NCT03918278

A Study of MK-0482 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-0482-001)

A Phase 1b, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0482 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2 part study. Part 1 is a dose escalation to determine the safety and tolerability and to establish a preliminary recommended Phase 2 dose (RP2D) dose of MK-0482 administered as monotherapy and in combination with pembrolizumab (MK-3475) in participants with advanced solid tumors for which there is no available therapy which may convey clinical benefit. Part 2 is expansion cohort to determine safety and tolerability of MK-0482 in combination with pembrolizumab with and without chemotherapy in participants with advanced tumor specific cohorts.

Conditions

• Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	MK-0482	IV infusion
BIOLOGICAL	pembrolizumab	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Nab-paclitaxel	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Pemetrexed	IV infusion

Timeline

• Start date: 2019-06-19
• Primary completion: 2025-06-09
• Completion: 2025-06-09
• First posted: 2019-04-17
• Last updated: 2025-06-25

Locations

16 sites across 8 countries: United States, Australia, Canada, Chile, Israel, Italy, South Korea, Spain

Regulatory

• FDA-regulated drug study