Clinical trial • Phase III • Oncology

PEMBROLIZUMAB for Muscle-invasive bladder cancer

Phase III trial of PEMBROLIZUMAB for Muscle-invasive bladder cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Muscle-invasive bladder cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|ADC

Key dates

Initial CTIS Submission Date
15-12-2023
First CTIS Authorization Date
02-02-2024

Trial design

Randomised, arm b: radical cystectomy + pelvic lymph node dissection (cystectomy alone) as control; arm a: perioperative pembrolizumab (keytruda/pembrolizumab) plus rc+plnd; arm c: perioperative enfortumab vedotin in combination with pembrolizumab plus rc+plnd. doses and schedules for the investigational regimens are not specified in the available summary (product entries list formulation and maximum dose attributes but not the arm-specific dosing schedule). Phase III trial in Sweden, Poland, Spain and others.

Randomised
Yes
Comparator
Arm B: Radical cystectomy + pelvic lymph node dissection (cystectomy alone) as control; Arm A: perioperative pembrolizumab (KEYTRUDA/pembrolizumab) plus RC+PLND; Arm C: perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND. Doses and schedules for the investigational regimens are not specified in the available summary (product entries list formulation and maximum dose attributes but not the arm-specific dosing schedule).
Target Sample Size
384

Eligibility

Recruits 384 Vulnerable population is not selected for this trial (isVulnerablePopulationSelected: false). Informed consent is handled via subject information and informed consent forms (Main consent and FBR consent) and multiple optional consent addenda (e.g., pregnant partner, infant follow-up, genetic consent) that are provided per country/language as applicable; adult participants provide consent (no assent or minor consent procedures described in the available records)..

Pregnancy Exclusion
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well
Vulnerable Population
Vulnerable population is not selected for this trial (isVulnerablePopulationSelected: false). Informed consent is handled via subject information and informed consent forms (Main consent and FBR consent) and multiple optional consent addenda (e.g., pregnant partner, infant follow-up, genetic consent) that are provided per country/language as applicable; adult participants provide consent (no assent or minor consent procedures described in the available records).

Inclusion criteria

  • {"criterion_text":"- Have a histologically confirmed diagnosis of urothelial carcinoma/muscle-invasive bladder cancer [MIBC] (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging).\n- Clinically nonmetastatic bladder cancer determined by imaging\n- Eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy if applicable)\n- Transurethral resection (TUR) of a bladder tumor that is submitted for central pathology assessment and adequate to determine urothelial histology and PD-L1 expression assessment\n- ECOG performance status of 0, 1, or 2\n- Adequate organ function\n- A male participant is eligible to participate if he agrees to use contraception and refrain from donating sperm during the intervention period and for at least 180 days after the last dose of enfortumab vedotin. If the male participants are receiving pembrolizumab only or undergoing surgery only, there are no contraception requirements\n- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP or a WOCBP who agrees to use a highly effective contraceptive method or be abstinent from heterosexual intercourse (as their preferred and usual lifestyle) during the intervention period and for at least 120 days after the last dose of pembrolizumab and at least 180 days after the last dose of enfortumab vedotin; whichever comes last. A female participant must agree not to donate eggs during this period as well\n- A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention"}

Exclusion criteria

  • {"criterion_text":"- Known additional nonurothelial malignancy that is progressing or has required active anticancer treatment ≤3 years of study randomization, with certain exceptions\n- Ongoing sensory or motor neuropathy Grade 2 or higher\n- Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Physiologic replacement doses of corticosteroids are permitted for participants with adrenal insufficiency.\n- Hypersensitivity to monoclonal antibodies (including pembrolizumab) and/or any of their excipients\n- Severe hypersensitivity (≥ Grade 3) to enfortumab vedotin or any excipient contained in the drug formulation of enfortumab vedotin\n- Active keratitis or corneal ulcerations. Participants with superficial punctate keratitis are allowed if the disorder is being adequately treated in the opinion of the investigator\n- Active autoimmune disease that has required systemic therapy in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic therapy and is allowed\n- Has uncontrolled diabetes\n- History of (noninfectious) pneumonitis that required steroids, or current pneumonitis\n- Active infection requiring systemic therapy\n- Has had an allogeneic tissue/solid organ transplant\n- Has ≥ N2 or metastatic disease (M1) as identified by imaging\n- Received any prior systemic treatment, chemoradiation, and/or radiation therapy for muscle-invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC)\n- Received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed cell death 1 ligand 2 (PD-L2), or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n- Received prior systemic anticancer therapy including investigational agents within 3 years prior to randomization\n- Received any prior radiotherapy to the bladder\n- Received a partial cystectomy of the bladder to remove any non-muscle-invasive bladder cancer (NMIBC) or MIBC\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n- Current participation in or participation in a study of an investigational agent or use of an investigational device within 4 weeks prior to the first dose of study intervention"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Event-Free Survival (EFS) between Arm C and Arm B","definition_or_measurement_approach":"To compare event-free survival (EFS) between Arm C (perioperative enfortumab vedotin in combination with pembrolizumab and RC+PLND) and Arm B (RC+PLND)."}

Secondary endpoints

  • {"endpoint_text":"- EFS between Arm A and Arm B","definition_or_measurement_approach":"Compare EFS between Arm A (perioperative pembrolizumab and RC+PLND) and Arm B."}
  • {"endpoint_text":"- Overall Survival (OS) between Arm C and Arm B","definition_or_measurement_approach":"Compare OS between Arm C and Arm B."}
  • {"endpoint_text":"- Overall Survival (OS) between Arm A and Arm B","definition_or_measurement_approach":"Compare OS between Arm A and Arm B."}
  • {"endpoint_text":"- Pathological Complete Response (pCR) Rate between Arm C and Arm B","definition_or_measurement_approach":"Compare pCR rates between Arm C and Arm B based on central pathologic review."}
  • {"endpoint_text":"- pCR Rate between Arm A and Arm B","definition_or_measurement_approach":"Compare pCR rates between Arm A and Arm B."}
  • {"endpoint_text":"- Disease-Free Survival (DFS)","definition_or_measurement_approach":"Assess DFS in participants from Arm A, Arm B, and Arm C who are disease-free after surgery."}
  • {"endpoint_text":"- Pathologic Downstaging (pDS) Rate between Arm A and Arm B","definition_or_measurement_approach":"Compare rates of pathologic downstaging between Arm A and Arm B."}
  • {"endpoint_text":"- pDS Rate between Arm C and Arm B","definition_or_measurement_approach":"Compare rates of pathologic downstaging between Arm C and Arm B."}
  • {"endpoint_text":"- Number of Participants Experiencing an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing AEs."}
  • {"endpoint_text":"- Number of Participants Discontinuing Study Treatment due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to AEs."}
  • {"endpoint_text":"- Number of Participants Experiencing Perioperative Complications","definition_or_measurement_approach":"Count of participants experiencing perioperative complications."}

Recruitment

Planned Sample Size
384
Recruitment Window Months
102
Consent Approach
Informed consent is obtained from adult participants via country- and language-specific subject information and informed consent forms (Main consent, FBR consent) and optional consent addenda for items such as genetic testing, pregnant partner, infant follow-up, etc. Consent documents are available in multiple languages per country (documents list shows country-specific consent forms). No minor assent/parental consent procedures are described in the available records.

Geography

Total Number Of Sites
64
Total Number Of Participants
279

Sweden

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
785
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Uppsala University Hospital
Department Name
KFUE Onkologikliniken
Contact Person Name
Anna Laurell
Contact Person Email
anna.laurell@igp.uu.se
Site Name
Karolinska University Hospital
Department Name
Cancerstudieenheten
Contact Person Name
Anders Ullén
Contact Person Email
anders.ullen@sll.se

Poland

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
7
Number Of Participants
60

Sites

Site Name
Lux Med Onkologia Sp. z o.o.
Contact Person Name
Jakub Żołnierek
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Tomasz Deja
Contact Person Email
tomasz.deja@cr-center.pl
Site Name
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Department Name
Oddział Urologii
Contact Person Name
Grzegorz Sulimka
Contact Person Email
urologia@lukasz.med.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
Oddział Urologiczny
Contact Person Name
Jacek Ołubiec
Contact Person Email
urologia@szpital.slupsk.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Urologii i Onkologii Urologicznej
Contact Person Name
Anna Kołodziej
Contact Person Email
badaniakliniczne@usk.wroc.pl
Site Name
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej
Department Name
Oddział Onkologiczny i Hematoonkologiczny
Contact Person Name
Marcin Kowalski
Contact Person Email
sekretariat@szpital.bielsko.p
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski

Spain

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
Hospital Universitario Virgen De Valme
Department Name
Medical Oncology
Contact Person Name
Eva María Fernández Parra
Contact Person Email
evamfparra@yahoo.es
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Germans Trias I Pujol
Department Name
Medical Oncology
Contact Person Name
Albert Font Pous
Contact Person Email
afont@iconcologia.net
Site Name
Hospital San Pedro De Alcantara
Department Name
Medical Oncology
Contact Person Name
Ricardo Collado Martin
Contact Person Email
porcupaintri1@yahoo.es
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Contact Person Name
Javier Puente Vázquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Contact Person Name
Javier Molina Cerrillo
Contact Person Email
javier.molinace@gmail.com
Site Name
Hospital Del Mar
Department Name
Urology-Oncology
Contact Person Name
Alejo Rodríguez-Vida Rodríguez
Site Name
Hospital Universitario La Paz
Department Name
Medical Oncology
Contact Person Name
Álvaro Pinto Marin
Contact Person Email
alvaropintomarin@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Urology-Oncology
Contact Person Name
José Luis Domínguez Escrig
Contact Person Email
jldominguezescrig@hotmail.com
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Contact Person Name
Nuria Sala González
Contact Person Email
nsgonzalez@iconcologia.net

Hungary

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Department Name
Onkológia Osztály
Contact Person Name
Erzsébet Lengyel
Contact Person Email
lengyel.erzsebet@bajcsy.hu
Site Name
University Of Szeged
Department Name
Onkoterápiás klinika
Contact Person Name
Judit Olah
Site Name
University Of Debrecen
Department Name
Klinikai Központ Onkológiai Klinika
Contact Person Name
Péter Árkosy
Contact Person Email
arkosy.peter@med.unideb.hu

Ireland

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
785
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
University Hospital Waterford
Department Name
Oncology
Contact Person Name
Emmet Jordan
Contact Person Email
emmet.jordan@hse.ie
Site Name
Tallaght University Hospital
Department Name
Oncology
Contact Person Name
Ray McDermott
Contact Person Email
ray.mcdermott@tuh.ie

Denmark

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
08-03-2026
Processing Time Days
784
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Rigshospitalet
Department Name
Oncology
Contact Person Name
Helle Pappot
Contact Person Email
helle.pappot@regionh.dk
Site Name
Herlev Hospital
Department Name
Oncology
Contact Person Name
Lisa Sengeloev
Contact Person Email
lisa.sengeloev@regionh.dk
Site Name
Odense University Hospital
Department Name
Oncology
Contact Person Name
Niels Viggo Jensen
Contact Person Email
niels.viggo.jensen@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Oncology
Contact Person Name
Mads Agerbaek
Contact Person Email
madsager@rm.dk

Italy

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
760
Number Of Sites
7
Number Of Participants
28

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.C.D.U. Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Medica 1
Contact Person Name
Valentina Guadalupi
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Medicina Oncologica
Contact Person Name
Andrea Necchi
Contact Person Email
Necchi.andrea@hsr.it
Site Name
Azienda USL Toscana Sud Est
Department Name
U.O.C. Oncologia medica
Contact Person Name
Alketa Hamzaj
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Struttura Complessa Oncologia Medica Uro-Ginecologica
Contact Person Name
Rosa Tambaro
Contact Person Email
r.tambaro@istitutotumori.na.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
S.C. Oncologia Medica
Contact Person Name
Hector Josè Soto Parra
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Giampaolo Tortora

Belgium

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Medical Oncology
Contact Person Name
Barbara Brouwers
Contact Person Email
barbara.brouwers@azsintjan.be
Site Name
Universite Catholique de Louvain
Department Name
Urology
Contact Person Name
Jean-Pascal Machiels
Site Name
Az Maria Middelares Gent
Department Name
Department of Oncology
Contact Person Name
Christof Vulsteke
Contact Person Email
christof.vulsteke@azmmsj.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Oncology
Contact Person Name
Marlies De Bock
Contact Person Email
marlies.debock@azdelta.be

Germany

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Urologie und Kinderurologie
Contact Person Name
Hubert Kübler
Contact Person Email
Kuebler_H@ukw.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Urologische Klinik
Contact Person Name
Peter Goebell
Contact Person Email
peter.goebell@uk-erlangen.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Stuttgart Cancer Center, Tumorzentrum Eva-Mayr-Stihl
Contact Person Name
Jens Bedke
Contact Person Email
j.bedke@klinikum-stuttgart.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Dept. Oif Urology
Contact Person Name
Niklas Kluemper
Contact Person Email
Niklas.Kluemper@ukbonn.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik III
Contact Person Name
Jozefina Casuscelli
Site Name
Universitaetsklinikum Magdeburg AöR
Department Name
Department of Urology, Urologic Oncology, Robotic and focal Therapy
Contact Person Name
Simon Blaschke
Contact Person Email
simon.blaschke@med.ovgu.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Urologie
Contact Person Name
Stefan Hinz
Contact Person Email
Stefan.Hinz@vivantes.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Hematology and Oncology
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinik für Urologie
Contact Person Name
Steffen Rausch

France

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
786
Number Of Sites
16
Number Of Participants
50

Sites

Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service d'oncologie
Contact Person Name
Nadine HOUEDE
Contact Person Email
nadine.HOUEDE@chu-nimes.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Oncologie Médicale
Contact Person Name
Caroline VIALA
Contact Person Email
caroline.viala@chu-nantes.fr
Site Name
Besancon University Hospital Center
Department Name
Service d'Oncologie Médicale
Contact Person Name
Tristan MAURINA
Contact Person Email
t1maurina@chu-besancon.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Service d'Oncologie Médicale – 1F
Contact Person Name
Sophie TARTAS
Contact Person Email
sophie.tartas@chu-lyon.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'urologie
Contact Person Name
Evanguelos Xylinas
Contact Person Email
evanguelos.xylinas@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de Cancérologie
Contact Person Name
Stéphane OUDARD
Contact Person Email
stephane.oudard@egp.aphp.fr
Site Name
Institut Gustave Roussy
Department Name
Service d'Oncologie Médicale
Contact Person Name
Yohann Loriot
Contact Person Email
yohann.loriot@gustaveroussy.fr
Site Name
Hopitaux Prives De Metz
Department Name
Oncologie Médicale
Contact Person Name
Jerome Edouard PLAZA
Contact Person Email
jerome.plaza@uneos.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Oncologie Médicale
Contact Person Name
Olivier HUILLARD
Contact Person Email
olivier.huillard@aphp.fr
Site Name
Hopital Saint Eloi
Department Name
Service d'Oncologie Médicale
Contact Person Name
Delphine TOPART
Contact Person Email
d-topart@chu-montpellier.fr
Site Name
Centr Georges Francois Leclerc
Contact Person Name
Luc CORMIER
Contact Person Email
luc.cormier@chu-dijon.fr
Site Name
CHU De Bordeauxt
Department Name
Service d'Oncologie
Contact Person Name
Marine Gross-Goupil
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service d'urologie
Contact Person Name
Romain MATHIEU
Contact Person Email
romain.MATHIEU@chu-rennes.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Service d'Oncologie Médicale
Contact Person Name
Loïc MOUREY
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Centre Francois Baclesse
Department Name
Comité Uro-Gynécologie
Contact Person Name
Florence JOLY
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Centre Hospitalier Universitaire De Rennes (additional site listing)
Department Name
Service d'urologie (duplicate entries consolidated)

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
Medical information (Physician Consulting) & EUB Call center and medical escalation service
Name
Iqvia Laboratories Limited
Name
Bioclinica Inc.
Responsibilities
Central imaging

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting) & EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Iqvia Laboratories Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
EU marketing authorisation number: EU/1/15/1024/002
Maximum Dose
200 mg (maxDailyDoseAmount: 200 mg)
Investigational Product Name
ENFORTUMAB VEDOTIN
Active Substance
Enfortumab vedotin
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
-
Maximum Dose
125 mg (maxDailyDoseAmount: 125 mg)
Combination Treatment
Yes

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