Immunotherapy combo shows promise in head and neck cancer trial
NCT ID NCT03480672
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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211 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Jan 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charité - Universitätsmedizin Berlin; Klinik für Radioonkologie und Strahlentherapie CVK
Berlin, Germany
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Charité - Universitätsmedizin, CVK und CCM, Klinik für Hals-Nasen-Ohrenheilkunde
Berlin, Germany
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Department of Head Medicine and Oral Health, University of Leipzig
Leipzig, 04103, Germany
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Ernst von Bergmann Klinikum Potsdam, Zentrum für Hämatologie, Onkologie und Strahlenheilkunde, Klinik für Hämatologie und
Potsdam, Germany
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Helios Klinikum Erfurt GmbH, Klinik für Hals-Nasen-Ohrenheilkunde
Erfurt, Germany
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Kath. Marienkrankenhaus gGmbH, Zentrum für Innere Medizin Hämatologie/Onkologie
Hamburg, Germany
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Klinikum Bielefeld, Onkologie/Hämatologie/ Palliativmedizin
Bielefeld, Germany
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Klinikum Stuttgart - Katharinenhospital, Klinik für Radioonkologie und Strahlentherapie
Stuttgart, Germany
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UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
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Universitätsklinikum Bonn; Med. Klinik III / ZIM, Hämatologie/Onkologie
Bonn, Germany
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Universitätsklinikum Düsseldorf, Klinik für Strahlentherapie und Radiologische Onkologie
Düsseldorf, Germany
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Universitätsklinikum Essen, Klinik und Poliklinik für Strahlentherapie
Essen, Germany
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Universitätsklinikum Jena, Klinik für Hals-Nasen-Ohrenheilkunde
Jena, Germany
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Universitätsklinikum Mannheim, Hals-Nasen-Ohren Klinik
Mannheim, Germany
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Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie
Regensburg, Germany
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Universitätsklinikum Würzburg; Klinik und Poliklinik für Strahlentherapie
Würzburg, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can less radiation be enough after chemoimmunotherapy for head and neck cancer?
- Can a DNA vaccine boost immunotherapy against HPV-Linked head and neck cancer?
- Can a Three-Drug combo wipe out head and neck tumors before surgery?
- Can a One-Two punch of radiation and immunotherapy shrink head and neck tumors before surgery?
- Can a glowing drug light up head and neck tumors?