Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
Public ClinicalTrials.gov record NCT03635567. 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, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).
Study identification
- NCT ID
- NCT03635567
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 617 participants
Conditions and interventions
Conditions
Interventions
- Pembrolizumab Biological
- Paclitaxel Drug
- Cisplatin Drug
- Carboplatin Drug
- Bevacizumab Biological
- Placebo to pembrolizumab Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- 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
- Oct 24, 2018
- Primary completion
- Oct 2, 2022
- Completion
- Jun 3, 2024
- Last update posted
- Feb 3, 2026
2018 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Women's Cancer Care ( Site 1770) | Anchorage | Alaska | 99508 | — |
| Arizona Oncology Associates, PC- HAL ( Site 8005) | Phoenix | Arizona | 85016 | — |
| UC Irvine Health ( Site 1796) | Orange | California | 92868 | — |
| Smilow Cancer Hospital at Yale New Haven ( Site 1809) | New Haven | Connecticut | 06510 | — |
| H. Lee Moffitt Cancer Center and Research Institute ( Site 1754) | Tampa | Florida | 33612 | — |
| Georgia Cancer Center at Augusta University ( Site 1767) | Augusta | Georgia | 30912 | — |
| Barbara Ann Karmanos Cancer Institute ( Site 1785) | Detroit | Michigan | 48201 | — |
| Henry Ford Health System ( Site 1810) | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine ( Site 1779) | St Louis | Missouri | 63110 | — |
| Cancer Institute of New Jersey at University Hospital ( Site 1762) | Newark | New Jersey | 07103 | — |
| Holy Name Medical Center ( Site 1776) | Teaneck | New Jersey | 07666 | — |
| Mount Sinai Chelsea ( Site 1760) | New York | New York | 10011 | — |
| Columbia University Medical Center ( Site 1800) | New York | New York | 10032 | — |
| OSU Wexner Medical Center ( Site 1817) | Hilliard | Ohio | 43026 | — |
| University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784) | Oklahoma City | Oklahoma | 73104 | — |
| Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768) | Tulsa | Oklahoma | 74146 | — |
| MUSC Hollings Cancer Center ( Site 1819) | Charleston | South Carolina | 29425 | — |
| West Cancer Center - East Campus ( Site 1763) | Germantown | Tennessee | 38138 | — |
| Texas Oncology-San Antonio Medical Center ( Site 8001) | San Antonio | Texas | 78240 | — |
| Seattle Cancer Care Alliance ( Site 1777) | Seattle | Washington | 98109 | — |
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 129 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03635567, 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 Feb 3, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03635567 live on ClinicalTrials.gov.