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Recurrent Head and Neck Squamous Cell CarcinomaPhase 3RePaIr-HNNCT07026474

Re-Radiochemotherapy and Pembrolizumab vs. Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive (CPS≥1) HNSCC

A Phase 3 study testing radiotherapy, Cisplatin and Pembrolizumab in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Universität des Saarlandes at 24 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
radiotherapy, Cisplatin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
24 sitesin 2 countries
Study dates
30 Oct 2025to 31 Dec 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
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  • 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.

Trial locations and contacts

24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Studienzentrum der Klinik für Strahlentherapie und Radioonkologie contact

+49 6841 - 16 24688

repair.radonk@uks.eu

Markus Hecht, Prof. Dr. med. contact

+49 6841 - 16 24606

markus.hecht.clinicaltrials@uks.eu

24 sites in 2 countries

Germany23 sites, 23 recruiting

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

    Berlin, 13353

    Not yet recruiting

  • Klinikum Chemnitz gGmbH, Klinik für Radioonkologie

    Chemnitz, 09116

    Recruiting

  • Klinikum Darmstadt GmbH, Institut für Radioonkologie und Strahlentherapie

    Darmstadt, 64283

    Recruiting

  • Gemeinschaftspraxis Hämatologie-Onkologie Dresden

    Dresden, 01307

    Recruiting

  • Helios Klinikum Erfurt, Klinik für Strahlentherapie

    Erfurt, 99089

    Recruiting

  • Uniklinikum Erlangen, Strahlenklinik

    Erlangen, 91054

    Recruiting

  • Universitätsmedizin Frankfurt, Klinik für Strahlentherapie und Onkologie

    Frankfurt am Main, 60590

    Recruiting

  • UKGM Gießen, Klinik für Strahlentherapie

    Giessen, 35392

    Recruiting

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

    Hamburg, 20246

    Recruiting

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

    Hanover, 30625

    Recruiting

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

    Herne, 44625

    Recruiting

  • Universitätsklinikum des Saarlandes, Klinik für Strahlentherapie und Radioonkologie

    Homburg, 66421

    Recruiting

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

    Kiel, 24105

    Not yet recruiting

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Strahlentherapie

    Leipzig, 4103

    Not yet recruiting

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

    Mainz, 55131

    Recruiting

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

    München, 81675

    Recruiting

  • Universitätsklinikum Münster, Klinik für Strahlentherapie - Radioonkologie

    Münster, 48149

    Recruiting

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie

    Regensburg, 93053

    Recruiting

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

    Rostock, 18059

    Recruiting

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

    Straubing, 94315

    Recruiting

  • Klinikum Stuttgart, Klinik für Strahlentherapie und Radioonkologie

    Stuttgart, 70174

    Recruiting

  • Universitätsklinikum Tübingen, Klinik für Radioonkologie

    Tübingen, 72076

    Recruiting

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

    Ulm, 89075

    Recruiting

Other trials in Germany

Switzerland1 site, 1 recruiting

  • Universitätsspital Zürich, Klinik für Radio-Onkologie

    Zurich, 8091

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: Randomized Phase III Trial of Sequential Re-Radiochemotherapy and Pembrolizumab Versus Immuno(Chemo)Therapy for Locoregionally Recurrent PD-L1 Positive HNSCC (CPS≥1)

Prospective, open-label, randomized controlled phase III trail that aims to investigate whether Re-Radiochemotherapy (Re-RCT) and sequential immunotherapy with pembrolizumab improves overall survival compared to the standard treatment with pembrolizumab alone (± chemotherapy) in locoregionally recurrent PD-L1 positive (CPS≥1) HNSCC.

Being tested
radiotherapy, Cisplatin, Pembrolizumab, cisplatin + 5-fluorouracil (5FU), Alternative medications: carboplatin + 5-fluorouracil (5FU)
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiotherapyOther

    single doses of 1.8Gy up to a total dose of 55.8Gy to 63.0Gy

  • CisplatinDrug

    40mg/m² BSA weekly concomitant to re-irradiation

  • PembrolizumabDrug

    i.v., 200mg absolute, q3w

  • cisplatin + 5-fluorouracil (5FU)Drug

    Cisplatin: 100mg/m² BSA d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

  • Alternative medications: carboplatin + 5-fluorouracil (5FU)Drug

    Carboplatin: AUC5 d1, q3w / 5-FU: 1000mg/m² BSA d1-4, q3w

  • Alternative medications: carboplatinDrug

    AUC2 weekly

  • PembrolizumabDrug

    i.v., 200mg absolute, q3w, starting within 8-14 days after completion of RCT

Study groups in NCT07026474
Study groupRoleWhat they receive
Investigational armExperimentalPatients receive Re-RCT followed by pembrolizumab immunotherapy for up to 2 years. Concomitant chemotheraphy is cisplatin. In case of renal dysfunction carboplatin can be used instead of cisplatin.
Receives: Other: radiotherapy; Drug: Cisplatin; Drug: Alternative medications: carboplatin; Drug: Pembrolizumab
Control armActive comparatorPatients receive pembrolizumab monotherapy for up to 2 years. At the discretion of the treating physician, up to 6 additional cycles of cisplatin or carboplatin in combination with 5-fluorouracil may be given.
Receives: Drug: Pembrolizumab; Drug: cisplatin + 5-fluorouracil (5FU); Drug: Alternative medications: carboplatin + 5-fluorouracil (5FU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    To evaluate the efficacy of a sequential treatment of Re-RCT followed by pembrolizumab compared to standard therapy with pembrolizumab ± chemotherapy, the primary endpoint of the trial is overall survival rate at 2 years.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start30 Oct 2025
  3. Primary completionDec 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07026474
Sponsor's protocol ID
RePaIr-HN
Other IDs
2024-520264-33-00
Acronym
RePaIr-HN
Status last verified
Oct 2025
First submitted
10 Jun 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiotherapy, Cisplatin and Pembrolizumab in people with Recurrent Head and Neck Squamous Cell Carcinoma, run by Universität des Saarlandes at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Studienzentrum der Klinik für Strahlentherapie und Radioonkologie (+49 6841 - 16 24688, repair.radonk@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07026474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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