Clinical trial • Phase III • Oncology

JNJ-78278343 for Metastatic castration-resistant prostate cancer (mCRPC) | Hormone-refractory prostate cancer

Phase III trial of JNJ-78278343 for Metastatic castration-resistant prostate cancer (mCRPC) | Hormone-refractory prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer (mCRPC) | Hormone-refractory prostate cancer
Trial Stage
Phase III
Drug Modality
Other antibody

Key dates

Initial CTIS Submission Date
30-07-2025
First CTIS Authorization Date
18-11-2025

Trial design

Randomised, placebo arm: placebo jnj-78278343 + best supportive care (placebo named 'placebo jnj-78278343'); active comparator: pasritamig (jnj-78278343) + best supportive care. dose and schedule not specified in available records.-controlled Phase III trial in Germany, Italy, Netherlands and others.

Randomised
Yes
Comparator
Placebo arm: Placebo JNJ-78278343 + Best Supportive Care (placebo named 'Placebo JNJ-78278343'); Active comparator: pasritamig (JNJ-78278343) + Best Supportive Care. Dose and schedule not specified in available records.
Target Sample Size
416

Eligibility

Recruits 416 No vulnerable populations selected (isVulnerablePopulationSelected = false). Trial population comprises adult male patients with mCRPC. Subject information and informed consent forms are provided (multiple ICF documents listed) and consent is obtained from participants..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected = false). Trial population comprises adult male patients with mCRPC. Subject information and informed consent forms are provided (multiple ICF documents listed) and consent is obtained from participants.

Inclusion criteria

  • {"criterion_text":"- 1. Histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed NE carcinoma, large cell NE carcinoma, or sarcoma of the prostate is disallowed.\n- 10. Hematologic Values Participants should have: - ANC ≥1.0 x 109/L. - Hemoglobin ≥8.0 g/dL. - Platelet count ≥75 x 109/L Note, transfusion or growth factor usage within 28 days of randomization is not allowed.\n- 2. mCRPC: Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening. Local-regional invasion (rectum, bladder) can be included.\n- 3. PSA ≥2 ng/mL at screening.\n- 4. In the opinion of the investigator, the next best treatment option is a clinical trial.\n- 5. Prior Therapy Requirements Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC). In particular, prior treatment specifications include receipt of the following: ARPI: Must have progressed on at least 1 ARPI and unlikely to benefit from retreatment with another ARPI. Taxanes: Should have received at least 2 previous taxane-based regimens. If a participant has received only 1 taxane regimen, the participant is eligible if: a) Cabazitaxel is not available. b) The participant’s physician deems the participant unsuitable to receive a second taxane regimen due to toxicity risk or prior intolerance. Note: a taxane-based regimen consists of at least 2 cycles of a taxane (either as a single agent or in combination with other therapies) administered within the same 2-month period. Radioligand therapy: Should have been previously treated with at least 1 dose of PSMA-targeted lutetium radioligand therapy (eg, lutetium Lu-177 vipivotide tetraxetan), unless one of the following applies: a) PSMA-targeted lutetium radioligand therapy is unavailable, not accessible, or not clinically indicated. b) The participant’s physician deems the participant unsuitable to receive PSMA-targeted lutetium radioligand therapy. PARPi: Should have been previously treated with PARPi, if the participant has a known germline or somatic BRCA mutation and treatment is available.\n- 6. Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase.\n- 7. Have an ECOG performance status of 0 to 2.\n- 8. Renal Function . Have an eGFR ≥30 mL/min, calculated with the CKD-epi formula, before randomization. Participants with obstructive uropathy should have treatment prior to randomization (eg, foley catheter, nephrostomy tubes, etc).\n- 9. Hepatic Function Participants are eligible if they have the following values: - ALT and AST ≤5 ×ULN. - Serum total bilirubin ≤3 x ULN"}

Exclusion criteria

  • {"criterion_text":"- 1. Venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of study treatment; uncomplicated (Grade ≤2) deep vein thrombosis is not exclusionary.\n- 2. Active autoimmune disease within the 12 months prior to signing consent that quires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus).\n- 3. Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 L/min by nasal cannula) to maintain adequate oxygenation.\n- 4. Participant has a prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n- 5. Any of the following within 6 months prior to first dose of study treatment: - Myocardial infarction - Severe or unstable angina - Clinically significant ventricular arrhythmias - Congestive heart failure (New York Heart Association class II to IV) - Transient ischemic attack - Cerebrovascular accident\n- 6. Prior treatment with any CD3-directed therapy.\n- 7. Received immunosuppressive doses of systemic medications, such as glucocorticoids (doses >10 mg/day prednisone or equivalent) within 3 days prior to the first dose of study treatment. A single course of glucocorticoids is permitted as prophylaxis for imaging contrast (ie, for participants with allergies to contrast). If glucocorticoids were used to treat immune-related adverse events associated with prior therapy, ≥7 days must have elapsed since the last dose of corticosteroid."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"To determine if pasritamig + BSC compared to placebo + BSC is superior in OS"}

Recruitment

Planned Sample Size
416
Recruitment Window Months
41
Consent Approach
Informed consent is obtained from participants using subject information and informed consent forms (SIS/ICF). ICF/SIS documents are provided in multiple languages as listed in the documents (including English, German, Italian, Dutch, Spanish, French, Polish); participant signs consent prior to enrolment.

Geography

Total Number Of Sites
60
Total Number Of Participants
247

Germany

Earliest CTIS Part Ii Submission Date
03-11-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
21
Number Of Sites
11
Number Of Participants
43

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Urologie
Principal Investigator Name
Christopher Darr
Principal Investigator Email
Christopher.Darr@uk-essen.de
Contact Person Name
Christopher Darr
Contact Person Email
Christopher.Darr@uk-essen.de
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Urologische Klinik
Principal Investigator Name
Lukas Manka
Principal Investigator Email
l.manka@skbs.de
Contact Person Name
Lukas Manka
Contact Person Email
l.manka@skbs.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
Studienpraxis fuer Urologie
Principal Investigator Name
Tilman Todenhoefer
Principal Investigator Email
todenhoefer@studienurologie.de
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Urologicum Duisburg
Department Name
Urologie
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
Universitaet Muenster
Department Name
Klinik fuer Urologie
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
University Medical Center Hamburg-Eppendorf
Department Name
Zentrum für Hematologie & Onkologie
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
Klinikum Nuernberg
Department Name
Klinik fuer Innere Medizin
Principal Investigator Name
Marinela Augustin
Principal Investigator Email
marinela.augustin@klinikum-nuernberg.de
Contact Person Name
Marinela Augustin
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Urologische Klinik
Principal Investigator Name
Guenter Niegisch
Principal Investigator Email
guenter.niegisch@med.uni-duesseldorf.de
Contact Person Name
Guenter Niegisch
Site Name
Krankenhaus Nordwest GmbH
Department Name
Oncology and Hematology
Principal Investigator Name
Mohammad Reza Rafiyan
Principal Investigator Email
rafiyan.reza@khnw.de
Contact Person Name
Mohammad Reza Rafiyan
Contact Person Email
rafiyan.reza@khnw.de
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Urooncology
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
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
Med. Oncology
Principal Investigator Name
Stefanie Zschaebitz
Principal Investigator Email
stefanie.zschaebitz@med.uni-heidelberg.de
Contact Person Name
Stefanie Zschaebitz

Italy

Earliest CTIS Part Ii Submission Date
02-10-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
49
Number Of Sites
8
Number Of Participants
34

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
Medical Oncology and Hematology Unit
Principal Investigator Name
Paolo Zucali
Principal Investigator Email
paolo.zucali@hunimed.eu
Contact Person Name
Paolo Zucali
Contact Person Email
paolo.zucali@hunimed.eu
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Medical Oncology 1U
Principal Investigator Name
Massimo Di Maio
Principal Investigator Email
massimo.dimaio@unito.it
Contact Person Name
Massimo Di Maio
Contact Person Email
massimo.dimaio@unito.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology Unit 3
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
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Unit of Medical Oncology and Biomolecular Therapy
Principal Investigator Name
Vincenza Conteduca
Principal Investigator Email
vincenza.conteduca@unifg.it
Contact Person Name
Vincenza Conteduca
Contact Person Email
vincenza.conteduca@unifg.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Medical Oncology Unit
Principal Investigator Name
Carlo Messina
Principal Investigator Email
carlo.messina@arnascivico.it
Contact Person Name
Carlo Messina
Contact Person Email
carlo.messina@arnascivico.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Medical Oncology Operating Unit
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
Istituto Nazionale Dei Tumori
Department Name
Medical Oncology Genitourinary Unit
Principal Investigator Name
Giuseppe Procopio
Principal Investigator Email
giuseppe.procopio@istitutotumori.mi.it
Contact Person Name
Giuseppe Procopio
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Medical Oncology Operating Unit
Principal Investigator Name
Roberto Iacovelli
Principal Investigator Email
roberto.iacovelli@policlinicogemelli.it
Contact Person Name
Roberto Iacovelli

Netherlands

Earliest CTIS Part Ii Submission Date
13-11-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
11
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Oncology
Principal Investigator Name
Nick Beije
Principal Investigator Email
n.beije@erasmusmc.nl
Contact Person Name
Nick Beije
Contact Person Email
n.beije@erasmusmc.nl
Site Name
Reinier de Graaf Groep
Department Name
Oncology
Principal Investigator Name
Addy van de Luijtgaarden
Principal Investigator Email
a.vandeluijtgaarden@rdgg.nl
Contact Person Name
Addy van de Luijtgaarden
Contact Person Email
a.vandeluijtgaarden@rdgg.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
Hematology
Principal Investigator Name
Aart Beeker
Principal Investigator Email
abeeker@spaarnegasthuis.nl
Contact Person Name
Aart Beeker
Contact Person Email
abeeker@spaarnegasthuis.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Oncology
Principal Investigator Name
Bart Kuenen
Principal Investigator Email
b.kuenen@mzh.nl
Contact Person Name
Bart Kuenen
Contact Person Email
b.kuenen@mzh.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
Oncology
Principal Investigator Name
Marieke Berends
Principal Investigator Email
marieke.berends@cwz.nl
Contact Person Name
Marieke Berends
Contact Person Email
marieke.berends@cwz.nl
Site Name
Isala Klinieken Stichting
Department Name
Oncology
Principal Investigator Name
Metin Tascilar
Principal Investigator Email
m.tascilar@isala.nl
Contact Person Name
Metin Tascilar
Contact Person Email
m.tascilar@isala.nl
Site Name
Tergooiziekenhuizen
Department Name
Oncology
Principal Investigator Name
Pieter van den Berg
Principal Investigator Email
pvandenberg@tergooi.nl
Contact Person Name
Pieter van den Berg
Contact Person Email
pvandenberg@tergooi.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Oncology
Principal Investigator Name
Thomas Kerkhofs
Principal Investigator Email
thomas.kerkhofs@mumc.nl
Contact Person Name
Thomas Kerkhofs
Contact Person Email
thomas.kerkhofs@mumc.nl
Site Name
Reinier de Graaf Groep (additional listed site record)
Department Name
Oncology
Principal Investigator Name
Addy van de Luijtgaarden
Principal Investigator Email
a.vandeluijtgaarden@rdgg.nl
Contact Person Name
Addy van de Luijtgaarden
Contact Person Email
a.vandeluijtgaarden@rdgg.nl

Poland

Earliest CTIS Part Ii Submission Date
21-10-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
31
Number Of Sites
5
Number Of Participants
20

Sites

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
sekretariatk3@nio.gov.pl
Contact Person Name
Pawel Wiechno
Contact Person Email
sekretariatk3@nio.gov.pl
Site Name
In Vivo Sp. z o.o.
Department Name
In Vivo Sp. z o.o.
Principal Investigator Name
Marcin Zaremba
Principal Investigator Email
kontakt@in-vivo.pl
Contact Person Name
Marcin Zaremba
Contact Person Email
kontakt@in-vivo.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Dzienny Chemioterapii
Principal Investigator Name
Mariusz Kwiatkowski
Principal Investigator Email
szpital@swk.med.pl
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
szpital@swk.med.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Urologii i Urologii Klinicznej
Principal Investigator Name
Jacek Kudelski
Principal Investigator Email
kl.urologii@uskwb.pl
Contact Person Name
Jacek Kudelski
Contact Person Email
kl.urologii@uskwb.pl
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
rejestracja-onkologiczna@grochowski.waw.pl
Contact Person Name
Iwona Skoneczna

Spain

Earliest CTIS Part Ii Submission Date
24-10-2025
Latest Decision Or Authorization Date
20-11-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Principal Investigator Name
María Dolores Fenor de la Maza López Olmedo
Principal Investigator Email
mfenor@vhio.net
Contact Person Name
María Dolores Fenor de la Maza López Olmedo
Contact Person Email
mfenor@vhio.net
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Medical Oncology
Principal Investigator Name
Teresa Alonso Gordoa
Principal Investigator Email
talonsogordoa@gmail.com
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
talonsogordoa@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Elena Castro Marcos
Principal Investigator Email
ecastro.imas12@h2o.es
Contact Person Name
Elena Castro Marcos
Contact Person Email
ecastro.imas12@h2o.es
Site Name
Hospital De Jerez De La Frontera
Department Name
Medical Oncology
Principal Investigator Name
Ana Isabel Vacas Rama
Principal Investigator Email
anavrama@gmail.com
Contact Person Name
Ana Isabel Vacas Rama
Contact Person Email
anavrama@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Medical Oncology
Principal Investigator Name
Lucía Oliva Fernández
Principal Investigator Email
luciaolifer3@gmail.com
Contact Person Name
Lucía Oliva Fernández
Contact Person Email
luciaolifer3@gmail.com
Site Name
Hospital Universitari Vall D Hebron (additional listed record)
Department Name
Medical Oncology
Principal Investigator Name
María Dolores Fenor de la Maza López Olmedo
Principal Investigator Email
mfenor@vhio.net
Contact Person Name
María Dolores Fenor de la Maza López Olmedo
Contact Person Email
mfenor@vhio.net

Belgium

Earliest CTIS Part Ii Submission Date
21-10-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
28
Number Of Sites
9
Number Of Participants
46

Sites

Site Name
Ziekenhuis Aan De Stroom
Department Name
Oncology
Principal Investigator Name
Tom Van den Mooter
Principal Investigator Email
tom.vandenmooter@zas.be
Contact Person Name
Tom Van den Mooter
Contact Person Email
tom.vandenmooter@zas.be
Site Name
Clinique Saint-Pierre
Department Name
Oncology
Principal Investigator Name
Nicolas Whenham
Principal Investigator Email
Nicolas.WHENHAM@cspo.be
Contact Person Name
Nicolas Whenham
Contact Person Email
Nicolas.WHENHAM@cspo.be
Site Name
Universiteit Gent
Department Name
Oncology
Principal Investigator Name
Sylvie Rottey
Principal Investigator Email
sylvie.rottey@ugent.be
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
CHC MontLegia
Department Name
Oncology
Principal Investigator Name
Geoffrey Matus
Principal Investigator Email
geoffrey.matus@chc.be
Contact Person Name
Geoffrey Matus
Contact Person Email
geoffrey.matus@chc.be
Site Name
CHU Helora
Department Name
Oncology
Principal Investigator Name
Guillaume Grisay
Principal Investigator Email
guillaume.grisay@jolimont.be
Contact Person Name
Guillaume Grisay
Contact Person Email
guillaume.grisay@jolimont.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Oncology
Principal Investigator Name
Barbara Brouwers
Principal Investigator Email
barbara.brouwers@azsintjan.be
Contact Person Name
Barbara Brouwers
Contact Person Email
barbara.brouwers@azsintjan.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Urology
Principal Investigator Name
Bertrand Tombal
Principal Investigator Email
bertrand.tombal@saintluc.uclouvain.be
Contact Person Name
Bertrand Tombal
Site Name
Az Maria Middelares Gent
Department Name
Oncology
Principal Investigator Name
Christof Vulsteke
Principal Investigator Email
christof.vulsteke@mijnziekenhuis.be
Contact Person Name
Christof Vulsteke
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Oncology
Principal Investigator Name
Sofie Demasure
Principal Investigator Email
Sofie.demasure@azgroeninge.be
Contact Person Name
Sofie Demasure
Contact Person Email
Sofie.demasure@azgroeninge.be

France

Earliest CTIS Part Ii Submission Date
27-10-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
92
Number Of Sites
12
Number Of Participants
48

Sites

Site Name
Hospices Civils De Lyon
Department Name
Medical 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
Site Name
Institut De Cancerologie De Lorraine
Department Name
Medical oncology
Principal Investigator Name
Vincent MASSARD
Principal Investigator Email
v.massard@nancy.unicancer.fr
Contact Person Name
Vincent MASSARD
Contact Person Email
v.massard@nancy.unicancer.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Medical oncology
Principal Investigator Name
Sylvain LADOIRE
Principal Investigator Email
sladoire@cgfl.fr
Contact Person Name
Sylvain LADOIRE
Contact Person Email
sladoire@cgfl.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Medical oncology
Principal Investigator Name
Philippe BARTHELEMY
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe BARTHELEMY
Contact Person Email
p.barthelemy@icans.eu
Site Name
Institut Bergonie
Department Name
Medical oncology
Principal Investigator Name
Guilhem ROUBAUD
Principal Investigator Email
g.roubaud@bordeaux.unicancer.fr
Contact Person Name
Guilhem ROUBAUD
Site Name
Centre Leon Berard
Department Name
Medical 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
Institut Gustave Roussy
Department Name
Medical oncology
Principal Investigator Name
Ronan FLIPPOT
Principal Investigator Email
ronan.flippot@gustaveroussy.fr
Contact Person Name
Ronan FLIPPOT
Contact Person Email
ronan.flippot@gustaveroussy.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Medical oncology
Principal Investigator Name
Emmanuelle BOMPAS
Principal Investigator Email
Emmanuelle.bompas@ico.unicancer.fr
Contact Person Name
Emmanuelle BOMPAS
Site Name
Centre Oscar Lambret
Department Name
Medical oncology
Principal Investigator Name
Eric Amela
Principal Investigator Email
y-amela@o-lambret.fr
Contact Person Name
Eric Amela
Contact Person Email
y-amela@o-lambret.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical oncology
Principal Investigator Name
Loic MOUREY
Principal Investigator Email
mourey.loic@iuct-oncopole.fr
Contact Person Name
Loic MOUREY
Contact Person Email
mourey.loic@iuct-oncopole.fr
Site Name
Fondation Hopital Saint Joseph
Department Name
Oncology
Principal Investigator Name
Carole Helissey
Principal Investigator Email
chelissey@ghpsj.fr
Contact Person Name
Carole Helissey
Contact Person Email
chelissey@ghpsj.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncology
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

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
4g Clinical LLC
Responsibilities
sponsorDuties code: 3 (role as listed in third party entries)
Name
Labcorp Central Laboratory Services LP
Responsibilities
laboratory services (sponsorDuties code: 4; contact Medical.affairs@labcorp.com)
Name
Eresearchtechnology Inc.
Responsibilities
eCOA vendor (explicitly listed: 'eCOA vendor')

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4 (contact: Medical.affairs@labcorp.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3 (contact: mscoville@4gclinical.com)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA vendor (value provided) (contact: Larmarrio.Harden@Clario.com)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
JNJ-78278343
Active Substance
JNJ-78278343
Modality
Other antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
Placebo JNJ-78278343
Modality
Other
Combination Treatment
Yes

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