drugset
drugset / Trial / NCT03918278

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

NCT03918278 ↗

Phase 1 Completed 222 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2019-06-19
Primary completion
2025-06-09
Completion
2025-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-0482 Unknown — Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous
Background Paclitaxel Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 125 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

neoplasm