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NCT04369937 · ClinicalTrials.gov registry record · Phase 2
HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Head and Neck Squamous Cell Carcinoma and HPV-Related Squamous Cell Carcinoma, sponsored by Dan Zandberg.
- Active
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04369937: Active Phase 2 study of Head and Neck Squamous Cell Carcinoma and HPV-Related Squamous Cell Carcinoma, sponsored by Dan Zandberg.
NCT04369937 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and HPV-Related Squamous Cell Carcinoma that is active but no longer recruiting, run by Dan Zandberg. The registered enrollment target is 18 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04369937, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and HPV-Related Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Dan Zandberg.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.
Primary Outcome
The percentage of participants whose disease has to progressed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at 2 years. PFS will be calculated from treatment initiation to disease progression or death from any cause for 2 years. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative incr
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- RADIATION IMRT (Intensity Modulated Radiotherapy)
- BIOLOGICAL ISA101b
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2026-01-15 |
| Phase | Phase 2 |
What the registry record for NCT04369937 still lists
NCT04369937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 (85% lower).
The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04369937 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04369937 about?
NCT04369937 is a clinical study titled "HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma". This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.
What is the current status of trial NCT04369937?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2020-07-06. Estimated completion is 2026-01-15.
What conditions does trial NCT04369937 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, HPV-Related Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04369937?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), IMRT (Intensity Modulated Radiotherapy) (RADIATION), ISA101b (BIOLOGICAL).
Who is sponsoring clinical trial NCT04369937?
This trial is sponsored by Dan Zandberg, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04369937 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04369937's enrollment target sits among peer trials
18 108th of 124 higher than 16 of 124 other Head and Neck Squamous Cell Carcinoma trials
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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.
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