Phase
Condition
Head And Neck Cancer
Carcinoma
Squamous Cell Carcinoma
Treatment
Pembrolizumab
Cetuximab
BI 770371
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with histologically confirmed metastatic or recurrent HNSCC of the primarytumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable tolocoregional treatment with curative intent.
Willingness to provide pretreatment (baseline) biopsy / tissue to the sponsor (freshor archival one). A recent biopsy (<3 months) is preferred, however an archivalbiopsy up to 12 months prior to screening could be accepted. If these requirementscannot be met, then the patient may be allowed to enter the study at Sponsordiscretion, after agreement between the Investigator and Sponsor. Details on therequirements for archival tumour tissue and on biopsy sample collection are providedin the Laboratory Manual.
Patients who have not received prior systemic treatment for metastatic or recurrentHNSCC. Systemic therapy (including cetuximab) which was completed more than 6 monthsprior to progression of disease if given as part of multimodal treatment for locallyadvanced disease is allowed.
Patients who do not have contraindications to pembrolizumab monotherapy according topembrolizumab local label, guidelines, treatment standards, regulations or thedocument (label of another country if pembrolizumab local label is not available)provided in the investigator site file (ISF) by the sponsor.
Patients who do not have contraindications to treatment with cetuximab according tocetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in theISF by the sponsor.
Presence of at least one measurable non-Central nervous system (CNS) lesion (according to RECIST v1.1.)
Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasalcavity, paranasal sinuses of any histology, any cancer of unknown primary.
Any tumour location necessitating an urgent therapeutic intervention (e.g.,palliative care, surgery, or radiation therapy), such as spinal cord compression,other compressive mass, uncontrolled painful lesion, bone fracture.
Patients with progressive HNSCC within 6 months of completion of systemic therapyfor locoregionally advanced disease with curative intent.
Receiving treatment for brain metastases or Leptomeningeal Disease (LMD) which mayinterfere with safety and/or endpoint assessment. Patients with previously diagnosedbrain metastases are eligible if they have completed their treatment and haverecovered from the acute effects of radiation therapy or surgery prior to trialentry, have discontinued corticosteroid treatment for these metastases and areclinically stable, off anticonvulsants for at least 4 weeks and are neurologicallystable before enrollment.
Patients for whom single agent pembrolizumab is not the preferred treatment (e.g.patients for whom chemotherapy or anti-PD-1 in combination with chemotherapy isconsidered the preferred therapy by the investigator or treating physician).
Prior treatment with any anti signal Regulatory Protein Alpha (SIRPα) oranti-integrin-associated protein (CD47) agent, regardless of treatment intent.
Prior cancer treatment with any anti PD-1 or anti PD-L1 agent or with an agentdirected to another stimulatory or co-inhibitory Tcell receptor (e.g. CTLA-4, OX 40,CD137), regardless of treatment intent.
Prior allogeneic stem cell or solid organ transplantation.
Further exclusion criteria apply.
Study Design
Connect with a study center
Gosford Hospital
Gosford, New South Wales 2250
AustraliaSite Not Available
Andrew Love Cancer Centre
Geelong, Victoria 3220
AustraliaSite Not Available
Hospital de Amor
Barretos, 14784-400
BrazilSite Not Available
Liga Norte Riograndense contra o cancer
Natal, 59062-000
BrazilActive - Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000
BrazilActive - Recruiting
MBAL Sveta Sofia
Sofia, 1404
BulgariaSite Not Available
CTR Oscar Lambret
Lille, 59020
FranceSite Not Available
CTR Leon Berard
Lyon Cedex 08, 69373
FranceSite Not Available
HOP Timone
Marseille, 13385
FranceSite Not Available
INS Gustave Roussy
Villejuif, 94805
FranceSite Not Available
ARENSIA Exploratory Medicine LLC
Tbilisi, 0112
GeorgiaSite Not Available
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38114
GermanySite Not Available
Universitätsklinikum Jena
Jena, 07743
GermanySite Not Available
Universität Leipzig
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89081
GermanySite Not Available
National Institute of Oncology
Budapest, 1122
HungarySite Not Available
Semmelweis University
Budapest, 1083
HungarySite Not Available
Clinexpert Gyongyos
Gyongyos, 3200
HungarySite Not Available
Istituto Scientifico Romagnolo
Meldola (fc), 47014
ItalySite Not Available
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20133
ItalySite Not Available
Azienda Ospedaliera Universitaria "Federico II"
Napoli, 80131
ItalySite Not Available
Istittuo Nazionale Tumori Regina Elena - IRCCS
Roma, 00144
ItalySite Not Available
A.O. Univ. Integrata di Verona
Verona, 37126
ItalySite Not Available
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
ItalySite Not Available
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
JapanSite Not Available
Kobe University Hospital
Hyogo, Kobe, 650-0017
JapanSite Not Available
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
JapanActive - Recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
JapanSite Not Available
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
JapanSite Not Available
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, St.Vincent's Hospital
Suwon-si, 16247
Korea, Republic ofSite Not Available
Unidad Clinica Farmacologica Bioemagno
Ciudad de México, 04660
MexicoSite Not Available
Centro Oncologico Personalizado
Mexico, 06760
MexicoSite Not Available
Instituto Nacional de Cancerologia
Mexico, 14080
MexicoSite Not Available
Centro Oncológico Internacional
Tlajomulco de Zuñiga, 45640
MexicoSite Not Available
ARENSIA Exploratory Medicine
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
National Oncology Institute Maria Sklodowskiej Curie State Research Institute
Gliwice, 44102
PolandSite Not Available
Center of Oncology of the Lublin Region St. Jana z Dukli
Lublin, 20090
PolandSite Not Available
"Prof. Dr. Alexandru Trestioreanu" Oncology Institut
Bucharest, 022328
RomaniaSite Not Available
National University Hospital-Singapore-22806
Singapore, 119228
SingaporeSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Virgen de la Victoria
Malaga, 29010
SpainSite Not Available
Hospital Clínico de Valencia
Valencia, 46010
SpainSite Not Available
Cantonspital Aarau
Aarau, 5001
SwitzerlandSite Not Available
University Hospital Zurich
Zuerich, 8091
SwitzerlandSite Not Available
National Taiwan University Hospital
Taipei, 10048
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Siriraj Hospital
Bangkoknoi, 10700
ThailandSite Not Available
Adana City Hospital
Adana, 01220
TurkeySite Not Available
Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200
TurkeySite Not Available
Ankara Bilkent City Hospital
Ankara, 06800
TurkeySite Not Available
Hacettepe University Oncology Hospital
Ankara, 06230
TurkeyActive - Recruiting
Istanbul University Medical Faculty Capa Hospital
Istanbul, 34093
TurkeySite Not Available
Ege University Tulay Aktas Oncology Hospital
Izmir, 35100
TurkeySite Not Available
St Bartholomew's Hospital
London, EC1A 7BE
United KingdomSite Not Available
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
United KingdomSite Not Available
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
United KingdomSite Not Available
University of Illinois Hospital and Health Sciences System
Chicago, Illinois 60612
United StatesSite Not Available
Norton Cancer Institute, Downtown
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Healthcare - Norton Cancer Institute - Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesSite Not Available
Texas Oncology - San Antonio
San Antonio, Texas 98240
United StatesSite Not Available
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