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NCT03944915 · ClinicalTrials.gov registry record · Phase 2

De-Escalation Therapy for Human Papillomavirus Negative Disease

A Phase 2 study of Squamous Cell Carcinoma and Human Papilloma Virus, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
35
Enrollment target
1
Study location

NCT03944915: Completed Phase 2 study of Squamous Cell Carcinoma and Human Papilloma Virus, sponsored by University of Chicago.

NCT03944915 is a Phase 2 study of Squamous Cell Carcinoma and Human Papilloma Virus that has completed, run by University of Chicago. The registered enrollment target is 35 participants, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03944915, a Phase 2 study of Squamous Cell Carcinoma and Human Papilloma Virus, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
35 participants
Enrollment target
1
Study location

Study Summary

This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

Primary Outcome

DRR is 50% or greater response to induction therapy based on RECIST criteria. The objective is to intensify induction chemotherapy with the addition of an immune checkpoint inhibitor aimed at increasing the proportion of patients achieving a deep tumor response in order to subsequently allow risk-adapted definitive chemoradiotherapy in advanced stage HPV negative head and neck squamous cell cancer patients.

Interventions

  • DRUG Carboplatin
  • DRUG Nivolumab
  • DRUG Paclitaxel
  • RADIATION Radiation
  • DRUG Hydroxyurea Pill

Study Locations (1)

Illinois

  • University Of Chicago Medicine Comprehensive Cancer Center - Chicago

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2019-08-26
Est. Completion 2023-11-01
Phase Phase 2
University of Chicago

796 total trials

What the finished NCT03944915 record still lists

NCT03944915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (66% lower).

The record links to 5 conditions, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT03944915 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT03944915 about?

NCT03944915 is a clinical study titled "De-Escalation Therapy for Human Papillomavirus Negative Disease". This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the subject's cancer.

What is the current status of trial NCT03944915?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2019-08-26. Estimated completion is 2023-11-01.

What conditions does trial NCT03944915 study?

This clinical trial studies the following conditions: Squamous Cell Carcinoma, Human Papilloma Virus, Squamous Cell Carcinoma of the Head and Neck, HNSCC, HPV-Related Squamous Cell Carcinoma.

What interventions are being tested in trial NCT03944915?

The interventions under investigation include: Carboplatin (DRUG), Nivolumab (DRUG), Paclitaxel (DRUG), Radiation (RADIATION), Hydroxyurea Pill (DRUG).

Who is sponsoring clinical trial NCT03944915?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03944915 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for 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 NCT03944915's enrollment target sits among peer trials

35 27th of 47 higher than 19 of 47 other Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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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Source: ClinicalTrials.gov NCT03944915, the US trial registry maintained by the National Library of Medicine. NCT03944915 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.