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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 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.

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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.

Interventions

  • DRUG Pembrolizumab
  • DRUG Cisplatin
  • RADIATION IMRT (Intensity Modulated Radiotherapy)
  • BIOLOGICAL ISA101b

Study Locations (1)

Pennsylvania

  • UPMC Hillman Cancer Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2020-07-06
Est. Completion 2026-01-15
Phase Phase 2

Sponsor

Dan Zandberg

9 total trials

What the Registry Record Tells You About NCT04369937

The ClinicalTrials.gov registry entry for NCT04369937 describes a study currently listed as active not recruiting, 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, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (85% lower). The listed sponsor is Dan Zandberg, which has 9 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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