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ACTIVE NOT RECRUITING Phase 2

HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

NCT04369937 · View on ClinicalTrials.gov ↗

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

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04369937

The ClinicalTrials.gov registry entry for NCT04369937 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 Dan Zandberg, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04369937 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04369937?

The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), IMRT (Intensity Modulated Radiotherapy) (RADIATION), ISA101b (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04369937?

This trial is sponsored by Dan Zandberg, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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