Clinical trial • Phase II/III • Oncology

PEMBROLIZUMAB for Head and neck squamous cell carcinoma | Recurrent head and neck cancer | Metastatic head and neck cancer

Phase II/III trial of PEMBROLIZUMAB for Head and neck squamous cell carcinoma | Recurrent head and neck cancer | Metastatic head and neck cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Head and neck squamous cell carcinoma | Recurrent head and neck cancer | Metastatic head and neck cancer
Trial Stage
Phase II/III
Drug Modality
Monoclonal antibody | mRNA

Key dates

Initial CTIS Submission Date
10-06-2024
First CTIS Authorization Date
03-07-2024

Trial design

Randomised, open-label, pembrolizumab monotherapy (pembrolizumab; intravenous infusion). product information lists a max daily dose amount of 200 mg (doseuom mg) and route 'intravenious infusion' in the ctis product entry; specific trial dosing schedule not detailed in the ctis summary.-controlled Phase II/III trial in Poland, Portugal, Czechia and others.

Randomised
Yes
Open Label
Yes
Comparator
Pembrolizumab monotherapy (PEMBROLIZUMAB; intravenous infusion). Product information lists a max daily dose amount of 200 mg (doseUom mg) and route 'INTRAVENIOUS INFUSION' in the CTIS product entry; specific trial dosing schedule not detailed in the CTIS summary.
Target Sample Size
252

Eligibility

Recruits 252 Vulnerable population flag is selected. All participants must be aged ≥18 and provide written informed consent before any screening procedures. Study-specific informed consent forms (ICFs) and participant information sheets are provided (including main ICFs, pre-screening ICFs, biomarker ICFs, pregnant partner / partner of pregnant patient ICFs, biological father of exposed baby forms, and optional future research ICFs). Special consent materials for pregnant participants/partners and for partners/biological fathers are available; assent is not applicable because minors are excluded..

Pregnancy Exclusion
Patients are pregnant or breastfeeding.
Vulnerable Population
Vulnerable population flag is selected. All participants must be aged ≥18 and provide written informed consent before any screening procedures. Study-specific informed consent forms (ICFs) and participant information sheets are provided (including main ICFs, pre-screening ICFs, biomarker ICFs, pregnant partner / partner of pregnant patient ICFs, biological father of exposed baby forms, and optional future research ICFs). Special consent materials for pregnant participants/partners and for partners/biological fathers are available; assent is not applicable because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Patients must sign the written informed consent form before any screening procedure. Informed consent must be documented before any trial-specific screening procedure is performed.\n- Patients have adequate bone marrow function as defined by hematological parameters.\n- Patients have adequate hepatic function.\n- Patients should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥30 mL/min/min/1.73m² using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n- Patients should be stable with adequate coagulation, as determined by the investigator.\n- All patients must provide a tumor tissue sample (formalin fixed paraffin embedded [FFPE] blocks or both slides and curls) from archival tissue. Alternatively, a fresh biopsy sample could be provided if a biopsy is performed as part of the patient’s standard clinical practice before the first dose of trial treatment.\n- Women of childbearing potential (WOCBP) must not be pregnant. WOCBP, male patients who are sexually active with WOCBP and female partners of male patients should use a highly effective method of contraception up to at least 6 months after receiving the last dose of trial treatment, and should agree not to donate eggs (ova, oocytes) or sperm.\n- Patients must be aged ≥18 years on the date of signing the informed consent.\n- Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the trial.\n- Patients who present with histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.\n- Patients who have a tumor that expresses PD-L1 [CPS ≥1] as determined by the CE-marked/FDA-approved CDx PD-L1 IHC 22C3 pharmDx performed according to the manufacturer’s instructions for use.\n- The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n- Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization, if given as part of multimodal treatment for locally advanced disease is allowed.\n- Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area are considered measurable, if progression has been demonstrated in such lesions by RECIST 1.1.\n- Patients have Eastern Cooperative Oncology Group (ECOG) performance status ≤1."}

Exclusion criteria

  • {"criterion_text":"- Patients are pregnant or breastfeeding.\n- Patients who have received or currently receive the following therapy/medication: 1. Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone >10 mg daily orally [PO] or intravenously [IV], or equivalent) in the 7 days prior to the first dose of trial treatment. 2. Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) or 5 half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated adverse events (AEs) that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment. 3. Prior treatment with live-attenuated vaccines within 4 weeks before the first dose of BNT113. 4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of BNT113. 5. Ongoing treatment with therapeutic PO or IV antibiotics.\n- Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or 5 half-lives of the agent (whichever is longer) before the first dose of BNT113.\n- Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization.\n- Current evidence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade >1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria. Patients with Grade 2 neuropathy, dry mouth, or any sequelae from previous treatments may be eligible at investigator's discretion if the conditions are stable and adequately managed (e.g., stable medication) and pose no further medical risk to the patient.\n- Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they: 1. had radiotherapy or another appropriate therapy for the brain or spinal metastases, 2. have no neurological symptoms (excluding Grade ≤2 neuropathy), 3. have no evidence of clinical or radiological progression within 4 weeks before signing the informed consent, 4. do not require steroid therapy within 7 days before randomization or are undergoing slow steroid tapering, currently at doses ≤10 mg and neurologically stable. 5. spinal bone metastases are allowed, unless imminent fracture or cord compression is anticipated.\n- Patients who have previously been enrolled in this trial (rescreening is allowed once).\n- Patients with substance abuse or known medical, psychological, or social conditions that in the opinion of the investigator may interfere with the patient's participation in the trial or evaluation of the trial results.\n- Patients affiliated with the investigational site (e.g., a close relative of the investigator or dependent person, such as an employee or student of the trial site) or sponsor. For patients meeting this criterion, a prospective exception and eventual contingencies to be put in place may be defined on a case-by-case basis by the local Institutional Review Board.\n- Patients that have disease suitable for local therapy administered with curative intent.\n- Patients that have a life expectancy of less than 3 months and/or have rapidly progressive disease, as assessed by the treating investigator.\n- Patients present primary tumor site of nasopharynx (any histology).\n- Patients with high burden of visceral metastatic disease or location in anatomically critical areas (e.g., causing significant biliary or respiratory obstruction), that in the opinion of the investigator may benefit from treatment with chemotherapy.\n- Patients with uncontrolled intercurrent illness, including but not limited to: Ongoing or active infection which requires systemic treatment with antibiotics on the first dose of trial treatment. \tSymptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), myocardial infarction within 3 months before screening, unstable angina pectoris, or cardiac arrhythmia. Arterial thrombosis or pulmonary embolism within ≤6 months before the start of trial treatment, if not on a stable dose of anticoagulants or if in the opinion of the investigator contra-indicates trial inclusion. Evidence or history of interstitial lung disease that, in the opinion of the investigator, is a contraindication for treatment with pembrolizumab, or active non-infectious pneumonitis. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management. Patients with arterial hypertension need to be on stable anti-hypertensive medication for at least 4 weeks prior to trial entry. Known primary immunodeficiencies. Evidence or history of significant autoimmune disease that (a) required treatment with systemic immunosuppressive treatments, (b) was associated with ongoing treatment with corticosteroids, or (c) was associated with a record of significant end-organ dysfunction (even if transient), which in the opinion of the investigator may suggest increased risk for immune-related AEs. Patients with prior allogeneic stem cell or solid organ transplantation. Any other disease, metabolic dysfunction, physical examination finding, and/or laboratory finding giving reasonable suspicion of a disease or condition that in the opinion of the investigator contraindicates the use of an investigational drug or may render the patient at high risk for complications.\n- Patients with a known allergy, hypersensitivity, or intolerance to BNT113 or its excipients, or to pembrolizumab or its excipients.\n- Patients who have had a splenectomy.\n- Patients who have had major surgery (e.g., requiring general anesthesia) within 4 weeks prior to treatment if fully recovered, or have not fully recovered from surgery, or have major surgery planned during the time of trial participation.\n- Patients who have a known history or a positive test at screening of any of the following: 1. Human immunodeficiency virus (HIV) 1 or 2. Inclusion is allowed if HIV 1/2 infection is adequately controlled and stable on a highly effective antiviral regimen. 2. Hepatitis B infection, as defined by the presence of hepatitis B surface antigen (HbsAg) or hepatitis B virus (HBV) DNA positivity. Testing of HBV DNA is mandatory if hepatitis B core antibody is positive. 3. Hepatitis C (unless considered cured).\n- Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).\n- Patients with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Safety Run-In Phase (Part A): Occurrence of TEAEs assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious and fatal treatment-emergent adverse events (TEAEs) by relationship.","definition_or_measurement_approach":"TEAEs assessed according to CTCAE v5.0, include Grade ≥3, serious and fatal TEAEs; evaluated by relationship to study treatment."}
  • {"endpoint_text":"- Randomized phase (Part B): Overall survival (OS) defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"OS measured as time from randomization to death from any cause."}
  • {"endpoint_text":"- Randomized phase (Part B): Progression-free survival (PFS) defined as the time from randomization to the first objective tumor progression (per RECIST 1.1 assessed by BICR), or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS measured per RECIST 1.1 assessed by blinded independent central review (BICR); time from randomization to first objective progression or death."}

Secondary endpoints

  • {"endpoint_text":"- Safety run-in phase (Part A): ORR defined as the proportion of patients in whom a CR or PR is observed as best overall response. Duration of response (DoR) defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression or death from any cause, whichever occurs first. Disease control rate (DCR) defined as the proportion of patients in whom a CR or PR or stable disease (SD) is observed as best overall response.","definition_or_measurement_approach":"ORR = proportion with CR or PR; DoR = time from first CR/PR to objective progression or death; DCR = proportion with CR, PR or SD as best response. Assessments per RECIST 1.1 and BICR/investigator as specified."}
  • {"endpoint_text":"- Randomized phase (Part B): Overall response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 assessed by BICR) is observed as best overall response.","definition_or_measurement_approach":"ORR per RECIST 1.1 assessed by BICR; proportion with CR or PR as best overall response."}
  • {"endpoint_text":"- Randomized phase (Part B): Progression-free survival (PFS) defined as the time from randomization to the first objective tumor progression (per RECIST 1.1 by investigator’s assessment), or death from any cause, whichever occurs first.","definition_or_measurement_approach":"PFS measured per RECIST 1.1 by investigator assessment; time from randomization to first objective progression or death."}
  • {"endpoint_text":"- Randomized Phase (Part B): Objective response rate (ORR) defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per RECIST 1.1 by investigator’s assessment) is observed as best overall response.","definition_or_measurement_approach":"ORR per RECIST 1.1 assessed by investigator; proportion with CR or PR as best overall response."}
  • {"endpoint_text":"- Randomized Phase (Part B): PFS rate at 6 months defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR) or death from any cause from randomization until 6 months after randomization. PFS rate at 12 months defined as the proportion of patients without objective tumor progression (per RECIST 1.1 assessed by BICR) or death from any cause from randomization until 12 months after randomization.","definition_or_measurement_approach":"PFS rates at 6 and 12 months per RECIST 1.1 assessed by BICR: proportion without objective progression or death at those timepoints."}
  • {"endpoint_text":"- Randomized Phase (Part B): PFS rate at 6 months defined as the proportion of patients without objective tumor progression (per RECIST 1.1 by investigator’s assessment) or death from any cause from randomization until 6 months after randomization. •\tPFS rate at 12 months defined as the proportion of patients without objective tumor progression (per RECIST 1.1 by investigator’s assessment) or death from any cause from randomization until 12 months after randomization.","definition_or_measurement_approach":"PFS rates at 6 and 12 months per RECIST 1.1 by investigator assessment: proportion without objective progression or death at those timepoints."}
  • {"endpoint_text":"- Randomized Phase (Part B): Duration of Response (DoR) defined as the time from first objective response (CR or PR per RECIST 1.1 assessed by BICR) to first occurrence of objective tumor progression (PD per RECIST 1.1) assessed by BICR), or death from any cause, whichever occurs first.","definition_or_measurement_approach":"DoR measured per RECIST 1.1 by BICR: time from first CR/PR to objective progression or death."}
  • {"endpoint_text":"- Randomized Phase (Part B): Occurrence of Treatment Emergent Adverse Events (TEAEs) assessed according to CTCAE v5.0 including Grade ≥3, and serious, fatal treatment-emergent adverse events (TEAEs) by relationship. Occurrence of dose reduction, delay, and discontinuation of trial treatments due to TEAEs.","definition_or_measurement_approach":"TEAEs assessed per CTCAE v5.0 including Grade ≥3, serious and fatal events; capture of dose modifications and discontinuations due to TEAEs."}

Recruitment

Registry Or Advocacy Recruitment
True, Patient advocacy groups (PAG) (materials referenced but specific organisation names not provided)
Planned Sample Size
252
Recruitment Window Months
93
Consent Approach
Written informed consent is required and must be signed by each patient before any screening procedures. Patients must be ≥18 years. Site-specific subject information sheets and informed consent forms are provided in local languages and country-specific versions (examples present for PL, PT, CZ, HU, DE, FR, ES, IT, SE, BE, AT). Additional consent/ICF modules are available for biomarker procedures, optional prescreening, future research, pregnant participants/partners, and biological father/partner materials where applicable. No assent procedures specified (minors excluded).

Methods

  • Dr-to-Dr letters (physician-to-physician referral) — country-specific recruitment materials submitted (e.g., 'Dr to Dr' letters present in K1/K2 recruitment documents for PL, PT, CZ, BE, HU, IT, SE, DE, FR, ES, AT).
  • Dr-to-Patient letters (direct letters from investigator/site to potential patients) — country-specific templates present (e.g., Portugal, Italy, Spain, Germany, Belgium recruitment materials).
  • Patient brochures and patient-facing informational leaflets — country-specific patient brochures and study brochures available (documents labelled Patient Brochure for PL, PT, CZ, BE, SE, FR, ES, IT, DE, AT).
  • Site-to-Patient Advocacy Group (PAG) and 'PAG to Patients Members' letters — materials to engage patient advocacy groups/organisations (country-specific K1 documents reference PAG letters).
  • GP/Primary care notifications and 'Dr to GP' or 'GP letter' materials (country-specific recruitment packs) — used to inform primary care and referring physicians where provided.

Geography

Total Number Of Sites
72
Total Number Of Participants
98

Poland

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
24-07-2024
Processing Time Days
26
Number Of Sites
8
Number Of Participants
10

Sites

Site Name
4 Wojskowy Szpital Kliniczny Z Polikliniką Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
Department Name
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ
Contact Person Name
Anna Jakiela
Contact Person Email
onkologiabadania@4wsk.pl
Site Name
Pratia S.A.
Department Name
Centrum Medyczne Pratia Poznan
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Anna Kowalczyk
Contact Person Email
akow@gumed.edu.pl
Site Name
Pratia S.A.
Department Name
Pratia MCM Kraków
Contact Person Name
Bożena Cybulska-Stopa
Contact Person Email
bcybulskastopa@vp.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddział Onkologii i Radioterapii
Contact Person Name
Iwona Danielewicz
Contact Person Email
iwonadan@interia.pl
Site Name
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie
Department Name
Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dziennym i Izbą przyjęć
Contact Person Name
Paweł Różanowski
Contact Person Email
patryk.zybala@wco.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
I Klinika Radioterapii i Chemioterapii
Contact Person Name
Tomasz Rutkowski
Contact Person Email
tomasz.rutkowski@io.gliwice.pl
Site Name
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III
Department Name
Przychodnia Lekarska KOMED Roman Kraszewski
Contact Person Name
Bogusława Karaszewska
Contact Person Email
karasiowa@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
10
Number Of Sites
7
Number Of Participants
3

Sites

Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Oncology
Contact Person Name
Diana Freitas
Contact Person Email
dsffreitas@gmail.com
Site Name
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Margarida Teixeira
Site Name
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Isabel Sargento
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Oncology
Contact Person Name
Leonor Ribeiro
Contact Person Email
lcaribeiro@netcabo.pt
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Oncology
Contact Person Name
Jose Dinis
Contact Person Email
jdinis@ipoporto.min-saude.pt
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Oncology
Contact Person Name
Ana Raquel Monteiro
Site Name
Instituto Portugues De Oncologia De Braga (duplicate institution name may appear in record)
Department Name
Oncology

Czechia

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
19-08-2024
Processing Time Days
52
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Fakultni Nemocnice Bulovka
Department Name
Ustav radiacni onkologie
Contact Person Name
Petra Holeckova
Contact Person Email
petra.holeckova@bulovka.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Bohuslav Melichar
Contact Person Email
bohuslav.melichar@fnol.cz

Hungary

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
03-07-2024
Processing Time Days
5
Number Of Sites
3
Number Of Participants
1

Sites

Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Onkoradiologiai Osztaly
Contact Person Name
Csilla Katona
Contact Person Email
katona.csilla@uzsoki.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Onkologiai Osztaly
Contact Person Name
Zsuzsanna Papai
Contact Person Email
trial.zspapai@gmail.com
Site Name
Zala Varmegyei Szent Rafael Korhaz
Department Name
Oncology
Contact Person Name
Karoly Mahr
Contact Person Email
onkologia.zeg@hotmail.com

Belgium

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
12-07-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Oncology
Contact Person Name
Ingrid Louviaux
Site Name
UZ Brussel
Department Name
Oncology
Contact Person Name
Christel Fontaine
Contact Person Email
christel.fontaine@uzbrussel.be

Germany

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
08-07-2024
Processing Time Days
10
Number Of Sites
16
Number Of Participants
22

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Mund- Kiefer und Plastische Gesichtschirurgie, Interdisziplinäres Studienzentrum, Haus A9
Contact Person Name
Urs Müller-Richter
Contact Person Email
Mueller_u2@ukw.de
Site Name
Rostock University Medical Center
Department Name
Medizinische Klinik III (Haematologie, Onkologie, Palliativmedizin),
Contact Person Name
Christian Junghanß
Site Name
Katholisches Marienkrankenhaus gGmbH
Department Name
Zentrum für Innere Medizin
Contact Person Name
Gunnar Hapke
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
NTC Heidelberg
Contact Person Name
Sebastian M. Dieter
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde
Contact Person Name
Barbara Wollenberg
Contact Person Email
hno@mri.tum.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Haematologie, Onkologie, Rheumatologie und Immunologie
Contact Person Name
Max-Felix Häring
Site Name
University Hospital Cologne AöR
Department Name
Klinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde
Contact Person Name
Jens Peter Klussmann
Contact Person Email
Jens.klussmann@uk-koeln.de
Site Name
Katholisches Krankenhaus Hagen gGmbH
Department Name
St. Josefs Hospital
Contact Person Name
Jonas Jae-Hyun Park
Contact Person Email
Jonas.Park@uni-wh.de
Site Name
Krankenhaus Nordwest GmbH
Contact Person Name
Dragan Kiselicki
Contact Person Email
Kiselicki.dragan@khnw.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Konrad Klinghammer
Contact Person Email
konrad.klinghammer@charite.de
Site Name
Universitaet Leipzig
Department Name
Poliklinik fuer Hals-, Nasen- und Ohrenheilkunde
Contact Person Name
Andreas Dietz
Site Name
Caritas Traegergesellschaft Saarbruecken mbH (CTS)
Department Name
Department of Otorhinolaryngology
Contact Person Name
Klaus Bumm
Contact Person Email
K.bumm@caritasklinikum.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hals-, Nasen- und Ohrenheilkunde
Contact Person Name
Achim Georg Beule
Contact Person Email
AchimGeorg.Beule@ukmuenster.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Medizinische Klinik und Poliklinik, Hämatologie und Medizinische Onkologie
Contact Person Name
Juergen Alt
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Haematologie, Haemostaseologie, Onkologie und Stammzelltransplantation, OE 6860
Contact Person Name
Philipp Ivanyi
Contact Person Email
Ivanyi.Philipp@mh-hannover.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Hals-Nasen-Ohrenheilkunde und Kopf-Halschirurgie
Contact Person Name
Simon Laban
Contact Person Email
Simon.Laban@uniklinik-ulm.de

Italy

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
15-07-2024
Processing Time Days
17
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncology
Contact Person Name
Franco Nolè
Contact Person Email
franco.nole@ieo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncology
Contact Person Name
Aurora Mirabile
Contact Person Email
mirabile.aurora@hsr.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncology
Contact Person Name
Andrea Alberti
Site Name
Azienda Ulss 9 Scaligera
Department Name
Oncology
Contact Person Name
Paolo Piacentini
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
Oncology
Contact Person Name
Michele Maio

Sweden

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
03-07-2024
Processing Time Days
5
Number Of Sites
3
Number Of Participants
2

Sites

Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Oncology
Contact Person Name
Jan Nyman
Contact Person Email
jan.nyman@vgregion.se
Site Name
Region Vaesterbotten
Department Name
Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, cancer center
Contact Person Name
Martin Hellström
Contact Person Email
martin.hellstrom@umu.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Oncology
Contact Person Name
Eva Brun
Contact Person Email
eva.brun@med.lu.se

Austria

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
09-07-2024
Processing Time Days
11
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
Hämatologie/Onkologie
Contact Person Name
Florian Kocher
Contact Person Email
Florian.kocher@i-med.ac.at
Site Name
Medical University Of Graz
Department Name
HNO-Universitätsklinik
Contact Person Name
Dietmar Thurnher
Contact Person Email
dietmar.thurnher@medunigraz.at
Site Name
Ordensklinikum Linz GmbH
Department Name
HNO, Kopf- und Halschirurgie, Ordensklinikum Linz Barmherzige Schwestern.
Contact Person Name
Andreas Strobl
Site Name
SCRI CCCIT Ges.m.b.H.
Department Name
Univ. Klinik für Innere Medizin III der PMU Uniklinikum Salzburg/Landeskrankenhaus
Contact Person Name
Teresa Magnes
Contact Person Email
t.magnes@salk.at

France

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
05-07-2024
Processing Time Days
7
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncologie medicale
Contact Person Name
Sebastien SALAS
Contact Person Email
sebastien.salas@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie medicale
Contact Person Name
Amaury Daste
Contact Person Email
amaury.daste@chu-bordeau.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Centre de recherche clinique
Contact Person Name
Emmanuel BABIN
Contact Person Email
babin-e@chu-caen.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Oncologie medicale
Contact Person Name
Michel GATINEAU
Contact Person Email
mgatineau@hpsj.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Corad
Contact Person Name
Sofia BAKKAR
Contact Person Email
s.bakkar@chu-tours.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie medicale
Contact Person Name
Caroline Even
Contact Person Email
caroline.even@gustaveroussy.fr
Site Name
Institut Curie
Department Name
Department of Drug Development and Innovation (D3i)
Contact Person Name
Edith BORCOMAN
Contact Person Email
edith.borcoman@curie.fr
Site Name
Centr Georges Francois Leclerc
Department Name
Oncologie medicale
Contact Person Name
Jean-David FUMET
Contact Person Email
jdfumet@cgfl.fr

Spain

Earliest CTIS Part Ii Submission Date
28-06-2024
Latest Decision Or Authorization Date
16-07-2024
Processing Time Days
18
Number Of Sites
13
Number Of Participants
7

Sites

Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Oncology
Contact Person Name
Juan Cristobal Sánchez González
Contact Person Email
juancristobal.sg@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Oncology
Contact Person Name
Gonzalo Fernandez Hinojal
Contact Person Email
gfernandezh@unav.es
Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Jose Fuster Salva
Contact Person Email
jose.fuster@ssib.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Imanol Martínez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitario De Jaen
Department Name
Oncology
Contact Person Name
Nuria Cárdenas Quesada
Contact Person Email
nuriacardenasq@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Manuel Alejandro Mazariegos Rubi
Contact Person Email
mazariegos@recerca.clinic.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology
Contact Person Name
Vanesa Gutierrez Calderón
Contact Person Email
vgutierrezcald@gmail.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Oncology
Contact Person Name
Javier Martínez Trufero
Contact Person Email
jmtrufero@seom.org
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Oncology
Contact Person Name
Jordi Rubió Casadevall
Contact Person Email
jrubio@iconcologia.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Javier Caballero Daroqui
Contact Person Email
Caballero_jav@gva.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Oncology
Contact Person Name
Gonzalo Fernandez Hinojal
Contact Person Email
gfernandezh@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Oncology
Contact Person Name
Beatriz Castelo Fernández
Contact Person Email
castelobeatriz@gmail.com
Site Name
University Hospital Son Espases (duplicate entry may appear in record)
Department Name
Oncology

Sponsor

Primary sponsor

Full Name
BioNTech SE
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Syneos Health Italy S.r.l.
Responsibilities
sponsorDuties codes: [1,10,11,12,2,5,6,8] (listed in CTIS; specific mapped responsibilities not textually provided in entry)

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4] (no textual duty string provided in CTIS entry)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14,15,3]; value: 'Importer and manufacturer, performs packaging, labelling, and QP-release of finished IMPs (BNT113 and pembrolizumab).'","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Syneos Health Italy S.r.l.","duties_or_roles":"sponsorDuties codes: [1,10,11,12,2,5,6,8] (roles per CTIS sponsor duties list; no further textual description provided)","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Abf Pharmaceutical Services GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: 'PBMC isolation'","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Precision for Medicine GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: 'PBMC isolation'","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: 'eCOA, ePRO'","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"sponsorDuties codes: [15]; value: 'Biomarker analysis'","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
prodAuthStatus 2 (authorized/marketed product indicated in CTIS entry)
Maximum Dose
maxDailyDoseAmount 200 mg; maxTotalDoseAmount 7000 mg (as listed in product entry)
Investigational Product Name
BNT113
Active Substance
RBL015.2, RBL016.2
Modality
mRNA
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS USE
Authorisation Status
prodAuthStatus 1 (investigational product entry in CTIS)
Maximum Dose
maxDailyDoseAmount 100 µg; maxTotalDoseAmount 3950 µg (as listed in product entry)
Combination Treatment
Yes

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