Trials / Completed
CompletedNCT03302234
Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 568 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pembrolizumab | Administered as an intravenous (IV) infusion every 3 weeks (Q3W) |
| BIOLOGICAL | Ipilimumab | Administered as an IV infusion every 6 weeks (Q6W) |
| OTHER | Placebo | Normal saline solution administered as an IV infusion Q6W |
Timeline
- Start date
- 2017-12-14
- Primary completion
- 2020-09-01
- Completion
- 2022-09-07
- First posted
- 2017-10-05
- Last updated
- 2023-09-26
- Results posted
- 2021-09-10
Locations
187 sites across 24 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Ireland, Italy, Latvia, Mexico, Peru, Poland, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03302234. Inclusion in this directory is not an endorsement.