Trial Title:
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
NCT ID:
NCT05911295
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Carboplatin
Gemcitabine
Pembrolizumab
Disitamab vedotin
Conditions: Keywords:
Urothelial Cancer
LA/mUC
Bladder Cancer
HER2 Overexpression
HER2 Amplification
HER2
Seattle Genetics
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
disitamab vedotin
Description:
Given into the vein (IV; intravenous) every 2 weeks
Arm group label:
Disitamab vedotin arm
Other name:
RC48, RC48-ADC
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
400mg given by IV every 6 weeks
Arm group label:
Disitamab vedotin arm
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
gemcitabine
Description:
1000 mg/m^2 given by IV on days 1 and 8 of every 3-week cycle
Arm group label:
Standard of care arm
Other name:
Gemzar
Intervention type:
Drug
Intervention name:
cisplatin
Description:
70 mg^2 given by IV on day 1 of every 3-week cycle
Arm group label:
Standard of care arm
Intervention type:
Drug
Intervention name:
carboplatin
Description:
Area under the plasma concentration-time curve (AUC) 4.5 or 5 given by IV on day 1 of
every 3-week cycle
Arm group label:
Standard of care arm
Summary:
This study will enroll participants with urothelial cancer (UC). UC can include cancer of
the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra). This
study will try to find out if the drugs disitamab vedotin with pembrolizumab works better
than platinum-containing chemotherapy to treat patients with UC. This study will also
test what side effects happen when participants take these drugs together. A side effect
is anything a drug does to the body besides treating the disease.
Participants in this study will have cancer that has spread through the body (metastatic)
or spread near where it started (locally advanced).
In this study, there are 2 different groups. Participants will be assigned to a group
randomly. Participants in the disitamab vedotin arm will get the study drug disitamab
vedotin once every two weeks and pembrolizumab once every 6 weeks. Participants in the
standard of care arm will get gemcitabine once a week for 2 weeks with either cisplatin
or carboplatin once every 3 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histopathological confirmation of locally advanced unresectable or metastatic
urothelial carcinoma (LA/mUC), including UC originating from the renal pelvis,
ureters, bladder, or urethra.
- Measurable disease by investigator assessment per RECIST v1.1.
- Participant must not have received prior systemic therapy for LA/mUC. Exception will
be made for neoadjuvant or adjuvant therapy, if disease recurrence/progression
occurred more than 12 months after the last dose of therapy.
- Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
- Able to provide archived formalin-fixed paraffin-embedded tumor tissue blocks from a
muscle-invasive or metastatic UC lesion or biopsy of metastatic UC prior to
treatment initiation. If archival tissue is not available a newly obtained baseline
biopsy of an accessible tumor lesion is required within 28 days of cycle 1 day 1.
- HER2 expression of 1+ or greater on immunohistochemistry (IHC).
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 within 7
days prior to randomization.
Exclusion Criteria:
- Known hypersensitivity to disitamab vedotin, cisplatin, carboplatin, gemcitabine, or
pembrolizumab or any of their components.
- History of severe/life threatening immune-related adverse event (irAE) with PD-(L)1
inhibitors are excluded.
- Central nervous system (CNS) and/or leptomeningeal metastasis. Participants with
treated CNS metastases are permitted if all of the following are met.
- CNS metastases have been clinically stable for at least 4 weeks and baseline
scans show no evidence of new or worsening CNS metastasis.
- Participant is on a stable dose of ≤ 10 mg/day of prednisone or equivalent for
at least 2 weeks.
- History of or active autoimmune disease that has required systemic treatment in the
past 2 years.
- 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).
- Prior solid organ or bone marrow transplantation.
- Pleural effusion or ascites with symptoms or requiring symptomatic treatment.
- Estimated life expectancy <12 week
- Prior treatment with an MMAE agent or anti-HER2 therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Completed
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Isaac Bowman
Phone:
347-673-9487
Email:
isaac.bowman@bannerhealth.com
Investigator:
Last name:
Isaac Bowman
Email:
Principal Investigator
Facility:
Name:
The Oncology Institute of Hope & Innovation - California
Address:
City:
Cerritos
Zip:
90703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Pamela Miel
Phone:
562-693-4477
Email:
miel.clinicaltrials@theoncologyinstitute.com
Investigator:
Last name:
Pamela Miel
Email:
Principal Investigator
Facility:
Name:
Los Angeles Cancer Network / Compassionate Care Research Group
Address:
City:
Fountain Valley
Zip:
92708
Country:
United States
Status:
Completed
Facility:
Name:
University of California Los Angeles Medical Center
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexandra Drakaki
Phone:
210-206-6766
Email:
adrakaki@mednet.ucla.edu
Investigator:
Last name:
Alexandra Drakaki
Email:
Principal Investigator
Facility:
Name:
Pacific Cancer Care
Address:
City:
Monterey
Zip:
93940
Country:
United States
Status:
Completed
Facility:
Name:
Kaiser Permanente Southern California
Address:
City:
Riverside
Zip:
92505
Country:
United States
Status:
Completed
Facility:
Name:
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vadim Koshkin
Phone:
773-837-0783
Email:
vadim.koshkin@ucsf.edu
Investigator:
Last name:
Vadim Koshkin
Email:
Principal Investigator
Facility:
Name:
Providence Medical Foundation
Address:
City:
Santa Rosa
Zip:
95403
Country:
United States
Status:
Completed
Facility:
Name:
PIH Health Hospital Whittier
Address:
City:
Whittier
Zip:
90602
Country:
United States
Status:
Completed
Facility:
Name:
Decatur Memorial Hospital - Illinois
Address:
City:
Decatur
Zip:
62526
Country:
United States
Status:
Completed
Facility:
Name:
Illinois Cancer Care
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Completed
Facility:
Name:
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Address:
City:
Sioux City
Zip:
51101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Donald Wender
Phone:
712-252-0088
Email:
wenderd@jencc.com
Investigator:
Last name:
Donald Wender
Email:
Principal Investigator
Facility:
Name:
Greater Baltimore Medical Center (GBMC) - Sandra & Malcolm Berman Cancer Institute
Address:
City:
Baltimore
Zip:
21204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Celano
Phone:
443-849-3051
Email:
pcelano@gbmc.org
Investigator:
Last name:
Paul Celano
Email:
Principal Investigator
Facility:
Name:
University of Minnesota
Address:
City:
Burnsville
Zip:
55337
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gautam Jha
Phone:
612-625-5469
Email:
jhaxx014@umn.edu
Investigator:
Last name:
Gautam Jha
Email:
Principal Investigator
Facility:
Name:
HealthPartners Institute
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yan Ji
Phone:
608-698-5962
Email:
yan.x.ji@healthpartners.com
Investigator:
Last name:
Yan Ji
Email:
Principal Investigator
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Status:
Completed
Facility:
Name:
Cancer Partners of Nebraska
Address:
City:
Lincoln
Zip:
68516
Country:
United States
Status:
Completed
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198-6840
Country:
United States
Status:
Recruiting
Contact:
Last name:
Benjamin Teply
Phone:
402-559-5166
Email:
ben.teply@unmc.edu
Investigator:
Last name:
Benjamin Teply
Email:
Principal Investigator
Facility:
Name:
OptumCare Cancer Center
Address:
City:
Las Vegas
Zip:
89102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Russell P Gollard, MD
Email:
Russell.gollard1@optum.com
Investigator:
Last name:
Russell P Gollard, MD
Email:
Principal Investigator
Facility:
Name:
North Shore Center for Advanced Medicine Monter Cancer Center / North Shore University Hospital
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Completed
Facility:
Name:
Mount Sinai Medical Center
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Recruiting
Contact:
Last name:
Matthew Galsky
Phone:
212-659-5452
Email:
matthew.galsky@mssm.edu
Investigator:
Last name:
Matthew Galsky
Email:
Principal Investigator
Facility:
Name:
Levine Cancer Institute
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Completed
Facility:
Name:
ECU Health Medical Center
Address:
City:
Greenville
Zip:
27834
Country:
United States
Status:
Recruiting
Contact:
Last name:
Musharraf Navaid
Phone:
252-847-4100
Email:
Musharraf.Navaid@Vidanthealth.com
Investigator:
Last name:
Musharraf Navaid
Email:
Principal Investigator
Facility:
Name:
MidLantic Urology
Address:
City:
Bala-Cynwyd
Zip:
19004
Country:
United States
Status:
Completed
Facility:
Name:
Allegheny General Hospital
Address:
City:
Pittsburgh
Zip:
15212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shifeng S Mao
Phone:
412-359-6147
Email:
shifeng.mao@ahn.org
Investigator:
Last name:
Shifeng S Mao
Email:
Principal Investigator
Facility:
Name:
West Cancer Center & Research Institute
Address:
City:
Germantown
Zip:
38138
Country:
United States
Status:
Completed
Facility:
Name:
Thompson Cancer Survival Center
Address:
City:
Knoxville
Zip:
37916
Country:
United States
Status:
Completed
Facility:
Name:
University of Tennessee
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Completed
Facility:
Name:
US Oncology Central Regulatory
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Completed
Facility:
Name:
Providence Regional Medical Center Everett
Address:
City:
Everett
Zip:
98201
Country:
United States
Status:
Completed
Facility:
Name:
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Evan Yu
Phone:
206-288-7222
Email:
evanyu@uw.edu
Investigator:
Last name:
Evan Yu
Email:
Principal Investigator
Facility:
Name:
Medical College of Wisconsin (Milwaukee)
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Completed
Facility:
Name:
Centro Oncologico Korben
Address:
City:
Buenos Aires
Zip:
1426
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Ernesto Korbenfeld
Email:
Principal Investigator
Facility:
Name:
Centro Medico Austral
Address:
City:
Buenos Aire
Zip:
C1019ABS
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Rodrigo Sanchez
Email:
Principal Investigator
Facility:
Name:
Investigaciones Clinicas Moleculares (ICM)
Address:
City:
Caba
Zip:
1425
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Fernando Galanternik
Email:
Principal Investigator
Facility:
Name:
CEMAIC - Centro Medico Privado
Address:
City:
Cordoba
Zip:
X5008HHW
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Jorge Emilio Salinas
Email:
Principal Investigator
Facility:
Name:
Sanatorio Parque
Address:
City:
Rosario
Zip:
S2000DSV
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Alejandro Dri
Email:
Principal Investigator
Facility:
Name:
Oncologia Salta
Address:
City:
Salta
Zip:
4400
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Miguel Angel Escudero
Email:
Principal Investigator
Facility:
Name:
Clinica Viedma
Address:
City:
Viedma
Zip:
8500
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Ruben Kowalyszyn
Email:
Principal Investigator
Facility:
Name:
Fundacion Cenit
Address:
City:
Caba
Zip:
1125
Country:
Argentina
Status:
Recruiting
Investigator:
Last name:
Natalia Laura Baltz Hehn
Email:
Principal Investigator
Facility:
Name:
Macquarie University Hospital
Address:
City:
Brisbane
Zip:
2109
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Alison Zhang
Email:
Principal Investigator
Facility:
Name:
Icon Cancer Care Chermside
Address:
City:
Chermside
Zip:
4032
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Chun Loo Gan
Email:
Principal Investigator
Facility:
Name:
Lyell McEwin Hospital
Address:
City:
Elizabeth Vale
Zip:
5112
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Christopher Hocking
Email:
Principal Investigator
Facility:
Name:
Peninsula and South East Oncology
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Sanjeev Sewak
Email:
Principal Investigator
Facility:
Name:
Port Macquarie Base Hospital
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Stephen Begbie, MD
Email:
Principal Investigator
Facility:
Name:
Mater Cancer Care Centre
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Niara Oliveira
Email:
Principal Investigator
Facility:
Name:
Royal North Shore Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Alexander Guminski
Email:
Principal Investigator
Facility:
Name:
Hospital Nossa Senhora da Conceicao
Address:
City:
Porto Alegre
Zip:
91350-200
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Juliana Menezes
Email:
Principal Investigator
Facility:
Name:
Hospital Alemao Oswaldo Cruz
Address:
City:
Sao Paulo
Zip:
01327-001
Country:
Brazil
Status:
Recruiting
Investigator:
Last name:
Ariel Galapo Kann, MD
Email:
Principal Investigator
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N4N2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Nimira Alimohamed
Email:
Principal Investigator
Facility:
Name:
University of Alberta / Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Naveen Basappa
Email:
Principal Investigator
Facility:
Name:
British Columbia Cancer Agency - Vancouver Centre
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Completed
Facility:
Name:
Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)
Address:
City:
Oshawa
Zip:
L1G 2B9
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Pawel Zalewski
Email:
Principal Investigator
Facility:
Name:
University Health Network, Princess Margaret Hospital
Address:
City:
Toronto
Zip:
M5G 2C1
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Srikala Sridhar
Email:
Principal Investigator
Facility:
Name:
Centro De Investigaciones Clinicas Vina Del Mar
Address:
City:
Vina del mar
Zip:
2540402
Country:
Chile
Status:
Recruiting
Investigator:
Last name:
Eugenia Loredo Fort
Email:
Principal Investigator
Facility:
Name:
University Hospital of Besancon
Address:
City:
Besancon cedex
Zip:
25030
Country:
France
Status:
Recruiting
Investigator:
Last name:
Fabien Calcagno
Email:
Principal Investigator
Facility:
Name:
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie
Address:
City:
Bordeaux
Zip:
33076
Country:
France
Status:
Recruiting
Investigator:
Last name:
Guilhem Roubaud
Email:
Principal Investigator
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Investigator:
Last name:
Gwenaelle Gravis
Email:
Principal Investigator
Facility:
Name:
Institut Regional du Cancer de Montpellier
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Investigator:
Last name:
Diego Tosi
Email:
Principal Investigator
Facility:
Name:
Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne
Address:
City:
Nice Cedex 2
Zip:
06189
Country:
France
Status:
Recruiting
Investigator:
Last name:
Delphine Borchiellini
Email:
Principal Investigator
Facility:
Name:
Hospices Civils de Lyon
Address:
City:
Pierre Benite
Zip:
69310
Country:
France
Status:
Recruiting
Investigator:
Last name:
Denis Maillet
Email:
Principal Investigator
Facility:
Name:
Institut de cancerologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Status:
Recruiting
Investigator:
Last name:
Philippe Barthelemy
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Investigator:
Last name:
Yohann Loriot
Email:
Principal Investigator
Facility:
Name:
HaEmek Medical Center
Address:
City:
Afula
Zip:
1834111
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Mahmud Abu Amna
Email:
Principal Investigator
Facility:
Name:
Soroka Medical Center, Dept. of Oncology
Address:
City:
Hadarom
Zip:
84101
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Keren Rouvinov
Email:
Principal Investigator
Facility:
Name:
Rambam Health Corp.
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Avivit Pe'er
Email:
Principal Investigator
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Hadas Dresler
Email:
Principal Investigator
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Stephen Frank
Email:
Principal Investigator
Facility:
Name:
Meir Medical Center
Address:
City:
Kfar Saba
Zip:
4428164
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Igal Kushnir
Email:
Principal Investigator
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Eli Rosenbaum
Email:
Principal Investigator
Facility:
Name:
Sheba Medical Center
Address:
City:
Ramat Gan
Zip:
52621
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Michal Sarfaty
Email:
Principal Investigator
Facility:
Name:
Kaplan Medical Center
Address:
City:
Rehovot
Zip:
7610010
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Ella Evron
Email:
Principal Investigator
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
64239
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
David Sarid
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Istituti Ospedalieri di Cremona
Address:
City:
Cremona
Zip:
26100
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Bruno Perrucci
Email:
Principal Investigator
Facility:
Name:
Policlinico Universitario Agostino Gemelli
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Roberto Iacovelli
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera S. Maria di Terni
Address:
City:
Terni
Zip:
05100
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Sergio Bracarda
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Integrata di Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Andrea Zivi
Email:
Principal Investigator
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Il-Hwan Kim, MD
Email:
Principal Investigator
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Woo Kyun Bae
Email:
Principal Investigator
Facility:
Name:
Wonkwang University Hospital
Address:
City:
Iksan
Zip:
54538
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Seung Chol Park
Email:
Principal Investigator
Facility:
Name:
National Cancer Center
Address:
City:
Ilsandong-gu
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Ho Kyung Seo
Email:
Principal Investigator
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21556
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Joo Hwan Park, MD
Email:
Principal Investigator
Facility:
Name:
Chonbuk National University Hospital
Address:
City:
Jeonju-si
Zip:
561-712
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Na-Ri Lee
Email:
Principal Investigator
Facility:
Name:
CHA Bundang Medical Center
Address:
City:
Seongnam-si
Zip:
13496
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Chan Kim
Email:
Principal Investigator
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Se Hyun Kim
Email:
Principal Investigator
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Yoon Ji Choi
Email:
Principal Investigator
Facility:
Name:
Kangbuk Samsung Hospital
Address:
City:
Seoul
Zip:
03181
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Eo Jin Kim
Email:
Principal Investigator
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Sang Joon Shin
Email:
Principal Investigator
Facility:
Name:
Asan Medical Center - Oncology
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Inkeun Park, MD
Email:
Principal Investigator
Facility:
Name:
St. Vincent's Hospital, The Catholic University of Korea
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Investigator:
Last name:
Byoung Yong Shim
Email:
Principal Investigator
Facility:
Name:
Hospital Militar Central
Address:
City:
Lima
Zip:
15072
Country:
Peru
Status:
Recruiting
Investigator:
Last name:
Ruth Huaringa
Email:
Principal Investigator
Facility:
Name:
Hospital Maria Auxiliadora
Address:
City:
Lima
Zip:
15081
Country:
Peru
Status:
Recruiting
Investigator:
Last name:
Ana Calle
Email:
Principal Investigator
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Status:
Recruiting
Investigator:
Last name:
Alvin Wong
Email:
Principal Investigator
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
169610
Country:
Singapore
Status:
Recruiting
Investigator:
Last name:
Ravindran Kanesvaran
Email:
Principal Investigator
Facility:
Name:
Raffles Hospital
Address:
City:
Singapore
Zip:
188770
Country:
Singapore
Status:
Recruiting
Investigator:
Last name:
Terence Tan
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Rafael Morales Barrera
Email:
Principal Investigator
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jose Pablo Maroto Rey
Email:
Principal Investigator
Facility:
Name:
Hospital General Universitario Gregorio Maranon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jose Arranz Arija
Email:
Principal Investigator
Facility:
Name:
MD Anderson Cancer Center - Madrid
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Enrique Grande Pulido
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Pablo Gajate Borau
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Daniel Castellano Gauna
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alvaro Pinto
Email:
Principal Investigator
Facility:
Name:
HM Centro Integral Oncologico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Elena Sevillano
Email:
Principal Investigator
Facility:
Name:
Hospital Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Aranzazu Gonzalez-del-Alba
Email:
Principal Investigator
Facility:
Name:
Complejo Hospitalario Universitario de Ourense (CHOU)
Address:
City:
Ourense
Zip:
32005
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ovidio Fernandez Calvo
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ignacio Duran Martinez
Email:
Principal Investigator
Facility:
Name:
Valencian Institute of Oncology Foundation
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Jose Juan Fita
Facility:
Name:
Kaohsiung Medical University Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Wen-Jeng Wu
Email:
Principal Investigator
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Chao-Hsiang Chang
Email:
Principal Investigator
Facility:
Name:
Chi Mei Hospital Liouying
Address:
City:
Tainan
Zip:
73657
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Chao-Jung Tsao
Email:
Principal Investigator
Facility:
Name:
National Cheng-Kung University Hospital
Address:
City:
Tainin
Zip:
704
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Wen-Pin Su
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Yu-Chieh Tsai
Email:
Principal Investigator
Start date:
September 22, 2023
Completion date:
April 30, 2029
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Collaborator:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911295
