A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)
Public ClinicalTrials.gov record NCT04199104. 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, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Study identification
- NCT ID
- NCT04199104
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 511 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
- Feb 5, 2020 (Actual)
- Primary completion
- May 30, 2023 (Actual)
- Completion
- Mar 31, 2025 (Actual)
- Last update posted
- May 5, 2026
2020 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Cancer Associates for Research & Excellence ( Site 0025) | Fresno | California | 93720 | — |
| California Cancer Associates for Research & Excellence ( Site 0059) | San Marcos | California | 92069 | — |
| University of Colorado Cancer Center ( Site 0023) | Aurora | Colorado | 80045 | — |
| University of Connecticut Health Center ( Site 0020) | Farmington | Connecticut | 06030 | — |
| Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069) | Hollywood | Florida | 33021 | — |
| Georgia Cancer Center at Augusta University ( Site 0013) | Augusta | Georgia | 30912 | — |
| Northwest Georgia Oncology Centers PC ( Site 0028) | Marietta | Georgia | 30060 | — |
| University of Kansas Cancer Center ( Site 0033) | Westwood | Kansas | 66205 | — |
| University of Louisville, James Graham Brown Cancer Center ( Site 0045) | Louisville | Kentucky | 40202 | — |
| Dana Farber Cancer Institute ( Site 0019) | Boston | Massachusetts | 02215 | — |
| University of Michigan ( Site 0064) | Ann Arbor | Michigan | 48109-5936 | — |
| Karmanos Cancer Institute ( Site 0054) | Detroit | Michigan | 48201 | — |
| Henry Ford Health System ( Site 0001) | Detroit | Michigan | 48202 | — |
| Washington University School of Medicine ( Site 0060) | St Louis | Missouri | 63110 | — |
| St. Vincent Frontier Cancer Center ( Site 0008) | Billings | Montana | 59102 | — |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053) | Omaha | Nebraska | 68130 | — |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002) | Hackensack | New Jersey | 07601 | — |
| Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040) | New York | New York | 10021 | — |
| SUNY Upstate Medical University ( Site 0051) | Syracuse | New York | 13210 | — |
| University of North Carolina- Chapel Hill ( Site 0056) | Chapel Hill | North Carolina | 27514 | — |
| Duke Cancer Center ( Site 0044) | Durham | North Carolina | 27710 | — |
| Providence Portland Medical Center ( Site 0048) | Portland | Oregon | 97213 | — |
| Blue Ridge Cancer Care ( Site 0015) | Blacksburg | Virginia | 24060 | — |
| Inova Schar Cancer Institute ( Site 0009) | Fairfax | Virginia | 22031 | — |
| Cancer Care Northwest ( Site 0017) | Spokane Valley | Washington | 99216 | — |
| University of Wisconsin- Madison Carbone Cancer Center ( Site 0006) | Madison | Wisconsin | 53792 | — |
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 126 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04199104, 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 May 5, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04199104 live on ClinicalTrials.gov.