drugset
drugset / Trial / NCT03396445

Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

NCT03396445 ↗

Phase 1 Completed 182 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults. Boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be administered in adults with advanced solid tumors, including endometrial cancer, for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non-squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.

Timeline

Start
2018-02-18
Primary completion
2024-09-27
Completion
2024-09-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Boserolimab Monoclonal antibody 2 mg Intravenous
Subject Boserolimab Monoclonal antibody 7 mg Intravenous
Subject Boserolimab Monoclonal antibody 20 mg Intravenous
Subject Boserolimab Monoclonal antibody 30 mg Intravenous
Subject Boserolimab Monoclonal antibody 70 mg Intravenous
Subject Boserolimab Monoclonal antibody 200 mg Intravenous
Subject Boserolimab Monoclonal antibody 700 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Paclitaxel Small molecule 100 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

non-small cell lung carcinoma triple-negative breast carcinoma