drugset / Trial / NCT04315155
Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label Phase I trial designed to determine the phase 2 recommended dose (RP2D) of belinostat in combination with nivolumab with or without ipilimumab.
Timeline
- Start
- 2020-10
- Primary completion
- 2023-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belinostat | Small molecule | 500 mg/m2 | — |
| Subject | Belinostat | Small molecule | 750 mg/m2 | — |
| Subject | Belinostat | Small molecule | 1000 mg/m2 | — |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | — |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 360 mg | Intravenous |