Treatment of Advanced Solid Tumors
“Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-4830-001)”
This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of MK-4830 administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumors; determine the safety and tolerability for the combination of MK-4830 with pembrolizumab + carboplatin/pemetrexed in participants with non-small-cell lung carcinoma (NSCLC), and MK-4830 in combination with pembrolizumab + lenvatinib in renal cell cancer; and to evaluate objective response rate (ORR) in participants with advanced solid tumors treated with MK-4830 in combination with pembrolizumab.
Drug - MK-4830
MK-4830 will be administered intravenously (IV) Q3W. In Part C, MK-4830 will be administered after completion of pembrolizumab infusion. Dose escalation will proceed based on emerging safety and tolerability data of MK-4830 as monotherapy (Part A and B) and as combination therapy with pembrolizumab (Part C). For each dose level, an assessment will be made of the safety and tolerability data in order to define the next dose level to be tested.
Drug - Pembrolizumab
Pembrolizumab will be dosed at 200 mg IV Q3W.
Drug - Carboplatin
Carboplatin will be administered intravenously (IV) Q3W.
Drug - Pemetrexed
Pemetrexed will be administered intravenously (IV) Q3W.
Drug - Lenvatinib
Lenvatinib will be administered orally once daily.
A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors