Calendario›INCY›Epacadostat
Epacadostat
A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)
Ensayo de INCYTE CORP en Tumor solido.
Más ensayos de: Tumor sólido.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 70
- Centros
- 16
- Fin del objetivo primario
- ene 2019
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2017.
Qué mide
Phases 1 & 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (del registro, en inglés) (hasta 21 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G below (see Study Drug and Background Therapies, Dose, and Mode of Administration). Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. Each efficacy expansion cohort was to enroll participants with 1 specific type of advanced or metastatic solid tumor. Additional cohorts (ie, the mandatory biopsy cohorts) were designed to evaluate changes in the tumor microenvironment in participants with any advanced or metastatic solid tumor who had progressed on previous therapy with a PD-1 or a PD-L1 inhibitor. No participants were enrolled in any Phase 2 efficacy expansion cohort, or in any Phase 2 mandatory biopsy cohort receiving Treatment A, B, F, or G. Phase 2 mandatory biopsy cohort participants received Treatments C, D, or E (ie, were included in Treatment Groups C, D, or E). Participants were assigned to a treatment group based on the chemotherapy regimen most appropriate for their tumor type.
Más ensayos de INCY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| tafasitamab · InMIND | Fase 3 | En marcha, sin reclutar | feb 2024 (real) |
| Tafasitamab · MINDway | Fase 1/2 | En marcha, sin reclutar | jul 2024 (real) |
| Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) | no aplica | Reclutando pacientes | jun 2025 (prevista, ya pasada: sin actualizar en el registro) |
| tafasitamab · J-MIND | Fase 1/2 | En marcha, sin reclutar | jul 2025 (real) |
| INCA034176 | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Povorcitinib | Fase 3 | En marcha, sin reclutar | feb 2026 (real) |
Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03085914), actualizada en sep 2022.