Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT05498792

Reclutamiento

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

Intervencionista

Fase Temprana 1

Fox Chase Cancer Center

Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

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Categoría de tratamiento

Otros medicamentos, Inhibidores de puestos de control

Erforderliche Mutationen

Ninguna

Ensayo iniciado

2022-11-30

Última actualización por el patrocinador

2025-04-04

Finalización estimada

2026-03-04

Elegibilidad

Criterios de inclusión

1. Patients must have:

1. Pathologically proven stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST v. 1.1) amenable to biopsy and/or surgery OR:

2. Patients considered to have stage III or stage IV disease amenable to serial biopsies as determined by the treating physician. Note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates.

3. Patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws.

2. Age > 18 years

3. ECOG performance status 0 or 1

4. Patients must have normal organ and marrow function

Criterios de exclusión

1. Patients may not be receiving any other investigational agents

2. Patients with a known active autoimmune disease

3. Prior treatment with CTLA-4 or PD1/PD-L1 pathway targeted systemic treatment

4. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids

5. Patients with ongoing diarrhea (> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy

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Detalles del diseño

AsignaciónNon-Randomized

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir12

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Intervenciones:

CBL0137
Ipilimumab
Nivolumab

Medidas de resultado

Medidas de resultado primarias

Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.28 days

The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Fox Chase Cancer Center
Philadelphia, Pennsylvania, US

Reclutando

Philadelphia, Pennsylvania, 19111 US

Fox Chase Cancer Center

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