Un estudio para probar si el tratamiento con BI 770371 en combinación con pembrolizumab con o sin cetuximab ayuda a las personas con cáncer de cabeza y cuello en comparación con pembrolizumab solo
Un ensayo clínico aleatorizado de etiqueta abierta de fase IB para evaluar la seguridad y la eficacia de BI 770371 en combinación con pembrolizumab con o sin cetuximab en comparación con la monoterapia con pembrolizumab para el tratamiento de primera línea de pacientes con carcinoma metastásico o recurrente de células cuadradas y cuellos de cabeza y cuello (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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Braunschweig, Alemania, 38114
- Städtisches Klinikum Braunschweig gGmbH
-
Jena, Alemania, 07743
- Universitätsklinikum Jena
-
Leipzig, Alemania, 04103
- Universität Leipzig
-
Ulm, Alemania, 89081
- Universitätsklinikum Ulm
-
-
-
-
New South Wales
-
Gosford, New South Wales, Australia, 2250
- Gosford Hospital
-
-
Victoria
-
Geelong, Victoria, Australia, 3220
- Andrew Love Cancer Centre
-
-
-
-
-
Barretos, Brasil, 14784-400
- Hospital de Amor
-
Natal, Brasil, 59062-000
- Liga Norte Riograndense contra o cancer
-
São José do Rio Preto, Brasil, 15090-000
- Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto
-
-
-
-
-
Sofia, Bulgaria, 1404
- MBAL Sveta Sofia
-
-
-
-
-
Seoul, Corea del Sur, 03722
- Severance Hospital
-
Seoul, Corea del Sur, 135-710
- Samsung Medical Center
-
Suwon, Corea del Sur, 16247
- The Catholic University of Korea, St.Vincent's Hospital
-
-
-
-
-
Barcelona, España, 08035
- Hospital Universitari Vall d'Hebron
-
-
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40202
- Norton Cancer Institute, Downtown
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55455
- M Health Fairview Clinics and Surgery Center - Minneapolis
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Wexner Medical Center
-
-
-
-
-
Lille, Francia, 59020
- CTR Oscar Lambret
-
Lyon, Francia, 69373
- CTR Leon Berard
-
Marseille, Francia, 13385
- HOP Timone
-
Villejuif, Francia, 94805
- Institut Gustave Roussy
-
-
-
-
-
Tbilisi, Georgia, 0112
- ARENSIA Exploratory Medicine LLC
-
-
-
-
-
Budapest, Hungría, 1083
- Semmelweis University
-
Gyöngyös, Hungría, 3200
- Clinexpert Gyongyos
-
-
-
-
-
Meldola (FC), Italia, 47014
- Istituto Scientifico Romagnolo
-
Verona, Italia, 37126
- Azienda Ospedaliera Universitaria Integrata Verona
-
-
-
-
-
Hokkaido, Sapporo, Japón, 060-8648
- Hokkaido University Hospital
-
Hyogo, Kobe, Japón, 650-0017
- Kobe University Hospital
-
Osaka, Hirakata, Japón, 573-1191
- Kansai Medical University Hospital
-
Shizuoka, Sunto-gun, Japón, 411-8777
- Shizuoka Cancer Center
-
Tokyo, Koto-ku, Japón, 135-8550
- Japanese Foundation for Cancer Research
-
-
-
-
-
Chisinau, Moldava, MD-2025
- ARENSIA Exploratory Medicine
-
-
-
-
-
Mexico City, México, 04660
- Unidad Clinica Farmacologica Bioemagno
-
México, México, 14080
- Instituto Nacional de Cancerologia
-
México, México, 06760
- Centro Oncologico Personalizado
-
Tlajomulco de Zuñiga, México, 45640
- Centro Oncológico Internacional
-
-
-
-
-
Lublin, Polonia, 20090
- Center of Oncology of the Lublin Region St. Jana z Dukli
-
-
-
-
-
London, Reino Unido, EC1A 7BE
- St Bartholomew's Hospital
-
London, Reino Unido, SW3 6JJ
- The Royal Marsden Hospital, Chelsea
-
Sutton, Reino Unido, SM2 5PT
- The Royal Marsden Hospital, Sutton
-
-
-
-
-
Bucharest, Rumania, 022328
- "Prof. Dr. Alexandru Trestioreanu" Oncology Institut
-
-
-
-
-
Singapore, Singapur, 119228
- National University Hospital-Singapore-22806
-
-
-
-
-
Aarau, Suiza, 5001
- Cantonspital Aarau
-
-
-
-
-
Bangkoknoi, Tailandia, 10700
- Siriraj Hospital
-
-
-
-
-
Taipei, Taiwán, 11217
- Taipei Veterans General Hospital
-
Taipei, Taiwán, 10048
- National Taiwan University Hospital
-
-
-
-
-
Adana, Turquía (Türkiye), 01220
- Adana City Hospital
-
Ankara, Turquía (Türkiye), 06800
- Ankara Bilkent City Hospital
-
Ankara, Turquía (Türkiye), 06200
- Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
Ankara, Turquía (Türkiye), 06230
- Hacettepe University Oncology Hospital
-
Istanbul, Turquía (Türkiye), 34093
- Istanbul University Medical Faculty Capa Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Pembrolizumab
|
Pembrolizumab |
|
Experimental: Pembrolizumab + BI 770371
|
Pembrolizumab BI 770371 |
|
Experimental: Pembrolizumab + BI 770371 + cetuximab
|
Pembrolizumab BI 770371 Cetuximab |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective response (OR) with confirmation
Periodo de tiempo: Up to 27 months
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ocurrencia del evento adverso relacionado con el tratamiento (AE) desde la primera administración de tratamiento hasta los primeros 90 días después de la última dosis, muerte, posterior terapia anticancerígena, perdida durante el seguimiento o la retirada del consentimiento
Periodo de tiempo: Hasta 27 meses
|
Hasta 27 meses
|
|
|
La ocurrencia de AE relacionada con el tratamiento que conduce a la interrupción del tratamiento de la primera administración de tratamiento hasta los primeros 90 días después de la última dosis, muerte, posterior terapia anticancerígena, perdida durante el seguimiento o retiro de consentimiento
Periodo de tiempo: Hasta 27 meses
|
Hasta 27 meses
|
|
|
Overall survival (OS)
Periodo de tiempo: Up to 27 months
|
OS defined as the time from first treatment administration until death from any cause. |
Up to 27 months
|
|
Overall survival at 6 and 12 months (OS6 and OS12)
Periodo de tiempo: At 6 months and 12 months
|
OS defined as being alive at 6 months or at 12 months from first treatment administration. |
At 6 months and 12 months
|
|
Progression-free survival (PFS)
Periodo de tiempo: Up to 27 months
|
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
|
|
Progression-free survival at 6 months (PFS6)
Periodo de tiempo: At 6 months
|
PFS defined as being alive and without progression at 6 months from first treatment administration. |
At 6 months
|
|
Duration of objective response (DOR)
Periodo de tiempo: Up to 27 months
|
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
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias de Cabeza y Cuello
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Carcinoma De Células Escamosas
- Carcinoma de células escamosas de cabeza y cuello
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Cetuximab
- pembrolizumab
Otros números de identificación del estudio
- 1501-0002
- U1111-1312-0435 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-517091-38-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .