drugset / Trial / NCT02723006
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
Non-randomizedParallel-groupOpen-labelOther
Summary
The purpose of this study is to determine the initial safety profile and initial antitumor activity of the combination treatments (immune checkpoint inhibitors \[nivolumab, ipilimumab\] with investigational drugs \[TAK-580, TAK-202 (plozalizumab), vedolizumab\]) in the 3 arms when administered to participants with advanced melanoma.
Timeline
- Start
- 2016-06-22
- Primary completion
- 2018-05-11
- Completion
- 2018-05-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PLOZALIZUMAB | Monoclonal antibody | 2 mg | Intravenous |
| Subject | Tovorafenib | Small molecule | — | Oral |
| Subject | Vedolizumab | Monoclonal antibody | — | Intravenous |
| Background | Ipilimumab | Monoclonal antibody | — | Intravenous |
| Background | Nivolumab | Monoclonal antibody | — | Intravenous |