Clinical trial • Phase III • Oncology

HAFNIUM OXIDE for Locally advanced head and neck squamous cell carcinoma

Phase III trial of HAFNIUM OXIDE for Locally advanced head and neck squamous cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Locally advanced head and neck squamous cell carcinoma
Trial Stage
Phase III
Drug Modality
Other|Monoclonal antibody

Key dates

Initial CTIS Submission Date
05-03-2025
First CTIS Authorization Date
25-06-2025

Trial design

Randomised, rt ± cetuximab (investigator's choice of radiotherapy alone or radiotherapy in combination with cetuximab) — comparator arm: radiotherapy with or without cetuximab; no dose/schedule specified in the available record.-controlled Phase III trial in Belgium, Germany, Hungary and others.

Randomised
Yes
Comparator
RT ± cetuximab (Investigator's choice of radiotherapy alone or radiotherapy in combination with cetuximab) — comparator arm: radiotherapy with or without cetuximab; no dose/schedule specified in the available record.
Target Sample Size
307

Eligibility

Recruits 307 isVulnerablePopulationSelected: false; no specific vulnerable population considerations or assent/consent handling described in the available record..

Vulnerable Population
isVulnerablePopulationSelected: false; no specific vulnerable population considerations or assent/consent handling described in the available record.

Inclusion criteria

  • {"criterion_text":"- 1. Age ≥ 60 years old\n- 2. Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab\n- 3. Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC\n- 4. One primary tumor lesion amendable for intratumoral injection\n- \"5. Ineligible to receive platinum-based chemotherapy with radiation: a.\tEstimated creatinine clearance ≥30 and <50 mL/min (per Cockcroft-Gault equation), Grade ≥2 hearing loss or tinnitus, Grade ≥2 peripheral neuropathy, ECOG Performance Status 2, New York Heart Association Class 3 b.\tAge 70-74 years old with Geriatric 8 (G8) score ≤ 14 c.\tAge ≥ 75 years old\""}

Exclusion criteria

  • {"criterion_text":"- 1.\tCarcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary\n- 2.\tNon-squamous cell histology\n- 3.\tClinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC\n- 4.\tLoco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy\n- 5.\tPrior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent\n- 6.\tOngoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause (whichever occurs first) as stated: \"Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first\"."}

Recruitment

Planned Sample Size
307
Recruitment Window Months
37
Consent Approach
Informed consent obtained using Subject Information Sheets (SIS) and Informed Consent Forms (ICF); country- and language-specific SIS/ICF documents are provided (examples: BE English/Dutch/French, DE German, HU Hungarian, RO Romanian, CZ Czech, ES Spanish, FR French, PT Portuguese, AT German). No details on assent or guardian consent are provided; trial population are adults (age ≥60).

Methods

  • Use of recruitment materials (documented in submission): patient letters, patient brochures, caregiver brochures, study posters, flipcharts/ICF flipcharts, participant clinical trial overview documents — country-specific versions available (examples in the record for Belgium, Germany, Hungary, Romania, Czechia, Spain, France, Portugal, Austria, Greece).

Geography

Total Number Of Sites
54
Total Number Of Participants
194

Belgium

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
15-09-2025
Processing Time Days
112
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
UZ Leuven
Department Name
Radiotherapy-Oncology
Principal Investigator Name
Sandra Nuyts
Principal Investigator Email
sandra.nuyts@uzleuven.be
Contact Person Name
Sandra Nuyts
Contact Person Email
sandra.nuyts@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Cancer et Hématologie adulte et pédiatrique
Principal Investigator Name
Eléonore Longton
Principal Investigator Email
eleonore.longton@uclouvain.be
Contact Person Name
Eléonore Longton
Contact Person Email
eleonore.longton@uclouvain.be
Site Name
Grand Hopital De Charleroi
Department Name
Service d’Oncologie-Hématologie
Principal Investigator Name
Benjamin Ledoux
Principal Investigator Email
benjamin.ledoux@ghdc.be
Contact Person Name
Benjamin Ledoux
Contact Person Email
benjamin.ledoux@ghdc.be

Germany

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
07-08-2025
Processing Time Days
134
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Rostock University Medical Center
Department Name
Clinic and Polyclinic for Radiation Therapy (“Klinik und Poliklinik für Strahlentherapie”)
Principal Investigator Name
Guido Hildebrandt
Principal Investigator Email
strahlentherapie@med.uni-rostock.de
Contact Person Name
Guido Hildebrandt
Site Name
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name
Department of Radiation Oncology
Principal Investigator Name
Stephanie E. Combs
Principal Investigator Email
stephanie.combs@tum.de
Contact Person Name
Stephanie E. Combs
Contact Person Email
stephanie.combs@tum.de
Site Name
University Hospital Cologne AöR
Department Name
Department of Othorinolaryngology, Head and Neck Surgery
Principal Investigator Name
Peter Klußmann
Principal Investigator Email
peter.klussmann@uk-koeln.de
Contact Person Name
Peter Klußmann
Contact Person Email
peter.klussmann@uk-koeln.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie (HNO)
Principal Investigator Name
Annette Affolter
Principal Investigator Email
annette.affolter@umm.de
Contact Person Name
Annette Affolter
Contact Person Email
annette.affolter@umm.de
Site Name
Justus-Liebig-Universitaet Giessen
Department Name
Ear, nose and throat clinic (“Hals- Nasen- und Ohrenklinik”)
Principal Investigator Name
Christine Langer
Principal Investigator Email
christine.langer@hno.med.uni-giessen.de
Contact Person Name
Christine Langer
Site Name
Universitaetsklinikum Jena KöR
Department Name
Department of Ear, Nose and Throat Medicine (“Klinik für Hals-, Nasen- und Ohrenheilkunde”)
Principal Investigator Name
Orlando Guntinas-Lichius
Principal Investigator Email
orlando.guntinas@med.uni-jena.de
Contact Person Name
Orlando Guntinas-Lichius
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Principal Investigator Name
Philipp Ivanyi
Principal Investigator Email
haematologie.onkologie@mh-hannover.de
Contact Person Name
Philipp Ivanyi

Hungary

Earliest CTIS Part Ii Submission Date
29-04-2025
Latest Decision Or Authorization Date
28-08-2025
Processing Time Days
121
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Sugárterápiás Központ, Sugárterápiás Osztály
Principal Investigator Name
Zoltán TAKÁCSI-NAGY
Principal Investigator Email
takacsi.zoltan@oncol.hu
Contact Person Name
Zoltán TAKÁCSI-NAGY
Contact Person Email
takacsi.zoltan@oncol.hu
Site Name
University Of Szeged
Department Name
Szent-György Albert Klinikai Központ Onkoterápiás Klinika)
Principal Investigator Name
Katalin HIDEGHÉTY
Principal Investigator Email
katalin.hideghety@gmail.com
Contact Person Name
Katalin HIDEGHÉTY
Contact Person Email
katalin.hideghety@gmail.com
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Fül-Orr-Gége, Fej- és Nyaksebészeti Osztály
Principal Investigator Name
Frigyes HELFFERICH
Principal Investigator Email
frigyes.helfferich@gmail.com
Contact Person Name
Frigyes HELFFERICH
Contact Person Email
frigyes.helfferich@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
166
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Radiotherapy Department II
Principal Investigator Name
Rodica Maricela Anghel
Principal Investigator Email
contact@iob.ro
Contact Person Name
Rodica Maricela Anghel
Contact Person Email
contact@iob.ro

Czechia

Earliest CTIS Part Ii Submission Date
25-11-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
27
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Fakultni Nemocnice Bulovka
Department Name
Ustav radiacni onkologie
Principal Investigator Name
Petra Holeckova
Principal Investigator Email
petra.holeckova@bulovka.cz
Contact Person Name
Petra Holeckova
Contact Person Email
petra.holeckova@bulovka.cz

Spain

Earliest CTIS Part Ii Submission Date
26-03-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
253
Number Of Sites
15
Number Of Participants
30

Sites

Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Head and Neck and Cancer, Gastrointestinal Cancer Unit
Principal Investigator Name
Luka Mihic
Principal Investigator Email
lmihic@hmhospitales.com
Contact Person Name
Luka Mihic
Contact Person Email
lmihic@hmhospitales.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Radiation Oncology
Principal Investigator Name
Jordi Giralt
Principal Investigator Email
jorgeluis.giralt@vallhebron.cat
Contact Person Name
Jordi Giralt
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Medical Oncology
Principal Investigator Name
Imanol Martínez Salas
Principal Investigator Email
imanol.martinez@quironsalud.es
Contact Person Name
Imanol Martínez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Radiation oncology
Principal Investigator Name
Jorge Contreras Martínez
Principal Investigator Email
jorgecontrerasmartinez@gmail.com
Contact Person Name
Jorge Contreras Martínez
Site Name
Hospital Universitario De Cruces
Department Name
Radiotherapeutic Oncology
Principal Investigator Name
Jon Cacicedo Fernandez Bobadilla
Principal Investigator Email
joncaci@gmail.com
Contact Person Name
Jon Cacicedo Fernandez Bobadilla
Contact Person Email
joncaci@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Principal Investigator Name
Marta Sotelo
Principal Investigator Email
Marta.sotelo@sc.salud.es
Contact Person Name
Marta Sotelo
Contact Person Email
Marta.sotelo@sc.salud.es
Site Name
Institut Catala D'oncologia
Department Name
Radiation Oncology
Principal Investigator Name
Isabel Linares Galiana
Principal Investigator Email
ilinaresgaliana@iconcologia.net
Contact Person Name
Isabel Linares Galiana
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Medical Oncology
Principal Investigator Name
Hector Aguilar Andino
Principal Investigator Email
haguilar@fivo.org
Contact Person Name
Hector Aguilar Andino
Contact Person Email
haguilar@fivo.org
Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology, Head and Neck and Tyroid Unit
Principal Investigator Name
Izaskun Valduvieco
Principal Investigator Email
Ivalduvi@clinic.cat
Contact Person Name
Izaskun Valduvieco
Contact Person Email
Ivalduvi@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Medical Oncology
Principal Investigator Name
Marta Sotelo
Principal Investigator Email
Marta.sotelo@sc.salud.es
Contact Person Name
Marta Sotelo
Contact Person Email
Marta.sotelo@sc.salud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Principal Investigator Name
Mª José Flor Oncala
Principal Investigator Email
mariajflor@hotmail.com
Contact Person Name
Mª José Flor Oncala
Contact Person Email
mariajflor@hotmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oral and Maxillofacial Surgery
Principal Investigator Name
Santiago Ochandiano
Principal Investigator Email
santiago.ochandiano@salud.madrid.org
Contact Person Name
Santiago Ochandiano
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medical Oncology
Principal Investigator Name
Lara Carmen Iglesias
Principal Investigator Email
laraiglesias@hotmail.com
Contact Person Name
Lara Carmen Iglesias
Contact Person Email
laraiglesias@hotmail.com
Site Name
Hospital Universitario Lucus Augusti
Department Name
Radiation Oncology
Principal Investigator Name
Alicia Folgar Torres
Principal Investigator Email
alicia.folgar.torres@sergas.es
Contact Person Name
Alicia Folgar Torres
Contact Person Email
alicia.folgar.torres@sergas.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Medical Oncology
Principal Investigator Name
Julio Jose Lambea
Principal Investigator Email
jjlambea@salud.aragon.es
Contact Person Name
Julio Jose Lambea
Contact Person Email
jjlambea@salud.aragon.es

Austria

Earliest CTIS Part Ii Submission Date
17-06-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
227
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Department of ENT, head and neck surgery (HNO, Kopf- und Halschirurgie)
Principal Investigator Name
Andreas Strobl
Principal Investigator Email
andreas.strobl@ordensklinikum.at
Contact Person Name
Andreas Strobl
Site Name
University Hospital Graz
Department Name
Clinical Department of General ENT (Klinische Abteilung für Allgemeine HNO)
Principal Investigator Name
Dietmar Thurnher
Principal Investigator Email
dietmar.thurnher@medunigraz.at
Contact Person Name
Dietmar Thurnher
Contact Person Email
dietmar.thurnher@medunigraz.at
Site Name
Medical University Of Vienna
Department Name
Clinical Department of Oncology (“Klinische Abteilung für Onkologie”)
Principal Investigator Name
Thorsten Füreder
Principal Investigator Email
thorsten.fuereder@meduniwien.ac.at
Contact Person Name
Thorsten Füreder

France

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
12-01-2026
Processing Time Days
234
Number Of Sites
16
Number Of Participants
65

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Radiology
Principal Investigator Name
Eric Jadaud
Principal Investigator Email
eric.jadaud@chu-st-etienne.fr
Contact Person Name
Eric Jadaud
Contact Person Email
eric.jadaud@chu-st-etienne.fr
Site Name
Oncopole Claudius Regaud
Department Name
Radiation oncology
Principal Investigator Name
Céline DALMASSO
Principal Investigator Email
dalmasso.celine@iuct-oncopole.fr
Contact Person Name
Céline DALMASSO
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
ENT and cervical facial surgery department
Principal Investigator Name
Franck Jegoux
Principal Investigator Email
franck.jegoux@chu-rennes.fr
Contact Person Name
Franck Jegoux
Contact Person Email
franck.jegoux@chu-rennes.fr
Site Name
Centre Francois Baclesse
Department Name
Radiation Oncology
Principal Investigator Name
Juliette Thariat
Principal Investigator Email
j.thariat@baclesse.unicancer.fr
Contact Person Name
Juliette Thariat
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Radiotherapy
Principal Investigator Name
Ulrike Schick
Principal Investigator Email
ulrike.schick@chu-brest.fr
Contact Person Name
Ulrike Schick
Contact Person Email
ulrike.schick@chu-brest.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
Oncology-Radiotherapy
Principal Investigator Name
Sophie Renard
Principal Investigator Email
s.renard@nancy.unicancer.fr
Contact Person Name
Sophie Renard
Contact Person Email
s.renard@nancy.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
ENT (Ear, Nose, and Throat) and Head and Neck Surgery Department
Principal Investigator Name
Emmanuelle Fabiano
Principal Investigator Email
emmanuelle.fabiano@aphp.fr
Contact Person Name
Emmanuelle Fabiano
Contact Person Email
emmanuelle.fabiano@aphp.fr
Site Name
Institut Curie
Department Name
ENT and cervico facial surgery
Principal Investigator Name
Maria Lesnik
Principal Investigator Email
maria.lesnik@curie.fr
Contact Person Name
Maria Lesnik
Contact Person Email
maria.lesnik@curie.fr
Site Name
Institut Gustave Roussy
Department Name
Radiotherapy
Principal Investigator Name
Thanh-Van Nguyen
Principal Investigator Email
th.nguyen@gustaveroussy.fr
Contact Person Name
Thanh-Van Nguyen
Contact Person Email
th.nguyen@gustaveroussy.fr
Site Name
Centre Henri Becquerel
Department Name
Radiotherapy
Principal Investigator Name
Sébastien Thureau
Principal Investigator Email
sebastien.thureau@chb.unicancer.fr
Contact Person Name
Sébastien Thureau
Site Name
Centr Georges Francois Leclerc
Department Name
Radiotherapy
Principal Investigator Name
Noémie VULQUIN
Principal Investigator Email
nvulquin@cgfl.fr
Contact Person Name
Noémie VULQUIN
Contact Person Email
nvulquin@cgfl.fr
Site Name
Centre Oscar Lambret
Department Name
Radiotherapy
Principal Investigator Name
Isaure Roquette
Principal Investigator Email
i-roquette@o-lambret.fr
Contact Person Name
Isaure Roquette
Contact Person Email
i-roquette@o-lambret.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Radiation Oncology
Principal Investigator Name
Jean-Michel Vannetzel
Principal Investigator Email
dr.vannetzel@gmail.com
Contact Person Name
Jean-Michel Vannetzel
Contact Person Email
dr.vannetzel@gmail.com
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Medical oncology and radiotherapy department
Principal Investigator Name
Etienne Fessart
Principal Investigator Email
fessart.etienne@chu-amiens.fr
Contact Person Name
Etienne Fessart
Contact Person Email
fessart.etienne@chu-amiens.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Medical Oncology
Principal Investigator Name
Sébastien Salas
Principal Investigator Email
sebastien.salas@ap-hm.fr
Contact Person Name
Sébastien Salas
Contact Person Email
sebastien.salas@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Radiotherapy
Principal Investigator Name
Charles Dupin
Principal Investigator Email
charles.dupin@chu-bordeaux.fr
Contact Person Name
Charles Dupin
Contact Person Email
charles.dupin@chu-bordeaux.fr

Portugal

Earliest CTIS Part Ii Submission Date
05-05-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
290
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncology
Principal Investigator Name
Diogo Alpuim Costa
Principal Investigator Email
diogo.costa@jmellosaude.pt
Contact Person Name
Diogo Alpuim Costa
Contact Person Email
diogo.costa@jmellosaude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Medical oncology
Principal Investigator Name
Joana Marinho
Principal Investigator Email
joana.marinho@ulsge.min-saude.pt
Contact Person Name
Joana Marinho

Greece

Earliest CTIS Part Ii Submission Date
20-05-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
294
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
University General Hospital Attikon
Department Name
Internal Medicine Clinic / Oncology Unit
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
psyrri237@yahoo.com
Contact Person Name
Amanda Psyrri
Contact Person Email
psyrri237@yahoo.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Principal Investigator Name
Sofia Baka
Principal Investigator Email
bakasofia@hotmail.com
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
General University Hospital Of Larissa
Department Name
Oncology Department / 1st Internal Medicine Division
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com

Sponsor

Primary sponsor

Full Name
Johnson & Johnson Enterprise Innovation Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research LLC
Responsibilities
ECG holter data analysis / review for the sub-study
Name
Icon Clinical Research Limited
Responsibilities
code 6
Name
Fortrea Inc.
Responsibilities
code 8
Name
Clinical Services International LLC
Responsibilities
Provider of non-IMP medication

Third parties

  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"ECG holter data analysis / review for the sub-study","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Medidata Solutions International Limited","duties_or_roles":"codes 3 and 7","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment rental","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Central imaging review","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Quality Assistance","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Aquilab By Coexya","duties_or_roles":"Radiotherapy QA service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Services International LLC","duties_or_roles":"Provider of non-IMP medication","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"reimbursement of study subject expenses","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
JNJ-90301900
Active Substance
HAFNIUM OXIDE
Modality
Other
Routes Of Administration
INTRATUMORAL USE
Route
INTRATUMORAL USE
Authorisation Status
Investigational (no marketing authorisation provided in record)
Investigational Product Name
Erbitux 5 mg/mL solution for infusion
Active Substance
CETUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
Authorised (marketing authorisation EU/1/04/281/003 listed)
Combination Treatment
Yes

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