Trials / Terminated
TerminatedNCT03099161
Study of Preladenant (MK-3814) Alone and With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3814A-062)
A Phase Ib/II Study to Evaluate the Safety and Tolerability of Preladenant as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and preliminary efficacy of preladenant (MK-3814A) alone and in combination with pembrolizumab (MK-3475) (pembro) in participants with advanced solid tumors that have not responded to prior therapy. This study will be done in 2 parts. Part 1 will identify and confirm the recommended Phase 2 dose (RP2D) of preladenant when given alone or in combination with pembrolizumab. Part 2 of the study will determine the safety and efficacy of preladenant in combination with pembrolizumab at the RP2D in participants with select solid tumors .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | preladenant | Administered as an oral capsule BID on Days 1 through 21 of each 21-day cycle |
| BIOLOGICAL | pembrolizumab | Administered as IV infusion on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2017-06-27
- Primary completion
- 2017-11-24
- Completion
- 2018-02-21
- First posted
- 2017-04-04
- Last updated
- 2019-06-05
- Results posted
- 2019-06-05
Locations
5 sites across 3 countries: United States, Canada, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03099161. Inclusion in this directory is not an endorsement.