Trials / Completed
CompletedNCT02674061
Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)
A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 376 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based treatment for ROC (1 to 6 total prior lines counting front line therapy). Participants will be enrolled into two separate cohorts based on the number of prior lines of treatment received for ROC. There will be no hypothesis testing in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Administered at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2016-02-25
- Primary completion
- 2019-09-18
- Completion
- 2021-03-18
- First posted
- 2016-02-04
- Last updated
- 2022-03-24
- Results posted
- 2020-09-22
Source: ClinicalTrials.gov record NCT02674061. Inclusion in this directory is not an endorsement.