizona, 85234
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
Foothill Cardiology Glendora
Glendora, California, 91741
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
- Recruiting
Cancer & Hematology Centers of Western Michigan, PC- Kit Storage
Grand Rapids, Michigan, 49546
- Recruiting
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546
- Recruiting
Kaiser Permanente South Bay Medical center
Harbor City, California, 90710
- Recruiting
MSK Wesrchester
Harrison, New York, 10604
- Recruiting
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426
- Active, not recruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Hiram, Georgia, 30141
- Active, not recruiting
WellStar Paulding Hospital
Hiram, Georgia, 30141
- Recruiting
The Cancer & Hematology Centers
Holland, Michigan, 49424
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
- Recruiting
Kaiser Permanente Alton/Sand Canyon Medical Offices
Irvine, California, 92618
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
- Active, not recruiting
Northwell Health
Lake Success, New York, 11042
- Recruiting
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
- Recruiting
Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy
Long Island City, New York, 11101
- Recruiting
UCLA Downtown Los Angeles Primary & Specialty Care
Los Angeles, California, 90017
- Recruiting
Kaiser Permanente Los Angeles Medical Offices
Los Angeles, California, 90027
- Recruiting
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
- Not yet recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
- Recruiting
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095
- Recruiting
UCLA Cardiovascular Center
Los Angeles, California, 90095
- Recruiting
UCLA Hematology Oncology
Los Angeles, California, 90095
- Recruiting
UCLA Westwood Specialty Care
Los Angeles, California, 90095
- Recruiting
UCLA Santa Monica Cardiology
Los Angeles, California, 90404
- Active, not recruiting
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, 30060
- Recruiting
MSK Monmouth
Middletown, New Jersey, 07748
- Recruiting
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Atrium Health Union (biopsy only)
Monroe, North Carolina, 28112
- Recruiting
UCLA Montecito Primary & Specialty Care
Montecito, California, 93108
- Recruiting
MSK Bergen
Montvale, New Jersey, 07645
- Recruiting
Florida Cancer Specialists
N. Venice, Florida, 34275
- Recruiting
Florida Cancer Specialists
Naples, Florida, 34102
- Recruiting
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451
- Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
Evelyn H. Lauder Breast and Imaging Centre (BAIC)
New York, New York, 10065
- Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
- Recruiting
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Newport Diagnostics Center (Radiology)
Newport Beach, California, 92660
- Recruiting
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
- Recruiting
OU Medical Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Kaiser Permanente Ontario Medical Center
Ontario, California, 91761
- Recruiting
UC Irvine Health
Orange, California, 92868
- Recruiting
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, 60462
- Recruiting
Kaiser Permanente Panorama City Medical Center, Medical Offices 3
Panorama City, California, 91402
- Recruiting
Foothill Cardiology Pasadena
Pasadena, California, 91105
- Recruiting
Southern California Heart Specialists
Pasadena, California, 91105
- Recruiting
UCLA Hematology/ Oncology- Pasadena
Pasadena, California, 91105
- Recruiting
Florida Cancer Specialists
Port Charlotte, Florida, 33980
- Recruiting
UCLA Hematology Oncology - Porter Ranch
Porter Ranch, California, 91326
- Recruiting
UCLA Porter Ranch Primary & Specialty Care
Porter Ranch, California, 91326
- Recruiting
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
- Recruiting
Southern California Permanente Medical Group (SCPMG)
Riverside, California, 92505
- Recruiting
Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
San Diego, California, 92108
- Recruiting
Kaiser Permanente Zion Medical Center
San Diego, California, 92120
- Recruiting
UCSF Cancer Center MZ Phlebotomy
San Francisco, California, 94115
- Recruiting
UCSF Mount Zion Phlebotomy
San Francisco, California, 94115
- Recruiting
UCSF Parnassus Phlebotomy
San Francisco, California, 94143
- Recruiting
UCSF Investigational Drugs Pharmacy
San Francisco, California, 94158
- Recruiting
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94158
- Recruiting
University of California, San Francisco
San Francisco, California, 94158
- Recruiting
Diagnostic Medical Group of Southern California (Radiology)
San Gabriel, California, 91776
- Recruiting
Southern California Heart Centers
San Gabriel, California, 91776
- Recruiting
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401
- Recruiting
Sierra Vista Regional Medical Center
San Luis Obispo, California, 93405
- Recruiting
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, 92078
- Recruiting
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Florida Cancer Specialists Sarasota Memorial Hospital (SAD)
Sarasota, Florida, 34239
- Recruiting
Harborview Medical Center
Seattle, Washington, 98104
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
- Recruiting
UCLA Simi Valley Alamo Specialty Care
Simi Valley, California, 93065
- Active, not recruiting
Florida Cancer Specialists
Stuart, Florida, 34994
- Active, not recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Recruiting
Florida Cancer Specialists
Tallahassee, Florida, 32308
- Recruiting
Moffitt Cancer Center McKinley Hospital
Tampa, Florida, 33612
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Not yet recruiting
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508
- Recruiting
Twin Cities Community Hospital
Templeton, California, 93465
- Recruiting
UCLA Thousand Oaks Primary & Specialty Care
Thousand Oaks, California, 91360
- Recruiting
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477
- Recruiting
UCLA Hematology/Oncology - Torrance
Torrance, California, 90505
- Recruiting
UCLA Torrance Lomita Specialty Care
Torrance, California, 90505
- Recruiting
MSK nassau
Uniondale, New York, 11553
- Recruiting
UCLA Hematology-Oncology Clinic - Santa Clarita
Valencia, California, 91355
- Recruiting
UCLA Santa Clarita Primary & Specialty Care
Valencia, California, 91355
- Recruiting
Florida Cancer Specialists
Venice, Florida, 34285
- Recruiting
Florida Cancer Specialists
Venice, Florida, 34292
- Recruiting
UCLA Hematology/Oncology - Ventura
Ventura, California, 93003
- Recruiting
UCLA Ventura Cardiology
Ventura, California, 93003
- Active, not recruiting
Florida Cancer Specialists
Vero Beach, Florida, 32960
- Recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
- Active, not recruiting
Florida Cancer Specialists
Wellington, Florida, 33414
- Active, not recruiting
Florida Cancer Specialists
West Palm Beach, Florida, 33401
- Recruiting
UCLA Hematology/Oncology - Westlake
Westlake Village, California, 91361
- Recruiting
Kaiser Permanente Woodland Hills Medical Center
Woodland Hills, California, 91367
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Italy9 sites
- Active, not recruiting
Centro di Riferimento Oncologico Di Aviano
Aviano, Pordenone, 33184
- Active, not recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
- Active, not recruiting
IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici
Milan, 20132
- Active, not recruiting
IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia
Padova, 35128
- Active, not recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
- Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, ROME, 00168
- Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
- Active, not recruiting
Azienda Ospedaliera S. Maria di Terni
Terni, 05100
- Active, not recruiting
S.C. Farmacia Interna
Terni, 05100
Argentina8 sites, 7 recruiting
- Active, not recruiting
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Buenos Aires F.D., 1113
- Recruiting
Hospital Aleman
Buenos Aires, C1118AAT
- Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, C1426ANZ
- Recruiting
Hospital Sirio Libanes - Buenos Aires
Buenos Aires, ZC 1419
- Recruiting
Centro Oncologico Korben
Caba, ZC 1426
- Recruiting
Centro Medico Austral
CABA, C1019ABS
- Recruiting
Instituto Oncologico de Cordoba
Córdoba, X5000
- Recruiting
Clinica Viedma
Viedma, Río Negro Province, R8500ACE
United Kingdom8 sites, 8 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
- Recruiting
Barts Health NHS Trust, St Bartholomew's Hospital
London, EC1A 7BE
- Recruiting
Guy's Hospital
London, SE1 9RT
- Recruiting
Charing Cross Hospital
London, W6 8RF
- Not yet recruiting
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M20 4BX
- Not yet recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral
Merseyside, CH63 4JY
Australia7 sites, 5 recruiting
- Recruiting
Cancer Care Research Pty Ltd (trading as GenesisCare)
Alexandria, New South Wales, 2015
- Recruiting
Metro South Hospital and Health Service
Brisbane, Queensland, 4102
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, 5112
- Active, not recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
- Recruiting
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, QLD 4101
- Recruiting
GenesisCare - North Shore
St Leonards, New South Wales, 2065
- Active, not recruiting
Macquarie University
Sydney, New South Wales, 2109
Canada6 sites, 5 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T3N 4N1
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Active, not recruiting
Centre integre universitaire de sante et de services sociaux de l'Estrie
Sherbrooke, Quebec, J1H 5N4
- Recruiting
BC Cancer - Vancouver Fairmont Medical Building
Vancouver, British Columbia, V5Z 1H7
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Japan6 sites
- Active, not recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
- Active, not recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Active, not recruiting
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, 541-8567
- Active, not recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
- Active, not recruiting
Osaka University Hospital
Suita-shi, Osaka, 565-0871
- Active, not recruiting
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
Israel5 sites, 1 recruiting
- Active, not recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Rabin medical Center
Petah Tikva, 4941492
- Active, not recruiting
Sheba Medical Center
Ramat Gan, 52621
- Active, not recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5265601
- Active, not recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Spain5 sites
- Active, not recruiting
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
- Active, not recruiting
MD Anderson Cancer Center - Madrid
Madrid, 28033
- Active, not recruiting
MD Anderson Cancer Center Madrid
Madrid, 28033
- Active, not recruiting
Hospital Universitari Parc Tauli Sabadell
Sabadell, Barcelona, 08208
- Active, not recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620
- Recruiting
Trakya Universitesi Tip Fakultesi Hastanesi (Saglik Arastirma ve Uygulama Merkezi)
Edirne, 22030
- Recruiting
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722
- Recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575
Chile3 sites, 3 recruiting
- Recruiting
Centro de Estudios Clínicos IC La Serena Research
La Serena, Coquimbo Region, 1720430
- Recruiting
Oncovida SA
Providencia, 8320000
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago, Providencia, 8330032
Belgium2 sites
- Active, not recruiting
AZ Maria Middelares
Ghent, 9000
- Active, not recruiting
CHU UCL Namur-Site de Saint Elisabeth
Namur, 5000
About this study
Official title: 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.
- Conditions
- Urothelial Carcinoma
- Being tested
- disitamab vedotin, pembrolizumab
- Keywords
- Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, RC48, Seattle Genetics
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disitamab vedotinDrug
Also called RC48-ADC
Given into the vein (IV; intravenous) every 2 weeks.
pembrolizumabDrug
Also called KEYTRUDA®
Given by IV on Day 1 of each 6-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - DV monotherapy for HER2-positive tumor types | Experimental | Disitamab vedotin monotherapy Receives: Drug: disitamab vedotin |
| Cohort B - DV monotherapy for HER2-low tumor types | Experimental | Disitamab vedotin monotherapy Receives: Drug: disitamab vedotin |
| Cohort C - Non-randomized combination therapy | Experimental | Disitamab vedotin + pembrolizumab Receives: Drug: disitamab vedotin; Drug: pembrolizumab |
| Cohort C - Randomized combination therapy | Experimental | Disitamab vedotin + pembrolizumab Receives: Drug: disitamab vedotin; Drug: pembrolizumab |
| Cohort C - Randomized monotherapy | Experimental | Disitamab vedotin monotherapy Receives: Drug: disitamab vedotin |
| Cohort D - DV monotherapy (Japan only) | Experimental | Disitamab vedotin monotherapy Receives: Drug: disitamab vedotin |
| Cohort E - DV combination therapy (Japan only) | Experimental | Disitamab vedotin + pembrolizumab Receives: Drug: disitamab vedotin; Drug: pembrolizumab |
| Cohort G - DV monotherapy | Experimental | Disitamab vedotin Receives: Drug: disitamab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G)
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Measured: Duration of treatment; approximately 2 years
Incidence of adverse events (AEs) (Cohorts D and E)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Approximately 2 years
Incidence of dose alterations (Cohorts D and E)
Measured: Approximately 2 years
Incidence of laboratory abnormalities (Cohorts D and E)
To be summarized using descriptive statistics.
Measured: Approximately 2 years
Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)
Measured: Approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
Measured: Approximately 2 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Maximum concentration (Cmax) (Cohorts D and E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Trough concentration (Ctrough) (Cohorts D and E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
Secondary outcomes (21)
cORR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
The proportion of participants with confirmed CR or PR according to RECIST v1.1
Measured: Duration of treatment; approximately 2 years
Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.
Measured: From start of treatment to completion of response assessment; approximately 2 years
Confirmed DOR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
The time from first documentation of objective tumor response (confirmed CR or PR) to the first documentation of tumor progression per RECIST v1.1 or death due to any cause.
Measured: From start of treatment to completion of response assessment; approximately 2 years
Progression-free survival (PFS) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
Measured: From start of treatment to completion of response assessment; approximately 2 years
PFS per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)
The time from the start of study treatment or randomization (if applicable) to the first documentation of disease progression per RECIST v1.1 or death due to any cause.
Measured: From start of treatment to completion of response assessment; approximately 2 years
Disease control rate (DCR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v1.1 criteria) or stable disease (SD) lasting at least 5 weeks.
Measured: From start of treatment to completion of response assessment; approximately 2 years
DCR per RECIST v1.1 by investigator (Cohorts A, B, C, and G)
The proportion of participants who have achieved objective response (confirmed CR or PR as per RECIST v 1.1 criteria) or SD lasting at least 5 weeks.
Measured: From start of treatment to completion of response assessment; approximately 2 years
Overall survival (OS) (Cohorts A, B, C, and G)
The time from start of study treatment or randomization (if applicable) to the date of death due to any cause.
Measured: Duration of study; approximately 3 years
Incidence of adverse events (AEs) (Cohorts A, B, C, and G)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Approximately 2 years
Incidence of dose alterations (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Approximately 2 years
Incidence of laboratory abnormalities (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Approximately 2 years
Incidence of ECG abnormalities (Cohorts A, B, C, and G)
Measured: Approximately 2 years
Change from baseline of LVEF (Cohorts A, B, C, and G)
Measured: Approximately 2 years
PK parameter - AUC (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Cmax (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Tmax (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter - Ctrough (Cohorts A, B, C, and G)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
PK parameter of pembrolizumab - Cmax (Cohort E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) against disitamab vedotin (All Cohorts)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of anti-drug antibodies (ADAs) against pembrolizumab (Cohorts C and E)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
Incidence of neutralizing antibodies (NABs) against disitamab vedotin (All Cohorts)
To be summarized using descriptive statistics.
Measured: Through 30-37 days following the last dose of DV; up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start3 May 2022
- Primary completion11 Dec 2026 (estimated)
- Study completion14 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cohorts A, B, C, D, and G will enroll simultaneously. Cohort E will begin enrollment after Cohort D participants have completed the DLT evaluation period.
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879329
- Sponsor's protocol ID
- RC48G001
- Other IDs
- C5731002, 2022-500030-28-01
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.