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Immunotherapy after second surgery shows promise for tough head and neck cancers

NCT ID NCT03355560

Disease control Sponsor: Trisha Wise-Draper Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug nivolumab (Opdivo) in 39 people with head and neck cancer who had already received radiation and then had a second surgery to remove remaining cancer. The goal was to see if nivolumab could help prevent the cancer from coming back and to check for side effects. Participants received nivolumab infusions after surgery, and researchers tracked serious side effects and cancer recurrence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nivolumab (Opdivo)
What this could lead to
If it works, this could offer a way to reduce the risk of cancer returning after salvage surgery in patients with head and neck cancer who have already had radiation.
What could go wrong
This is a small, single-arm phase 2 study with only 39 participants, so results may not apply to everyone. Nivolumab can cause serious immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Dec 2017

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options * Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated. * Able to provide archived biopsy or resected tissue. * Adequate performance status and labs. Exclusion Criteria: * Patients who did not receive at least radiotherapy as prior definitive treatment. * Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control. * Has nasopharyngeal or sinonasal carcinoma. * Has confirmed metastatic disease.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • UC Health

    Cincinnati, Ohio, 45219, United States

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