Estado del programa
Activo, no reclutaFase
Fase 2Inmunoterapia previa permitida
NoEnsayo dirigido por el CRC
SíDrogas
ALX148, cetuximab, Evorpacept (ALX148), Pembrolizumab, Erbitux, KeytrudaEtiquetas
MSS/ MMRpComentarios
ALX148 + cetuximab + pembrolizumab for MSS patients who have received at least 2 lines of systemic therapy.
ALX148 (evorpacept): anti CD47, immunotherapy
Cetuximab: EGFR inhibitor (Erbitux)
Pembrolizumab: anti-PD1 checkpoint inhibitor, immunotherapy (Keytruda)
Left-sided RAS/BRAF Wild must have received EGFR inhibitor (cetuximab or panitumumab).
No prior checkpoint inhibitor (immunotherapy) allowed
| Ubicación | Situación |
|---|---|
| Estados Unidos | |
|
University of Arizona Cancer Center Tucson, Arizona 85724 |
Activo, no recluta |
|
University of Colorado Cancer Center Aurora, Colorado 80045 |
Activo, no recluta |
|
Rutgers Cancer insititute New Brunswick, Nueva Jersey 08903 |
Activo, no recluta |
|
Instituto Oncológico Inova Schar Fairfax, Virginia 22031 |
Activo, no recluta |
Criterios de inclusión
Criterios de inclusión:
To be eligible to participate in this study, an individual must meet all of the following criteria:
* Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
* Have microsatellite stable disease
* Adequate hematologic and end organ function
Criterios de exclusión
Criterios de exclusión:
An individual who meets any of the following criteria will be excluded from participation in this study:
* Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
* Patients in whom both mismatch repair and microsatellite stability status are unknown
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
* Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
