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NCT04489888 · ClinicalTrials.gov registry record · Phase 4
A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 101
- Enrollment target
NCT04489888: Completed Phase 4 study, sponsored by Merck Sharp & Dohme.
NCT04489888 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 101 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04489888, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 101 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
Primary Outcome
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) per Response Evaluation Criteria in Solid Tumors Update and Clarification 1.1 (RECIST 1.1) which was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of parti
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2024-06-28 |
| Phase | Phase 4 |
What the finished NCT04489888 record still lists
NCT04489888 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04489888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04489888 about?
NCT04489888 is a clinical study titled "A Study of Pembrolizumab (MK-3475) Plus Carboplatin and Paclitaxel as First-line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (MK-3475-B10/KEYNOTE B10)". The goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). No statistical hypothesis will be tested in this study.
What is the current status of trial NCT04489888?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 101 participants. The study started on 2020-10-27. Estimated completion is 2024-06-28.
What interventions are being tested in trial NCT04489888?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04489888?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04489888's enrollment target sits among peer trials
101 766th of 2000 higher than 1,231 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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