drugset / Trial / NCT03332498
Pembrolizumab in Combination With Ibrutinib for Advanced, Refractory Colorectal Cancers
Phase 1/2
Completed
40 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Janssen Scientific Affairs, LLC · collabMerck Sharp & Dohme LLC · collab
NaSequentialOpen-labelTreatment
Summary
The purpose of this study is to determine the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) (or the highest protocol-defined dose level in the absence of establishing an MTD) of ibrutinib in combination with pembrolizumab in participants with advanced, refractory colorectal cancers.
Timeline
- Start
- 2018-01-24
- Primary completion
- 2019-12-05
- Completion
- 2021-09-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |