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NCT04414540 · ClinicalTrials.gov registry record · Phase 2
Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients
A Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Trisha Wise-Draper.
- Active
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04414540: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma, sponsored by Trisha Wise-Draper.
NCT04414540 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Trisha Wise-Draper. The registered enrollment target is 20 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04414540, a Phase 2 study of Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Trisha Wise-Draper.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
Primary Outcome
A complete response is defined as the disappearance of all target lesions, with any affected lymph nodes reduced to less than 10 mm. A partial response occurs when there is at least a 30% reduction in the total size of target lesions compared with baseline. Progressive disease is indicated by at least a 20% increase in lesion size (with a minimum absolute increase of 5 mm) or the appearance of new lesions. Stable disease describes cases where tumor size changes do not meet criteria for partial r
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Metformin Extended Release Oral Tablet
Study Locations (1)
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-08-31 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT04414540 still lists
NCT04414540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04414540 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04414540 about?
NCT04414540 is a clinical study titled "Combining Pembrolizumab and Metformin in Metastatic Head and Neck Cancer Patients". The purpose of this study is to determine anti-tumor activity by measuring overall response rate in recurrent and/or metastatic HNSCC patients receiving the combination of metformin and pembrolizumab.
What is the current status of trial NCT04414540?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-08-31. Estimated completion is 2025-12.
What conditions does trial NCT04414540 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04414540?
The interventions under investigation include: Pembrolizumab (DRUG), Metformin Extended Release Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT04414540?
This trial is sponsored by Trisha Wise-Draper, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04414540 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Squamous Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04414540's enrollment target sits among peer trials
20 105th of 124 higher than 19 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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