Trial Title:
Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
NCT ID:
NCT03485209
Condition:
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Exocrine Pancreatic Cancer
Carcinoma, Squamous Cell of Head and Neck
Conditions: Official terms:
Carcinoma
Pancreatic Neoplasms
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carboplatin
Pembrolizumab
Tisotumab vedotin
Conditions: Keywords:
Colorectal cancer
NSCLC
sqNSCLC
CRC
Pancreatic cancer
Head and neck cancer
Seattle Genetics
HNSCC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tisotumab vedotin
Description:
Given into the vein (IV; intravenously)
Arm group label:
Part A: Tisotumab Vedotin - Q3W Schedule
Arm group label:
Part B: Tisotumab Vedotin - 3Q4W Schedule
Arm group label:
Part C: Tisotumab Vedotin - 2Q4W Schedule
Arm group label:
Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Arm group label:
Part E: Tisotumab Vedotin - 2Q4W Schedule
Arm group label:
Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Arm group label:
Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Other name:
TIVDAK
Intervention type:
Drug
Intervention name:
pembrolizumab
Description:
200mg or 400mg given by IV
Arm group label:
Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Arm group label:
Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Arm group label:
Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Other name:
KEYTRUDA®
Intervention type:
Drug
Intervention name:
carboplatin
Description:
AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
Arm group label:
Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Arm group label:
Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
Intervention type:
Drug
Intervention name:
cisplatin
Description:
100mg/m^2 given by IV
Arm group label:
Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
Summary:
This trial will study tisotumab vedotin to find out whether it is an effective treatment
alone or with other anticancer drugs for certain solid tumors and what side effects
(unwanted effects) may occur. There are seven parts to this study.
- In Part A, the treatment will be given to participants every 3 weeks (3-week
cycles).
- In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every
4-week cycle.
- In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every
4-week cycle.
- In Part D, participants will be given treatment on Day 1 of every 3-week cycle.
Participants in Part D will get tisotumab vedotin with either:
- Pembrolizumab or,
- Pembrolizumab and carboplatin, or
- Pembrolizumab and cisplatin
- In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every
4-week cycle.
- In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of
every 6-week cycle. Participants in Part F will get tisotumab vedotin with
pembrolizumab.
- In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of
every 6-week cycle. Participants in Part G will get tisotumab vedotin with
pembrolizumab and carboplatin.
Detailed description:
The primary goal of this trial is to assess the activity, safety, and tolerability of
tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated
with single agent tisotumab vedotin or tisotumab vedotin in combination with other
anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts
based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous
non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and
neck squamous cell carcinoma (HNSCC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Parts A, B, and C
- Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer,
sqNSCLC, or HNSCC participants who are not candidates for standard therapy.
- All participants must have experienced disease progression on or after their
most recent systemic therapy.
- Colorectal cancer (closed to enrollment): participants must have received prior
therapy with each of following agents, if eligible: a fluoropyrimidine,
oxaliplatin, irinotecan, and/or bevacizumab. Participants should have received
no more than 3 systemic regimens in the metastatic setting.
- sqNSCLC (closed to enrollment): Participants with NSCLC must have predominant
squamous histology. Participants must have received prior therapy with a
platinum-based treatment and a checkpoint inhibitor (CPI), if eligible.
Participants should have received no more than 3 lines of systemic therapy in
the metastatic setting.
- Participants eligible for a tyrosine kinase inhibitor should have received
such therapy. These participants should have received no more than 4 lines
of systemic therapy in the metastatic setting.
- Exocrine pancreatic adenocarcinoma (closed to enrollment): Participants with
exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma
histology. Participants must have received prior therapy with a
gemcitabine-based or 5FU-based regimen, if eligible, and should have received
no more than 1 systemic regimen in the unresectable or metastatic setting.
- HNSCC (closed to enrollment): Participants with HNSCC in Part C must have
received prior therapy with a platinum-based regimen and/or a checkpoint
inhibitor (CPI), if eligible, and must have experienced disease progression
following such therapy. Participants should have received no more than 3
systemic lines of therapy in the recurrent or metastatic setting.
- Part E
- Participants with HNSCC must have experienced disease progression on or after
their most recent systemic therapy. Participants should have received no more
than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as
specified below. Participants must have received a platinum-based regimen and a
PD-(L)1 inhibitor.
- Parts D, F, and G
- Part D is closed to enrollment. Part F and Part G will enroll only participants
with HNSCC.
- Participants with HNSCC must have received no previous systemic therapy in the
recurrent or metastatic disease setting.
- Part D only
- Participants with NSCLC must have histologically or cytologically
documented squamous cell NSCLC and must have received no previous systemic
therapy for metastatic disease or radiation therapy to the lung that is >
30 Gy within 6 months of the first dose of study treatment.
- PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be
available
- Part F only
- Participants must have CPS ≥1 by local PD-L1 IHC assay to be eligible for
enrollment. Participants must be able to submit a tissue sample for
retrospective PD-L1 testing. Tissue may be fresh biopsy or archival,
collected within 2 years of Cycle 1 Day 1.
- Part G only
- Non-EU eligibility criteria: No CPS requirement for the cohort evaluating
tisotumab vedotin in combination with pembrolizumab and carboplatin.
- EU-specific eligibility criteria: Participants must have a CPS ≥1 by local
PD-L1 IHC assay.
- Participants must be able to submit a tissue sample for retrospective
PD-L1 testing. Tissue may be fresh biopsy or archival, collected within 2
years of Cycle 1 Day 1.
- Baseline measurable disease as measured by RECIST v1. 1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Exclusion Criteria:
- Participants with primary neuroendocrine or sarcomatoid histologies. For HNSCC,
participants may not have a primary site of nasopharynx or salivary gland.
- Active bleeding conditions
- Ocular surface disease at the time of enrollment (Note: cataract is not considered
active ocular surface disease for this protocol)
- Other cancer: known past or current malignancy other than inclusion diagnosis.
- Uncontrolled tumor-related pain
- Inflammatory lung disease. Participants with pulmonary disease are allowed if
systemic steroids and long-term oxygen are not required
- Peripheral neuropathy greater than or equal to Grade 2
- Active brain metastasis
- Ongoing clinically significant toxicity associated with prior treatment (including
radiotherapy or surgery).
- Part D, F, and G Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
agent or with an agent directed to another stimulatory or co-inhibitory T-cell
receptor.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashish V Chintakuntlawar
Email:
Chintakuntlawar.Ashish@mayo.edu
Investigator:
Last name:
Ashish V Chintakuntlawar
Email:
Principal Investigator
Facility:
Name:
UC San Diego / Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Last name:
Assuntina Gesualda Sacco, MD
Phone:
586-260-9288
Email:
agsacco@ucsd.edu
Investigator:
Last name:
Assuntina Gesualda Sacco, MD
Email:
Principal Investigator
Facility:
Name:
University of California Davis
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Completed
Facility:
Name:
Stanford Cancer Center / Blood and Marrow Transplant Program
Address:
City:
San Jose
Zip:
95124
Country:
United States
Status:
Completed
Facility:
Name:
Poudre Valley Health System (PVHS)
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Saller
Phone:
970-297-6154
Email:
Jennifer.Saller@uchealth.org
Investigator:
Last name:
Steven R Schuster
Email:
Principal Investigator
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Completed
Facility:
Name:
Shands Cancer Center / University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniela Skiff
Email:
daniela.skiff@ufl.edu
Investigator:
Last name:
Thomas George
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yujie Zhao
Phone:
217-383-6828
Email:
zhao.yujie@mayo.edu
Investigator:
Last name:
Yujie Zhao
Email:
Principal Investigator
Facility:
Name:
H. Lee Moffitt Cancer Center and Research Institute
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alaa Taha
Phone:
813-745-7025
Email:
alaa.taha@moffitt.org
Investigator:
Last name:
Christine Chung
Email:
Principal Investigator
Facility:
Name:
University Cancer & Blood Center, LLC
Address:
City:
Athens
Zip:
30607
Country:
United States
Status:
Completed
Facility:
Name:
Winship Cancer Institute / Emory University School of Medicine
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Completed
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briana Porwisz
Phone:
312-695-1352
Email:
briana.porwisz@northwestern.edu
Investigator:
Last name:
Jochen Lorch, MD
Email:
Principal Investigator
Facility:
Name:
University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ari Rosenberg, MD
Phone:
773-702-8222
Email:
arirosenberg@medicine.bsd.uchicago.edu
Investigator:
Last name:
Ari Rosenberg, MD
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Kishwaukee / Kishwaukee Cancer Center
Address:
City:
DeKalb
Zip:
60115
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jochen Lorch, MD
Email:
Principal Investigator
Facility:
Name:
Northwestern Medicine Cancer Center Delnor
Address:
City:
Geneva
Zip:
60134
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jochen Lorch, MD
Email:
Principal Investigator
Facility:
Name:
Ingalls Cancer Care / Ingalls Memorial Hospital
Address:
City:
Harvey
Zip:
60426
Country:
United States
Status:
Completed
Facility:
Name:
Northwestern Medicine Cancer Center Warrenville
Address:
City:
Warrenville
Zip:
60555
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jochen Lorch, MD
Email:
Principal Investigator
Facility:
Name:
Community Health Network
Address:
City:
Indianapolis
Zip:
46250
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cindy Stoner
Phone:
317-621-3836
Email:
CStoner@ecommunity.com
Investigator:
Last name:
Bert H O'Neil
Email:
Principal Investigator
Facility:
Name:
University of Kansas Cancer Center
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Completed
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jane Lindsay Godbey
Phone:
502-629-2500
Email:
JaneLindsay.Godbey@nortonhealthcare.org
Investigator:
Last name:
John Hamm
Email:
Principal Investigator
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vaishnavi "Vaishu" Bandaru
Phone:
410-502-3474
Email:
vbandar3@jhu.edu
Investigator:
Last name:
Tanguy Y Seiwert
Email:
Principal Investigator
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114-2696
Country:
United States
Status:
Recruiting
Contact:
Last name:
Norka Snyder
Phone:
617-643-4971
Email:
nsnyder@mgh.harvard.edu
Investigator:
Last name:
Thomas Roberts
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Completed
Facility:
Name:
Karmanos Cancer Institute / Wayne State University
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ammar Sukari
Phone:
313-576-8778
Email:
sukaria@karmanos.org
Investigator:
Last name:
Ammar Sukari
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katharine Price
Phone:
507-284-2511
Email:
price.katharine@mayo.edu
Investigator:
Last name:
Katharine Price
Email:
Principal Investigator
Facility:
Name:
HealthPartners Institute
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Completed
Facility:
Name:
Washington University in St Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Adkins, MD
Phone:
314-747-8092
Email:
dadkins@wustl.edu
Investigator:
Last name:
Douglas Adkins, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lara Dunn, MD
Phone:
212-639-2000
Email:
dunnl1@mskcc.org
Investigator:
Last name:
Lara Dunn, MD
Email:
Principal Investigator
Facility:
Name:
Weill Cornell Medicine
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Completed
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Shetal Patel
Email:
Principal Investigator
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jameel Muzaffar, MD
Email:
jameel.muzaffar@duke.edu
Investigator:
Last name:
Jameel Muzaffar, MD
Email:
Principal Investigator
Facility:
Name:
Wake Forest Baptist Medical Center / Wake Forest University
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Status:
Recruiting
Contact:
Last name:
Deonna Asbury
Phone:
336-713-7035
Email:
dasbury@wakehealth.edu
Investigator:
Last name:
Lowell L Hart
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239-3098
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeremy Cetnar
Phone:
503-494-3606
Email:
cetnarj@ohsu.edu
Investigator:
Last name:
Jeremy Cetnar
Email:
Principal Investigator
Facility:
Name:
University of Pennsylvania / Perelman Center for Advanced Medicine
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lova Sun
Phone:
267-847-9623
Email:
Lova.sun@pennmedicine.upenn.edu
Investigator:
Last name:
Lova Sun
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kevin Contrera
Email:
contrerakj@upmc.edu
Investigator:
Last name:
Kevin Contrera
Email:
Principal Investigator
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jimmy Rodrigues
Email:
JRodrigues10@Lifespan.org
Investigator:
Last name:
Howard Safran
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Fort Worth
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Completed
Facility:
Name:
MD Anderson Cancer Center / University of Texas
Address:
City:
Houston
Zip:
77030-4095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Guermarie Velazquez-Torres
Phone:
713-745-4367
Email:
gvtorres@mdanderson.org
Investigator:
Last name:
Neal S. Akhave
Email:
Principal Investigator
Facility:
Name:
Joe Arrington Cancer Research and Treatment Center
Address:
City:
Lubbock
Zip:
79410
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sonia Salas
Phone:
806-725-8068
Email:
ssalas@covhs.org
Investigator:
Last name:
Isaac Tafur
Email:
Principal Investigator
Facility:
Name:
Renovatio Clinical
Address:
City:
The Woodlands
Zip:
77380
Country:
United States
Status:
Completed
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22903
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:
Cristina P Rodriguez
Phone:
206-288-7222
Email:
rodrigcr@uw.edu
Investigator:
Last name:
Cristina P Rodriguez
Email:
Principal Investigator
Facility:
Name:
University of Alberta / Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Neil Chua
Email:
Principal Investigator
Facility:
Name:
Hospitalier Jean Minjoz
Address:
City:
Besancon
Zip:
25030
Country:
France
Status:
Recruiting
Investigator:
Last name:
Christophe Borg
Email:
Principal Investigator
Facility:
Name:
Centre léon Bérard
Address:
City:
LYON cedex 08
Zip:
69008
Country:
France
Status:
Completed
Facility:
Name:
APHM Hôpital Nord
Address:
City:
Marseille Cedex 20
Zip:
13915
Country:
France
Status:
Recruiting
Investigator:
Last name:
Sebastien Salas
Email:
Principal Investigator
Facility:
Name:
Hopital Prive du Confluent
Address:
City:
Nantes Cedex 2
Zip:
44277
Country:
France
Status:
Recruiting
Investigator:
Last name:
Claude El Kouri, MD
Email:
Principal Investigator
Facility:
Name:
Hopital Foch
Address:
City:
Suresnes
Zip:
92150
Country:
France
Status:
Recruiting
Investigator:
Last name:
Jaafar Bennouna
Email:
Principal Investigator
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Investigator:
Last name:
Caroline Even
Email:
Principal Investigator
Facility:
Name:
Ruhr-Uni. Bochum, St. Josef-Hospital
Address:
City:
Bochum
Zip:
44791
Country:
Germany
Status:
Completed
Facility:
Name:
Universitätsklinikum Halle-Universitätsklinik und Poliklinik
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Completed
Facility:
Name:
Vincentius-Diakonissen-Kliniken gAG
Address:
City:
Karlsruhe
Zip:
76137
Country:
Germany
Status:
Recruiting
Investigator:
Last name:
Christian Meyer
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Alfredo Berruti
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero Universitaria (AOU) Master Domin U.O. Oncologia Medica Traslazzionale
Address:
City:
Catanzaro
Zip:
88100
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Pierfrancesco Tassone, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Address:
City:
Meldola FC
Zip:
47014
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Sebastiano Calpona
Email:
Principal Investigator
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Giuseppe Curigliano
Email:
Principal Investigator
Facility:
Name:
Seconda Università degli Studi di Napoli, AOU
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Fortunato Ciardiello
Email:
Principal Investigator
Facility:
Name:
Azienda USL Toscana Centro
Address:
City:
Pistoia
Zip:
51100
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Mauro Iannopollo, MD
Email:
Principal Investigator
Facility:
Name:
Oncologia Medica, Ospedale Civile S. Maria delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Claudia Casanova
Email:
Principal Investigator
Facility:
Name:
PU Campus Bio-medico di Roma
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Completed
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Investigator:
Last name:
Maria Garcia Pallas, MD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Germans Trias i Pujol
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Beatriz Cirauqui
Email:
Principal Investigator
Facility:
Name:
Hospital Quironsalud Barcelona Instituto Oncologico Baselga
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejandro Martinez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Irene Brana
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Teresa Alonso Gordoa
Email:
Principal Investigator
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jorge Bartolome Arcilla
Email:
Principal Investigator
Facility:
Name:
HM Centro Integral Oncologico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Completed
Facility:
Name:
Althaia Xarxa Assistencial Manresa
Address:
City:
Manresa
Zip:
08243
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Silvia Catot Tort, MD
Email:
Principal Investigator
Facility:
Name:
Son LLatzer University Hospital
Address:
City:
Palma de Mallorca
Zip:
07198
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Juan Coves Sarto
Email:
Principal Investigator
Facility:
Name:
Guys and St Thomas Hospital
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Completed
Facility:
Name:
The Royal Marsden Hospital Chelsea
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Kevin Harrington
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden NHS Foundation Trust (RM)
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Kevin Harrington
Email:
Principal Investigator
Start date:
June 25, 2018
Completion date:
November 30, 2026
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Collaborator:
Agency:
Genmab
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/NCT03485209
