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

NCT03396445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-11-05

Study results available
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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.

Conditions

  • Pharmacokinetics
  • Solid Tumor
  • Carcinoma, Non-Small-Cell Lung
  • Triple Negative Breast Neoplasms

Interventions

DRUG

Boserolimab

IV infusion

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Nab-paclitaxel

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-18
Primary Completion
2024-09-27
Completion
2024-09-27
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Israel
  • Netherlands
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396445 on ClinicalTrials.gov