Clinical trial • Phase III • Oncology

LOXO-435 (LY3866288 / vepugratinib) for Urothelial carcinoma | Bladder cancer | Metastatic disease

Phase III trial of LOXO-435 (LY3866288 / vepugratinib) for Urothelial carcinoma | Bladder cancer | Metastatic disease.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Urothelial carcinoma | Bladder cancer | Metastatic disease
Trial Stage
Phase III
Drug Modality
Small molecule|ADC|Monoclonal antibody

Key dates

Initial CTIS Submission Date
08-12-2025
First CTIS Authorization Date
20-04-2026

Trial design

Randomised, enfortumab vedotin (enfortumab vedotin) — intravenous (dose unit mg/kg; listed max amount 1.25 mg/kg); pembrolizumab (pembrolizumab) — intravenous (dose unit mg; listed max amount 200 mg); placebo to match ly (oral tablet placebo).-controlled Phase III trial in Czechia, Denmark, France and others.

Randomised
Yes
Comparator
Enfortumab vedotin (ENFORTUMAB VEDOTIN) — intravenous (dose unit mg/kg; listed max amount 1.25 mg/kg); Pembrolizumab (PEMBROLIZUMAB) — intravenous (dose unit mg; listed max amount 200 mg); Placebo to match LY (oral tablet placebo).
Biomarker Stratified
True, biomarker = FGFR3 genetic alteration
Target Sample Size
306
Trial Duration For Participant
2190

Eligibility

Recruits 306 No vulnerable populations selected (isVulnerablePopulationSelected=false)..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false).

Inclusion criteria

  • {"criterion_text":"- A type of cancer called urothelial cancer that has spread to other parts of your body and cannot be removed with surgery"}
  • {"criterion_text":"- A specific genetic change in the FGFR3 gene that can be found in a tumor or blood sample"}
  • {"criterion_text":"- Tumors that can be measured by a doctor using a special system called RECIST v1.1"}
  • {"criterion_text":"- Moderate to good level of physical ability"}
  • {"criterion_text":"- Adequate laboratory test results"}

Exclusion criteria

  • {"criterion_text":"- Have already had treatment for cancer that has spread to other parts of your body"}
  • {"criterion_text":"- Still have side effects from previous cancer treatment that are worse than mild"}
  • {"criterion_text":"- Have nerve damage that affects your senses or movement"}
  • {"criterion_text":"- Have cancer that has spread to the brain that is untreated or uncontrolled"}
  • {"criterion_text":"- Have eye problems like corneal keratopathy or retinal disorder that are symptomatic or haven't been treated yet"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab","definition_or_measurement_approach":"Not further specified in the record (safety and tolerability assessments in the Safety Lead-in)."}
  • {"endpoint_text":"- Safety Lead-in:Overall Response Rate (ORR)","definition_or_measurement_approach":"Overall Response Rate (ORR) as endpoint; no additional measurement definition provided in the record."}
  • {"endpoint_text":"- Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR)."}

Recruitment

Digital Remote Recruitment
True — eCOA participant materials and Study-Connect participant materials are listed; third-party organisations with 'AI'/'digital' names (Clinical AI Inc., Tempus AI Inc.) and materials indicating electronic participant engagement are listed.
Planned Sample Size
306
Recruitment Window Months
71
Consent Approach
Informed consent obtained from participants using subject information and informed consent form (ICF) documents; multiple country- and language-specific ICF/SIS documents are included in the dossier (L1/L2 documents in Czech, HU, PL, NL, etc.). Consent is by the participant; no specific assent procedures for minors are described in the available materials.

Methods

  • Healthcare provider referral / site-facing doctor referral slides (site-facing doctor referral materials listed under recruitment documents).
  • Patient-facing materials: flyers, posters, brochures (multiple K2 recruitment materials and flyers/posters/brochures listed in documents).
  • Use of commercial third parties for patient referral, recruitment, screening and/or retention (organisations listed in thirdParties with duties including patient referral and recruitment).
  • Use of eCOA / Study-Connect / participant digital materials for participant engagement and retention (eCOA Participant Quick-Start Guide and Study-Connect-Participant materials listed).

Geography

Total Number Of Sites
103
Total Number Of Participants
306

Czechia

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
28
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika 1. LF UK a FTN
Principal Investigator Name
Michaela Matoušková
Principal Investigator Email
matouskova@urocentrum.cz
Contact Person Name
Michaela Matoušková
Contact Person Email
matouskova@urocentrum.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologická klinika
Principal Investigator Name
Jan Dvořák
Principal Investigator Email
jan.dvorak@fnkv.cz
Contact Person Name
Jan Dvořák
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Principal Investigator Name
Hana Študentová
Principal Investigator Email
hana.studentova@fnol.cz
Contact Person Name
Hana Študentová
Contact Person Email
hana.studentova@fnol.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Principal Investigator Name
Tomáš Büchler
Principal Investigator Email
tomas.buchler@fnmotol.cz
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie (budova č. 23)
Principal Investigator Name
Jindřich Kopecký
Principal Investigator Email
jindrich.kopecky@fnhk.cz
Contact Person Name
Jindřich Kopecký
Contact Person Email
jindrich.kopecky@fnhk.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Principal Investigator Name
Alexandr Poprach
Principal Investigator Email
alexandr.poprach@mou.cz
Contact Person Name
Alexandr Poprach
Contact Person Email
alexandr.poprach@mou.cz

Denmark

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
10
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Rigshospitalet
Department Name
Urooncology
Principal Investigator Name
Helle Pappot
Principal Investigator Email
Helle.Pappot@regionh.dk
Contact Person Name
Helle Pappot
Contact Person Email
Helle.Pappot@regionh.dk
Site Name
Aarhus University Hospital
Department Name
Oncology
Principal Investigator Name
Mads Agerbaek
Principal Investigator Email
madsager@rm.dk
Contact Person Name
Mads Agerbaek
Contact Person Email
madsager@rm.dk
Site Name
Næstved Hospital
Principal Investigator Name
Anne Vest Sørensen
Principal Investigator Email
avess@regionsjaelland.dk
Contact Person Name
Anne Vest Sørensen
Contact Person Email
avess@regionsjaelland.dk
Site Name
Aalborg University Hospital
Principal Investigator Name
Andreas Carus
Principal Investigator Email
andreas.carus@rn.dk
Contact Person Name
Andreas Carus
Contact Person Email
andreas.carus@rn.dk
Site Name
Herlev and Gentofte Hospital
Department Name
Oncology
Principal Investigator Name
Line Dohn
Principal Investigator Email
line.hammer.dohn.02@regionh.dk
Contact Person Name
Line Dohn
Contact Person Email
line.hammer.dohn.02@regionh.dk

France

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
59
Number Of Sites
12
Number Of Participants
24

Sites

Site Name
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Department Name
Oncology
Principal Investigator Name
Diego Teyssonneau
Principal Investigator Email
d.teyssonneau@bordeaux.unicancer.fr
Contact Person Name
Diego Teyssonneau
Site Name
Institut de Cancérologie de l'Ouest
Department Name
Oncology
Principal Investigator Name
Sophie Abadie-Lacourtoisie
Contact Person Name
Sophie Abadie-Lacourtoisie
Site Name
Centre Francois Baclesse
Department Name
Oncology
Principal Investigator Name
Florence Joly-Lobbedez
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly-Lobbedez
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
Oncology
Principal Investigator Name
Yaovi Eric Amela
Principal Investigator Email
y-amela@o-lambret.fr
Contact Person Name
Yaovi Eric Amela
Contact Person Email
y-amela@o-lambret.fr
Site Name
CHRU de Brest
Department Name
Institut de cancérologie et d'Hématologie
Principal Investigator Name
Benjamin Auberger
Principal Investigator Email
benjamin.auberger@chu-brest.fr
Contact Person Name
Benjamin Auberger
Contact Person Email
benjamin.auberger@chu-brest.fr
Site Name
Oncopole Claudius Regaud
Department Name
Oncology
Principal Investigator Name
Damien Pouessel
Principal Investigator Email
pouessel.damien@iuct-oncopole.fr
Contact Person Name
Damien Pouessel
Site Name
Institut Gustave Roussy
Department Name
Oncology
Principal Investigator Name
Yohann Loriot
Principal Investigator Email
yohann.loriot@gustaveroussy.fr
Contact Person Name
Yohann Loriot
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Centre Leon Berard
Department Name
Oncology
Principal Investigator Name
Aude Flechon
Principal Investigator Email
aude.flechon@lyon.unicancer.fr
Contact Person Name
Aude Flechon
Contact Person Email
aude.flechon@lyon.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'oncologie medicale
Principal Investigator Name
Marine Gross-Goupil
Principal Investigator Email
marine.gross-goupil@chu-bordeaux.fr
Contact Person Name
Marine Gross-Goupil
Site Name
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire
Department Name
Medical Oncology
Principal Investigator Name
Letitia Aptecar
Principal Investigator Email
leticia.aptecar@chu-nimes.fr
Contact Person Name
Letitia Aptecar
Contact Person Email
leticia.aptecar@chu-nimes.fr
Site Name
Institut Paoli-Calmettes
Department Name
Oncology
Principal Investigator Name
Gwenaelle Gravis
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaelle Gravis
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Oncology
Principal Investigator Name
Denis Maillet
Principal Investigator Email
denis.maillet@chu-lyon.fr
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr

Germany

Earliest CTIS Part Ii Submission Date
08-04-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
15
Number Of Sites
25
Number Of Participants
28

Sites

Site Name
Klinikum Nuernberg
Department Name
Oncology and/or Hematology
Principal Investigator Name
Marinela Augustin
Principal Investigator Email
marinela.augustin@klinikum-nuernberg.de
Contact Person Name
Marinela Augustin
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Urology
Principal Investigator Name
Axel Merseburger
Principal Investigator Email
axel.merseburger@uksh.de
Contact Person Name
Axel Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
Universitaetsklinikum Essen AöR
Principal Investigator Name
Viktor Gruenwald
Principal Investigator Email
viktor.gruenwald@uk-essen.de
Contact Person Name
Viktor Gruenwald
Contact Person Email
viktor.gruenwald@uk-essen.de
Site Name
Medical Center - University Of Freiburg
Department Name
Urology
Principal Investigator Name
Markus Grabbert
Principal Investigator Email
markus.grabbert@uniklinik-freiburg.de
Contact Person Name
Markus Grabbert
Site Name
Institut Fuer Versorgungsforschung In Der Onkologie GbR
Principal Investigator Name
Christoph Lutz
Principal Investigator Email
lutz@invo-koblenz.de
Contact Person Name
Christoph Lutz
Contact Person Email
lutz@invo-koblenz.de
Site Name
Krankenhaus Nordwest GmbH
Principal Investigator Name
Inga Peters
Principal Investigator Email
peters.inga@khnw.de
Contact Person Name
Inga Peters
Contact Person Email
peters.inga@khnw.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Principal Investigator Name
Tilman Todenhoefer
Principal Investigator Email
todenhoefer@studienurologie.de
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Urology
Principal Investigator Name
Friedemann Zengerling
Principal Investigator Email
friedemann.zengerling@uniklinik-ulm.de
Contact Person Name
Friedemann Zengerling
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Urology
Principal Investigator Name
Guenter Niegisch
Principal Investigator Email
guenter.niegisch@med.uni-duesseldorf.de
Contact Person Name
Guenter Niegisch
Site Name
Urologicum Duisburg Fachärztesozietät - Walsum
Department Name
Urology
Principal Investigator Name
Eva Hellmis
Principal Investigator Email
hellmis@urologicum-duisburg.de
Contact Person Name
Eva Hellmis
Contact Person Email
hellmis@urologicum-duisburg.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Urology
Principal Investigator Name
Peter J. Goebell
Principal Investigator Email
peter.goebell@uk-erlangen.de
Contact Person Name
Peter J. Goebell
Contact Person Email
peter.goebell@uk-erlangen.de
Site Name
Universitaetsmedizin Greifswald KöR
Principal Investigator Name
Cindy Roennau
Principal Investigator Email
cindy.roennau@med.uni-greifswald.de
Contact Person Name
Cindy Roennau
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Urology
Principal Investigator Name
Anna Seitz
Principal Investigator Email
seitz_a3@ukw.de
Contact Person Name
Anna Seitz
Contact Person Email
seitz_a3@ukw.de
Site Name
Universitaetsklinikum Tuebingen AöR
Principal Investigator Name
Steffen Rausch
Principal Investigator Email
steffen.rausch@med.uni-tuebingen.de
Contact Person Name
Steffen Rausch
Site Name
Studienzentrum Bayenthal Urologische Partnerschaft Köln
Principal Investigator Name
Joerg Klier
Principal Investigator Email
dr.klier@urologie-bayenthal.de
Contact Person Name
Joerg Klier
Contact Person Email
dr.klier@urologie-bayenthal.de
Site Name
Johanniter GmbH
Department Name
Urology
Principal Investigator Name
Carsten Ohlmann
Principal Investigator Email
carsten.ohlmann@bn.johanniter-kliniken.de
Contact Person Name
Carsten Ohlmann
Site Name
Charite Universitaetsmedizin Berlin KöR
Principal Investigator Name
Maria De Santis
Principal Investigator Email
maria.de-santis@charite.de
Contact Person Name
Maria De Santis
Contact Person Email
maria.de-santis@charite.de
Site Name
Rostock University Medical Center
Principal Investigator Name
Angelika Borkowetz
Principal Investigator Email
angelika.borkowetz@med.uni-rostock.de
Contact Person Name
Angelika Borkowetz
Site Name
Universitaet Muenster
Department Name
Urology
Principal Investigator Name
Martin Boegemann
Principal Investigator Email
martin.boegemann@ukmuenster.de
Contact Person Name
Martin Boegemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Urology
Principal Investigator Name
Margitta Retz
Principal Investigator Email
margitta.retz@tum.de
Contact Person Name
Margitta Retz
Contact Person Email
margitta.retz@tum.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Principal Investigator Name
Florian Weissinger
Principal Investigator Email
florian.weissinger@evkb.de
Contact Person Name
Florian Weissinger
Contact Person Email
florian.weissinger@evkb.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Onkologisches Zentrum
Principal Investigator Name
Gunhild Von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild Von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
HELIOS Klinikum Bad Saarow GmbH
Principal Investigator Name
Tobias Klatte
Principal Investigator Email
tobias.klatte@helios-gesundheit.de
Contact Person Name
Tobias Klatte
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Klinik und Poliklinik fuer Urologie
Principal Investigator Name
Severine Banek
Principal Investigator Email
severine.banek@ukdd.de
Contact Person Name
Severine Banek
Contact Person Email
severine.banek@ukdd.de
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Oncology and/or Hematology
Principal Investigator Name
Maximilian Jenzer
Principal Investigator Email
Maximilian.Jenzer@med.uni-heidelberg.de
Contact Person Name
Maximilian Jenzer

Hungary

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
40
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Urogenitalis Tumorok és Klinikai Farmakologiai Osztaly
Principal Investigator Name
Lajos Geczi
Principal Investigator Email
geczi.lajos@oncol.hu
Contact Person Name
Lajos Geczi
Contact Person Email
geczi.lajos@oncol.hu
Site Name
University Of Szeged
Department Name
Onkoterapias Klinika
Principal Investigator Name
Aniko Maraz
Principal Investigator Email
dr.aniko.maraz@gmail.com
Contact Person Name
Aniko Maraz
Contact Person Email
dr.aniko.maraz@gmail.com
Site Name
Semmelweis University
Department Name
Urologiai Klinika
Principal Investigator Name
Peter Nyirady
Principal Investigator Email
nyirady.peter@semmelweis.hu
Contact Person Name
Peter Nyirady
Contact Person Email
nyirady.peter@semmelweis.hu
Site Name
University Of Debrecen
Department Name
Onkologiai Klinika
Principal Investigator Name
Peter Arkosy
Principal Investigator Email
arkosy.peter@med.unideb.hu
Contact Person Name
Peter Arkosy
Contact Person Email
arkosy.peter@med.unideb.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiologia
Principal Investigator Name
Agnes Weber
Principal Investigator Email
agneswebermd@gmail.com
Contact Person Name
Agnes Weber
Contact Person Email
agneswebermd@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
31
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Istituto Nazionale Tumori Regina Elena
Department Name
Oncologia Medica 1
Principal Investigator Name
Fabio Calabro'
Principal Investigator Email
fabio.calabro@ifo.it
Contact Person Name
Fabio Calabro'
Contact Person Email
fabio.calabro@ifo.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica
Principal Investigator Name
Marica Gentile
Principal Investigator Email
m.gentile@oncologico.bari.it
Contact Person Name
Marica Gentile
Contact Person Email
m.gentile@oncologico.bari.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Complessa Oncologia Medica 1
Principal Investigator Name
Giuseppe Procopio
Principal Investigator Email
giuseppe.procopio@istitutotumori.mi.it
Contact Person Name
Giuseppe Procopio
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Oncologia Medica 2 Universitaria
Principal Investigator Name
Luca Galli
Principal Investigator Email
lugal71@yahoo.it
Contact Person Name
Luca Galli
Contact Person Email
lugal71@yahoo.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Oncologia Medica
Principal Investigator Name
Luigi Formisano
Principal Investigator Email
luigi.formisano1@unina.it
Contact Person Name
Luigi Formisano
Contact Person Email
luigi.formisano1@unina.it
Site Name
Universita Cattolica Del Sacro Cuore
Department Name
Medical Oncology
Principal Investigator Name
Roberto Iacovelli
Principal Investigator Email
roberto.iacovelli@policlinicogemelli.it
Contact Person Name
Roberto Iacovelli
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 3 - Dipartimento di Oncologia
Principal Investigator Name
Marco Maruzzo
Principal Investigator Email
marco.maruzzo@iov.veneto.it
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it

Spain

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
46
Number Of Sites
26
Number Of Participants
56

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Pablo Gajate Borau
Principal Investigator Email
pgajateborau@gmail.com
Contact Person Name
Pablo Gajate Borau
Contact Person Email
pgajateborau@gmail.com
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Unidad de Ensayos Clínicos
Principal Investigator Name
Jose Pablo Garcia Sanchez
Principal Investigator Email
joseche812@hotmail.com
Contact Person Name
Jose Pablo Garcia Sanchez
Contact Person Email
joseche812@hotmail.com
Site Name
Hospital Universitario De La Princesa
Department Name
Medical Oncology
Principal Investigator Name
Patricia Toquero Diez
Principal Investigator Email
kiku.toquero@gmail.com
Contact Person Name
Patricia Toquero Diez
Contact Person Email
kiku.toquero@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Principal Investigator Name
Jose Angel Arranz Arija
Principal Investigator Email
jarranza.oncomed@gmail.com
Contact Person Name
Jose Angel Arranz Arija
Contact Person Email
jarranza.oncomed@gmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Nuria Lainez Milagro
Principal Investigator Email
nuria.lainez.milagro@navarra.es
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital Clinic De Barcelona
Department Name
ICHMO- Clinic Institut of Haematological and Oncological diseases
Principal Investigator Name
Oscar Reig Torras
Principal Investigator Email
oreig@clinic.cat
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Principal Investigator Name
Alvaro Montesa Pino
Principal Investigator Email
amontesa76@hotmail.com
Contact Person Name
Alvaro Montesa Pino
Contact Person Email
amontesa76@hotmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Principal Investigator Name
Ignacio Duran Martinez
Principal Investigator Email
ignacioduranmartinez@gmail.com
Contact Person Name
Ignacio Duran Martinez
Contact Person Email
ignacioduranmartinez@gmail.com
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Medical Oncology
Principal Investigator Name
Juan Martín Liberal
Principal Investigator Email
jmartinliberal@iconcologia.net
Contact Person Name
Juan Martín Liberal
Contact Person Email
jmartinliberal@iconcologia.net
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Principal Investigator Name
Elena Almagro Casado
Principal Investigator Email
elena.almagro@quironsalud.es
Contact Person Name
Elena Almagro Casado
Contact Person Email
elena.almagro@quironsalud.es
Site Name
Hospital Universitario De Badajoz
Department Name
Medical Oncology
Principal Investigator Name
Marta González Cordero
Principal Investigator Email
marta.gonzalezc@salud-juntaex.es
Contact Person Name
Marta González Cordero
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Oncology
Principal Investigator Name
Alfonso Gómez de Liaño Lista
Principal Investigator Email
agomlis@gobiernodecanarias.org
Contact Person Name
Alfonso Gómez de Liaño Lista
Contact Person Email
agomlis@gobiernodecanarias.org
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Medical Oncology
Principal Investigator Name
Nuria Sala Gonzalez
Principal Investigator Email
nsgonzalez@iconcologia.net
Contact Person Name
Nuria Sala Gonzalez
Contact Person Email
nsgonzalez@iconcologia.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Principal Investigator Name
Begoña Perez Valderrama
Principal Investigator Email
bpvalderrama@gmail.com
Contact Person Name
Begoña Perez Valderrama
Contact Person Email
bpvalderrama@gmail.com
Site Name
Hospital Universitario Reina Sofia
Department Name
Medical Oncology
Principal Investigator Name
Maria Jose Mendez Vidal
Principal Investigator Email
mjosemv@yahoo.es
Contact Person Name
Maria Jose Mendez Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Universitario De Cruces
Department Name
Medical Oncology
Principal Investigator Name
Ricardo Fernández Rodríguez
Principal Investigator Email
ricardo.fernandezrodriguez@osakidetza.eus
Contact Person Name
Ricardo Fernández Rodríguez
Site Name
Hospital Clínico San Carlos
Department Name
Oncology
Principal Investigator Name
Javier Puente Vazquez
Principal Investigator Email
javierpuente.hcsc@gmail.com
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology - VHIO
Principal Investigator Name
Rafael Morales Barrera
Principal Investigator Email
rmorales@vhio.net
Contact Person Name
Rafael Morales Barrera
Contact Person Email
rmorales@vhio.net
Site Name
Hospital General Universitario De Elche
Department Name
Medical Oncology
Principal Investigator Name
Federico Jose Vazquez Mazon
Principal Investigator Email
fvazquez.md@gmail.com
Contact Person Name
Federico Jose Vazquez Mazon
Contact Person Email
fvazquez.md@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Daniel Castellano Gauna
Principal Investigator Email
cdanicas@hotmail.com
Contact Person Name
Daniel Castellano Gauna
Contact Person Email
cdanicas@hotmail.com
Site Name
Institut Catala D'oncologia (L'hospitalet)
Department Name
Medical Oncology
Principal Investigator Name
Irene Ortiz
Principal Investigator Email
ireneortiz@iconcologia.net
Contact Person Name
Irene Ortiz
Contact Person Email
ireneortiz@iconcologia.net
Site Name
MD Anderson Cancer Center (Madrid)
Department Name
Oncology
Principal Investigator Name
Ana Lucrecia Ruiz Echeverría
Principal Investigator Email
alruiz@hospiten.es
Contact Person Name
Ana Lucrecia Ruiz Echeverría
Contact Person Email
alruiz@hospiten.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Urbano Anido Herranz
Principal Investigator Email
urbano.anido.herranz@sergas.es
Contact Person Name
Urbano Anido Herranz
Contact Person Email
urbano.anido.herranz@sergas.es
Site Name
Hospital Universitari Sant Joan de Reus
Department Name
Oncology
Principal Investigator Name
Marc Grifoll Escoda
Principal Investigator Email
marc.grifoll@salutsantjoan.cat
Contact Person Name
Marc Grifoll Escoda
Contact Person Email
marc.grifoll@salutsantjoan.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Medical Oncology
Principal Investigator Name
Jose Pablo Maroto Rey
Principal Investigator Email
jmaroto@santpau.cat
Contact Person Name
Jose Pablo Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Principal Investigator Name
Alvaro Pinto Marin
Principal Investigator Email
alvaropintomarin@gmail.com
Contact Person Name
Alvaro Pinto Marin
Contact Person Email
alvaropintomarin@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
30
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Amphia Hospital
Department Name
Oncologie
Principal Investigator Name
Hans Westgeest
Principal Investigator Email
HWestgeest@amphia.nl
Contact Person Name
Hans Westgeest
Contact Person Email
HWestgeest@amphia.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Medical Oncology
Principal Investigator Name
Debbie Robbrecht
Principal Investigator Email
d.robbrecht@erasmusmc.nl
Contact Person Name
Debbie Robbrecht
Contact Person Email
d.robbrecht@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Medische Oncologie
Principal Investigator Name
Johannes Voortman
Principal Investigator Email
j.voortman@amsterdamumc.nl
Contact Person Name
Johannes Voortman
Contact Person Email
j.voortman@amsterdamumc.nl
Site Name
Radboud Translational Medicine B.V.
Department Name
Medical Oncology
Principal Investigator Name
Mira Franken
Principal Investigator Email
mira.franken@radboudumc.nl
Contact Person Name
Mira Franken
Contact Person Email
mira.franken@radboudumc.nl

Poland

Earliest CTIS Part Ii Submission Date
03-04-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
20
Number Of Sites
12
Number Of Participants
15

Sites

Site Name
In Vivo Sp. z o.o.
Principal Investigator Name
Anna Krause
Principal Investigator Email
arkrause@interia.pl
Contact Person Name
Anna Krause
Contact Person Email
arkrause@interia.pl
Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
md.piotr.tomczak@gmail.com
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Szpital Grochowski Im.Dr Med. Rafała Masztaka Sp. z o.o.
Department Name
Oddział Chemioterapii
Principal Investigator Name
Iwona Skoneczna
Principal Investigator Email
iskoneczna@grochowski.waw.pl
Contact Person Name
Iwona Skoneczna
Contact Person Email
iskoneczna@grochowski.waw.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Nowotworów Układu Moczowego
Principal Investigator Name
Pawel Wiechno
Principal Investigator Email
pawel.wiechno@nio.gov.pl
Contact Person Name
Pawel Wiechno
Contact Person Email
pawel.wiechno@nio.gov.pl
Site Name
Wsd Medi Clinical Sp. z o.o.
Principal Investigator Name
Anna Wasko-Grabowska
Principal Investigator Email
annawaskograbowska@gmail.com
Contact Person Name
Anna Wasko-Grabowska
Contact Person Email
annawaskograbowska@gmail.com
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddzial Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
mariusz.kwiatkowski@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
mariusz.kwiatkowski@swk.med.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Principal Investigator Name
Szymon Borowiec
Principal Investigator Email
sborowiec@wim.mil.pl
Contact Person Name
Szymon Borowiec
Contact Person Email
sborowiec@wim.mil.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Oddział Kliniczny Urologii
Principal Investigator Name
Anna Kolodziej
Principal Investigator Email
ak-kolodziej@wp.pl
Contact Person Name
Anna Kolodziej
Contact Person Email
ak-kolodziej@wp.pl
Site Name
Medical Concierge, Centrum Medyczne
Principal Investigator Name
Piotr Radziszewski
Principal Investigator Email
pradziszewski@medicalconcierge.pl
Contact Person Name
Piotr Radziszewski
Site Name
Gyncentrum Sp. z o.o.
Principal Investigator Name
Sylwia Szablowska-Siwik
Principal Investigator Email
s.szablowska-siwik@holsaclinical.com
Contact Person Name
Sylwia Szablowska-Siwik
Site Name
Centrum Medyczne Luxmed Sp. z o.o.
Department Name
Oddzial Onkologii Klinicznej/Chemioterapii
Principal Investigator Name
Pawel Morawski
Principal Investigator Email
this.is.morrow@gmail.com
Contact Person Name
Pawel Morawski
Contact Person Email
this.is.morrow@gmail.com
Site Name
Pratia S.A.
Principal Investigator Name
Anna Drosik-Kwasniewska
Principal Investigator Email
adrosik-kwasniewska@pratia.pl
Contact Person Name
Anna Drosik-Kwasniewska
Contact Person Email
adrosik-kwasniewska@pratia.pl

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Q2 Solutions LLC
Name
Bioclinica Inc.
Name
Iqvia Biotech LLC
Name
PPD (Thermo Fisher Clinical Scientific)

Third parties

  • {"country":"United States","full_name":"Caerus US 1 Inc.","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Patient Screening Recruitment, and/or Retention","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical AI Inc","duties_or_roles":"Patient Referral, Recruitment, Screening, and/or Retention","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Tempus AI Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Florence Healthcare Inc.","duties_or_roles":"Archival of Essential Documents","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Patient Reimbursement","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Thermo Fisher Clinical Services","duties_or_roles":"Management of Clinical Site Supplies","organisation_type":"Health care"}
  • {"country":"Belgium","full_name":"PPD (Thermo Fisher Clinical Scientific)","duties_or_roles":"","organisation_type":"Health care"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Copyright licensing, Standard and Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
LOXO-435 (LY3866288 / vepugratinib)
Active Substance
LOXO-435 (LY3866288 / vepugratinib)
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Not authorised (investigational)
Maximum Dose
400 mg (max daily amount listed)
Investigational Product Name
ENFORTUMAB VEDOTIN
Active Substance
Enfortumab vedotin
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
1.25 mg/kg (listed max daily amount)
Investigational Product Name
PEMBROLIZUMAB
Active Substance
Pembrolizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
200 mg (listed max daily amount)
Investigational Product Name
Placebo to match ly
Modality
Other
Combination Treatment
Yes

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