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NCT03396445 · ClinicalTrials.gov registry record · Phase 1
Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 182
- Enrollment target
NCT03396445: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03396445 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 182 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (203% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03396445, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 182 participants
- Enrollment target
Study 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.
Primary Outcome
DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in init
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Nab-paclitaxel
- DRUG Boserolimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2018-02-18 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 1 |
What the finished NCT03396445 record still lists
NCT03396445 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (203% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03396445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03396445 about?
NCT03396445 is a clinical study titled "Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)". 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 advance...
What is the current status of trial NCT03396445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2018-02-18. Estimated completion is 2024-09-27.
What interventions are being tested in trial NCT03396445?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Pemetrexed (DRUG), Nab-paclitaxel (DRUG), Boserolimab (DRUG).
Who is sponsoring clinical trial NCT03396445?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03396445's enrollment target sits among peer trials
182 299th of 2000 higher than 1,702 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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