- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02485990
Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
9 de abril de 2021 actualizado por: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
An Open Label Dose Escalation/Expansion Study of Tremelimumab Alone or Combined With Olaparib for Recurrent or Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)
This study will be looking at what dose of tremelimumab and olaparib is safe and effective in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This clinical trial was initially intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2 prior to termination.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Signed informed consent form
- Age ≥ 18 years
- Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
- Have archival tissue or willingness to undergo a tumor biopsy
- Have measurable disease
- Have had one prior taxane-platinum-based chemotherapeutic regimen
- Have had a treatment-free interval following platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen
- Have received hormonal therapy
- ECOG Performance Status of 0 to 1
- Ability to take oral medications
- HIV, HTLV-1, HBV, and HCV negative
- Adequate organ and bone marrow function as defined by study-specified laboratory tests
- Normal blood coagulation parameters
- Life expectancy greater than 16 weeks
- Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
- Willing and able to comply with study procedures
Exclusion Criteria:
- Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
- Active infection requiring antibiotics
- Active autoimmune disease
- Active and uncontrolled intercurrent illness
- History of other cancers within the past 5 years
- Systemically active steroid use
- Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug
- Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
- Requirement for chronic parenteral hydration/nutrition
- Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug
- Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy
- Patients with myelodysplastic syndrome/acute myeloid leukaemia
- History of diverticulitis
- History of bleeding disorder or diathesis.
- Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
- Major surgical procedure within 28 days of study enrollment, or anticipated while on study.
- Pregnant or breast feeding woman
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Arm A: Tremelimumab Alone
25 patients will receive tremelimumab alone at 10 mg/kg IV every 4 weeks for 7 doses then every 12 weeks until disease progression.
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Experimental: Arm B1: DESE Tremelimumab and Olaparib
18 patients will receive tremelimumab (3 or 10 mg/kg IV) every 4 weeks for 7 doses then every 12 weeks and olaparib (150 or 300 mg orally twice a day) until disease progression.
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Otros nombres:
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Experimental: Arm B2: Tremelimumab and Olaparib
25 patients will receive tremelimumab (every 4 weeks for 7 doses then every 12 weeks) and olaparib (daily) until disease progression.
Dose of tremelimumab and olaparib will be determined during the DESE (Arm B1).
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse events as a measure of the safety and tolerability profile of tremelimumab in combination with olaparib
Periodo de tiempo: 4 years
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Number of participants experiencing study drug-related dose limiting toxicities (DLTs).
Dose escalation (phase I) portion of the trial only.
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4 years
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Fold change from baseline in the ratio of peripheral CD4+ICOShi T cells and Regulatory T cells
Periodo de tiempo: 4 years
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Dose escalation (phase I) portion of the trial only.
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4 years
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Maximum Tolerated Dose (MTD) of tremelimumab combined with olaparib
Periodo de tiempo: 4 years
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Dose escalation (phase I) portion of the trial only.
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4 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Supervivencia general (SG)
Periodo de tiempo: 4 años
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La OS se medirá desde la fecha de la primera dosis hasta la muerte o el final del seguimiento (la OS se censurará en la fecha en que se supo por última vez que el sujeto estaba vivo para los sujetos sin documentación de muerte en el momento del análisis).
Estimación basada en la curva de Kaplan-Meier.
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4 años
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Progression Free Survival (PFS) Rate at 6 months by RECIST
Periodo de tiempo: 6 months
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PFS rate is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months.
Per RECIST 1.1 criteria, Complete Response (CR) = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Estimation based on the Kaplan-Meier curve.
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6 months
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Progression Free Survival (PFS) Rate at 6 months by irRECIST
Periodo de tiempo: 6 months
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PFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRECIST criteria) or death due to any cause at 6 months.
Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, irPD is >20% increase in tumor burden compared with nadir, irSD is <30% decrease in tumor burden compared with baseline cannot be established nor <20% increase compared with nadir.
Estimation based on the Kaplan-Meier curve.
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6 months
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Objective Response Rate (ORR) by RECIST
Periodo de tiempo: 4 years
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Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Per RECIST 1.1 criteria, CR = disappearance of all target lesions and PR is =>30% decrease in sum of diameters of target lesions.
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4 years
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Objective Response Rate (ORR) by irRECIST
Periodo de tiempo: 4 years
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Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRECIST criteria.
Per irRECIST criteria, irCR = disappearance of all lesions and irPR is =>30% decrease in tumor burden.
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4 years
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Duration of Response by RECIST
Periodo de tiempo: 4 years
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Number of months from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented.
Per RECIST 1.1 criteria, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, and PD is >20% increase in sum of diameters of target lesions.
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4 years
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Duration of Response by irRECIST
Periodo de tiempo: 4 years
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Number of months from the start date of irPR or irCR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented.
Per irRECIST criteria, irCR = disappearance of all lesions, irPR is =>30% decrease in tumor burden, and irPD is is >20% increase in tumor burden compared with nadir.
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4 years
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Disease Control Rate (DCR)
Periodo de tiempo: 4 years
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DCR is defined as the number of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria at any time during the study.
CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions.
Estimation based on the Kaplan-Meier curve.
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4 years
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Progression-Free Survival (PFS)
Periodo de tiempo: 4 years
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PFS is defined as the number of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause.
Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Estimation based on the Kaplan-Meier curve.
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4 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Stéphanie Gaillard, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de enero de 2016
Finalización primaria (Actual)
5 de marzo de 2020
Finalización del estudio (Actual)
5 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
29 de junio de 2015
Publicado por primera vez (Estimar)
30 de junio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- J15113
- IRB00064379 (Otro identificador: JHM IRB)
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. .
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