Nivolumab neoadyuvante con inhibidor de CCR2/5 o anti-IL-8) para el cáncer de pulmón de células no pequeñas (NSCLC) o el carcinoma hepatocelular (HCC)
Tisch Cancer Institute - Estudio BMS n.° CA027-005: Nivolumab neoadyuvante + BMS-813160 (inhibidor de CCR2/5) o BMS-986253 (Anti-IL-8) para NSCLC o HCC
The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in:
- A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery)
- Improvement in long term survival rates
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Objectives:
Cohorts A,B (NSCLC):
Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Cohorts C,D,E (HCC):
Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response
Diagnosis and Main Inclusion Criteria:
Patients must have disease deemed resectable before enrollment.
Study Product:
Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of NSCLC or HCC
- Willing to provide blood samples
- Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
- Willing to have excisional or core needle biopsies
- At least 18 years of age
- ECOG 0-1
- Surgical candidate for resection of their tumor
- Agree to use adequate contraception
- Adequate organ and marrow function
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
- Patients receiving any other investigational agents
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled intercurrent illness
- Pregnant or nursing
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
- Has active autoimmune disease that has required systemic treatment in the past year
- Has a known additional malignancy that is progressing and/or requires active treatment
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
- HIV positive with detectable viral load or anyone not on stable anti-viral regimen
- Has known active Hepatitis B
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation
- Documented allergic or hypersensitivity response to any protein therapeutics
- Patients may not have prolonged QRS or QTc
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: Cohort A
NSCLC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
Otros nombres:
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|
Experimental: Cohort B
NSCLC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
Otros nombres:
|
|
Experimental: Cohort C
HCC: Nivolumab |
q4w, dosed twice before surgery and three times following recovery from surgery by injection |
|
Experimental: Cohort D
HCC: Nivolumab + BMS-813160 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 300mg oral twice a day for 28 days
Otros nombres:
|
|
Experimental: Cohort E
HCC: Nivolumab + BMS-986253 |
q4w, dosed twice before surgery and three times following recovery from surgery by injection 2400mg once by injection
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Major Pathologic Response (MPR)
Periodo de tiempo: 2 Years
|
MPR is defined as <10% viable tumor within resection, at time of surgery. |
2 Years
|
|
Significant Tumor Necrosis (STN)
Periodo de tiempo: 2 Years
|
STN is defined as necrosis of >70% of tumor base on pathologic analysis of gross tumor resection at time of surgery. |
2 Years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Surgery
Periodo de tiempo: 2 Years
|
Measured as the time in days that elapses between the first dose of neoadjuvant therapy and surgical resection. |
2 Years
|
|
Percent of individuals who experience adverse events
Periodo de tiempo: 2 Years
|
Safety and Tolerability defined by the percent of individuals who experience adverse events at any point during the neoadjuvant period, or within 30 days following the final dose of nivolumab received. |
2 Years
|
|
Percent of individuals who experience radiographic response
Periodo de tiempo: 2 Years
|
As per RECIST v1.1 as determined by pre-surgical imaging, following receipt of the neoadjuvant therapy. For NSCLC this will be based on CT imaging, while for HCC this imaging will be based on MRI radiographic post-contract subtraction. |
2 Years
|
|
Progression-free survival (PFS)
Periodo de tiempo: 2 Years
|
Defined as the time, in days, between treatment initiation and when the patient is found to have recurrent and/or metastatic disease on imaging, or death for any reason. |
2 Years
|
|
Overall Survival (OS)
Periodo de tiempo: 5 Years
|
Defined as the time, in days, between treatment initiation and when the patient dies from any cause regardless of etiology. |
5 Years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas Marron, MD PhD, Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma Hepatocelular
- Carcinoma de pulmón de células no pequeñas
- Aminoácidos, péptidos y proteínas
- Proteínas
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Nivolumab
- Humax-il8
- BMS-813160
Otros números de identificación del estudio
- GCO 19-1754
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.
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