Cure My Disease

Don't miss your cure!

 Log in / Sign up

New combo therapy aims to extend life in hard-to-treat head and neck cancer

NCT ID NCT07026474

Disease control Sponsor: Universität des Saarlandes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether giving re-radiation with chemotherapy followed by the immunotherapy drug pembrolizumab can help people with recurrent head and neck cancer live longer compared to standard pembrolizumab alone or with chemotherapy. The study includes 214 adults whose cancer has returned locally and cannot be surgically removed. The main goal is to see if the new sequence improves survival at two years.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2032

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: * Written informed consent obtained from the subject prior to performing any protocol-related procedures. * Age ≥ 18 years at time of study entry. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Locoregionally recurrent or second primary HNSCC. * Histological confirmation of HNSCC. * Tumor is surgically not resectable or surgical resection bears great potential for relevant functional morbidity or patient refuses surgery. * No distant metastases (cM0). * PD-L1 combined positive score (CPS) ≥1 according to local pathological PD-L1 assessment. A validated test must be used in an accredited laboratory. * Prior radio(chemo)therapy of the neck (time interval ≥ 6 months). * Adequate normal organ and marrow function as defined: Haemoglobin ≥ 9.0 g/dL; Leukocytes (WBC) ≥ 3,000 per mm\^3 or Neutrophils ≥ 1,500 per mm\^3; Platelet count \> 100,000 per mm\^3. * Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology). * AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional ULN. * Creatinine Clearance ≥ 40ml/min (calculated from serum creatinine using the Cockcroft-Gault formula). * Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of RT and/or the first dose of pembrolizumab. A highly sensitive pregnancy test must be used. * Female subjects of childbearing potential must be willing to use a highly effective contraceptive measure (see also Section 7.1.9 Contraception and pregnancy testing during the trial). Highly effective contraception is required for the course of the trial through 120 days after the last dose of trial therapy. * Generative male subjects must agree to use a highly effective method of contraception (see also Section 7.1.9 Contraception and pregnancy testing during the trial), starting with the first dose of trial therapy through 120 days after the last dose of trial therapy. * Subject is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations including. Exclusion Criteria: * Prior radio(chemo)therapy of the neck less than 6 months ago. * Distant metastases (cM1). * Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 4 weeks of the first dose of treatment. * Current or prior use of immunosuppressive medication within 14 days before the first dose of trial treatment. The following are exceptions to this criterion: 1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) 2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent 3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * Prior chemotherapy or targeted small molecule therapy within 2 weeks or anti-cancer monoclonal antibody (mAb) within 4 weeks prior to trial day 1 or who has not recovered from AEs due to a previously administered agent. (Subjects with ≤ grade 2 neuropathy are an exception to this criterion and may qualify for the trial.) * History or concurrent other malignancy. Exceptions include patients, who have been disease free for at least 3 years. Further exceptions are completely resected basal cell carcinoma or squamous cell carcinoma of the skin or successfully treated in situ carcinoma. * Active autoimmune disease that has required systemic treatment in the past 2 years (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. * History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. * Has an active or chronic infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to randomization or first dose of study drugs. * Known hypersensitivity to the active substances or to any of the excipients. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Infection with human immunodeficiency virus (HIV) (HIV 1/2 antibodies). * Active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * Live vaccine within 30 days of planned start of trial therapy. * Performance status of \>2 on the ECOG Performance Scale. * Prior treatment with a PD-1/PD-L1 antibody in primary treatment of locally advanced HNSCC less than 6 months ago.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Recurrent head and neck squamous cell carcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Recurrent head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Radioonkologie und Strahlentherapie

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Gemeinschaftspraxis Hämatologie-Onkologie Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Helios Klinikum Erfurt, Klinik für Strahlentherapie

    RECRUITING

    Erfurt, 99089, Germany

  • Klinikum Chemnitz gGmbH, Klinik für Radioonkologie

    RECRUITING

    Chemnitz, 09116, Germany

  • Klinikum Darmstadt GmbH, Institut für Radioonkologie und Strahlentherapie

    RECRUITING

    Darmstadt, 64283, Germany

  • Klinikum St.-Elisabeth Straubing GmbH, Klinik für Hals-Nasen-Ohren-Heilkunde

    RECRUITING

    Straubing, 94315, Germany

  • Klinikum Stuttgart, Klinik für Strahlentherapie und Radioonkologie

    RECRUITING

    Stuttgart, 70174, Germany

  • Marien Hospital Herne, Klinik für Strahlentherapie und Radio-Onkologie

    RECRUITING

    Herne, 44625, Germany

  • Medizinische Hochschule Hannover (MHH), Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

    RECRUITING

    Hanover, 30625, Germany

  • TUM Klinikum Rechts der Isar, Klinik und Poliklinik für RadioOnkologie und Strahlentherapie

    RECRUITING

    München, 81675, Germany

  • UKGM Gießen, Klinik für Strahlentherapie

    RECRUITING

    Giessen, 35392, Germany

  • Uniklinikum Erlangen, Strahlenklinik

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Hamburg-Eppendorf, Zentrum für Onkologie; II. Medizinische Klinik und Poliklinik

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Strahlentherapie

    NOT_YET_RECRUITING

    Leipzig, 4103, Germany

  • Universitätsklinikum Münster, Klinik für Strahlentherapie - Radioonkologie

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

    RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Strahlentherapie

    NOT_YET_RECRUITING

    Kiel, 24105, Germany

  • Universitätsklinikum Tübingen, Klinik für Radioonkologie

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm, Klinik für Hals- Nasen-Ohrenheilkunde, Kopf- und Halschirurgie

    RECRUITING

    Ulm, 89075, Germany

  • Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie

    RECRUITING

    Homburg, 66421, Germany

  • Universitätsmedizin Frankfurt, Klinik für Strahlentherapie und Onkologie

    RECRUITING

    Frankfurt am Main, 60590, Germany

  • Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie / MVZ der Universitätsmedizin Rostock am Standort Südstadt gGmbH

    RECRUITING

    Rostock, 18059, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Radioonkologie der Strahlentherapie

    RECRUITING

    Mainz, 55131, Germany

  • Universitätsspital Zürich, Klinik für Radio-Onkologie

    NOT_YET_RECRUITING

    Zurich, 8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.