Calendario›INCY›Pembrolizumab
Pembrolizumab
Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
Ensayo de INCYTE CORP en Colorectal Cancer (CRC) · Endometrial Cancer · Melanoma · Head and Neck Cancer · Lung Cancer · MMR-deficient Tumors · Breast Cancer · Pancreatic Cancer · Renal Cell Carcinoma (RCC) · Solid Tumors · UC (Urothelial Cancer) (del registro, en inglés).
Más ensayos de: Cáncer colorrectal · Cáncer de endometrio · Melanoma · Cáncer de cabeza y cuello · Cáncer de pulmón · Cáncer de mama · Cáncer de páncreas · Tumor sólido.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 159
- Centros
- 17
- Fin del objetivo primario
- nov 2019
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en ene 2016.
Qué mide
Part 1: Evaluation of safety and tolerability as measured by the frequency, duration, and severity of adverse events (Duration of study treatment and up to 120 days after the last dose of study drug) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2). Two treatment groups (Group A and Group B) will be evaluated Part 1a utilizes a 3+3 design to evaluate pembrolizumab and INCB combinations in advanced solid tumors. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b safety expansion with each combination. Once the recommended dose has been identified in Part 1a, subjects with select solid tumor types will be enrolled into safety expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b) for each combination. Part 2 utilizes a Simon 2-Stage design to evaluate INCB050465 in combination with pembrolizumab in patients with small cell lung cancer (SCLC) and a 1 stage design to evaluate the combination in patients with non-small cell lung cancer (NSCLC) and urothelial cancer (UC).
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 (NCT02646748), actualizada en mar 2022.