En undersøgelse for at teste, om behandling med BI 770371 i kombination med pembrolizumab med eller uden cetuximab hjælper mennesker med hoved- og halskræft sammenlignet med pembrolizumab alene
En fase IB åben etiket randomiseret klinisk forsøg til evaluering af sikkerhed og effektivitet af BI 770371 i kombination med pembrolizumab med eller uden cetuximab sammenlignet med pembrolizumab monoterapi til den første linjebehandling af patienter med metastatisk eller tilbagevendende hoved- og hals-squamous cell carcinoma (HNSCC)
This study is open to adults with head and neck cancer. The purpose of this study is to find out whether combining different study medicines makes tumors shrink in people with head and neck cancer.
The tested medicines in this study are antibodies that act in different ways against cancer. BI 770371 and pembrolizumab may help the immune system fight cancer. Cetuximab blocks growth signals and may prevent the tumor from growing.
Participants are put into 3 groups randomly. Each group receives a different combination of study medicines. All study medicines are given as an infusion into a vein at the study site.
Participants can stay in the study as long as they benefit from treatment. Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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New South Wales
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Gosford, New South Wales, Australien, 2250
- Gosford Hospital
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Victoria
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Geelong, Victoria, Australien, 3220
- Andrew Love Cancer Centre
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Barretos, Brasilien, 14784-400
- Hospital de Amor
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Natal, Brasilien, 59062-000
- Liga Norte Riograndense contra o cancer
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São José do Rio Preto, Brasilien, 15090-000
- Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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Sofia, Bulgarien, 1404
- MBAL Sveta Sofia
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London, Det Forenede Kongerige, EC1A 7BE
- St Bartholomew's Hospital
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London, Det Forenede Kongerige, SW3 6JJ
- The Royal Marsden Hospital, Chelsea
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Sutton, Det Forenede Kongerige, SM2 5PT
- The Royal Marsden Hospital, Sutton
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Norton Cancer Institute, Downtown
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- M Health Fairview Clinics and Surgery Center - Minneapolis
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- The Ohio State University Wexner Medical Center
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Lille, Frankrig, 59020
- CTR Oscar Lambret
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Lyon, Frankrig, 69373
- CTR Leon Berard
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Marseille, Frankrig, 13385
- HOP Timone
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Villejuif, Frankrig, 94805
- Institut Gustave Roussy
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Tbilisi, Georgien, 0112
- ARENSIA Exploratory Medicine LLC
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Meldola (FC), Italien, 47014
- Istituto Scientifico Romagnolo
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Verona, Italien, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
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Hokkaido, Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Hyogo, Kobe, Japan, 650-0017
- Kobe University Hospital
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Osaka, Hirakata, Japan, 573-1191
- Kansai Medical University Hospital
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Shizuoka, Sunto-gun, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Koto-ku, Japan, 135-8550
- Japanese Foundation for Cancer Research
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Mexico City, Mexico, 04660
- Unidad Clinica Farmacologica Bioemagno
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México, Mexico, 14080
- Instituto Nacional de Cancerologia
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México, Mexico, 06760
- Centro Oncologico Personalizado
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Tlajomulco de Zuñiga, Mexico, 45640
- Centro Oncológico Internacional
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Chisinau, Moldova, MD-2025
- ARENSIA Exploratory Medicine
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Lublin, Polen, 20090
- Center of Oncology of the Lublin Region St. Jana z Dukli
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Bucharest, Rumænien, 022328
- "Prof. Dr. Alexandru Trestioreanu" Oncology Institut
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Aarau, Schweiz, 5001
- Cantonspital Aarau
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Singapore, Singapore, 119228
- National University Hospital-Singapore-22806
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Seoul, Sydkorea, 03722
- Severance Hospital
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Seoul, Sydkorea, 135-710
- Samsung Medical Center
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Suwon, Sydkorea, 16247
- The Catholic University of Korea, St.Vincent's Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10048
- National Taiwan University Hospital
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Bangkoknoi, Thailand, 10700
- Siriraj Hospital
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Adana, Tyrkiet (Türkiye), 01220
- Adana City Hospital
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Ankara, Tyrkiet (Türkiye), 06800
- Ankara Bilkent City Hospital
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Ankara, Tyrkiet (Türkiye), 06200
- Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Ankara, Tyrkiet (Türkiye), 06230
- Hacettepe University Oncology Hospital
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Istanbul, Tyrkiet (Türkiye), 34093
- Istanbul University Medical Faculty Capa Hospital
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Braunschweig, Tyskland, 38114
- Städtisches Klinikum Braunschweig gGmbH
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Jena, Tyskland, 07743
- Universitätsklinikum Jena
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Leipzig, Tyskland, 04103
- Universität Leipzig
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Ulm, Tyskland, 89081
- Universitätsklinikum Ulm
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Budapest, Ungarn, 1083
- Semmelweis University
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Gyöngyös, Ungarn, 3200
- Clinexpert Gyongyos
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with histologically confirmed metastatic or recurrent HNSCC of the primary tumour location of oral cavity, oropharynx, hypopharynx, and larynx not amenable to locoregional treatment with curative intent.
- Willingness to provide pretreatment (baseline) biopsy/tissue to the sponsor (fresh or archival one). A newly obtained biopsy is preferred but an archival sample is acceptable, with tumor tissue (formalin fixed paraffin embedded [FFPE] block preferred, or at least 10 freshly sectioned unstained FFPE slides) from a core or excisional biopsy. Any deviation from this rule requires approval by the sponsor. Details on the requirements for archival tumour tissue and on biopsy sample collection are provided in the Laboratory Manual.
- Patients who have not received prior systemic treatment for metastatic or recurrent HNSCC. Systemic therapy (including cetuximab) which was completed more than 6 months prior to progression of disease if given as part of multimodal treatment for locally advanced disease is allowed.
- Patients who do not have contraindications to pembrolizumab monotherapy according to pembrolizumab local label, guidelines, treatment standards, regulations or the document (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 to cetuximab local label, guidelines, treatment standards, regulations, or the document (label of another country if cetuximab local label is not available) provided in the ISF 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 Criteria:
- Nasopharyngeal carcinoma (NPC) of any histology, primary tumour location at nasal cavity, 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 therapy for locoregionally advanced disease with curative intent.
- Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to trial entry, have discontinued corticosteroid treatment for these metastases and are clinically stable, off anticonvulsants for at least 4 weeks and are neurologically stable 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 is considered the preferred therapy by the investigator or treating physician).
- Prior treatment with any anti signal regulatory protein alpha (SIRPα) or anti-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 agent directed 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Pembrolizumab
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Pembrolizumab |
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Eksperimentel: Pembrolizumab + BI 770371
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Pembrolizumab BI 770371 |
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Eksperimentel: Pembrolizumab + BI 770371 + cetuximab
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Pembrolizumab BI 770371 Cetuximab |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Objective response (OR) with confirmation
Tidsramme: Up to 27 months
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OR defined as the best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to response evaluation criteria in solid tumours version 1.1 (RECIST v1.1). Objective response (OR) will be defined by investigator's assessment from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up or withdrawal of consent. |
Up to 27 months
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Forekomst af behandlingsrelateret bivirkning (AE) fra første behandlingsadministration indtil den tidligste af 90 dage efter den sidste dosis, død, efterfølgende anticancerterapi, tabt til opfølgning eller tilbagetrækning af samtykke
Tidsramme: Op til 27 måneder
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Op til 27 måneder
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Forekomst af behandlingsrelateret AE, der fører til seponering af behandling fra første behandlingsadministration indtil den tidligste af 90 dage efter den sidste dosis, død, efterfølgende anticancerterapi, tabt til opfølgning eller tilbagetrækning af samtykke
Tidsramme: Op til 27 måneder
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Op til 27 måneder
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Overall survival (OS)
Tidsramme: Up to 27 months
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OS defined as the time from first treatment administration until death from any cause. |
Up to 27 months
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Overall survival at 6 and 12 months (OS6 and OS12)
Tidsramme: At 6 months and 12 months
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OS defined as being alive at 6 months or at 12 months from first treatment administration. |
At 6 months and 12 months
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Progression-free survival (PFS)
Tidsramme: Up to 27 months
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PFS defined as the time from first treatment administration until disease progression (PD) according to RECIST v1.1 or death from any cause, whichever occurs earlier. |
Up to 27 months
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Progression-free survival at 6 months (PFS6)
Tidsramme: At 6 months
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PFS defined as being alive and without progression at 6 months from first treatment administration. |
At 6 months
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Duration of objective response (DOR)
Tidsramme: Up to 27 months
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DOR defined as the time from first documented CR or PR (RECIST v1.1) until the earliest of PD or death among patients with OR. |
Up to 27 months
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i hoved og hals
- Neoplasmer, kirtel og epitel
- Karcinom
- Karcinom, pladecelle
- Planocellulært karcinom i hoved og hals
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Cetuximab
- pembrolizumab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 1501-0002
- U1111-1312-0435 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-517091-38-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD-delingstidsramme
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
IPD-delingsadgangskriterier
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .