A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies.
- Promotor: Merck. IP: Ramón García-Sanz. Data manager: Manuel Delgado.
- Periodo de inclusión: 180 pacientes en 6 cohortes.
- Diseño y tratamiento:
- Fase 2. Objetivo principal: Tasa de respuestas.
- Fármaco en investigación: 7684A (MK-7684 [Vibostolimab], inh checkpoint anti-TIGIT, with MK-3475 [Pembrolizumab] Coformulation).
- Tratamiento experimental: Participants will receive pembrolizumab / vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years. All participants who achieve a CR may be eligible for a second course of treatment (up to an additional 17 cycles of MK-7684A) if there is an investigator-determined disease progression
- Medicación concomitante.
- Población. LDCBG, primario mediastínico, LF, pretratados con al menos 2 líneas. También LH y MM.
Alejandro Martín García-Sancho (amartingar@usal.es)
Norma Gutiérrez Gutiérrez (normagu@usal.es)
Dolores Caballero Barrigón (cabarri@usal.es)
Hospital Universitario de Salamanca, IBSAL, CIBERONC