Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)
Summary
This study consists of several parts: dose escalation, dose expansion, dose expansion in Chinese participants residing in China, and coformulation. Dose escalation is to evaluate the safety, tolerability, and preliminary efficacy of MK-4830 monotherapy administration (Arms A and B) and in combination with pembrolizumab (Arm C). Dose expansion is to evaluate the objective response rate (ORR) of MK-4830 in combination with pembrolizumab (Arms A-F); evaluate the safety and tolerability of MK-4830 administered in combination with pembrolizumab, carboplatin, and pemetrexed (Arm G) and of MK-4830 administered in combination with pembrolizumab and lenvatinib (Arm H); evaluate the safety, tolerability and ORR of MK-4830 in combination with pembrolizumab plus chemotherapy (Arms I-L); and evaluate the safety and tolerability of MK-4830 in combination with pembrolizumab in Chinese participants from China (Arm M). The coformulation part (Arm N) evaluates the safety and tolerability of MK-4830A (coformulation of MK-4830 800 mg + pembrolizumab 200 mg). There is no formal hypothesis testing in this study.
Timeline
- Start
- 2018-07-11
- Primary completion
- 2025-09-26
- Completion
- 2025-09-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-4830 | Unknown | — | Intravenous |
| Subject | MK-4830A | Unknown | 200 mg | Intravenous |
| Subject | MK-4830A | Unknown | 800 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Lenvatinib | Small molecule | — | Oral |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |