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NCT04858269 · ClinicalTrials.gov registry record · Phase 2
First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients
A Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Head Neck Cancer, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT04858269: Recruiting Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Head Neck Cancer, sponsored by Wake Forest University Health Sciences.
NCT04858269 is a Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Head Neck Cancer that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 32 participants, below the 135-participant average among 8 other Oral Cavity Squamous Cell Carcinoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04858269, a Phase 2 study of Oral Cavity Squamous Cell Carcinoma and Head Neck Cancer, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
Primary Outcome
Using RECIST 1.1 will be defined as the percentage of analyzed participants with a complete response (defined as disappearance of all target lesions) or partial response (defined as decrease by ≥ 30% in sum of longest diameter of target lesions) as compared to the historical objective response rate (19%) reported for pembrolizumab alone.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Paclitaxel
Study Locations (1)
North Carolina
- Wake Forest Baptist Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT04858269 shows while recruiting
NCT04858269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 135-participant average among 8 other Oral Cavity Squamous Cell Carcinoma trials with a reported enrollment target (76% lower).
The record links to 6 conditions, with Oral Cavity Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04858269 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04858269 about?
NCT04858269 is a clinical study titled "First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients". The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil
What is the current status of trial NCT04858269?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2021-05-27. Estimated completion is 2028-08.
What conditions does trial NCT04858269 study?
This clinical trial studies the following conditions: Oral Cavity Squamous Cell Carcinoma, Head Neck Cancer, Oropharynx Squamous Cell Carcinoma, Metastatic Squamous Cell Carcinoma, Hypopharynx Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04858269?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04858269?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04858269 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Oral Cavity 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 NCT04858269's enrollment target sits among peer trials
32 8th of 8 higher than 1 of 8 other Oral Cavity Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Cavity 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
-
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage Oral Cavity Cancer
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