Trials / Completed
CompletedNCT03396445
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 of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 182 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy at an eligible dose for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor. Per protocol, pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Boserolimab | IV infusion |
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Pemetrexed | IV infusion |
| DRUG | Carboplatin | IV infusion |
| DRUG | Nab-paclitaxel | IV infusion |
Timeline
- Start date
- 2018-02-18
- Primary completion
- 2024-09-27
- Completion
- 2024-09-27
- First posted
- 2018-01-11
- Last updated
- 2025-11-05
- Results posted
- 2025-11-05
Locations
18 sites across 7 countries: United States, Chile, Israel, Netherlands, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03396445. Inclusion in this directory is not an endorsement.