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NCT04220866 · ClinicalTrials.gov registry record · Phase 2
Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT04220866 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 18 participants.
The verdict
NCT04220866, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Ulevostinag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2022-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04220866
The ClinicalTrials.gov registry entry for NCT04220866 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 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 2 interventions - of which Pembrolizumab is the first listed.
NCT04220866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04220866 about?
NCT04220866 is a clinical study titled "Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)". The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary stud...
What is the current status of trial NCT04220866?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-03-04. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT04220866?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Ulevostinag (DRUG).
Who is sponsoring clinical trial NCT04220866?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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