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Immunotherapy combo shows promise in head and neck cancer trial

NCT ID NCT03480672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested whether adding the immunotherapy drug pembrolizumab (Keytruda) to standard chemotherapy and radiation after surgery could help prevent cancer from returning in people with advanced head and neck cancer. The study enrolled 211 patients who had their tumors completely removed. The goal was to see if the combination improved the time patients lived without their cancer coming back. Results are not yet final, but the study aims to find a more effective treatment for this high-risk group.

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) plus cisplatin chemotherapy
What this could lead to
If successful, this could lead to a new standard treatment that lowers the chance of cancer returning after surgery for high-risk head and neck cancer.
What could go wrong
This is a phase 2 trial with only 211 participants, so results are preliminary. Adding pembrolizumab may increase side effects without improving survival, and the benefit may not apply to all patients.

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

211 people

The number who actually took part.

Started

Aug 2018

Finished

Jan 2025

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: 1. Macroscopically complete resection of newly diagnosed (not recurrent, not secondary primary) advanced squamous-cell carcinoma arising in the oral cavity, oropharynx, larynx, or hypopharynx 2. Advanced stage III, IVA/B HNSCC according to the TNM classification version 7th edition (Note! The 8th edition will not be used, please adhere to the national cancer institute guidelines) 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; performance status allows adjuvant chemo radiation with cisplatin. 4. Had either intermediate or high-risk characteristics, i.e. any or all of the following: * histologic evidence of invasion of two or more regional lymph nodes * extracapsular extension of nodal disease, * microscopically involved mucosal margins of resection (R1) or margins of resection \< 5mm (R0) 5. Had pathological histologic assessment of p16 (only oropharyngeal carcinoma) 6. Be \> 18 years of age 7. Written informed consent 8. Demonstrate adequate organ function 9. Female subject of childbearing potential should have a negative pregnancy test within 3 days prior to receiving the first dose of study medication. 10. Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. 11. Reproductive male subjects must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy Exclusion Criteria: 1. Concurrent participation in any other interventional clinical trial or participation in any other interventional trial within one month before enrolment into this trial. 2. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before enrolment into this trial. 3. Known history of active TB (Bacillus Tuberculosis) 4. Hypersensitivity to Pembrolizumab or comparable medicinal products or any of its excipients. 5. Prior anti-cancer monoclonal antibody (mAb) therapy within one month before enrolment into this trial or who has not recovered (i.e., ≤ Grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to agents administered more than one month earlier. 6. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within one month before enrolment into this trial or who has not recovered (i.e., ≤ grade 1 (NCI CTCAE Grade) at baseline) from adverse events due to a previously administered agent. 1. Note: Subjects with ≤ Grade 2 (NCI CTCAE Grade) neuropathy are an exception to this criterion and may qualify for the study. 2. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 7. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 8. Active autoimmune disease that has required systemic treatment in the past 2 years prior to enrolment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 9. Evidence of interstitial lung disease or history of (non-infectious) pneumonitis that required steroids within the last 6 months before enrolment into this trial, or current pneumonitis. 10. Active infection requiring systemic therapy. 11. Suspected lack of compliance 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the baseline visit through 120 days after the last dose of trial treatment. 13. HIV, HBV or HCV infection 14. Application of a live vaccine within one month of enrolment. 15. Hypersensitivity to cisplatin or any of its excipients 16. Any potential relationship to the investigator/his deputy or to medical staff of the study team, to the coordinating investigator or is an employee of the study sit

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK

    Berlin, Germany

  • Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde

    Berlin, Germany

  • Department of Head Medicine and Oral Health, University of Leipzig

    Leipzig, 04103, Germany

  • Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und

    Potsdam, Germany

  • Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde

    Erfurt, Germany

  • Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie

    Hamburg, Germany

  • Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin

    Bielefeld, Germany

  • Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie

    Stuttgart, Germany

  • UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck

    Lübeck, Germany

  • Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie

    Bonn, Germany

  • Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie

    Düsseldorf, Germany

  • Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie

    Essen, Germany

  • Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde

    Jena, Germany

  • Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik

    Mannheim, Germany

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

    Regensburg, Germany

  • Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie

    Würzburg, Germany

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