A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
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
3 other identifiers
interventional
372
12 countries
223
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2022
Longer than P75 for phase_2
223 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 10, 2021
CompletedStudy Start
First participant enrolled
May 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 14, 2029
April 21, 2026
April 1, 2026
4.6 years
April 19, 2021
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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.
Approximately 2 years
Incidence of dose alterations (Cohorts D and E)
Approximately 2 years
Incidence of laboratory abnormalities (Cohorts D and E)
To be summarized using descriptive statistics.
Approximately 2 years
Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)
Approximately 2 years
Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)
Approximately 2 years
Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
To be summarized using descriptive statistics.
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.
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.
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.
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)
Duration of treatment; approximately 2 years
Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G)
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)
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)
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)
From start of treatment to completion of response assessment; approximately 2 years
- +16 more secondary outcomes
Study Arms (8)
Cohort A - DV monotherapy for HER2-positive tumor types
EXPERIMENTALDisitamab vedotin monotherapy
Cohort B - DV monotherapy for HER2-low tumor types
EXPERIMENTALDisitamab vedotin monotherapy
Cohort C - Non-randomized combination therapy
EXPERIMENTALDisitamab vedotin + pembrolizumab
Cohort C - Randomized combination therapy
EXPERIMENTALDisitamab vedotin + pembrolizumab
Cohort C - Randomized monotherapy
EXPERIMENTALDisitamab vedotin monotherapy
Cohort D - DV monotherapy (Japan only)
EXPERIMENTALDisitamab vedotin monotherapy
Cohort E - DV combination therapy (Japan only)
EXPERIMENTALDisitamab vedotin + pembrolizumab
Cohort G - DV monotherapy
EXPERIMENTALDisitamab vedotin
Interventions
Given into the vein (IV; intravenous) every 2 weeks.
Given by IV on Day 1 of each 6-week cycle.
Eligibility Criteria
You may qualify if:
- 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
- +22 more criteria
You may not qualify if:
- 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
- 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
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (223)
Banner Gateway Medical Center
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Kaiser Permanente Anaheim Kraemer Medical Offices
Anaheim, California, 92806, United States
Foothill Cardioology
Arcadia, California, 91007, United States
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706, United States
Kaiser Permanente Bellflower Medical Offices
Bellflower, California, 90706, United States
Beverly Hills Multi-Specialties Practice
Beverly Hills, California, 90211, United States
Providence Saint Joseph Medical Center
Burbank, California, 91505, United States
UCLA Burbank Cardiology
Burbank, California, 91505, United States
UCLA Hematology/Oncology - Burbank
Burbank, California, 91505, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
UCLA Encino Specialty Care (Radiology)
Encino, California, 91436, United States
UCLA Hematology/Oncoclogy-Encino
Encino, California, 91436, United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335, United States
Foothill Cardiology Glendora
Glendora, California, 91741, United States
Kaiser Permanente South Bay Medical center
Harbor City, California, 90710, United States
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
Kaiser Permanente Alton/Sand Canyon Medical Offices
Irvine, California, 92618, United States
UCLA Downtown Los Angeles Primary & Specialty Care
Los Angeles, California, 90017, United States
Kaiser Permanente Los Angeles Medical Offices
Los Angeles, California, 90027, United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, 90095, United States
UCLA Cardiovascular Center
Los Angeles, California, 90095, United States
UCLA Hematology Oncology
Los Angeles, California, 90095, United States
UCLA Westwood Specialty Care
Los Angeles, California, 90095, United States
UCLA Santa Monica Cardiology
Los Angeles, California, 90404, United States
UCLA Montecito Primary & Specialty Care
Montecito, California, 93108, United States
Newport Diagnostics Center (Radiology)
Newport Beach, California, 92660, United States
Kaiser Permanente Ontario Medical Center
Ontario, California, 91761, United States
UC Irvine Health
Orange, California, 92868, United States
Kaiser Permanente Panorama City Medical Center, Medical Offices 3
Panorama City, California, 91402, United States
Foothill Cardiology Pasadena
Pasadena, California, 91105, United States
Southern California Heart Specialists
Pasadena, California, 91105, United States
UCLA Hematology/ Oncology- Pasadena
Pasadena, California, 91105, United States
UCLA Hematology Oncology - Porter Ranch
Porter Ranch, California, 91326, United States
UCLA Porter Ranch Primary & Specialty Care
Porter Ranch, California, 91326, United States
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505, United States
Southern California Permanente Medical Group (SCPMG)
Riverside, California, 92505, United States
Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
San Diego, California, 92108, United States
Kaiser Permanente Zion Medical Center
San Diego, California, 92120, United States
UCSF Cancer Center MZ Phlebotomy
San Francisco, California, 94115, United States
UCSF Mount Zion Phlebotomy
San Francisco, California, 94115, United States
UCSF Parnassus Phlebotomy
San Francisco, California, 94143, United States
UCSF Investigational Drugs Pharmacy
San Francisco, California, 94158, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94158, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Diagnostic Medical Group of Southern California (Radiology)
San Gabriel, California, 91776, United States
Southern California Heart Centers
San Gabriel, California, 91776, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401, United States
Sierra Vista Regional Medical Center
San Luis Obispo, California, 93405, United States
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, 92078, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
UCLA Simi Valley Alamo Specialty Care
Simi Valley, California, 93065, United States
Twin Cities Community Hospital
Templeton, California, 93465, United States
UCLA Thousand Oaks Primary & Specialty Care
Thousand Oaks, California, 91360, United States
UCLA Hematology/Oncology - Torrance
Torrance, California, 90505, United States
UCLA Torrance Lomita Specialty Care
Torrance, California, 90505, United States
UCLA Hematology-Oncology Clinic - Santa Clarita
Valencia, California, 91355, United States
UCLA Santa Clarita Primary & Specialty Care
Valencia, California, 91355, United States
UCLA Hematology/Oncology - Ventura
Ventura, California, 93003, United States
UCLA Ventura Cardiology
Ventura, California, 93003, United States
UCLA Hematology/Oncology - Westlake
Westlake Village, California, 91361, United States
Kaiser Permanente Woodland Hills Medical Center
Woodland Hills, California, 91367, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34205, United States
Florida Cancer Specialists
Bradenton, Florida, 34211, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
Florida Cancer Specialists
Daytona Beach, Florida, 32117, United States
Florida Cancer Specialists
Fleming Island, Florida, 32003, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
N. Venice, Florida, 34275, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Florida Cancer Specialists Sarasota Memorial Hospital (SAD)
Sarasota, Florida, 34239, United States
Florida Cancer Specialists
Stuart, Florida, 34994, United States
Florida Cancer Specialists
Tallahassee, Florida, 32308, United States
Moffitt Cancer Center McKinley Hospital
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Florida Cancer Specialists
Vero Beach, Florida, 32960, United States
Florida Cancer Specialists
Wellington, Florida, 33414, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117, United States
West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica
Carrollton, Georgia, 30117, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Cartersville, Georgia, 30121, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Douglasville, Georgia, 30134, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Hiram, Georgia, 30141, United States
WellStar Paulding Hospital
Hiram, Georgia, 30141, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Marietta, Georgia, 30060, United States
UChicago Medicine - River East
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Accellacare - Deerfield
Deerfield, Illinois, 60015, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, 60422, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, 60426, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, 60462, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, 60477, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
The Cancer & Hematology Centers
Big Rapids, Michigan, 49307, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503, United States
Cancer & Hematology Centers of Western Michigan, PC- Kit Storage
Grand Rapids, Michigan, 49546, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49546, United States
The Cancer & Hematology Centers
Holland, Michigan, 49424, United States
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910, United States
The Cancer & Hematology Centers
Norton Shores, Michigan, 49444, United States
MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
MSK Monmouth
Middletown, New Jersey, 07748, United States
MSK Bergen
Montvale, New Jersey, 07645, United States
MSK Commack
Commack, New York, 11725, United States
MSK Wesrchester
Harrison, New York, 10604, United States
Northwell Health
Lake Success, New York, 11042, United States
Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy
Long Island City, New York, 11101, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Evelyn H. Lauder Breast and Imaging Centre (BAIC)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065, United States
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
MSK nassau
Uniondale, New York, 11553, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center (biopsy only)
Charlotte, North Carolina, 28203, United States
Carolinas Medical Center Investigational Drug Services
Charlotte, North Carolina, 28204, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Atrium Health Mercy (biopsy only)
Charlotte, North Carolina, 28207, United States
Atrium Health University City (biopsy only)
Charlotte, North Carolina, 28262, United States
Levine Cancer Institute University
Charlotte, North Carolina, 28262, United States
Levine Cancer Institute - Ballantyne
Charlotte, North Carolina, 28277, United States
Atrium Health Cabarrus (biopsy only)
Concord, North Carolina, 28025, United States
Levine Cancer Institute Concord
Concord, North Carolina, 28025, United States
Levine Cancer Institute- Gaston
Gastonia, North Carolina, 28054, United States
Atrium Health Union (biopsy only)
Monroe, North Carolina, 28112, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 43210, United States
OSU Wexner Medical Center & James Cancer Hospital
Columbus, Ohio, 43210, United States
OSU Wexner Medical Center, Investigational Drug Services
Columbus, Ohio, 43210, United States
The James Cancer Hospital & Solove Research Institute at The OSU Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
The James Outpatient Care West Campus
Columbus, Ohio, 43221, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75204, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Buenos Aires F.D., 1113, Argentina
Clinica Viedma
Viedma, Río Negro Province, R8500ACE, Argentina
Hospital Aleman
Buenos Aires, C1118AAT, Argentina
Instituto Medico Especializado Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Hospital Sirio Libanes - Buenos Aires
Buenos Aires, ZC 1419, Argentina
Centro Medico Austral
CABA, C1019ABS, Argentina
Centro Oncologico Korben
Caba, ZC 1426, Argentina
Instituto Oncologico de Cordoba
Córdoba, X5000, Argentina
Cancer Care Research Pty Ltd (trading as GenesisCare)
Alexandria, New South Wales, 2015, Australia
GenesisCare - North Shore
St Leonards, New South Wales, 2065, Australia
Macquarie University
Sydney, New South Wales, 2109, Australia
Metro South Hospital and Health Service
Brisbane, Queensland, 4102, Australia
Mater Cancer Care Centre, Mater Misericordiae Limited
South Brisbane, Queensland, QLD 4101, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Lyell McEwin Hospital
Elizabeth Vale, 5112, Australia
AZ Maria Middelares
Ghent, 9000, Belgium
CHU UCL Namur-Site de Saint Elisabeth
Namur, 5000, Belgium
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T3N 4N1, Canada
BC Cancer - Vancouver Fairmont Medical Building
Vancouver, British Columbia, V5Z 1H7, Canada
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre integre universitaire de sante et de services sociaux de l'Estrie
Sherbrooke, Quebec, J1H 5N4, Canada
Centro de Estudios Clínicos IC La Serena Research
La Serena, Coquimbo Region, 1720430, Chile
Pontificia Universidad Catolica de Chile
Santiago, Providencia, 8330032, Chile
Oncovida SA
Providencia, 8320000, Chile
Rambam Health Care Campus
Haifa, 3109601, Israel
Rabin medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Centro di Riferimento Oncologico Di Aviano
Aviano, Pordenone, 33184, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, ROME, 00168, Italy
IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici
Milan, 20132, Italy
IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Azienda Ospedaliera S. Maria di Terni
Terni, 05100, Italy
S.C. Farmacia Interna
Terni, 05100, Italy
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Osaka Prefectural Hospital Organization - Osaka International Cancer Institute
Osaka, 541-8567, Japan
Hospital Universitari Parc Tauli Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
MD Anderson Cancer Center - Madrid
Madrid, 28033, Spain
MD Anderson Cancer Center Madrid
Madrid, 28033, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Arastirma ve Uygulama Hastanesi
Ankara, 06620, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi Hastanesi (Saglik Arastirma ve Uygulama Merkezi)
Edirne, 22030, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa, Cerrahpasa Tip Fakultesi Hastanesi
Istanbul, 34098, Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575, Turkey (Türkiye)
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Barts Health NHS Trust, St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester, M20 4BX, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral
Merseyside, CH63 4JY, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2021
First Posted
May 10, 2021
Study Start
May 3, 2022
Primary Completion (Estimated)
December 11, 2026
Study Completion (Estimated)
April 14, 2029
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.