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NCT03521570 · ClinicalTrials.gov registry record · Phase 2

Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

A Phase 2 study, sponsored by Emory University.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT03521570: Completed Phase 2 study, sponsored by Emory University.

NCT03521570 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03521570, a Phase 2 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Primary Outcome

95% confidence interval will be estimated by Kaplan-Meier method for all participants.

Interventions

  • BIOLOGICAL Nivolumab
  • RADIATION IMRT

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2018-06-28
Est. Completion 2023-09-07
Phase Phase 2
Emory University

1,208 total trials

What the finished NCT03521570 record still lists

NCT03521570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT03521570 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03521570 about?

NCT03521570 is a clinical study titled "Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer". This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors...

What is the current status of trial NCT03521570?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2018-06-28. Estimated completion is 2023-09-07.

What interventions are being tested in trial NCT03521570?

The interventions under investigation include: Nivolumab (BIOLOGICAL), IMRT (RADIATION).

Who is sponsoring clinical trial NCT03521570?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03521570's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03521570, the US trial registry maintained by the National Library of Medicine. NCT03521570 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.