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NCT04199104 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
NCT04199104 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 511 participants.
The verdict
NCT04199104, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
Study Summary
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).
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Placebo
- DRUG Lenvatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04199104
The ClinicalTrials.gov registry entry for NCT04199104 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04199104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04199104 about?
NCT04199104 is a clinical study titled "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)". 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 pe...
What is the current status of trial NCT04199104?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2020-02-05. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT04199104?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Placebo (DRUG), Lenvatinib (DRUG).
Who is sponsoring clinical trial NCT04199104?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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