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Immune booster added to standard cancer care shows promise in early trial

NCT ID NCT02641093

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial is testing whether adding the immunotherapy drug pembrolizumab (Keytruda) to standard treatment—surgery, radiation, and sometimes chemotherapy—can help people with head and neck cancer live longer without the cancer returning. About 96 participants will receive pembrolizumab before and after surgery, along with standard care. The study focuses on safety and disease-free survival.

What this could mean

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

Active substance
Pembrolizumab (Keytruda)
What this could lead to
If successful, this could lead to a new standard treatment that improves disease-free survival for people with head and neck cancer after surgery.
What could go wrong
This is a phase 2 trial with only 96 participants, so results are preliminary. Adding pembrolizumab may increase side effects without clear benefit.

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

96 people

The number who actually took part.

Started

Jan 2016

Expected to finish

Nov 2026

An estimate. End dates often move.

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: * Patients eligible for resection with one or more of the following 1. Any T stage with ≥ N2 disease; 2. T4 disease, any N stage; 3. T3 Oral Cavity, any N stage; or 4. Clinical evidence of extra-capsular extension on scans. * Must be willing to undergo definitive resection with neck dissection. * Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale. * Adequate labs * Appropriate staging imaging. Exclusion Criteria: * Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment. * Nasopharyngeal or sinonasal carcinoma * Confirmed metastatic disease * Human Papillomavirus (HPV)+ disease of the oropharynx * Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C

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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

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Louisville - James Graham Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

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