drugset / Trial / NCT02680184
Clinical Study of CMP-001 in Combination With Pembrolizumab or as a Monotherapy
Non-randomizedSequentialOpen-labelTreatment
Summary
This study will be conducted in two parts: Part 1 will be conducted using a Dose Escalation and Expansion design. The Part 1 Dose Escalation Phase of this study will identify a safe and tolerable dose to be further evaluated in the Part 1 Dose Expansion phase. Part 2 of the study will be conducted in parallel with the Part 1 Dose Expansion Phase and will evaluate the safety and efficacy of CMP-001 when administered as a monotherapy. A Treatment Extension to assess the safety profile of CMP-001 when given in combination with pembrolizumab or as monotherapy will be available to those who are currently being treated in either Part 1 or Part 2 of this study at the time of protocol Amendment 9, v10.0.
Timeline
- Start
- 2016-04-12
- Primary completion
- 2022-12-06
- Completion
- 2022-12-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Vidutolimod | Other / unclassified | 1 mg | Other |
| Subject | Vidutolimod | Other / unclassified | 3 mg | Other |
| Subject | Vidutolimod | Other / unclassified | 5 mg | Other |
| Subject | Vidutolimod | Other / unclassified | 7.5 mg | Other |
| Subject | Vidutolimod | Other / unclassified | 10 mg | Other |