Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
Public ClinicalTrials.gov record NCT03302234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03302234
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 568 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2017 (Actual)
- Primary completion
- Sep 1, 2020 (Actual)
- Completion
- Sep 7, 2022 (Actual)
- Last update posted
- Sep 26, 2023
2017 – 2022
United States locations
- U.S. sites
- 25
- U.S. states
- 15
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Cancer Center ( Site 0007) | Phoenix | Arizona | 85054 | — |
| Disney Family Cancer Center ( Site 0035) | Burbank | California | 91505 | — |
| Pacific Cancer Care ( Site 0001) | Monterey | California | 93940 | — |
| John Wayne Cancer Institute ( Site 0021) | Santa Monica | California | 90404 | — |
| Florida Hospital Cancer Institute ( Site 0009) | Orlando | Florida | 32804 | — |
| Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018) | Paducah | Kentucky | 42003 | — |
| New England Cancer Specialists ( Site 0019) | Scarborough | Maine | 04074 | — |
| Boston Medical Center ( Site 0025) | Boston | Massachusetts | 02118 | — |
| Lahey Hospital & Medical Center ( Site 0020) | Burlington | Massachusetts | 01805 | — |
| Holy Name Medical Center ( Site 0022) | Teaneck | New Jersey | 07666 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0034) | New York | New York | 10029 | — |
| The Ohio State University Wexner Medical Center ( Site 0016) | Columbus | Ohio | 43210 | — |
| Mid Ohio Oncology/Hematology Inc. ( Site 0003) | Columbus | Ohio | 43219 | — |
| Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031) | Portland | Oregon | 97213 | — |
| Greenville Health System ( Site 8010) | Greenville | South Carolina | 29615 | — |
| University of Tennessee Erlanger Oncology & Hematology ( Site 0026) | Chattanooga | Tennessee | 37403 | — |
| Tennessee Cancer Specialists ( Site 0017) | Knoxville | Tennessee | 37909 | — |
| Texas Oncology-Arlington South ( Site 8006) | Arlington | Texas | 76014 | — |
| Texas Oncology-Methodist Dallas Cancer Center ( Site 8000) | Dallas | Texas | 75203 | — |
| Texas Oncology-Flower Mound ( Site 8007) | Flower Mound | Texas | 75028 | — |
| Texas Oncology-Longview Cancer Center ( Site 8009) | Longview | Texas | 75601 | — |
| Northwest Cancer Specialists, P.C. ( Site 8001) | Vancouver | Washington | 98684 | — |
| Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033) | Yakima | Washington | 98902 | — |
| University of Wisconsin Carbone Cancer Center ( Site 0004) | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin Clinical Cancer Center ( Site 0027) | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 162 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03302234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2023 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03302234 live on ClinicalTrials.gov.