Clinical trial • Phase III • Oncology

PETOSEMTAMAB for Head and neck squamous cell carcinoma (PD-L1 positive, recurrent or metastatic)

Phase III trial of PETOSEMTAMAB for Head and neck squamous cell carcinoma (PD-L1 positive, recurrent or metastatic).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Head and neck squamous cell carcinoma (PD-L1 positive, recurrent or metastatic)
Trial Stage
Phase III
Drug Modality
Bispecific antibody | Monoclonal antibody

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
27-08-2024

Trial design

Randomised, open-label, two arms: petosemtamab plus pembrolizumab versus pembrolizumab monotherapy (doses/schedules not specified in the provided record)-controlled Phase III trial in Belgium, Poland, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Two arms: petosemtamab plus pembrolizumab versus pembrolizumab monotherapy (doses/schedules not specified in the provided record)
Target Sample Size
316

Eligibility

Recruits 316 Vulnerable population selection is indicated in the record. Informed consent is required: "Signed ICF before initiation of any study specific procedures". The record does not provide further details on assent or guardian consent procedures..

Pregnancy Exclusion
13. Pregnant or breastfeeding participants; participants of childbearing potential must use highly effective contraception methods per local standards prior to study entry, for the duration of study participation, and for 6 months after the last dose of petosemtamab or 4 months after the last dose of pembrolizumab, whichever is longer.
Vulnerable Population
Vulnerable population selection is indicated in the record. Informed consent is required: "Signed ICF before initiation of any study specific procedures". The record does not provide further details on assent or guardian consent procedures.

Inclusion criteria

  • {"criterion_text":"- 1. Signed ICF before initiation of any study specific procedures"}
  • {"criterion_text":"- 2. Age ≥ 18 years at signing of ICF"}
  • {"criterion_text":"- 3. Histologically confirmed HNSCC with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent. Participants with HNSCC primary tumor locations in oropharynx, oral cavity, hypopharynx, and larynx are eligible."}
  • {"criterion_text":"- 4. HNSCC participants eligible to receive pembrolizumab as 1L monotherapy with tumors expressing PD L1, CPS ≥1, as determined by an IHC test in a central laboratory"}
  • {"criterion_text":"- 5. HNSCC participants should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if progressive disease (PD) was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed."}
  • {"criterion_text":"- 6. Tumor tissue biopsy (as specified per protocol)"}
  • {"criterion_text":"- 7. Measurable disease as defined by RECIST v1.1 by radiologic methods"}
  • {"criterion_text":"- 8. ECOG PS of 0 or 1"}
  • {"criterion_text":"- 9. Life expectancy ≥ 12 weeks, as per investigator assessment"}
  • {"criterion_text":"- 10.\tLeft ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan"}
  • {"criterion_text":"- 11. Adequate organ function (as per protocol)"}
  • {"criterion_text":"- 12.\tHuman immunodeficiency virus (HIV) positive participants are eligible (if certain criteria are met per protocol)."}

Exclusion criteria

  • {"criterion_text":"- 1. Central nervous system (CNS) metastases that are untreated or already treated but symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 21 days of study entry"}
  • {"criterion_text":"- 10. Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. Participants with a history of non-infectious pneumonitis/interstitial lung disease (ILD) or evidence of current pneumonitis/ILD on baseline chest imaging will be excluded."}
  • {"criterion_text":"- 11. Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic, or psychiatric disorders that preclude safety and efficacy evaluation"}
  • {"criterion_text":"- 12. Participants with known infectious diseases (as per protocol)"}
  • {"criterion_text":"- 13. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment"}
  • {"criterion_text":"- 14. Requirement for immunosuppressive medication (eg, methotrexate, cyclophosphamide)"}
  • {"criterion_text":"- 15. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment"}
  • {"criterion_text":"- 16. Clinically significant toxicities related to prior anticancer therapy that have not returned to ≤ Grade 1 or baseline except for ≤Grade 2 myalgia, neuropathy, alopecia, and prior therapy-related endocrinopathies."}
  • {"criterion_text":"- 7. History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab required for this study"}
  • {"criterion_text":"- 8. Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except appropriately treated atrial fibrillation, paroxysmal supraventricular tachycardia); or history of myocardial infarction within 6 months of study entry"}
  • {"criterion_text":"- 9. History of prior malignancies, with the exception of excised local cancer, or treated cancer deemed at low risk for recurrence with no evidence of disease for ≥3 years"}
  • {"criterion_text":"- 18. Received a live or live-attenuated vaccine within 28 days prior to randomization"}
  • {"criterion_text":"- 2. Known leptomeningeal involvement"}
  • {"criterion_text":"- 3. Any systemic anticancer therapy within 4 weeks of the first dose of study treatment"}
  • {"criterion_text":"- 4. Requirement for immunosuppressive medication (eg, methotrexate, cyclophosphamide)"}
  • {"criterion_text":"- 5. Major surgery or radiotherapy within 3 weeks of the first dose of study treatment"}
  • {"criterion_text":"- 6. Clinically significant toxicities related to prior anticancer therapy that have not returned to ≤ Grade 1 or baseline except for ≤Grade 2 myalgia, neuropathy, alopecia, and prior therapy-related endocrinopathies."}
  • {"criterion_text":"- 17. The participant has a primary tumor site (as specified per protocol)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Objective response rate (ORR)","definition_or_measurement_approach":"ORR measured per RECIST v1.1 (as specified in protocol)"}
  • {"endpoint_text":"- 2. Overall survival (OS)","definition_or_measurement_approach":"Overall survival (OS) as stated in protocol"}

Secondary endpoints

  • {"endpoint_text":"- 1. PFS per RECIST v1.1 as assessed by investigator review","definition_or_measurement_approach":"Progression-free survival (PFS) per RECIST v1.1 (investigator review)"}
  • {"endpoint_text":"- 2. The Duration of Response (DoR) per RECIST v1.1 and by investigator review","definition_or_measurement_approach":"Duration of Response (DoR) per RECIST v1.1 (investigator review)"}
  • {"endpoint_text":"- 3. The Clinical Benefit Rate (CBR) per RECIST v1.1 and by investigator review","definition_or_measurement_approach":"Clinical Benefit Rate (CBR) per RECIST v1.1 (investigator review)"}
  • {"endpoint_text":"- 4. Percentage of participants with PFS at visit 1 and visit 2 per RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Percentage with PFS at specified visits per RECIST v1.1 as assessed by Blinded Independent Central Review (BICR)"}

Recruitment

Planned Sample Size
316
Recruitment Window Months
42
Consent Approach
Signed informed consent form (ICF) required before initiation of any study-specific procedures. ICF and participant information materials are provided in multiple languages (examples present in the record include English, French, Dutch/German (BE), Greek, Italian, Spanish, Polish, Lithuanian, Czech, Portuguese, Hungarian). Participants must be ≥18 years; no assent or guardian consent procedures are described in the provided record.

Geography

Total Number Of Sites
86
Total Number Of Participants
479

Belgium

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
03-09-2025
Processing Time Days
401
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
Antwerp University Hospital
Department Name
Oncology
Principal Investigator Name
Marika Rasschaert
Principal Investigator Email
marika.rasschaert@uza.be
Contact Person Name
Marika Rasschaert
Contact Person Email
marika.rasschaert@uza.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Medical oncology
Principal Investigator Name
Aurélie Poncin
Principal Investigator Email
aponcin@chuliege.be
Contact Person Name
Aurélie Poncin
Contact Person Email
aponcin@chuliege.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Head and Neck Oncology
Principal Investigator Name
Stéphanie Henry
Principal Investigator Email
comite.ethique.se@chuuclnamur.uclouvain.be
Contact Person Name
Stéphanie Henry
Site Name
Universitair Ziekenhuis Gent
Department Name
Medical oncology
Principal Investigator Name
Michael Saerens
Principal Investigator Email
michael.saerens@uzgent.be
Contact Person Name
Michael Saerens
Contact Person Email
michael.saerens@uzgent.be
Site Name
UZ Leuven
Department Name
Medical oncology
Principal Investigator Name
Paul Clement
Principal Investigator Email
paul.clement@uzleuven.be
Contact Person Name
Paul Clement
Contact Person Email
paul.clement@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Medical oncology
Principal Investigator Name
Jean-Pascal Machiels
Principal Investigator Email
jean-pascal.machiels@saintluc.uclouvain.be
Contact Person Name
Jean-Pascal Machiels

Poland

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
403
Number Of Sites
6
Number Of Participants
31

Sites

Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Zakład Teleradioterapii i Oddział Chorób Rozrostowych
Principal Investigator Name
Jacek Fijuth
Principal Investigator Email
jacekf@kopernik.lodz.pl
Contact Person Name
Jacek Fijuth
Contact Person Email
jacekf@kopernik.lodz.pl
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Principal Investigator Name
Anna Kowalczyk-Tekiela
Principal Investigator Email
atekiela@initeria.pl
Contact Person Name
Anna Kowalczyk-Tekiela
Contact Person Email
atekiela@initeria.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
Department Name
Klinika Nowotworów Glowy i Szyi
Principal Investigator Name
Andrzej Kawecki
Principal Investigator Email
andrzej.kawecki@nio.gov.pl
Contact Person Name
Andrzej Kawecki
Contact Person Email
andrzej.kawecki@nio.gov.pl
Site Name
Uniwersyteckie Centrum Kliniczne (Gdansk)
Department Name
Klinika Onkologii i Radioterapii
Principal Investigator Name
Krzysztof Konopa
Principal Investigator Email
konopa@gumed.edu.pl
Contact Person Name
Krzysztof Konopa
Contact Person Email
konopa@gumed.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
Department Name
Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Tomasz Rutkowski
Principal Investigator Email
tomasz.rutkowski@gliwice.nio.gov.pl
Contact Person Name
Tomasz Rutkowski
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl

Netherlands

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
29-08-2025
Processing Time Days
395
Number Of Sites
3
Number Of Participants
13

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Oncology
Principal Investigator Name
Carla van Herpen
Principal Investigator Email
carla.vanherpen@radboudumc.nl
Contact Person Name
Carla van Herpen
Contact Person Email
carla.vanherpen@radboudumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Oncology
Principal Investigator Name
Lot Devriese
Principal Investigator Email
l.a.devriese@umcutrecht.nl
Contact Person Name
Lot Devriese
Contact Person Email
l.a.devriese@umcutrecht.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Oncolocy
Principal Investigator Name
Jan Paul de Boer
Principal Investigator Email
j.d.boer@nki.nl
Contact Person Name
Jan Paul de Boer
Contact Person Email
j.d.boer@nki.nl

Czechia

Earliest CTIS Part Ii Submission Date
26-11-2025
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
48
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
University Hospital Olomouc
Department Name
Onkologická klinika
Principal Investigator Name
Bohuslav Melichar
Principal Investigator Email
bohuslav.melichar@fnol.cz
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologická klinika
Principal Investigator Name
Michaela Jirkovská
Principal Investigator Email
michaela.jirkovska@fnmotol.cz
Contact Person Name
Michaela Jirkovská
Contact Person Email
michaela.jirkovska@fnmotol.cz

Lithuania

Earliest CTIS Part Ii Submission Date
02-12-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
2
Number Of Sites
2
Number Of Participants
22

Sites

Site Name
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Department Name
Chemotherapy Day Inpatient Unit
Principal Investigator Name
Giedrė Anglickienė
Principal Investigator Email
ieva.kasiliauskaite@nvc.santa.lt
Contact Person Name
Giedrė Anglickienė
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Department of Oncology and Hematology
Principal Investigator Name
Viktoras Rudžianskas
Principal Investigator Email
viktoras.rudzianskas@kaunoklinikos.lt
Contact Person Name
Viktoras Rudžianskas

Croatia

Earliest CTIS Part Ii Submission Date
26-01-2026
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
8
Number Of Sites
4
Number Of Participants
65

Sites

Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Department for medical oncology
Principal Investigator Name
Ljubica Vazdar
Principal Investigator Email
ljubica.vazdar@kbcsm.hr
Contact Person Name
Ljubica Vazdar
Contact Person Email
ljubica.vazdar@kbcsm.hr
Site Name
University Hospital Centre Zagreb
Department Name
Department of oncology
Principal Investigator Name
Vesna Bisof
Principal Investigator Email
vesna.bisof@kbc-zagreb.hr
Contact Person Name
Vesna Bisof
Contact Person Email
vesna.bisof@kbc-zagreb.hr
Site Name
Klinicki Bolnicki Centar Osijek
Department Name
Department for head and neck tumors
Principal Investigator Name
Zdenka Kotromanovic
Principal Investigator Email
zdenka.kotromanovic@gmail.com
Contact Person Name
Zdenka Kotromanovic
Contact Person Email
zdenka.kotromanovic@gmail.com
Site Name
KBC Split
Department Name
Department of oncology and radiotherapy
Principal Investigator Name
Eduard Vrdoljak
Principal Investigator Email
edo.vrdoljak@gmail.com
Contact Person Name
Eduard Vrdoljak
Contact Person Email
edo.vrdoljak@gmail.com

France

Earliest CTIS Part Ii Submission Date
29-07-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
565
Number Of Sites
14
Number Of Participants
58

Sites

Site Name
Clinique Victor Hugo (Centre De Cancerologie De La Sarthe)
Department Name
Radiothezapy - Oncology
Principal Investigator Name
Yoann POINTREAU
Principal Investigator Email
essaispointreau@ilcgroupe.fr
Contact Person Name
Yoann POINTREAU
Contact Person Email
essaispointreau@ilcgroupe.fr
Site Name
Centre Henri Becquerel
Department Name
Medical Oncology
Principal Investigator Name
Florian Clatot
Principal Investigator Email
florian.clatot@chb.unicancer.fr
Contact Person Name
Florian Clatot
Site Name
Institut Gustave Roussy
Department Name
Medical Oncology
Principal Investigator Name
Caroline Even
Principal Investigator Email
caroline.even@gustaveroussy.fr
Contact Person Name
Caroline Even
Contact Person Email
caroline.even@gustaveroussy.fr
Site Name
Institut Curie
Department Name
Medical Oncology
Principal Investigator Name
Edith Borcoman
Principal Investigator Email
edith.borcoman@curie.fr
Contact Person Name
Edith Borcoman
Contact Person Email
edith.borcoman@curie.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
Institut De Cancerologie De Lorraine
Department Name
Oncologie
Principal Investigator Name
Camille JAUD
Principal Investigator Email
c.jaud@nancy.unicancer.fr
Contact Person Name
Camille JAUD
Contact Person Email
c.jaud@nancy.unicancer.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Principal Investigator Name
Thibault Mazard
Principal Investigator Email
thibault.mazard@icm.unicancer.fr
Contact Person Name
Thibault Mazard
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Jerome Fayette
Principal Investigator Email
jerome.fayette@lyon.unicancer.fr
Contact Person Name
Jerome Fayette
Site Name
Centre Antoine Lacassagne
Department Name
Medical Oncology
Principal Investigator Name
Esma Saada-Bouzid
Principal Investigator Email
esma.saada-bouzid@nice.unicancer.fr
Contact Person Name
Esma Saada-Bouzid
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medical Oncology
Principal Investigator Name
Armaury Daste
Principal Investigator Email
amaury.daste@chu-bordeaux.fr
Contact Person Name
Armaury Daste
Contact Person Email
amaury.daste@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Medical oncology - immunology
Principal Investigator Name
Matthieu BAINAUD
Principal Investigator Email
matthieu.bainaud@chu-poitiers.fr
Contact Person Name
Matthieu BAINAUD
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Principal Investigator Name
Cyril Abdeddaim
Principal Investigator Email
c-abdeddaim@o-lambret.fr
Contact Person Name
Cyril Abdeddaim
Contact Person Email
c-abdeddaim@o-lambret.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Medical Oncology
Principal Investigator Name
Victor Sarradin
Principal Investigator Email
sarradin.victor@iuct-oncopole.fr
Contact Person Name
Victor Sarradin
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Medical Oncology
Principal Investigator Name
Aurore VOZY
Principal Investigator Email
aurore.vozy@aphp.fr
Contact Person Name
Aurore VOZY
Contact Person Email
aurore.vozy@aphp.fr

Greece

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
715
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Internal Medicine Clinic (P.C 12462)
Principal Investigator Name
Amanda Psyrri
Principal Investigator Email
secr.bppk@yahoo.gr
Contact Person Name
Amanda Psyrri
Contact Person Email
secr.bppk@yahoo.gr
Site Name
St. Luke's Hospital S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Eleni Fountzila
Principal Investigator Email
info@klinikiagiosloukas.gr
Contact Person Name
Eleni Fountzila
Contact Person Email
info@klinikiagiosloukas.gr
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology, Department of Medicine
Principal Investigator Name
Angelos Koutras
Principal Investigator Email
angkoutr@otenet.gr
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.
Department Name
1st Department of Medical Oncology
Principal Investigator Name
Athanasios Argyris
Principal Investigator Email
argirisoncology@gmail.com
Contact Person Name
Athanasios Argyris
Contact Person Email
argirisoncology@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Department of Medical Oncology
Principal Investigator Name
Sofia Agelaki
Principal Investigator Email
agelaki@uoc.gr
Contact Person Name
Sofia Agelaki
Contact Person Email
agelaki@uoc.gr

Hungary

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
15-05-2026
Processing Time Days
186
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
University Of Pecs
Department Name
Onkoterápiás Intézet
Principal Investigator Name
Szabolcs BELLYEI
Principal Investigator Email
onkoterapias.intezet@pte.hu
Contact Person Name
Szabolcs BELLYEI
Contact Person Email
onkoterapias.intezet@pte.hu
Site Name
University Of Szeged
Department Name
Onkoterápiás klinika
Principal Investigator Name
Melinda CSENKI-LALIA
Principal Investigator Email
office.onko@med.u-szeged.hu
Contact Person Name
Melinda CSENKI-LALIA
Contact Person Email
office.onko@med.u-szeged.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Onkoradiológia
Principal Investigator Name
Agnes WEBER
Principal Investigator Email
dr.weber.agnes@szszbmk.hu
Contact Person Name
Agnes WEBER
Contact Person Email
dr.weber.agnes@szszbmk.hu

Austria

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
715
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Uniklinikum Salzburg Landeskrankenhaus Universitätsklinik für Innere Medizin III
Principal Investigator Name
Teresa Magnes
Principal Investigator Email
t.magnes@salk.at
Contact Person Name
Teresa Magnes
Contact Person Email
t.magnes@salk.at
Site Name
Medical University Of Graz
Department Name
Universitätsklinikum für Hals-, Nasen- und Ohrenheilkunde Graz
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
Ordensklinikum Linz GmbH
Department Name
Ordensklinikum Linz GmbH Barmherzige Schwestern
Principal Investigator Name
Andreas Strobl
Principal Investigator Email
studien.bhs@ordensklinikum.at
Contact Person Name
Andreas Strobl
Contact Person Email
studien.bhs@ordensklinikum.at

Portugal

Earliest CTIS Part Ii Submission Date
10-11-2025
Latest Decision Or Authorization Date
14-05-2026
Processing Time Days
185
Number Of Sites
6
Number Of Participants
15

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Medical Oncology Department
Principal Investigator Name
Leonor Pinto
Principal Investigator Email
10331@ulscoimbra.min-saude.pt
Contact Person Name
Leonor Pinto
Contact Person Email
10331@ulscoimbra.min-saude.pt
Site Name
Hospital Cuf Descobertas S.A.
Department Name
Oncology department
Principal Investigator Name
Diogo Alpuim Costa
Principal Investigator Email
diogo.costa@cuf.pt
Contact Person Name
Diogo Alpuim Costa
Contact Person Email
diogo.costa@cuf.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology Department
Principal Investigator Name
José Dinis
Principal Investigator Email
jdinis@ipo.porto.min-saude.pt
Contact Person Name
José Dinis
Contact Person Email
jdinis@ipo.porto.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Medical Oncology Department
Principal Investigator Name
Fernando Gonçalves
Principal Investigator Email
fernando.goncalves@ulssa.min-saude.pt
Contact Person Name
Fernando Gonçalves
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Oncology department
Principal Investigator Name
Ana Varges Gomes
Principal Investigator Email
ana.varges.gomes@chalgarve.min-saude.pt
Contact Person Name
Ana Varges Gomes
Site Name
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Oncology Department
Principal Investigator Name
Teresa Sarmento
Principal Investigator Email
tsarmento@chtmad.min-saude.pt
Contact Person Name
Teresa Sarmento
Contact Person Email
tsarmento@chtmad.min-saude.pt

Italy

Earliest CTIS Part Ii Submission Date
28-05-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
715
Number Of Sites
10
Number Of Participants
44

Sites

Site Name
ARNAS G. Brotzu
Department Name
Oncologia medica
Principal Investigator Name
Massimo Ghiani
Principal Investigator Email
massimo.ghiani@aob.it
Contact Person Name
Massimo Ghiani
Contact Person Email
massimo.ghiani@aob.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
clinical and experimental oncology of immunotherapy and rare cancers
Principal Investigator Name
Sebastiano Calpona
Principal Investigator Email
sebastiano.calpona@irst.emr.it
Contact Person Name
Sebastiano Calpona
Contact Person Email
sebastiano.calpona@irst.emr.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di Oncologia Medica Urogenitale e Cervico facciale
Principal Investigator Name
Maria Cossu Rocca
Principal Investigator Email
Maria.cossurocca@ieo.it
Contact Person Name
Maria Cossu Rocca
Contact Person Email
Maria.cossurocca@ieo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
UOC Oncologia
Principal Investigator Name
Alessio Cirillo
Principal Investigator Email
alessio.cirillo@uniroma1.it
Contact Person Name
Alessio Cirillo
Contact Person Email
alessio.cirillo@uniroma1.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Operating unit of Oncology and Hematology
Principal Investigator Name
Paolo Bossi
Principal Investigator Email
paolo.bossi@hunimed.eu
Contact Person Name
Paolo Bossi
Contact Person Email
paolo.bossi@hunimed.eu
Site Name
Azienda Ospedaliero Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
U.O.C. oncologia medica
Principal Investigator Name
Morena Fasano
Principal Investigator Email
morena.fasano@unicampania.it
Contact Person Name
Morena Fasano
Contact Person Email
morena.fasano@unicampania.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia medica
Principal Investigator Name
Lisa Licitra
Principal Investigator Email
lisa.licitra@istitutotumori.it
Contact Person Name
Lisa Licitra
Contact Person Email
lisa.licitra@istitutotumori.it
Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Muscle scheletrical and head and neck - Unit
Principal Investigator Name
Francesco Perri
Principal Investigator Email
f.perri@istitutotumori.na.it
Contact Person Name
Francesco Perri
Contact Person Email
f.perri@istitutotumori.na.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di medicina interna - SOD Clinica Oncologica
Principal Investigator Name
Rossana Berardi
Principal Investigator Email
rossana.berardi@ospedaliriuniti.marche.it
Contact Person Name
Rossana Berardi
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
University of Brescia – Medical Oncology Unit
Principal Investigator Name
Andrea Alberti
Principal Investigator Email
a.alberti@unibs.it
Contact Person Name
Andrea Alberti
Contact Person Email
a.alberti@unibs.it

Germany

Earliest CTIS Part Ii Submission Date
17-06-2024
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
694
Number Of Sites
13
Number Of Participants
58

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Interdisziplinäres Studienzentrum (ISZ) mit ECTU
Principal Investigator Name
Urs Müller-Richter
Principal Investigator Email
mueller_u2@ukw.de
Contact Person Name
Urs Müller-Richter
Contact Person Email
mueller_u2@ukw.de
Site Name
Klinikum Dortmund gGmbH
Department Name
Department of Otorhinolaryngology, Head and Neck Surgery
Principal Investigator Name
Claus Wittekindt
Principal Investigator Email
Claus.wittekindt@klinikumdo.de
Contact Person Name
Claus Wittekindt
Contact Person Email
Claus.wittekindt@klinikumdo.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hals-, Nasen- und Ohrenheilkunde
Principal Investigator Name
Achim Beule
Principal Investigator Email
achimgeorg.beule@ukmuenster.de
Contact Person Name
Achim Beule
Contact Person Email
achimgeorg.beule@ukmuenster.de
Site Name
Medizinische Hochschule Hannover
Department Name
Department of Hematology, hemostasis, oncology and stem cell transplantation
Principal Investigator Name
Philipp Ivanyi
Principal Investigator Email
ivanyi.philipp@mh-hannover.de
Contact Person Name
Philipp Ivanyi
Contact Person Email
ivanyi.philipp@mh-hannover.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Department for Otorhinolaryngology, Head and Neck Surgery
Principal Investigator Name
Barbara Wollenberg
Principal Investigator Email
barbara.wollenberg@tum.de
Contact Person Name
Barbara Wollenberg
Contact Person Email
barbara.wollenberg@tum.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Klinik Altona Abteilung Onkologie, Hämatologie
Principal Investigator Name
Dirk Arnold
Principal Investigator Email
d.arnold@asklepios.com
Contact Person Name
Dirk Arnold
Contact Person Email
d.arnold@asklepios.com
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Klinik für Hals- Nasen- und Ohrenheilkunde
Principal Investigator Name
Sven Becker
Principal Investigator Email
sven.becker@med.uni-tuebingen.de
Contact Person Name
Sven Becker
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Otorhinolaryngology, Head and Neck Surgery
Principal Investigator Name
Markus Blaurock
Principal Investigator Email
Markus.blaurock@med.uni-greifswald.de
Contact Person Name
Markus Blaurock
Site Name
University Hospital Cologne AöR
Department Name
Klinik für HNO-Heilkunde, Kopf- und Hals-Chirurgie
Principal Investigator Name
Malte Suchan
Principal Investigator Email
malte.suchan@uk-koeln.de
Contact Person Name
Malte Suchan
Contact Person Email
malte.suchan@uk-koeln.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Ulrike Ubbelohde
Principal Investigator Email
ulrike.ubbelohde@uniklinikum-dresden.de
Contact Person Name
Ulrike Ubbelohde
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Oto-Rhino-Laryngology and Head and Neck Surgery
Principal Investigator Name
Simon Laban
Principal Investigator Email
simon.laban@uniklinik-ulm.de
Contact Person Name
Simon Laban
Contact Person Email
simon.laban@uniklinik-ulm.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Oncology, hematology, and bone marrow transplantation with section of pneumology
Principal Investigator Name
Philippe Schafhausen
Principal Investigator Email
schafhausen@uke.de
Contact Person Name
Philippe Schafhausen
Contact Person Email
schafhausen@uke.de
Site Name
Heidelberg University
Department Name
Department of Otorhinolaryngology, Head and Neck Surgery, Experimantal Head and Neck Oncology
Principal Investigator Name
Annette Affolter
Principal Investigator Email
Annette.affolter@umm.de
Contact Person Name
Annette Affolter
Contact Person Email
Annette.affolter@umm.de

Spain

Earliest CTIS Part Ii Submission Date
16-06-2024
Latest Decision Or Authorization Date
13-05-2026
Processing Time Days
696
Number Of Sites
9
Number Of Participants
44

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Principal Investigator Name
Irene Braña Garcia
Principal Investigator Email
ibrana@vhi.net
Contact Person Name
Irene Braña Garcia
Contact Person Email
ibrana@vhi.net
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 12 De Octubre
Department Name
Oncology
Principal Investigator Name
Lara Iglesias Docampo
Principal Investigator Email
laracarmen.iglesias@salud.madrid.org
Contact Person Name
Lara Iglesias Docampo
Site Name
Institut Catala D'oncologia
Department Name
Medical Oncology
Principal Investigator Name
Angelica Ferrando Díez
Principal Investigator Email
aferrandod@iconcologia.net
Contact Person Name
Angelica Ferrando Díez
Contact Person Email
aferrandod@iconcologia.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Principal Investigator Name
Hector Augusto Aguilar Andino
Principal Investigator Email
hagilar@fivo.org
Contact Person Name
Hector Augusto Aguilar Andino
Contact Person Email
hagilar@fivo.org
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Principal Investigator Name
Jose Maria Lopez-Picazo Gonzalez
Principal Investigator Email
jlpicazo@unav.es
Contact Person Name
Jose Maria Lopez-Picazo Gonzalez
Contact Person Email
jlpicazo@unav.es
Site Name
Hospital Universitario De Navarra
Department Name
Oncology
Principal Investigator Name
Virginia Arrazubi Arrula
Principal Investigator Email
virginia.arrazubi.arrula@navarra.es
Contact Person Name
Virginia Arrazubi Arrula
Site Name
H.C. Hospitales S.L.
Department Name
Medical Oncology
Principal Investigator Name
José Manuel Trigo Pérez
Principal Investigator Email
jmtrigo@seom.org
Contact Person Name
José Manuel Trigo Pérez
Contact Person Email
jmtrigo@seom.org
Site Name
Hospital Clinico San Carlos
Department Name
Medical Oncology
Principal Investigator Name
Santiago Cabezas-Camarero
Principal Investigator Email
santiago.cabezas@salud.madrid.org
Contact Person Name
Santiago Cabezas-Camarero

Sponsor

Primary sponsor

Full Name
Merus B.V.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Netherlands

Contract research organisations

Name
Medpace Finland Oy
Responsibilities
Operational CRO activities as per sponsorDuties [1,12,13,2,5,6]; contact RS-Advisor-support@medpace.com
Name
Drug Development Solutions Limited
Responsibilities
Study support (sponsorDuties code 4); contact info@resolian.com
Name
Almac Clinical Services (Ireland) Limited
Responsibilities
IMP labeling, packaging and distribution, comparator sourcing
Name
Medpace Ellas Monoprosopi I.K.E.
Responsibilities
Operational/study support (sponsorDuties codes: 1,12)
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory / biomarker testing

Third parties

  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"sponsorDuties codes: [1,12,13,2,5,6]; contact RS-Advisor-support@medpace.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"sponsorDuties codes: [4]; contact info@resolian.com","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Median Technologies","duties_or_roles":"Central imaging (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"ADA testing (sponsorDuties code 15, value: 'ADA testing'); additional sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [1,12] (as provided)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"genetic testing (sponsorDuties code 15, value: 'genetic testing'); additional sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"IMP labeling, packaging and distribution, comparator sourcing (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Medpace Ellas Monoprosopi I.K.E.","duties_or_roles":"sponsorDuties codes: [1,12]","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"biomarker and/or genetic testing (sponsorDuties code 15) and code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
MCLA-158 (petosemtamab)
Active Substance
PETOSEMTAMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Investigational (not described as marketed in record)
Maximum Dose
1500 mg (product maxDailyDoseAmount field)
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketed drug (listed as pembrolizumab, comparator/marketed product)
Maximum Dose
400 mg (product maxDailyDoseAmount field)
Combination Treatment
Yes

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